BioTech Archives - Page 47 of 52

Huge chance to innovate as online medical services take root, Platform makes name for itself in disease management during pandemic

Digital healthcare will play a major role in changing people’s lives and health as the development of internet-based medical care in China grows, said Kuang Ming, CEO of Cloudr.

Founded in 2014, Cloudr is a smart medical service provider engaged in chronic disease management.

From favorable policies to market expansion, Cloudr has witnessed the progress of internet healthcare in China, Kuang said.

Currently, the information revolution has not affected the medical industry and digital technology plays a small part, Kuang said, which signals “a huge opportunity for enterprises to innovate”.

Recently, Cloudr signed a cooperation agreement with Tianjin Economic and Technological Development Area to base its operation in the city, according to the company.

That move came after a forum focused on the high-growth Chinese enterprises held in Tianjin.

Cloudr was listed in a research report on the city’s first batch of gazelle enterprises. Gazelle companies are fast-growing and have base revenues of at least $1 million and four years of sustained revenue growth.

In early August, the company was listed in the 2020 China’s top 100 prospective unicorn companies released by China Internet Weekly. A unicorn is a startup valued at more than $1 billion.

As a developing medical innovation company, Cloudr has been dedicated to developing digital medical service products for the industrial chain covering hospitals, pharmaceutical enterprises and pharmacies.

Focused on using data and internet technology to innovate medical practices, the company has developed a system using data management for chronic diseases in hospitals.

It has proved to be more efficient than previous methods and frees up doctors’ and nurses’ time.

In 2019, the company continued to expand its system service through big data.

When applied to pharmacies, it helps doctors conduct online diagnoses and make prescriptions for patients.

“Big data technology will significantly promote drug research and development to improve data processing and sharing.

“The reform of technology changes the minds not only for patients but also for supervisory and medical practitioners,” Kuang said.

He noted data has become a new resource of production and will play a key role in future medical devices.

To further improve its medical service with data analysis, the company has cooperated with China Electronics Corp to set up a big data center for chronic disease. It aims to increase treatment efficiency by providing information to the medical industry.

“Cloudr has a huge database of chronic diseases and strictly protects patients’ privacy,” Kuang said.

In addition, the company will devote itself to medical innovation and to further improve its services including online physical examination, diagnosis and express delivery, he said.

So far, Cloudr has cooperated with nearly 2,000 hospitals and more than 50,000 pharmacies.

It has provided its services to about 500 million patients with chronic diseases, according to the company.

In 2019, the company saw its revenue reach 1 billion yuan ($145.6 million).

With its advantages in technology, the company has also played its part in fighting the COVID-19 pandemic.

For example, the company installed its data management system in Wuhan’s temporary Huoshenshan Hospital. It then organized a team with 100 computers for chronic disease management and other materials and sent them to Wuhan.

In addition, it launched platforms for patients’ urgent enquiries. During the pandemic, the company said it received increased online enquiries, almost 15 times as much as the same period last year.

Despite the effects of COVID-19, Cloudr said it had maintained a steady growth throughout its businesses.

The development of connected hospitals helps complement the current medical service, said Lily Wang, product vice-president of the company.

“For internet-based companies like us, we can cooperate with the health management industry with a more open mind, advanced technologies and effective data analysis,” Wang said.

“Relying on the trust of doctors and patients, we can provide more services based on data,” she said.

Cloudr will continue to promote the establishment of industry standards around chronic disease data and cooperate with related forces to build a new environment for the management of chronic diseases through digital services, Wang added.

By LIANG KAIYAN
liangkaiyan@chinadaily.com.cn

Avance Clinical Client Immunic, Inc. Announced Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that its client Immunic Therapeutics has announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an novel treatment for patients suffering from gastrointestinal diseases, including diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Immunic Therapeutics (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases.

According to the public announcement released by Immunic Therapeutics on 20 August 2020:

> IMU-856, an orally available, small molecule modulator, serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and potentially paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency.

> Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received approval from the Bellberry Human Research Ethics Committee in Australia to conduct a phase 1 clinical trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this program to assess biomarker, safety and drug trough levels in patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, noted, “Current treatments for many gastrointestinal conditions focus on inhibiting inflammation and do not directly address impaired intestinal barrier function. In contrast, IMU-856 appears to have a unique targeted ability to strengthen and thereby normalize this function, potentially avoiding the bacterial triggers which can occur when the intestinal barrier is impaired. Moreover, because this approach appears to avoid any detrimental effects on the immune system, we believe that IMU-856 has the potential to change the treatment paradigm for gastrointestinal diseases.”

