Universal Medical Announced its 2020 Interim Results

Maintained Steady Financial Performance under COVID-19 Pandemic
Proceed with Hospital Group Business

The board (the “Board”) of directors (the “Directors”) of Genertec Universal Medical Group Company Limited (the “Company” or “Universal Medical”) is pleased to announce the interim results of the Company and its subsidiaries (together, the “Group”) for the 6 months ended 30 June 2020.

2020 INTERIM RESULTS HIGHLIGHTS
– The revenue amounted to approximately RMB4,024.2 million, representing an increase of 25.9% as compared with that of approximately RMB3,195.4 million for the corresponding period of 2019.
– The profit for the period amounted to approximately RMB861.0 million, representing a decrease of 1.3% as compared with that of approximately RMB872.5 million for the corresponding period of 2019.
– The profit for the period attributable to owners of the parent amounted to approximately RMB793.4 million, representing a decrease of 2.3% as compared with that of approximately RMB812.0 million for the corresponding period of 2019.
– The total assets amounted to approximately RMB59,199.2 million, representing an increase of 2.3% as compared with that of approximately RMB57,852.5 million as at 31 December 2019.
– The equity attributable to owners of the parent amounted to approximately RMB9,851.0 million, representing an increase of 3.8% as compared with that of approximately RMB9,489.3 million as at 31 December 2019.
– For the six months ended 30 June 2020, the return on equity was 16.41% and the return on total assets was 2.94%.

In the first half of 2020, Universal Medical was actively engaged in epidemic prevention and control of the new novel coronavirus (COVID-19) epidemic. A total of 23 member medical institutions were identified as designated hospitals for treatment and isolation, and all Grade II Class A and above hospitals have established fever clinics and participated in the joint prevention and control work of communities, stations, terminals, and airports. Additionally, the headquarters of the Group has implemented various medical supplies for the hospitals and strived to ensure the smooth development of the epidemic prevention and control work in the hospitals. Universal Medical orderly promoted the resumption of work and production and minimize the impact of the epidemic as much as possible, while adapting to the new normal of ongoing epidemic control. In the first half of 2020, the operating results of the Group were generally stable.

Maintained Steady Financial Performance and Proceed with Hospital Group Business
The Group recorded revenue of RMB4,024.2 million, representing an increase of 25.9% as compared to the corresponding period of the previous year, as a result of more medical institutions being consolidated into the Group’s financial statements in the second half of 2019 and the first half of 2020; recorded profit for the period of RMB861.0 million, representing a slight decrease of 1.3% as compared to the corresponding period of the previous year due to the impact of the epidemic; recorded profit for the period attributable to the owners of the parent of RMB793.4 million, representing a slight decrease of 2.3% as compared to the corresponding period of the previous year; and recorded total assets of RMB59,199.2 million as of 30 June 2020, representing an increase of 2.3% as compared to the end of 2019, with asset quality generally safe and controllable.

Hospital group is the most essential resources of building a medical and health conglomerate. In the first half of 2020, the Group continued to actively participate in the integration and takeover of medical institutions of SOEs, and build up a tightly-knit medical networks surrounding key regions and cities across China. As of 30 June 2020, the Group had entered into contracts in relation to takeover of 48 medical institutions (including 5 Grade III Class A hospitals and 24 Grade II hospitals) with actual capacity of over 15,000 beds. Meanwhile, the Group continued to improve the post-investment management of our medical institutions, and comprehensively improved the medical technology, management efficiency and service capabilities of our medical institutions by focusing on discipline construction, operation management, organization management innovation, service system construction, hospital digitalization, supply chain management, hospital renovation and expansion, so as to ensure their sound and orderly development.

Affected by the epidemic control in the first half of 2020, the number of outpatient visits of the medical institutions decreased by approximately 15% as compared to the corresponding period of the previous year, the number of inpatient visits decreased by approximately 18% as compared to the corresponding period of the previous year, and the number of medical examination services decreased by approximately 25% as compared to the corresponding period of the previous year, resulting in varying degrees of decline in the income of medical institutions of the Group and their profit contribution to the Group. The Group believes that the impact of the epidemic on the business of member medical institutions is temporary. With the epidemic under control in the second quarter, the number of patient visits of the medical institutions of the Group has rebounded significantly. Since May 2020, the overall monthly income has basically recovered to the same level for the corresponding period of the previous year, and the monthly income of most medical institutions in June 2020 has exceeded the level of the corresponding period of the previous year.

Steady Develop Finance and Advisory Business with Safe and Controllable Asset Quality
The Group’s finance business, which is the cornerstone underpinning the Group’s steady development and mainly provides finance lease services for county level public hospitals, and provides financial support for the Company, was affected by the epidemic control policies. The development of the Group’s finance and advisory business and collection of receivables from hospital customers relatively slowed down. Meanwhile, due to the continued and steady downward adjustment of the national monetary policies after the Loan Prime Rate (LPR) reform, the interest rate of the Group’s new leasing business decreased accordingly. Therefore, the average yield dropped as compared to the corresponding period of the previous year, and the operating performance of the finance and advisory business experienced short term fluctuations. During the reporting period, the finance and advisory business of the Group recorded revenue of RMB2,480.5 million, increased by 0.4% as compared to the corresponding period of the previous year; recorded gross profit of RMB1,521.5 million, decreased by 1.7% as compared to the corresponding period of the previous year. Finance lease business recorded revenue of RMB2,049.7 million, increased by 8.3% as compared to the corresponding period of the previous year; recorded gross profit of RMB1,090.7 million, increased by 10.9% as compared to the corresponding period of the previous year; the net interest spread was 3.55% and the net interest margin was 4.13%, still a high ranking among domestic competitors. As at 30 June 2020, the Group’s interest-bearing assets reached RMB50,869.6 million, representing an increase of 2.2% as compared with the beginning of the year; non-performing assets ratio was 0.98% and the overdue ratio (30 days) was 0.92%. The Group strictly controlled the operating risks, and continuously enhanced internal management. Although the non-performing assets ratio and the overdue ratio (30 days) slightly increased due to the epidemic, the overall asset quality was safe and controllable and continued to maintain its leading position in the industry.

Layout the Health Industry Chain and Explore New Opportunities in the Health Industry
In the first half of 2020, the Group continued to promote model exploration, pilot projects and layout in various fields of the health industry chain based on our hospital group, and focused on the Internet medical business. As of 30 June 2020, 4 member medical institutions of the Group, namely XD Group Hospital, Genertec Universal Xi’an Aero-Engine Hospital, Xianyang Caihong Hospital and Yantai Port Hospital, were approved for conducting Internet hospital business. A total of 13 member medical institutions went online based on the Internet platform, with the offline to online conversion rate reaching 5.1% within 4 months, over 30% of online patients showing needs for offline medical services and the patient satisfaction rate reaching 99%. In addition, based on full evaluation of our existing advantages, market prospects and our talent strategies, the Group actively developed businesses of equipment sales and maintenance, and third-party inspection center through various cooperation modes, such as acquisition of majority interest, investment in minority interest and strategic alliance, to build a health industry ecosystem and realize win-win results enjoyed by all.

Prospect for the Future
In the future, the Group will continue to uphold the philosophy of whole industry chain and whole life cycle, which is centered on medical services and supported by financial services, to build a shared and win-win health industry ecosystem, strive for a trustworthy medical and health group, and contribute to construction of “Healthy China”.

About Genertec Universal Medical Group Company Limited
Genertec Universal Medical Group Company Limited (“Universal Medical”) is a listed subsidiary (Stock code: HK.02666) of China General Technology (Group) Holding Co., Ltd (“Genertec”), one of the backbone SOEs directly administrated by the central government. Universal Medical is a diversified healthcare company focused on China’s rapidly evolving healthcare industry. With reliance on modern management concepts, professional teams, high-quality medical resources, solid financial strength and inclusive corporate culture, Universal Medical upholds the philosophy of whole industry chain and whole life cycle, which is centered on medical services and supported by financial services, to build a shared and win-win health industry ecosystem, strive for a trustworthy medical and health group, and contribute to construction of “Healthy China”.

This press release is issued by Institutional Capital Advisory (Asia) Limited on behalf of Genertec Universal Medical Group Company Limited.

For further information, please contact:
Institutional Capital Advisory (Asia) Limited
E-mail: unimedical@icaasia.com

Novotech the Asia-Pacific CRO Leader – Awarded ‘2020 Frost & Sullivan Asia-Pacific CRO Company of the Year’

Novotech, the largest biotech specialist CRO in the Asia-Pacific region, was awarded the ‘2020 Frost & Sullivan Asia-Pacific CRO Company of the Year’ in an overnight virtual global ceremony. This is the fourth consecutive year Novotech has been recognized with the prestigious CRO regional award.

Yooni Kim accepting the award

Accepting the award at the ceremony last night, Novotech’s Executive Director Asia Operations Yooni Kim said:

“On behalf of Novotech I am extremely pleased the company has again been recognized as the CRO leader in the region. Novotech is growing rapidly due to its reputation for specialist teams on the ground across the Asia region with local knowledge, partnerships and expertise. Our staff numbers have grown by over 20% over the last 12 months. We now have over 750 Novotech people delivering excellence in clinical research management, biometrics and monitoring. Novotech helps biotechnology companies progress their R&D programs by investing in upfront regulatory and clinical consulting, continued focus on developing site relationships across the region, and a commitment to creating an exceptional workplace. Everyone at Novotech is very proud of our recent successes. So once again many thanks to the Frost & Sullivan jury for selecting Novotech for this award and congratulations to all nominees!”

Award recipients are selected after extensive research and market analysis by the Frost & Sullivan industry team.

Senior Industry Analyst Transformational Health Frost & Sullivan Khushbu Jain said:

“Novotech’s commitment to offering its customers unparalleled value has guided its investments in IT infrastructure such as CTMS upgrade, Medidata Rave coding systems and developing its clinical consulting capabilities through BioDesk. In addition, the company’s strong understanding of cultures, language and regulatory requirements has uniquely positioned Novotech in APAC to offer a level of service comparable to that of global CROs, but with the local flexibility and scale that appeal to biotech companies.”

Novotech has been delivering clinical research excellence in the Asia-Pacific for US, EU and APAC biotechs for more than 24 years with its specialist Novotech teams across 11 countries, and supported by more than 30 partnerships with major health institutions.

Novotech is always hiring the best people in the region – please see our careers page here. https://novotech-cro.com/careers

Watch the ceremony here. https://youtu.be/qslO6K0XlYk

About Novotech – https://novotech-cro.com

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotechnology companies. Novotech was established in 1996, with offices in 11 locations across the region, and site partnerships with major health institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert

Media Contact
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Sihuan Pharmaceutical Announces 2020 Interim Results

Revenue and Profit Attributable to Owners of the Company from Continuing Operations are RMB1,054.5 million and RMB170.5 million, respectively;
Multiple R&D and Production Platforms as Core of the Group, with Investment and Incubation, etc. Supporting the Group’s Development;
Innovation-driven, Imitation and Creation Co-exist, Multiple Carefully Incubated R&D Platforms have Significant Progress;
Focus on the Rapid Development of the Therapeutic Areas with a Rich Product Pipeline

Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460 “Sihuan Pharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) is pleased to announce its interim results for the 6 months ended 30 June 2020 (the “Period”).

Financial Summary

Under the influence of pharmaceutical policies and COVID-19 during the Period, the Group recorded a revenue of approximately RMB1,054.5 million, representing a year-on-year decrease of 36.4%. Gross profit amounted to approximately RMB786.1 million, decreased 42.4% year-on-year. Gross profit margin is 74.5%, decreased 7.9 p.p. from the same period last year. The lower gross profit margin was resulted from decreased sales of drugs which had better profit margin but were captured in the Key Monitoring Drug List during the Period. Profit attributable to owners of the Company for the Period amounted to approximately RMB170.5 million.

During the Period, revenue from CCV products recorded approximately RMB609.6 million, decreased 58.0% year-on-year, accounting for 57.8% of the Group’s total revenue. The sales decline was mainly due to the drop in patient flow in hospital during the COVID-19 pandemic and products exclusion from PRDL and NRDL starting from the second half of last year.

Revenue from non-CCV products sharply by 114.6% year-on-year to approximately RMB444.9 million, accounting for 42.2% of the Group’s total revenue. This sales growth was mainly attributable to the group’s strong sales platform, hospital coverage has sharply increased.

The Group maintained strong financial position during the Period, with net cash of approximately RMB4,336.0 million recorded as at 30 June 2020. The Group’s net cash-to-equity ratio is 50.3%, and debt-to-equity ratio is 7.1%.

An interim cash dividend of RMB0.1 cents per share and special cash dividend of RMB3.0 cents per share were declared by the Board.

Strategic planning

The Group values the development of innovative drug R&D center, generic drug R&D center and high-quality production enterprises as its core: During the Period, innovative drug R&D center Xuanzhu Biopharmaceutical spun off and became independent. WIth the support of the Group, it is able to quickly develop innovative drugs that are differentiated, effective and safe, and with global intellectual property rights, therefore achieves the goal of solving the huge and unmet clinical needs in oncology, metabolic diseases and anti-infective field, etc. Jilin Huisheng Biopharmaceuticals, a biopharmaceutical R&D center, is committed to building a full product-line platform in the field of diabetes, covering products from biosimilar insulin products to oral preparations and compound preparations. It is actively introducing other varieties and plans to become an independent spin-off and get listed in the future. Beijing Aohe Research Institute, a generic drug R&D center which has very mature technology, and is looking for varieties with high-tech barriers in APIs, dosage forms, and preparation processes in key therapeutic areas for R&D process. In addition, Beijing Sihuan, Jilin Sihuan, Jilin Jinsheng and other manufacturing companies will rely on their high-efficiency, low-cost, modern production lines for unique formulations and dosage forms and experienced production technical teams. The Group’s superior sales teams will support the above-mentioned companies, and quickly promote product commercialization. As a result, Sihuan Pharmaceutical will thus become a group which integrates production, sales, and research.

Innovation-driven, imitation and creation co-exist

Significant progress has been made in multiple R&D platforms that are carefully incubated by the Group. Xuanzhu Biopharmaceutical is one of the few domestic innovative drug companies that have a complete R&D industry chain, and with more than ten innovative products, mainly covering oncology, diabetes, metabolic diseases, digestive system, male reproduction, anti-infection and other fields for product line R&D layout. Some of the products have already entered their late clinical stage. The key product Birociclib, a CDK4/6 inhibitor for advanced breast cancer, has successfully carried out multiple clinical trials. Another blockbuster product, Janagliflozin, an SGLT-2 inhibitor for the treatment of diabetes, can reduce blood sugar while protecting the heart and kidneys, and has entered clinical phase III and is expected to bring hope to patients in China. Biopharmaceutical R&D platform, Jilin Huisheng Biological Co., Ltd. focuses on the treatment of diabetes and complications, covering biological drugs and chemical drugs, and has a comprehensive product pipeline. Currently, the products under research include insulin and its analogues, GLP-1 analogues and oral solid preparations. In addition, Beijing Aohe Generic Drug R&D Center, a generic drug R&D platform has obtained many product approvals: rivastigmine hydrogen tartrate capsule and levetiracetam tablets have obtained pharmaceutical production approval, midazolam oromucosal solution has been granted drug registration, ibuprofen injection has been granted production approval, and the paediatric compound amino acid injection (18AA-II) also obtained drug registration approval.

At the same time, the Group is actively enhancing international business cooperation through investment and mergers and acquisitions, with businesses covering multiple therapeutic areas with huge clinical needs. In 2020, the Group became equity investment partners with Zhongrui and Chempion to ensure the stable supply of the Group’s related preparations and raw materials and strengthen the Group’s R&D capabilities in high-tech barrier raw materials, continuous flow processes, and enzymatic processes. The Group also reached a cooperation framework agreement with HETETO, India to cooperate in the R&D of high-end generic drugs in the field of cardiovascular and cerebrovascular, central nervous system and anti-infection.

Focus on the rapid developing therapeutic fields, lay out the investment and optimization of APIs

Oncology, diabetes, metabolic, non-alcoholic hepatitis and other diseases have become the fastest growing therapeutic areas in global pharmaceutical market, especially in China pharmaceutical market. The Group focuses on products layout in these areas, including independently developed innovative products, biosimilars and generic drugs with huge clinical demand.

On the premise of ensuring science and quality, the Group will reduce operating and production costs, especially the in investment and optimization of APIs, so as to increase the competitiveness and product profits of future products, and thus to create greater value. The Group also values the unique sales model and marketing network which have rich experience, high performance and extensive hospital coverage, as well as a multi-dimensional international business cooperation platform.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said, “Sihuan Pharmaceutical values innovative drug R&D center, generic drug R&D center and high-quality manufacturing companies as its core value, supplemented with investment, mergers, incubation, holdings, spin-offs, etc., for a group of independently operating subsidiary companies. The Company will realize the initiative of each sub-enterprise through the introduction of capital, CMO and other independent operations, and to improve the efficiency and competitiveness of Sihuan Pharmaceutical, therefore adapt to MAH and a series of policy changes and industry competition patterns. At the same time, the Company will help the subsidiaries to be able to land in the capital market soon, also add value to the parent company. This dual approach of strategic planning and core values will enable Sihuan Pharmaceutical to focus on global level, focus on the pharmaceutical field, and form the most competitive, international and professional pharmaceutical group enterprise.