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said, “We consider ourselves fortunate to be working with Immunic on this exciting project. IMU-856 is the second compound that Immunic has selected Avance Clinical as their CRO. Our engagement in these projects has been from early planning, study design, preparation of the investigator brochures and clinical trial protocols. Working with the Immunic team and the Bellberry Human Research Ethics Committee, we have been able to design clinical trials which include careful data informed adaptive elements aimed at expediting the transition of these promising products from healthy volunteers to the patient populations.”

See full announcement here: https://tinyurl.com/y5rvh7fa

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of RORrt; and IMU-856 targets the restoration of the intestinal barrier function. On August 2, 2020, Immunic announced positive top-line results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance, indicating activity for IMU-838 in this indication. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn’s disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.imux.com.

About Avance Clinical

Australia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons

Media Contact:
media@avancecro.com
Chris Thompson

Regent Pacific enters longevity medicine business driven by leading AI technology through acquisition of Deep Longevity, Inc.

Regent Pacific Group Limited (“Regent Pacific” or the “Company” and together with its subsidiaries, the “Group”; Hong Kong stock code: 00575), a specialist healthcare, wellness and life sciences investment group, has signed legally binding Share Purchase Agreements with the shareholders and DLI ESOP award recipients of Deep Longevity, Inc. (“DLI”) to fully acquire DLI for a consideration of approximately US$3.79 million, by way of the issuance of approximately 422.69 million consideration shares, representing a dilution of approximately 18.70% of the issued share capital of the Company as to be enlarged by the allotment and issue of the consideration shares. Following the transaction, DLI will be a wholly owned subsidiary of the Company.

– Fully acquires Deep Longevity, Inc. for approximately US$3.79 million via issuing approximately 422.69 million consideration shares

– Strengthening shareholder base with addition of numerous experienced longevity and wellness biotechnology investors and entrepreneurs

– Deep Longevity, Inc. provides a high-quality growth asset and key platform for expanding into the emerging field of artificial intelligence (AI) and longevity medicine

– Key developments of Deep Longevity, Inc. include:

i. Developing comprehensible user-friendly AI systems to track rates of aging at the molecular, cellular, tissue, organ, system, physiological and psychological levels

ii. Developing systems for longevity medicine to help physicians make better decisions on interventions that may slow down or reverse the aging processes

iii. Developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed “deep aging clocks” which provide a universal multifactorial measure of human biological age

– DLI’s deep haematological clocks can be explored as a predictive tool for the analysis of COVID-19 positive patients

The number of consideration shares was determined on the basis of a share price of HK$0.07 per share of the Company, which was referable to: (i) the closing Share price of HK$0.067 per Share on 29 May 2020, which was the business day on which a non-legally binding understanding was reached on the respective valuations of each of the Company and DLI, subject to confirmatory due diligence; (ii) the 5-day average closing Share price of HK$0.071 per Share concluding on 29 May 2020; and (iii) the 30-day average closing Share price of HK$0.074 per Share concluding on 29 May 2020, in each case as quoted on the HK Stock Exchange. Based on a professional independent valuation conducted by the Company, the fair value of the equity of DLI is US$4.30 million. Through the acquisition, the Board believes that DLI will become a high-quality growth asset and a key platform for expanding into the emerging field of longevity medicine.

Solid investor base with expert AI and biotechnology investors
Originally incubated by Insilico Medicine, DLI closed a Series A funding round at the end of June 2020 that includes some of the most credible and world-renowned venture capitalists specializing in biotechnology, longevity, and artificial intelligence (“AI”). Among these strategic investors are such well known funds as BOLD Capital Partners, ETP Ventures, Human Longevity and Performance Impact Venture Fund, Longevity Vision Fund, LongeVC, Michael Antonov (co-founder of Facebook owned Oculus VR) and other expert AI and biotechnology investors. DLI has also established a key research partnership with one of the world’s leading longevity research and development organizations, Human Longevity, Inc (“HLI”). Under this partnership, HLI will provide a range of aging clocks to a global network of advanced physicians and longevity researcher specialists. The Group is delighted to have these biotech and investment experts as part of its shareholder mix upon completion of the acquisition.