Future prospects

With regard to existing products on sale, the Group will continue to improve the evidence-based research system, promote key products to be included in the diagnosis and treatment guidelines, and evaluate the launched exclusive and major products. At the same time, giving full play to the advantages of diversified product structure, actively promote products in the growth period through refined market management, and strengthen the Group’s pipeline layout and market advantages in the fields of cardiovascular, oncology and diabetes, and establish a sustainable drug product line. The group will also increase its resources for drug R&D projects and establish a sustainable drug product line, adjust the product structure through mergers and acquisitions and international cooperation. In order to enrich the project resources and optimize the product portfolio continuously, domestic and overseas mergers and acquisitions will be the Group’s sustainable strategy to provide short-, medium- and long-term growth engines. Several products are expected to be launched on the market in the next year or two, including leading generic drugs, such as midazolam oromucosal solution and rivastigmine hydrogen tartrate capsule, specialty drugs, such as quetiapine fumarate SR tablet, and innovative drugs, such as Janagliflozin and Anaprozole sodium.The Group also conforms to policies and market trends, seizes policy opportunities, studies and judges market development directions, focuses on business synergy and resource integration, accelerates the cultivation of new businesses, and continuously improves the Group’s core competitiveness by adjusting the business structure and encouraging model innovation. Under the assistance of the Group’s experienced, high-performance, and comprehensive hospital coverage professional sales team and marketing network, and under the leadership of an international management team, Sihuan Pharmaceutical will steadily enhance its competitive advantage in the pharmaceutical industry.

About Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. It is one of the China’s largest suppliers of cardiovascular and cerebrovascular prescription drugs. Sihuan Pharmaceutical integrates production, R&D, and marketing. It has an excellent and professional marketing model, a nationwide distribution network, and a diversified product portfolio with great market potential. The Group continues to increase investment in R&D every year. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.

For more information about Sihuanpharm, please visit the company website https://www.sihuanpharm.com/.

Ivermectin Triple Therapy Protocol for COVID-19 Released to Australian GPs for Infected Elderly and Frontline Workers

Triple therapy specialist Professor Thomas Borody, famous for curing peptic ulcers using a triple antibiotic therapy saving millions of lives, today released the COVID-19 treatment protocol to Australian GPs, who can legally prescribe it to their COVID-19 positive patients, and can also prescribe it as a preventative medication. Borody says this could be the fastest and safest way to end the pandemic in Australia within 6-8 weeks.

The Centre for Digestive Disease (CDD) Medical Director Professor Thomas Borody

Professor Thomas Borody MB, BS, BSc(Med), MD, PhD, DSc, FRACP, FACP, FACG, AGAF, FRS(N) said:
“The three medications are on chemist shelves right now. GPs can email GP@CDD.com.au to obtain the dosing protocol and COVID-19 treatment information for their patients.

“GPs can legally prescribe the therapy today as an “off label” treatment according to Australian Guidelines – a standard practice in medicine. In fact more than 60% of prescriptions in Australia are “off-label”. It’s not a new concept. It’s happening every day to manage diseases and save lives.”

Professor Borody continued:
“We have a therapy that can fight COVID-19. The medications have been around for 50 years, they are cheap, FDA and TGA approved and have an outstanding safety profile. Why are we just waiting around for a vaccine? To save lives we should be using whatever is safe and available right now. We could lead the world in this fight.

“Australia has some of the best medical and science people in the world – indeed the Ivermectin connection was first discovered by Dr Kylie Wagstaff’s team at Monash University in April. How long do we need to wait before Australian politicians get behind Australian medical science and use ‘war room’ tactics with safe and approved medications.”

Professor Borody, an internationally regarded physician with 4 FDA approved drugs on the US and Australian markets, is famous for developing the triple therapy that cured peptic ulcers, saving more than 18,000 lives just in Australia and millions internationally. [See Professor Borody’s published research at ORCID: http://orcid.org/0000-0002-0519-4698]

“No trial has shown Ivermectin-based therapy to be ineffective. In-fact, international data reports an almost 100% cure rate and a symptom improvement within 4-6 days. We should share Australian findings from this triple therapy with the world,” said Professor Borody.

“An Ivermectin tablet can cost as little as $2 – which could make it by far the cheapest, safest, and fastest cure for Australians and the Australian economy. This needs to be available for aged care facilities and frontline health workers today.

“We have written the Federal Health Minister Greg Hunt and Victorian Premier Daniel Andrews for an urgent medical briefing to bypass the raft of ‘advisors’ who need to know TGA-approved medicines do not require animal studies and prolonged clinical trials already done to approve them in the first place.

“The Government could end the pandemic by openly encouraging GPs to prescribe these TGA approved medications. Those who test positive, are identified in contact tracing, as well as those in high-risk groups like the elderly and healthcare workers, can then access the therapy quickly,” said Professor Borody.

Ivermectin was discovered in the 1970s and is on the World Health Organization (WHO) list of essential medicines.
“There is mounting worldwide clinical literature pointing to a 100% cure rate using Ivermectin Triple Therapy,” he said.

There are currently 28 COVID-19 Ivermectin treatment studies running globally. Research papers include:

WHO:
Mass treatment with ivermectin: an underutilized public health strategy
https://www.who.int/bulletin/volumes/82/8/editorial30804html/en/

ResearchSquare:
A Randomized Trial of Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients
https://www.researchsquare.com/article/rs-38896/v1

MedRxiv:
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial)
https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1

Journal of Antibiotics:
Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen
https://www.nature.com/articles/s41429-020-0336-z

ResearchGate:
A Case Series of 100 COVID-19 Positive Patients Treated with Combination of Ivermectin and Doxycycline
https://www.researchgate.net/publication/343305357 _A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline

Journal of Bangladesh College of Physicians and Surgeons:
A Case Series of 100 COVID-19 Positive Patients Treated with Combination of Ivermectin and Doxycycline
https://www.banglajol.info/index.php/JBCPS/article/view/47512

Journal of Bangladesh College of Physicians and Surgeons:
Comparison of Viral Clearance between Ivermectin with Doxycycline and Hydroxychloroquine with Azithromycin in COVID-19 Patients
https://www.banglajol.info/index.php/JBCPS/article/view/47514

MedRxiv:
ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19
https://www.medrxiv.org/content/10.1101/2020.06.06.20124461v2

ChemRxiv:
Has Ivermectin Virus-Directed Effects against SARS-CoV-2? Rationalizing the Action of a Potential Multitarget Antiviral Agent
https://chemrxiv.org/articles/preprint/12782258 Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258

Professor Borody says his research has led him to a triple therapy of Ivermectin, zinc and an antibiotic – which are all TGA and FDA approved. The therapy comprises:

1. Ivermectin – TGA and FDA approved as an anti-parasitic therapy with an established safety profile since the 1970s. Known as the “Wonder Drug” from Japan.
2. Zinc
3. Doxycycline – TGA and FDA approved tetracycline antibiotic that fights bacterial infections, eg. acne or urinary tract infections, viral and malarial infections.

Professor Borody is involved in a Phase 2 study in the US to potentially develop the triple therapy as a single “blister pack” compliance product. He says, “Our study in the US is looking at developing the triple therapy as a single product which requires FDA approval, even though all 3 medications separately are already approved.” [US clinical trial: https://clinicaltrials.gov/ct2/show/NCT04482686?term=Ivermectin+borody]

About the Centre for Digestive Diseases (CDD)

The Sydney-based Centre for Digestive Diseases (CDD) provides patients with innovative therapies not available in the rest of the world. The Hospital features cutting-edge technologies enabling our specialists to provide world-class treatments. Visit https://centrefordigestivediseases.com.

Professor Borody is best known internationally for his work in gut and its mircobiome infections and re-purposing antimicrobial drugs for new diseases including the triple therapy cure for peptic ulcers. His discoveries prevented premature deaths in over 18,000 people and saved the Federal Government a reported $10 billion. [THEMA Report]

Professor Borody developed a triple therapy for the treatment for Crohn’s Disease, and has developed 4 FDA approved pharmaceuticals for the USA and international markets.

For interviews please contact:
Kate Newton, Digital Mantra Group
E: team@DMGPR.com; AU: +61 2 8218 2144
US: +1 415 951 3228; ASIA: +65 3159 3427

Bayer and Hua Medicine announce commercialization agreement and strategic partnership for investigational first-in-class novel diabetes treatment dorzagliatin in China

– Investigational first-in-class glucokinase activator, with a novel mode of action, focused on fixing the glucose sensor and restoring glucose homeostasis for Type 2 diabetes mellitus (“T2DM”) patients, with sustained efficacy in phase III clinical trial in Chinese T2DM patients.
– 116 million T2DM patients in China, with an unsatisfied treatment and control rate.
– Agreement further strengthens Bayer’s diabetes management leadership in China.

Bayer and Hua Medicine, a leading innovative drug development company, today announced a commercialization agreement and strategic partnership for dorzagliatin, a novel diabetes treatment, in China. The agreement aims to provide Chinese diabetes patients with access to a new treatment option, building on Bayer’s existing strength and leadership in diabetes management in China and the innovation capabilities of Hua Medicine.

On behalf of Bayer and Hua Medicine, Wei Jiang (Left) and Dr. Li Chen (Right) signed agreement on strategic partnership in China

“Bayer has been long committed to Chinese patients living with diabetes and diabetic macular edema (DME) by offering innovative treatment options including Glucobay and Eylea,” said Wei Jiang, Executive Vice President and President of Bayer Pharmaceuticals Region China & APAC and President of Bayer Group Greater China. “In the face of significantly increasing challenges caused by diabetes to public health in China, our collaboration with Hua Medicine will further address unmet medical needs of Chinese patients living with diabetes. By leveraging Bayer’s well-established products as well as the upcoming continuous glucose monitoring system under the partnership with WaveForm, we will be able to provide integrated solutions ranging from prevention, diagnosis, treatment and complication management.”

Type 2 diabetes continues to be an important health challenge. According to the China Mainland National Cross Sectional Study in the British Medical Journal, the prevalence rate of T2DM for adults in China is 11.2%, but the proportion of patients who have their hemoglobin A1c (HbA1c) levels controlled is 49.4%(1). Among patients taking oral anti-diabetic drugs, fasting plasma glucose and 2-hour postprandial plasma glucose level lower than or equal to target were only achieved by 51.3% and 53.4%, respectively. These observations from real-world data highlights the unmet medical needs in diabetes, and are the reasons why biotech companies continue to explore novel therapies to improve diabetes management. With a novel mechanism of action, dorzagliatin is an investigational first-in-class glucokinase activator (“GKA”) targeting the restoration of glucose homeostasis in T2DM patients by addressing the defect of the glucose sensor function in the pancreas. A recently completed phase III clinical study of dorzagliatin monotherapy by Hua Medicine showed positive 52-week efficacy data. In addition, 24-week topline results were announced recently: The phase III metformin combination clinical trial met the primary efficacy endpoint.

“We are very excited to have this great opportunity, joining forces with Bayer to bring a first-in-class diabetes medicine, dorzagliatin, to Chinese patients,” said Dr. Li Chen, CEO of Hua Medicine. “Bayer has been a leader in diabetes treatment for the past 10 years in China and will be a great partner for Hua Medicine to advance diabetes care. T2DM currently affects approximately 463 million patients worldwide, 116 million of which are in China(2). Over the last ten years, Hua Medicine has translated the novel concept of glucose homeostasis management into a breakthrough T2DM therapy that aspires to cure diabetes. For the first time, a drug has demonstrated, in clinical trials, the potential ability to improve glucose metabolism and Bata-cell function in T2DM patients. The partnership between Hua Medicine and Bayer will bring this medical innovation to a broader patient population in China even faster.”

Under the terms of the agreement, Hua Medicine as the market authorization holder shall be responsible for clinical development, registration, product supply and distribution, whilst Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. Hua Medicine will receive an upfront payment of RMB 300 million and additional payments could reach up to RMB 4.18 billion if certain milestones are met. Bayer receives the exclusive rights to commercialize the product in China and will receive tiered service fee based on the net sales. Initially, both parties will share equally in sales derived from China net sales, with adjusting sales percentages based on agreed China net sales thresholds.

“China is a key focus of Bayer’s partnering efforts and we are continuously looking for assets and health technologies to help address significant unmet medical needs of patients,” said Marianne De Backer, PhD, Member of the Executive Committee and Head of Strategy and Business Development & Licensing, Pharmaceuticals Division of Bayer AG. “Through this new partnership, we further expand treatment options for millions of Type 2 diabetes patients in China by leveraging our commercial expertise and diabetes leadership position in China and combining it with the external know-how of a strong partner.”

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.

(1). British Medical Journal. Prevalence of diabetes recorded in China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. https://www.bmj.com/content/369/bmj.m997
(2). International Diabetes Federation. 9th Edition of IDF Diabetes Atlas. https://www.diabetesatlas.org/en/

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with T2DM. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with T2DM and serve as a standard-of-care therapy for the treatment of the disease, or as a combination therapy with currently approved anti-diabetes drugs. For more information, please go to www.huamedicine.com

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes to satisfy unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period, and completed its 52-week Phase III monotherapy trial. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

Contact Bayer:
Bayer China Communications – Pharmaceuticals
Tel No.: (86)10-5921-8499
Email: pharma.china.comm@bayer.com

Contact Hua Medicine
Investors: ir@huamedicine.com
Media: pr@huamedicine.com

Bayer Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Hua Forward-Looking Statements
This press release may contain statements that constitute “forward-looking statements”, including, but not limited to, statements relating to the implementation of strategic initiatives, and other statements relating to Hua Medicine’s future business development and economic performance. While these forward-looking statements represent Hua Medicine’s judgments and future expectations concerning the development of business, a number of risks, uncertainties and other statutory requirements may render actual developments and results to differ materially from our expectations. For more information, go to www.huamedicine.com.

QBiotics Announces Clinical Collaboration with MSD Targeting Unresectable Melanoma

  • MSD collaboration to investigate QBiotics’ lead molecule tigilanol tiglate in combination with KEYTRUDA(R) (pembrolizumab)
  • Tigilanol tiglate is a novel, small molecule being developed as an intratumoural treatment for solid tumours
  • Melanoma the second human application for tigilanol tiglate following Company’s ongoing Phase I/II study in head and neck squamous cell carcinoma

QBiotics Group Limited (QGL), a life sciences company developing novel anticancer and wound healing pharmaceuticals, is pleased to announce that it has entered into an agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, NJ, USA), to evaluate use of its lead molecule tigilanol tiglate, in combination with Keytruda(R) (pembrolizumab) in patients with unresectable melanoma.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said, “We are delighted to announce this collaboration with MSD. Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. Through this program we hope to see that when combined, tigilanol tiglate and Keytruda may produce additive anti-tumour immune responses, and improve outcomes for patients.”

The Phase I/II open label ‘QBC46-H06’ study is a dose escalation and expansion study with the primary objective of determining the maximum tolerated dose or maximum feasible dose of the combination therapy. Secondary measures include assessing tumour responses in both injected tumours and uninjected tumours, as well as clinical efficacy parameters. Patients with unresectable melanoma and who have had exposure to immune checkpoint inhibitors are eligible for the study.

Dr Gordon continued, “This study follows on from encouraging Phase I data where tigilanol tiglate as a monotherapy showed a 27% treatment response rate*, including an 18% complete response with full tumour destruction across a wide variety of solid tumour types(2). Two patients with melanoma that had complete responses also had an abscopal (anenestic) response. Melanoma is the second human application we are pursuing for tigilanol tiglate following on from our Phase I/II clinical trial in patients with Head and Neck Squamous Cell Carcinoma (HNSCC) which commenced in December 2019”.

Tigilanol tiglate is a small molecule administered by intratumoural injection directly into the solid tumour mass. Once injected, it has a multi-modal action including (i) rapid, but highly localised, inflammatory responses, (ii) increased permeability and destruction of tumour vascular endothelium, and (iii) rapid tumour cell death by oncosis(1).

*27% treatment response rate (n=6); 18% complete response rate (n=4)2.

Issued by QBiotics Group Limited – www.qbiotics.com

For further information
Dr Victoria Gordon, CEO & Managing Director, QBiotics Group
victoria.gordon@qbiotics.com or + 61 418 453 737

For media enquiries
Jane Lowe, IR Department
jane.lowe@irdepartment.com.au or +61 411 117 774

About QBiotics
QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets. Its lead product, tigilanol tiglate, is an anticancer pharmaceutical targeting a range of solid tumours across multiple species. QBiotics’ business model is to develop products that have application in both veterinary and human markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues. https://qbiotics.com

About Tigilanol tiglate
Tigilanol tiglate is a small molecule that is being tested as an intratumoural treatment for solid tumours. Its effect on tumours is multimodal and involves injected tumour responses as well as distal responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption as well as death of tumour cells by oncosis1. Following tumour destruction, rapid wound healing has been shown to ensue.