Jamie Gibson, Chief Executive Officer of Regent Pacific, said, “Our long-term vision is to transform Regent Pacific into a global end-to-end longevity and wellness biotechnology company dedicated to extending healthy productive lives of billions of people worldwide by developing a longevity ecosystem. It is only logical to start executing on this vision via the acquisition of the most sophisticated AI system designed to track the rate of human aging and evaluate the effectiveness of longevity interventions. This system can be used by the longevity and performance clinics, insurance companies, pharmaceutical companies, and large employers that deeply care about their workforce.”

“DLI is the original inventor of deep aging clocks with granted US patents, high-end clinics as clients, great scientific publications, top AI and longevity scientists, and more than half of the acquisition value being held in cash from expert investors. It is a great asset to serve as a core engine of our longevity ecosystem.”

“Deep aging clocks” – a tool for predicting COVID-19 relevance

DLI is developing explainable and user-friendly AI systems to track the rate of aging at the molecular, cellular, tissue, organ, system, physiological and psychological levels and systems for the emerging field of longevity medicine, enabling physicians to make better decisions on interventions that may slow down or reverse the aging processes. DLI has also developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed “deep aging clocks” which provide a universal multifactorial measure of human biological age.

Further, there is an increased interest in the longevity market where DLI is looking to have first mover advantage with its applications, including COVID-19 relevance (where epidemiological studies suggest that age is one of the most important factors of COVID-19 illness severity). DLI’s deep haematological clocks can be explored as a predictive tool for analysis of COVID-19 positive patients. The Group, therefore, believes there is significant growth potential in acquiring DLI at this stage of its development, and, importantly, on attractive terms to shareholders.

Mr Gibson added, “DLI will be run by the most credible experts in aging and longevity with Jim Mellon, the Company’s chairman and the author of “Juvenescence” being joined by other noted biotechnology investors and entrepreneurs including Dr. Wei-Wu He, chairman of HLI, and Alex Zhavoronkov, PhD, the founder and CEO of DLI and adjunct professor at the Buck Institute for Research on Aging. Together these individuals will combine their efforts to create a dedicated and focussed longevity company.”

“By becoming part of Regent Pacific, we are planning to help it transform into the first public company to become the engine for the emerging longevity ecosystem and help everyone on the planet live longer and better regardless of their nationality, race, gender, or social status. As part of Regent Pacific, we aim to service the longevity biotechnology industry as well as the health and life insurance industries and become the ultimate instrument to hedge the longevity risk,” said Alex Zhavoronkov, PhD, the founder and CEO of DLI.

The Acquisition constitutes a discloseable transaction of the Company under Chapter 14 of the HK Listing Rules. Therefore, no shareholder approval is required for the Acquisition and the Share Purchase Agreements. However, the Company proposes to seek an approval of a specific mandate for the issue and allotment of the Consideration Shares from the Shareholders at the Extraordinary General Meeting.

Forward Looking Statements

This announcement, including any information included or incorporated by reference in this announcement, contains statements about REGENT PACIFIC that are or may be forward looking statements. Such forward looking statements involve risks and uncertainties that could significantly affect expect results and are based on certain key assumptions. Many factors could cause actual results to differ materially from those projected or implied in any forward-looking statement. Much of the risk and uncertainty relates to factors that are beyond REGENT PACIFIC’s abilities to control or estimate precisely, such as future market conditions and the behaviours of other market participants, and therefore undue reliance should not be placed on such statements. Neither REGENT PACIFIC nor any of its associates or directors, officers, employees, managers, agents, representatives, partners, members, consultants or advisers: (i) provide any representation, warranty, assurance or guarantee that the occurrence of the events expressed or implied in any forward looking statement will actually occur; nor (ii) assume any obligation to, and do not intend to, revise or update these forward looking statements, except as required pursuant to applicable law, the HK Listing Rules or other applicable regulation. REGENT PACIFIC disclaims any obligation to update any forward looking or other statements contained herein, except as required by applicable law, the HK Listing Rules or other applicable regulation.

No Profit Forecasts or Estimates

No statement in this announcement is intended as a profit forecast or estimate for any period and no statement in this announcement should be interpreted to mean that earnings or earnings per share for REGENT PACIFIC for the current or future financial years would necessarily match or exceed the historical published earnings or earnings per share for REGENT PACIFIC. REGENT PACIFIC does not undertake to update information contained in this announcement, except as required by applicable law, the HK Listing Rules or other applicable regulation.

About Deep Longevity
Deep Longevity is developing explainable artificial intelligence systems to track the rate of aging at the molecular, cellular, tissue, organ, system, physiological, and psychological levels. It is also developing systems for the emerging field of longevity medicine enabling physicians to make better decisions on the interventions that may slow down, or reverse the aging processes. Deep Longevity developed Longevity as a Service (LaaS) solution to integrate multiple deep biomarkers of aging dubbed “deep aging clocks” to provide a universal multifactorial measure of human biological age. Originally incubated by Insilico Medicine, Deep Longevity started its independent journey in 2020 after securing a round of funding from the most credible venture capitalists specializing in biotechnology, longevity, and artificial intelligence. ETP Ventures, Human Longevity and Performance Impact Venture Fund, BOLD Capital Partners, Longevity Vision Fund, LongeVC, co-founder of Oculus, Michael Antonov, and other experts AI and biotechnology investors supported the company. Deep Longevity established a research partnership with one of the most prominent longevity organizations, Human Longevity, Inc. to provide a range of aging clocks to the network of advanced physicians and researchers.
http://longevity.ai/

About Regent Pacific
Regent Pacific is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering in May 1997.

Aptorum Group Announces Further Positive Data on ALS-4 against MRSA Wound Infection and MRSA Bacteraemia against Linezolid and Vancomycin Respectively in In Vivo Models

Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) (“Aptorum Group”), a biopharmaceutical company focused on novel therapeutics including the development of next-generation approach therapeutics targeting antimicrobial resistance, announced two sets of positive data showing both significant in vivo activities of its lead compound ALS-4 against Methicillin-Resistant Staphylococcus aureus (MRSA, one of the “super-bugs”) in wound infected and bacteraemia mouse models, respectively when compared to prevailing antibiotics.

ALS-4 is currently undergoing final stages of IND enabling studies, which involves a 14-Day oral toxicity in rats and dogs, a functional observation battery study in rats and a cardiovascular telemetry and respiratory study in dogs. Subject to the final IND-enabling studies results, ALS-4 is on track to target the regulatory submission in Q4 2020 subject to which to commence Phase I clinical trials in Canada.

“Despite the two current mainstay treatments, vancomycin and daptomycin, being the only FDA approved antibiotics for MRSA bacteraemia thus far, patient mortality, morbidity and recurrence rates remain significant1. With the fragile antibiotic pipeline being at risk globally, antimicrobial resistance issues continue to gain significant attention from global bodies including the World Health Organization and the FDA, as well as the pharmaceutical industry. We believe that our oral ALS-4 drug based on a novel first-in-class anti-virulence concept can potentially tackle a variety of infections related to MRSA, including (but not limited to) bacteraemia and skin & soft tissue infections, subject to the respective clinical trials. We are greatly encouraged by the data because ALS-4 appears to be effective against MRSA superbug and could be a potential alternative and sustainable treatment for different MRSA indications including, but not limited to, MRSA bacteraemia and skin infections. ALS-4’s anti-virulent properties are a novel approach in tackling antimicrobial resistance issues as encouraged by recent global action plans. We are also pleased to report that our IND enabling studies are also at their final stages and we remain on track to target regulatory submission to commence phase 1 clinical trials,” said Mr. Darren Lui, President and Executive Director of the company.

Efficacy of ALS-4 in a MRSA Wound Infection Mouse Model
A recent study, conducted by a third party contract research organization, assessed ALS-4’s effect in the healing of open wounds infected with MRSA in a mouse model. Compared with topical dosing of 2% Mupirocin and oral dosing of Linezolid at 100mg/kg twice a day, oral dosing of ALS-4 at 30mg/kg twice a day showed statistically significant improvement in wound healing. Specifically, at the end of the study on Day 7, ALS-4 exhibited 63.8% of wound closure compared with 48.4% for oral Linezolid and 43.2% for topical Mupirocin 2%. The results are further illustrated in the graph below.