A single injection of tigilanol tiglate has been shown in canine patients to ablate (completely destroy) 75% of treated tumours(3). Veterinary use of tigilanol tiglate (branded STELFONTA(R)) has received marketing authorisation by the European Medicines Authority and the Veterinary Medicines Directorate in the United Kingdom as a treatment for canine mast cell tumours. STELFONTA(R) is also under review by the US Food and Drug Administration – Center for Veterinary Medicine and the Australian Pesticides and Veterinary Medicines Authority. STELFONTA(R) is partnered with Virbac, a global animal health company and launched in Europe in April 2020.

References
1. Boyle et al., (2014) Intra-tumoural injection of the novel PKC activator EBC-46 rapidly ablates tumours in mouse models. PLoS One 9:e1068887. DOI: 10.1371/journal.pone.0108887.
2. Panizza et al., (2019) Phase I dose-escalation study to determine the safety, tolerability, preliminary efficacy and pharmacokinetics of an intra tumoural injection of tigilanol tiglate (EBC-46). EBioMedicine 50: 433-441.
3. De Ridder et al., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46). Journal of Veterinary Internal Medicine. 1-15. DOI: 10.1111/jvim.15806

China Medical System Holdings Limited 2020 Interim Results Announcement

Turnover (excl. the effect of “two-invoice system”) up 4.6% to RMB3,557.1 Million;
Profit up 11.4% to RMB1,300.5 Million;
Continuous Expansion of Innovative Pipeline;
Positive Progress Made in China Registration and Clinical Work;
Driven by Product Competence, Promotion Capability, Efficient Management System;
Operating Performance Hit a New High

China Medical System Holdings Limited (“CMS”, or the “Company”, SEHK:867), together with its subsidiaries (the “Group”), a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China, announced its unaudited results for the 6 months ended 30 June 2020 ( the “Reporting Period”).

In the first half of 2020, the Group recorded a turnover of RMB3,108.1 million (H1 2019: RMB2,964.4 million), an increase of 4.8% over the same period last year; excluding the effect of the “two-invoice system”, turnover was up 4.6% to RMB3,557.1 million (H1 2019: RMB3,401.5 million). Profit for the period recorded an increase of 11.4% to RMB1,300.5 million (H1 2019: RMB1,167.5 million). Declared interim dividend was up 11.8% compared with the same period last year to RMB0.2105 per share (H1 2019: RMB0.1883).

Mr. Lam Kong, Chairman and Chief Executive of CMS, said: “Sustainable product competence is the key competitive factor for future development of enterprises. Adhering to the development strategy with innovative products as the core, the Group constantly expanded the innovative pipeline, while accelerating the registration progress of innovative products in China, so as to fulfill the unmet medical needs in China pharmaceutical market. Meanwhile, the Group continued to optimize the professional promotion system as well as the compliant and refined management system. Empowered by the product competence, promotion capability and efficient management system, the Group achieved steady and good growth.”

Product Pipeline
The Group concentrates on the innovative products that are global first-in-class or with the best efficacy or best cost-effectiveness in the same class due to their innovative formulations or drug delivery systems. Capitalizing on its resources of global product development accumulated for more than two decades, as well as the market reputation earned, the Group has established strategic cooperation relationships with a number of leading pharmaceutical companies around the world and made equity investments in innovative R&D companies from the U.K., France, the U.S. and Switzerland. The Group’s product pipeline includes 20 innovative products with great market potential and competitive differentiation advantages at relatively high innovation level, covering therapeutic fields including nervous system, ophthalmology, dermatology, endocrine system, oncology, nephrology, immune system, digestive system, anti-infection, etc.

During the Reporting Period, the Group’s innovative pipeline continued to expand. The Group successively acquired exclusive licenses of the innovative product Desidustat (a patented new molecular entity for the treatment of anemia in patients with chronic kidney disease) and PLENITY (the U.S. FDA-cleared safe and effective orally-administered weight management product made from naturally derived materials) in Mainland China, HK SAR, Macau SAR, TWN and/or other countries in Asia. Meanwhile, the registration and clinical work of innovative products was accelerated. Two blockbuster innovative products (Diazepam Nasal Spray and Cyclosporine Eye Drops 0.09%) have been granted clinical trial notices issued by China NMPA for comparative PK study and confirmatory clinical trial respectively; the confirmatory clinical trial application of one blockbuster innovative product (Tildrakizumab) has been accepted by China NMPA; and the Phase II clinical trial of one innovative product (CF102) in Israel has yielded positive top line results.

Meanwhile, the Group deployed complex generics and competitive generics and actively worked on their registration in China, so as to capitalize on the opportunities brought by the National Volume-based Procurement to capture additional driving forces for the future development of the Group. As at 30 June 2020, two generics were under the review for marketing approval in China and one was granted clinical trial notice in China.

Existing Product Development
The Group’s existing products mainly involve products under cardio-cerebrovascular line (mainly include Plendil, XinHuoSu and Deanxit), digestion line (mainly include Ursofalk, Salofalk, Bioflor and Combizym), ophthalmology line (mainly include Augentropfen Stulln Mono Eye Drops) and dermatology line (mainly include Hirudoid). Through deeply exploring and enhancing the evidence-based medical evidence and reinforcing the expert network construction and academic platform integration, the Group constantly increased products’ academic influence and solidified the competitive advantages of the existing products. During the Reporting Period, the Group recorded solid growth across core product lines. The revenue of products under cardio-cerebrovascular line would increase by 4.4% to RMB2,026.6 million if excluding the effect of the “two-invoice system”; the revenue of products under digestion line increased by 12.7% to RMB1,157.9 million; the revenue of products under ophthalmology line decreased by 1.2% to RMB113.8 million; the revenue of products under dermatology line decreased by 0.9% to RMB85.2 million.

Promotion System
During the Reporting Period, the Group focused on the expansion of the promotion network and strengthened the market segmentation as well as the lower-tier market penetration. The Group actively explored the improvement and innovation of the promotion model while solidifying the existing promotion system, so as to accumulate experiences and make deployments in advance for the academic promotion of innovative products. In the meantime, aiming to building a more professional and compliant promotion team with higher execution capability, the Group further perfected the job qualification and employee training system, optimized the remuneration and incentive system, and intensified the compliance training and inspection. In addition, the Group capitalized on digital tools to hold online academic conferences with high frequency. Complying with the industry trend, the Group steadily promoted the construction of the retail network, expanded the coverage of retail chains and terminal stores, and further strengthened the cooperation with e-commerce platforms.

During the Reporting Period, the Group’s promotion network covered about 57,000 hospitals and medical institutions in China.

Manufacturing Facilities
As at 30 June 2020, the Group owned pharmaceutical manufacturing sites in Hunan, Hebei and Shenzhen, occupying a total area of more than 110,000 square meters. The Group has the Pharmaceutical Production License and the Pharmaceutical GMP Certificate for various dosage forms such as powder, oral solution, small-volume injections, tablets, hard capsules, etc. With more than two decades of pharmaceutical production experiences, the Group has instituted stringent quality management standards and regulations to guarantee the product quality, ensuring the localized preparation manufacturing of overseas innovative products in China.

Mr. Lam Kong concluded, “The Group focuses firmly on the two core values in the pharmaceutical industry chain: product competence and promotion capability. Capitalizing on our extensive global resources, the Group will continue to expand the innovative pipeline and facilitate the further development and commercialization of drugs in China, so as to enhance product competence. At the same time, the Group will continuously strengthen the professional, compliant and efficient promotion system to achieve sustainable and steady growth. Adhering to the mission of “Offering competitive products and services to meet China’s unmet medical needs”, CMS will benefit and provide Chinese patients with more effective, safer, and more cost-effective drugs.”

Milestone for Biowin’s Rapid COVID-19 Nucleic Acid Detector

Nasdaq-listed Shineco, Inc to acquire 73.7% stake in Changzhou Biowin Pharmaceutical

Changzhou Biowin Pharmaceutical Co., Ltd. (“Biowin”), a Chinese biotech company focusing on diagnostic product R&D and high-tech biomedical manufacturing, has announced that their rapid COVID-19 nucleic acid detection kit has passed the laboratory evaluation tests. Designed for individual use at home or in the office, the RT-LAMP nucleic acid and easy-sample test kit is fast, portable and affordable.

Shineco, Inc (NASDAQ:TYHT) has agreed to acquire a 73.7% stake in Changzhou Biowin Pharmaceutical.
Dr. Fengming Liu, CEO and Chief Scientist at Shineco from Aug 3, serving the Company’s strategic transformation.
Biowin’s coronavirus (COVID-19) nucleic acid test kit (RT-LAMP) with Biowin’s new sampling technology, ready to ship.