Efficacy of ALS-4 in a Bacteraemia Mouse Model
In a further round of in vivo studies, conducted by a third party contract research organization, in a non-lethal MRSA bacteraemia mouse model, the mice were orally administered with different doses of ALS-4 from 0.3 to 30mg/kg twice a day for 7 days, compared to those who received vancomycin only group (3mg/kg of vancomycin administered intravenously) and a no treatment control group.

At the conclusion of the study on Day 7, ALS-4 brought a statistically significant reduction in bacterial counts in major organs such as the kidneys, lungs, liver and spleen compared with the no drug control and vancomycin only groups (unpaired student’s t-test, p<0.05). This is in addition to the previous in vivo results announced in February 2020, whereby ALS-4 demonstrated on a statistically significant basis better survival rates (56% vs 0% control group) in the lethal MRSA bacteraemia rat model and higher reduction of bacterial load (by 99.5% against the control group) in the non-lethal MRSA bacteraemia rat model.

About ALS-4
As part of Aptorum Group’s Acticule infectious disease platform, ALS-4 is a novel first-in-class small molecule developed in oral form based on an anti-virulence approach targeting Methicillin resistant Staphylococcus aureus (MRSA). ALS-4 targets the antimicrobial resistant properties of S. aureus and render the bacteria to become highly susceptible to the host’s immune clearance and also potentially other existing antibiotics, as shown in the preclinical data.

About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum Group is pursuing therapeutic projects in orphan diseases, infectious diseases, metabolic diseases, woman’s health and other disease areas.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company’s anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group’s Form 20-F and other filings that Aptorum Group may make with the SEC in the future, as well as the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020.

As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n2019/980 of 14 March 2019 and n2019/979 of 14 March 2019.

This press release is provided “as is” without any representation or warranty of any kind.
1 https://link.springer.com/article/10.1186/s13054-017-1801-3

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department:
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
Dave Gentry
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22

Aptorum Group Announces Further Positive Data on SACT-1 Against Neuroblastoma and Other Potential Tumor Types

Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) (“Aptorum Group”), a biopharmaceutical company focused on the development of novel therapeutics including orphan diseases and oncology indications, announced further positive data from its latest in vivo studies showing significant activity against neuroblastoma tumor reduction when treated with its lead compound SACT-1 in combination with standard of care (SOC) chemotherapy. Separately, SACT-1 was also screened for its in vitro activity against over 300 cancer cell lines and showed positive results in a number of cancer types including in particular colorectal cancer, leukemia and lymphoma, etc.

Our repurposed drug candidate, SACT-1 is undergoing preparation for IND submission and is on track for regulatory application to target to commence phase 1b/2a clinical trials under the US FDA’s 505(b)(2) pathway.

“Neuroblastoma is one of the most prevailing solid tumor cancers in children, representing 8% – 10% of all childhood tumors, accounting for c. 15% of all cancer related deaths in the pediatric population1. For the high-risk patient group, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society2 based on existing treatment. We are delighted to see the progress of our SACT-1, one of our first assets from our SMART-ACT platform. We are extremely excited to observe SACT-1’s significant effect on tumor shrinkage when used in combination with standard of care chemotherapy in our latest in vivo studies. Moreover, we believe that SACT-1 may have potential applications in a number of other cancer types, including non-orphan cancers, which we will be continuing to investigate further for its wider application,” said Dr. Clark Cheng, the Chief Medical Officer and Executive Director of the company.

Summary of our in vivo assessment against neuroblastoma and in vitro assessment against other cancers are discussed below.

Neuroblastoma In Vivo Assessment
Based on the initial 22 day data of a recent study we conducted in a xenograft mouse model of neuroblastoma, SACT-1 was orally administered daily at 60mg/kg in combination of SOC chemotherapy brought a statistically significant tumor shrinkage (unpaired student’s t-test, p<0.01) from Day 15 to Day 22, compared to the control group which received SOC only. Indeed, the combination reduced the tumor size by up to 54.2% in the first 22 days compared with the control (SOC only). SACT-1 appears to be effective in accelerating the effect of the SOC in early time points (from Day 1 – 7 vs control). This further supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.

Other Cancer Types In Vitro Assessment
In addition, SACT-1 was also screened for in vitro activity in a panel of over 300 cancer cell lines. Similar to our previous findings against neuroblastoma cell lines, SACT-1 exhibits similar anti-tumor efficacy across one or more other major cancer types, including but not limited to colorectal cancer, leukemia and lymphoma cell lines. As a result, in addition to treating neuroblastoma, SACT-1 may have potential applications in the treatment of other cancers. Based on this discovery, the company plans to carry out further in vivo studies to study the efficacy of SACT-1 over other types of cancers to maximize the potential of SACT-1.

About SACT-1
As part of Aptorum Group’s SMART-ACT platform, SACT-1 was discovered from our SMART-ACT platform focused on orphan and unmet diseases. SACT-1 is a repurposed drug targeted for the treatment of neuroblastoma (and potentially other cancer types) especially in combination with SOC chemotherapy. SACT-1’s mechanism has been demonstrated in vitro to enhance DNA damage and tumor cell death.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release is provided “as is” without any representation or warranty of any kind.
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/#:~:text=Neuroblastoma%20is%20the%20most%20common,deaths%20in%20the%20pediatric%20population.
2 https://www.cancer.org/cancer/neuroblastoma/detection-diagnosis-staging/survival-rates.html

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department:
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
RedChip Companies, Inc.
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22

Aptorum Group Limited Reports Financial Results and Business Update for the Six Months Ended June 30, 2020

Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) (“Aptorum Group”or the “Company”), a biopharmaceutical company focuses on the development of novel therapeutics to address global unmet medical needs, today provided a business update and announced financial results for the six months ended June 30, 2020.

“I am pleased with the developments that were achieved during the first half of 2020 despite the challenges presented by the COVID-19 pandemic,” said Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group. “Throughout the COVID-19 crisis, we remained focused on advancing the development of our therapeutic programs. As announced today, further positive data showing significant in vivo activities of ALS-4 (for MRSA wound healing and MRSA bacteraemia) and also in vitro and in vivo studies of SACT-1 (for neuroblastoma and other potential tumor types). Also, as an emerging company, we have been expanding our global strategic presence. In July, Aptorum Group became the first Nasdaq listed biopharmaceutical company admitted to trading on Euronext Paris. We are also delighted about 3 new appointments we made to support the development of our various programs. Looking forward, we remain committed to accelerating the Company’s commercial growth and transformation into a biopharmaceutical company with exciting clinical stage assets being developed.”

Clinical Pipeline Update and Upcoming Milestones
SACT-1-lead program of the Smart-ACTTM platform, a repurposed drug for neuroblastoma and others: Undergoing preparation and on track for IND submission to commence Phase 1b/2a human clinical trials targeting the US FDA’s 505(b)(2) pathway. Further in vitro screening to assess SACT-1’s potential effect on over 300 cancer cell lines has been completed and showed promising effect on including, but not limited to, colorectal cancer, leukemia and lymphoma.

ALS-4-lead program of the Acticule platform, a small drug molecule candidate for methicillin resistant Staphylococcus aureus (“MRSA” superbug): ALS-4 is undergoing final stages of IND enabling studies and is targeted for regulatory submission in Q4 2020 to commence a Phase 1 human clinical trial thereafter.

CLS-1-lead program of the Claves platform, a macromolecule approach for obesity: Currently in lead optimization stage, aimed for IND enabling studies to commence in 2021.

NLS-2 NativusWell-a dietary supplement for woman’s health, including menopause and osteoporosis: Undergoing registration in the United Kingdom, Europe and Asia, aimed for distribution to market in 2020.

Corporate Highlights
Commenced trading on Euronext Paris stock exchange:
Aptorum Group became the first Nasdaq listed biopharmaceutical company admitted to trading on Euronext Paris. The Class A Ordinary Shares of Aptorum Group have commenced trading on the Professional Compartment of Euronext in Paris under the Euronext ticker symbol “APM” and ISIN Code: KYG6096M1069 on 24 July 2020.

Three new personnel appointed to Aptorum Group’s team:
– Dr. Herman Weiss, M.D., Chief Executive Officer and Executive Director of Claves Life Sciences Limited and Senior Medical Advisor of Aptorum Group
– Dr. Kira Sheinerman, Senior Strategic Consultant of Aptorum Group
– Dr. Robbie Majzner, Scientific Advisor of Aptorum Group

Financial Results for the Six Months Ended June 30, 2020
Aptorum Group reported a net loss of $7.0 million for the six months ended June 30, 2020 compared to $9.6 million for the same period in 2019. The decrease in net loss in current period was driven by decrease in interest expenses, net of $3.6 million, partly offset by the increase in research and development expenses by $1.6 million.