Early detection is of primary importance to the prevention and control of COVID-19. Rapid detection reflects in the efficacy of follow-on events including treatments following diagnosis and isolation or quarantine to prevent further transmission. At the ‘Two Sessions’ in May, Premier Keqiang Li spoke about detection in the battle against coronavirus, and encouraged the industry to develop a nucleic acid technology that was fast, accurate and convenient, with no lab, as soon as possible.

As expected, Biowin’s “Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (RT-LAMP)” can be carried anywhere and used at any time, allowing individuals privacy and an accurate, real-time understanding of their status, so they can return to work, business and markets with ease. For completion of the full development process, Biowin is in discussions with its partners in relevant countries and regions regarding clinical trials.

Biowin entered an LOI on July 27 with Beijing-based Shineco, Inc (Nasdaq: TYHT), a producer and distributor of Chinese herbal medicines, and organic agricultural and hemp products in China. Shineco is to acquire a 73.7% interest, and join Biowin as it steps into the market for COVID-19 nucleic acid detection. On August 4, the BoD appointed Dr. Fengming Liu, CEO and Chief Scientist of Shienco, Inc, to guide the company through this strategic transformation,

INTERVIEW with Dr. Fengming Liu, CEO and Chief Scientist, Shienco, Inc.

– Q: Biowin Pharmaceutical Co., Ltd. is known for quality biotechnology development and industrial operation team. Can you mention your personal experience, as a nationally distinguished expert and leading returnee?

– Dr. Liu: I obtained my doctoral degree in cardiovascular medicine from Peking Union Medical College, and later received my post-doctoral training at Dartmouth College in the USA. In business, I successfully operated a number of bioengineering technology enterprises before becoming the General Manager of Biowin. I presided over 5 national projects and 8 local projects, contributing in the fields of biopharmaceutical, clinical diagnostic reagents and functional food development. I have organized more than 60 patent applications, and have obtained 48 market approvals for new drug and in vitro diagnostics from the Chinese FDA.

– Q: It has been nearly half a year since the worldwide outbreak of COVID-19, and it has not been effectively controlled yet. What are the main reasons for this situation now?

– Dr. Liu: The main reason is that some countries or regions are currently facing a variety of problems, which can not be effectively solved. I think there exists 4 main problems. First, insufficient detection capacity: virus nucleic acid detection is the main method currently used, but it needs to be operated by specialized instruments and professionals, so the current detection capacity is short of actual requirements; Second, the legal system is not ready to deal with epidemic disease like Covid-19: effective isolation and control for mild and asymptomatic infected people is an important measure to reduce or prevent the spread of the disease. However, many western countries can not implement the unified isolation control for the undiagnosed and latent infection population due to the lack of legal support.

Therefore, timely detection of mild and asymptomatic infections and isolation and control according to the law is an effective means of epidemic prevention and control; Third, insufficient public cooperation: for mild and asymptomatic infected people, especially in other countries, there are such phenomena as unwilling to inspect, unwilling to report, deliberately concealing and not cooperating with the follow-up prevention and treatment management, which leads to the continuous increase of infectious sources; Fourth, the contradiction between returning to work and epidemic prevention and control: a large number of undiagnosed mild and asymptomatic infected people largely exist in the group who have returned to work, which will lead to further spread of the disease, and make it harder to be controlled.

– Q: The world is facing insufficient detection capacity, can you give us a detailed introduction of this home nucleic acid detector in a language that is easy for the public to understand?

– Dr. Liu: Our detector is based on the nucleic acid test kit (RT-LAMP) and developed by using genetic engineering and immune detection technology. It is mainly used for the detection of various viral nucleic acids, especially for the current nucleic acid detection of coronavirus, which can be used at home. It has the advantages of small size, convenient use, low price, high detection sensitivity, low risk of cross infection and broad detection coverage. It can also be used as a screening tool for large sample centralized detection. We just finished the laboratory research test and require further clinical trials to be fully approved..

– Q: What are the characteristics of this domestic nucleic acid detector compared with other existing nucleic acid detection technologies?

– Dr. Liu: Nucleic acid detection is the only way to recognize the coronal virus. The existing fluorescent PCR detection reagents must be operated by professionals in specific molecular laboratories and corresponding large-scale instruments, which greatly limits the detection progress and cannot cover all the population in the control area in a short time. By using at-home nucleic acid detector produced by our company and accompanied by our sampling technology and our nucleic acid detection reagent, ordinary people can complete sampling and testing independently at home without the help of professional testing personnel. Compared with other existing nucleic acid detection technologies on the market, it is more convenient, faster with higher sensitivity and accuracy, and low average detection cost. It can thoroughly help our society solve problems like difficulty in appointment, expensive detection and cross infection risk, etc., and is suitable for effective monitoring of coronal virus in companies or communities.

– Q: The current situation of the epidemic situation is still not optimistic, especially in foreign countries. A large number of ordinary people are still dominated by the fear brought about by coronavirus. So we need a quick and effective easy-taken nucleic acid detector. When can your nucleic acid detector be put on the market to meet the huge demand?

– Dr. Liu: The home nucleic acid detector is progressing well in clinical trials, and will soon contribute to international efforts at prevention and control of COVID-19 . In terms of reagents, Biowin has developed 3 nucleic acid testing products: a novel coronavirus (COVID-19) IgG/IgM antibody test kit (colloidal gold) has already received the CE certification, while the novel coronavirus (COVID-19) nucleic acid test kit (fluorescence RT-PCR), and novel coronavirus (COVID-19) nucleic acid test kit (RT-LAMP) are applying for the process. With respect to testing instruments, we are applying for the registration certificate of medical devices and preparing for trial production. At present, the self collecting disposable nucleic acid detection sampler has obtained the approval certificate of medical device registration, and is in production.

Biowin’s home nucleic acid detector is composed of two main parts: self sampling technology and nucleic acid testing instrument. It requires no laboratory environment and does not rely on medical staff. With it, people can easily complete the detection at home and get results within 30 minutes. It is expected that everyone can achieve scientific and accurate prevention and control of COVID-19 in the process of returning to work and production. We hope that this product will enter the market quickly, and that the world will win in its fight against COVID-19 through technological innovation.

About Changzhou Biowin Pharmaceutical Co., Ltd

Established in Changzhou, China in 2012, Changzhou Biowin Pharmaceutical Co, Ltd focuses on R&D, manufacture and distribution of point-of-care diagnostic test kits (POCT). The Company currently has 33 in vitro diagnostics products with marketing approval, 12 Chinese patents, and 28 Chinese patent applications, covering a variety of diseases including heart disease, infectious diseases, stroke, kidney function, diabetes, cancer and bone metabolism disorders. Biowin has a well-established diagnostics R&D laboratory and five technology platforms, and a rapid response system for the delivery of emergency-use in vitro diagnostics products. For more information, please visit http://www.czbiowin.com/.

About Shineco, Inc.

Incorporated in Delaware in August 1997 and headquartered in Beijing, Shineco is a holding company. Through its subsidiaries and related entities, Shineco undertakes vertically- and horizontally-integrated production, distribution, and sales channels to provide health and well-being focused plant-based products in China. Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce, and specialized textiles. For more information, please visit http://tianyiluobuma.com.

Media contact:
Changzhou Biowin Biopharm Co., Ltd
Contact Person: Yue Liu
Telephone: +86 18850050087
Website: http://www.czbiowin.com

Made-in-Singapore Cancer Drug ETC-159 Advances Further in Clinical Trials

First dose of ETC-159 administered in Phase 1B of clinical trials, advancing the development of this drug to treat solid tumours

Made-in-Singapore cancer drug, ETC-159, has achieved a new developmental milestone in achieving “First Patient First Visit[1]” in Phase 1B. The first dose of ETC-159 has been administered to patients in this new phase of clinical testing, which for the first time, will look at efficacy in addition to assessing the safety of ETC-159 in treating different types of cancers.

Scientists from the Experimental Drug Development Centre, A*STAR, preparing ETC-159 clinical samples for real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) which amplifies the genetic material. (Photo credit: A*STAR)
Scientists from the Experimental Drug Development Centre, A*STAR, using centrifuges to bring ETC-159 clinical sample reactions down. (Photo credit: A*STAR)
Scientists from the Experimental Drug Development Centre, A*STAR, performing real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) to amplify the genetic material from ETC-159 clinical samples. From L-R: Ms Sylvia Gan, Senior Research Manager; Ms Nurul Rozaini, Research Associate (Photo credit: A*STAR)

This clinical study will include subgroups of colorectal, endometrial and ovarian cancer patients from two sites in Singapore (National University Cancer Institute, Singapore and National Cancer Centre Singapore) and up to seven clinical sites in the United States, including four confirmed sites, The University of Texas MD Anderson Cancer Center (Houston, Texas); University of Colorado (Aurora, Colorado); Washington University in St. Louis (Missouri); and Duke University (Durham, North Carolina). The trial is expected to be completed by 2023 at the latest.