Research and development expenses were $4.3 million for the six months ended June 30, 2020 compared to $2.7 million for the same period in 2019. The increase was primarily due to the increase in consultation service provided by our consultants, advisory and contracted research organization as a result of the progress of our projects’ development.

General and administrative fees were $2.1 million for the six months ended June 30, 2020 compared to $3.2 million for the same period in 2019. The decrease was mainly driven by the decrease in bonus related expenses to our directors, employees, external consultants and advisors. Also, there was a significant decrease in business trips and sponsoring conference in 2020 due to the outbreak of COVID-19.

Legal and professional fees were $1.5 million for the six months ended June 30, 2020 compared to $2.0 million for the same period in 2019. The decrease in legal and professional fees was mainly due to the decrease of consultancy service fees during the period.

Interest expenses, net were $0.1 million for the six months ended June 30, 2020 compared to $3.7 million for the same period in 2019. The decrease in interest expenses, net was mainly due to the convertible debts were fully repaid in 2019. The interest expenses, net for the six month ended June 30, 2019 contained $3.1 million amortization of beneficial conversion feature of our convertible debts.

As of June 30, 2020, cash, restricted cash and marketable securities totaled approximately $4.4 million and total equity was approximately $17.5 million.

Aptorum Group expects that its existing cash, restricted cash and marketable securities, together with undrawn line of credit facility from related parties, will enable it to fund its operating and capital expenditure requirements to the end of 2021.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company’s anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group’s Form 20-F and other filings that Aptorum Group may make with the SEC in the future and the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020. As a result, the projections included in such forward-looking statements are subject to change and actual results could be materially different from those described herein.

Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This press release is provided “as is” without any representation or warranty of any kind.

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
RedChip Companies, Inc.
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22

Junshi Biosciences Announces Financial Results for Six Months Ended June 30, 2020 and Provides Corporate Updates

Supplemental NDAs for Toripalimab filed
Expanding into infectious disease and collaborating with IMCAS and Lilly for COVID-19 neutralizing antibodies
Dual Listing on the STAR Market

Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced its financial results for the six months ended June 30, 2020 and provided corporate updates.

First Half 2020 Financial Highlights

– Total revenues reached RMB575 million in the first half year of 2020, representing an 86% increase compared with the first half year of 2019. Sales of Toripalimab was RMB426 million, out of which RMB254 million was generated in the second quarter, representing recovery from the initial outbreak of COVID-19 in early 2020. Gross margin increased slightly to approximately 90% due to capacity utilization and productivity improvement. Sub-licensing and service income was RMB149 million. Junshi entered into a research collaboration and license agreement with Lilly and granted Lilly a license to conduct research, development and commercialization of JS016, an innovative drug for the treatment and prevention of COVID-19 in May 2020.

– The research and development (“R&D”) expenses were RMB709 million in the first half year of 2020, representing an increase of 92% compared to RMB369 million for the same period in 2019. The increase was primarily due to progress of key clinical trials, more R&D collaboration and license-in activities expanding our pipelines to small molecule drugs, antibody drug conjugates (ADCs) and JS016.

– The property, plant and equipment (“PPE”) by the end of June 2020 increased 11% to RMB2,026 million compared with the end of year 2019. The significant growth of the PPE was primarily due to the construction of the Lingang Production Base, which will enhance our current production capacity by ten folds.

– Total comprehensive expense for the Reporting Period was RMB593 million, representing an increase of 105% compared to first half of 2019, mainly due to profit generated from Toripalimab sales, service income and sub-licensing income but offset by the increase in R&D expenses and administrative and selling expenses.

– As of 30 June 2020, our bank and cash balances decreased to RMB676 million from RMB1,214 million as of 31 December 2019. The decrease was mainly due to: 1) investment in ongoing R&D projects, new R&D collaboration and license-in projects; 2) investment in and acquisition of companies in the pharmaceutical sector; and 3) investment in the production bases especially the Lingang Production Base. Subsequently, in July 2020, the company completed a public offering of A shares on the STAR Market of the Shanghai Stock Exchange and received gross proceeds of approximately RMB483.6 million.