ETC-159 was jointly developed by Duke-NUS Medical School (Duke-NUS) and the Agency for Science, Technology and Research (A*STAR), and first entered clinical trials in June 2015[2]. ETC-159 targets a range of cancers including colorectal, endometrial, ovarian and pancreatic cancers, which contribute to a significant fraction of Singapore’s cancer burden. A subset of these cancers are caused by hyperactivity in a cell signalling pathway known as the Wnt pathway.

ETC-159 is an upstream inhibitor of the Wnt pathway and the clinical trial will determine to what extent this drug can slow or halt the growth of Wnt-high cancers or if ETC-159 can enhance the activity of immunotherapy in those patients that normally do not respond to immunotherapy. It has previously been shown that increased expression of Wnt pathway related genes is associated with drug resistance and exclusion of tumour-killing immune cells in the targeted types of cancers. The clinical trial uses ETC-159 to block the Wnt pathway so that immune cells can infiltrate the tumour. The trial will also combine ETC-159 with the immune checkpoint inhibitor pembrolizumab to stimulate the immune cells to kill tumour cells.

The Experimental Drug Development Centre (EDDC), a national platform for drug discovery and development, brought ETC-159 to the successful completion of Phase 1A clinical trials in July 2018. In that phase, proof of the drug’s mechanism of action was achieved and a safe dose level established in 32 patients with advanced solid tumours.

EDDC, together with POLARIS[3] at A*STAR’s Genome Institute of Singapore (GIS), and the Diagnostics Development (DxD) Hub, have also developed a novel diagnostic test in agreement with the US FDA, to identify a particular subgroup of colorectal cancer patients predicted to respond well to ETC-159 due to the presence of gene fusions involving R-spondin genes (RSPO2 or RSPO3) in their tumours. Such patients comprise only about 8% of colorectal cancers and will be identified upfront, based on left-over tumour tissue to be included in Phase 1B of the study. The test will be performed at POLARIS for all clinical samples from this trial.

“A significant milestone for EDDC and Singapore has been achieved with the progression of ETC-159 into Phase 1B clinical trials. We are grateful for the collaboration and input of our partners, such as Duke-NUS, POLARIS, clinical investigators and others within Singapore and beyond, which has enabled the successful completion of the Phase 1A trial and led us to initiate this next critical stage of ETC-159 development. We are optimistic about rapidly recruiting patients for the next phase of the clinical trial given the unmet need and opportunity ETC-159 brings to these patients, and will continue leveraging great science to make great medicines.” – Professor Damian O’Connell, CEO EDDC, A*STAR

“The progression of ETC-159 to this exciting new phase of study is the result of a tremendous Singapore team effort, spanning from basic bench science to international clinical trials. With this critical study, we will learn whether ETC-159, by targeting a set of cancers that has previously been untreatable, will indeed help patients in Singapore and internationally. This important milestone is yet another testament to the research excellence and strong collaborations Singapore can achieve with focused effort. I hope this is just one of many such achievements.” – Professor David Virshup, Duke-NUS Medical School

“This study will help address a critical and unmet need in gastrointestinal cancers. The novel design to molecularly screening for R-spondin fusion colorectal cancers that may be driven by the Wnt pathway and to target them with ETC-159 and immunotherapy has never been done before. Furthermore, most gastrointestinal cancers particularly colorectal cancers do not respond to immunotherapy. This may be due to suppression of immune cells in the tumour by Wnt-related pathways. We hope that by combining ETC-159 and immunotherapy we can circumvent this problem and achieve long-lasting responses for our patients.” – Dr Matthew Ng, Senior Consultant, National Cancer Centre Singapore (NCCS)

“The incidence of ovarian and endometrial cancers is rising in the developed world, with many patients presenting at advanced stages of the disease. Despite initial responses to chemotherapy, the majority of patients with advanced ovarian and endometrial cancer will experience disease recurrence and eventually develop treatment refractory disease. At the National University Cancer Institute, Singapore (NCIS), we have long recognised this unmet medical need and have consistently been working with various academic and industry partners to develop new therapeutic approaches for these hard to treat gynaecological cancers. This clinical trial represents a novel and exciting therapeutic concept for the treatment of ovarian and endometrial cancers. In our continual drive to find better treatments for our patients, we certainly look forward to adding this study to the burgeoning portfolio of early phase trials at the NCIS Developmental Therapeutics Unit.” – Associate Professor David Tan, Senior Consultant, National University Cancer Institute, Singapore (NCIS)

For more information on the ETC-159 clinical trials, please visit:
https://clinicaltrials.gov/ct2/show/NCT02521844

Relevant images can be downloaded from:
https://tinyurl.com/y3kodlbk

For media queries and clarifications, please contact:
Mr Robin Chan
Head, Corporate Communications
Agency for Science, Technology and Research (A*STAR)
Tel: +65 6826 6281
HP: +65 9830 2610
Email: robin_chan@hq.a-star.edu.sg

Lekshmy Sreekumar, Ph.D.
Communications
Duke-NUS Medical School
Tel: +65 6516 1138
Email: lekshmy_sreekumar@duke-nus.edu.sg

About the Experimental Drug Development Centre (EDDC)
The Experimental Drug Development Centre (EDDC) is a national platform for drug discovery and development formed in 2019 from the integration of A*STAR drug discovery and development units, namely, the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC). Together, these three units have forged partnerships with more than 70 academic institutions and 25 companies, locally and internationally, with close to 20 licensing deals executed.

The Centre will continue to champion public-private partnerships in the drug development industry. EDDC will allow for better coordination and optimised use of public sector resources, giving industry partners and Singapore greater ability to translate discoveries into new medicines for patients.

EDDC possesses a full range of drug discovery capabilities, including assay development, high throughput screening, antibody cloning, medicinal chemistry and ADME/toxicology. These capabilities allow EDDC to identify drug hits and leads, and develop them to the preclinical candidate stage in-house. In addition, EDDC enables translational drug development activities by having the internal expertise to support candidates through First-in-Human/Patient Phase 1 studies as well as being able to conduct Proof-of-Mechanism or Proof-of-Concept Studies.

About the Agency for Science, Technology and Research (A*STAR)
The Agency for Science, Technology and Research (A*STAR) is Singapore’s lead public sector R&D agency, spearheading economic-oriented research to advance scientific discovery and develop innovative technology. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit society.

As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by contributing to societal benefits such as improving outcomes in healthcare, urban living, and sustainability.

We play a key role in nurturing and developing a diversity of talent and leaders in our Agency and research entities, the wider research community and industry. A*STAR’s R&D activities span biomedical sciences and physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis. For ongoing news, visit www.a-star.edu.sg.

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About Duke-NUS Medical School
Duke-NUS is Singapore’s flagship graduate entry medical school, established in 2005 with a strategic, government-led partnership between two world-class institutions: Duke University School of Medicine and the National University of Singapore (NUS). Through an innovative curriculum, students at Duke-NUS are nurtured to become multi-faceted ‘Clinicians Plus’ poised to steer the healthcare and biomedical ecosystem in Singapore and beyond. A leader in ground-breaking research and translational innovation, Duke-NUS has gained international renown through its five signature research programmes and nine centres. The enduring impact of its discoveries is amplified by its successful Academic Medicine partnership with Singapore Health Services (SingHealth), Singapore’s largest healthcare group. This strategic alliance has spawned 15 Academic Clinical Programmes, which harness multi-disciplinary research and education to transform medicine and improve lives. For more information, please visit www.duke-nus.edu.sg.

[1] “First Patient First Visit” is a term used in the pharmaceutical industry to refer to the administration of the first dose of a compound or drug product to the first patient at his or her first visit in a clinical trial.
[2] “First made-in-Singapore cancer drug enters clinical testing:” A*STAR press release, July 16, 2015. National Archives of Singapore.
[3] POLARIS (Personalized OMIC Lattice for Advanced Research and Improving Stratification) https://www.a-star.edu.sg/polaris/


Impact Biomedical initiates Quantum Research Program to solve the Patent Cliff

SGX-listed Singapore eDevelopment Limited’s (SeD; SGX:40V) wholly-owned subsidiary Impact Biomedical Inc. (“Impact”), announced today the initiation of Quantum, their research program designed to solve the impending pharmaceutical patent cliff threat.

Impact Biomedical’s transition to the Quantum research program comes on the heels of the completion of the research and development stage of its existing biodefense intellectual portfolio, which is now moving to the licensing and commercialization phase. The portfolio, valued by independent experts at approximately US$1.39 billion as announced by the Group on 1 June 2020 includes: Linebacker, a universal therapeutic designed to shadow the Panacea Project, a US Defense Advanced Research Projects Agency (DARPA) program to provide novel, multi-target therapeutics for unmet physiological needs; 3F BioFragrance, designed for the Open Air Defense Initiative, a strategy to protect locations where large numbers of people gather or transit; and Equivir, an OTC medication designed as an antiviral treatment and prophylactic comprising polyphenols that are GRAS or Generally Recognized as Safe, meaning its safety and behaviour in humans is already well understood and therefore is designed to proceed directly to human trials.

The patent cliff is a severe threat to pharmaceutical companies. The patent cliff arises when patents for blockbuster drugs expire without being replaced with new drugs, pharmaceutical companies experience an abrupt decrease in revenue. This depletes financial resources needed for the development of new therapeutics, which in turn reduces overall pharmaceutical innovation globally including crucial research into new methods to prevent and treat illnesses. The global pharmaceutical market research firm EvaluatePharma estimates that the patent cliff puts approximately US$198 billion in revenue at risk between 2019 and 2024[1]. Typical drug development uses schemes that have become less and less tenable. For example, drugs based on molecules found in cannabis are largely unpatentable due to the vast body of published research on new molecules derived from cannabis. Most existing techniques have already been contemplated. Without the patentability of the foregoing, the resources needed to develop a new drug based on cannabis cannot be secured.

Impact, through their strategic partner Global Research and Discovery Group Sciences (“GRDG”), has created a solution called Quantum, a new frontier in pharmaceutical development. Quantum is a new class of medicinal chemistry that uses advanced methods to boost efficacy and persistence of natural compounds and existing drugs while maintaining the safety profile of the original molecules. Instead of modifying functional groups, as is typically done presently in drug discovery, this new technique alters the behavior of molecules at the sub-molecular level. GRDG estimates that 65% of the World Health Organization Essential Medicines List can be improved and re-patented using Quantum. This approach can be used to enhance and patent natural compounds which includes many substances used in traditional medicines around the world.

This research follows the success of GRDG’s recently completed exploratory program to address biomedical threats including the current COVID-19 pandemic which produced the 3F Antimicrobial BioFragrance, the universal therapeutic Linebacker, and the antiviral OTC medication Equivir, which is moving to human clinical trials. These inventions form the core of Impact’s suite of next generation medical technology that was recently valued at approximately US$1.39 Billion by independent experts.

GRDG’s Chief Scientific Advisor is Dr. Roscoe M. Moore, Jr., the former United States Assistant Surgeon General and former Epidemic Intelligence Service Officer at the U.S. Centers for Disease Control and Prevention. Dr. Moore said, “A new direction in drug discovery is sorely needed and Quantum has the potential to revive innovation and development of lifesaving pharmaceuticals.”

GRDG’s Chief Strategy Advisor is Lieutenant Colonel William H. Lyerly Jr., a retired U.S. Army Medical Service Corps Officer, as well as a retired Career Senior Executive / Scientific Professional (ST), with decorated civilian service as a senior official within the U.S. Department of Homeland Security, the U.S. Department of Health and Human Services, the U.S. Agency for International Development, and the U.S. Executive Office of the President (White House). Lieutenant Colonel Lyerly said, “Continued innovation in drug discovery is vital to combat new dangers to human health such as the current COVID-19 pandemic and beyond. Quantum can improve the drug development industry and enable scores of new solutions.”

Impact Biomedical Chairman, Mr. Chan Heng Fai said, “Today, the difficulty in obtaining a pharmaceutical patent and retaining market exclusivity after it expires thwarts the momentum required by pharmaceutical companies to spur greater innovation. Backed by our newly established Quantum solution, we are proud to lead the field by bringing real and cutting-edge solutions to this immense global health challenge. In due time, we believe that Quantum will provide a practical solution for pharmaceutical companies to extend the patent life of their existing drug portfolio, thereby reducing abrupt declines in revenue following the expiration of patents. More importantly, they will be able to focus their resources on developing new, innovative drugs to treat and prevent illnesses for society at-large.”

Daryl Thompson, Director of Scientific Initiatives and founder of GRDG, said, “The patent cliff represents a significant crisis in pharmaceutical innovation. The primary cause of the crisis is that most techniques for modifying natural molecules to pharmaceutical grade products are essentially ‘played out.’

“Another way to explain this is that most of the methods to make drugs have already been published in scientific papers or rationalized in long expired patents. This means that these methods can render the development of new, novel compounds unpatentable. It is essential for a new drug in development qualify for patent protection due to the high costs of bringing a single compound to market. The medium cost of bringing a drug to market today is roughly US$985 million.

“Previous strategies for increasing the potency of a natural compound to pharmaceutically therapeutic levels employed the used of other molecular modification schemes. These techniques typically included standard practices such as altering functional groups, the addition or substitution of halogens and or the inclusion of lipid structures. The goal of these modifications would be to increase stimulation or inhibition of the molecule against its target site as well as increase bioavailability. Unfortunately, these effective techniques are being rendered moot due to lack of patentability due to prior disclosure.

“We have devised a method to break through this barrier and open a new path for drug development. We will be moving past macro-molecular techniques as mentioned above and will go deeper into the sub-atomic. Here we can look at molecular modification from the perspective of quantum physics. For instance, our previous work on the Linebacker program utilized halogenation to create electron rich portions in the molecule to increase its therapeutic potential. This technique, called sigma-hole generation or X-bonding, is well understood in the scientific community. However, once we disclose how we used this technique in a patent to create a new drug, it can never be patented again once the patents are expired.

“Quantum molecular modifications approach this problem from the perspective of manipulating the sub-atomic electron balance as a whole in consideration of the sum of both kinetic and potential energies within the molecular state. The exploitation of modification of this type by total energy configurations allows the use of quantum principles such as the Hamiltonian Operator as tools for understanding how to manipulate subatomic forces to increase a molecule’s effectiveness as potential new life saving drug.

“This approach allows for a virtually endless array of methods that can lead to a new era in drug discovery possibilities. With our Biodefense mission complete, we will now move forward with the initialization of our Quantum Applications Research Platform. We expect to deliver the first 6 Quantum molecules to research institutes within three business quarters.”

This new research will propel global drug discovery forward and foster increased innovation and ultimately better health worldwide.

There is currently no outlay of funds required for the initiation of Impact BioMedical’s Quantum research program. Depending on the state of development of Quantum, SeD will fund its development through a variety of sources ranging from its internal source of funds and/or externally such as through funds generated from financial institutions as well as potential debt and/or equity fund raising.

Shareholders and potential investors of SeD should note that there is no certainty or assurance as at the date of this Press Release that Impact BioMedical’s biodefense intellectual portfolio will be licensed or close to monetisation. Shareholders and potential investors of SeD are advised to read this Press Release and any further announcements made by SeD carefully. Shareholders and potential investors of SeD are advised to refrain from taking any action with respect to their securities in SeD which may be prejudicial to their interests, and to exercise caution when dealing in the securities of SeD. Shareholders and potential investors of SeD should consult their stockbrokers, bank managers, solicitors or other professional advisers if they have any doubt about the actions they should take.

About Singapore eDevelopment Limited
Incorporated on 9 September 2009 and listed on the Singapore Exchange in July 2010, Singapore eDevelopment Limited is involved in (i) property development and investments primarily in the United States and Western Australia; (ii) information technology-related businesses; (iii) development, research, testing, manufacturing, licensing and distribution of biomedical products; and (iv) investment activities. For more information, please visit: www.SeD.com.sg or email contact@sed.com.sg.

About Impact BioMedical, Inc.
Impact BioMedical, Inc. (“Impact BioMedical”) is a wholly-owned direct subsidiary of Global BioMedical Pte. Ltd., which in turn is a wholly-owned direct subsidiary of Singapore eDevelopment Limited, a company listed on the Singapore Exchange.

Impact BioMedical strives to leverage its scientific know-how and intellectual property rights to provide solutions that have been plaguing the biomedical field for decades. By tapping into the scientific expertise of GRDG Sciences, LLC. and Australian Exchange-listed Holista CollTech Limited, Impact BioMedical pledges to undertake a concerted effort in the R&D, drug discovery and development for the prevention, inhibition, and treatment of neurological, oncological and immuno related diseases.

About GRDG Sciences, LLC.
GRDG Sciences, LLC is an advanced research team formed in Florida by natural products discovery drug research scientist, Daryl Thompson. For more information, please visit: http://www.globalrdg.com.

[1] EvaluatePharma(R) World Preview 2019, Outlook to 2024 Report, 12th Edition, June 2019 https://tinyurl.com/y3lbhutm