Business Highlights

During the Reporting Period, we achieved significant progress with respect to our product commercialization, clinical trials and pipeline expansion. The Company’s products concentrated on self-developed biological products with original innovation. At the same time, through co-development and technology transfer/license-in, we further expanded our product pipeline. As of the end of the Reporting Period, we had 21 drug candidates, including 19 innovative drugs and 2 biosimilars, covering five major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases.

– During the Reporting Period, 15 pivotal registered clinical trials for Toripalimab were being conducted, in which 2 pivotal registered clinical trials were applied for NDA to the National Medical Products Administration (“NMPA”) and included in the process of priority review, covering a broad spectrum of indications, including: melanoma, urothelial carcinoma, nasopharyngeal carcinoma, non-small cell lung carcinoma, esophageal carcinoma, small cell lung carcinoma, triple negative breast carcinoma, hepatocellular carcinoma, gastric carcinoma and renal cell carcinoma.
— In March 2020, Toripalimab in combination with Axitinib for treatment of mucosal melanoma was granted the orphan-drug designation by the US Food and Drug Administration (“FDA”).
— In April and May 2020, the supplemental NDAs in respect of Toripalimab as a treatment for recurrent/metastatic NPC after failure of second-line and above systemic treatment and for locally advanced or metastatic urothelial carcinoma who received previous treatment were accepted by the NMPA, marking a new stage in the layout of indications in the segmented areas of Toripalimab. The two supplemental NDAs had been included in the process of priority review by the NMPA in July 2020.
— In June 2020, the Company and Merck KGaA entered into clinical trial collaboration in respect of the use of Toripalimab in combination with Cetuximab (Erbitux) for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.

– The Company’s drug candidate TAB004/JS004 (a recombinant humanized anti-BTLA monoclonal antibody for injection) was approved for clinical trials in China by the NMPA, and the first patient was dosed in a Phase I clinical study in April 2020. In addition, its Phase I clinical study in the United States has completed dose-escalation study and entered dose-expansion stage.

– The first subject was dosed in a Phase I clinical study of JS005 (a recombinant humanized anti-IL-17A monoclonal antibody for injection) in China in May 2020. At present, the Phase I clinical study has completed random enrollment.

– In March 2020, the Company and the Institute of Microbiology, Chinese Academy of Sciences (“IMCAS”) entered into a project cooperation agreement to jointly develop and produce novel coronavirus neutralizing antibody JS016 (a recombinant fully human anti-SARS-CoV-2 monoclonal antibody for injection), an innovative drug for the treatment and prevention of COVID-19.
— In May 2020, the Company and Lilly entered into an agreement to collaborate on research, develop and commercialize potential preventive and therapeutic antibody therapies for COVID-19, and Lilly was granted an exclusive license to conduct research, develop and commercialize JS016 outside Greater China.
— In May 2020, the international authoritative journal “Nature” published the results of JS016 pre-clinical research, which reported for the first time that the neutralizing antibody of SARS-CoV-2 can significantly inhibit novel coronavirus infection in the test on non-human primate rhesus monkeys, showing the dual effect of treatment and prevention.
— In June 2020, JS016 was approved to conduct Phase I clinical trial in China, and the enrollment of subjects in the Phase I clinical trial was completed in July 2020. The international multi-center clinical trial was a randomized, double-blind and placebo controlled Phase I clinical study, aiming at evaluating the tolerability and safety of single-dose intravenous infusion of JS016 in healthy subjects. We plan to recruit 40 healthy subjects (including both male and female) as the world’s first novel coronavirus neutralizing antibody clinical trial conducted in healthy subjects. We are conducting Phase Ib international multi-center clinical studies for patients with mild/normal novel coronavirus pneumonia. And we expect to commence Phase II/III clinical study for patients with severe and critical novel coronavirus pneumonia as soon as possible. At the same time, the Company will also conduct follow-up studies on groups who are at high risks of the novel coronavirus to evaluate the preventive effect of JS016 on novel coronavirus infection.

After the Reporting Period, we continued to make significant progress in business operations including the following:

– The Company applied to The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) and obtained approval for the dis-application of Rules 18A.09 to18A.11 of the Rules Governing the Listing of Securities on the Hong Kong Stock Exchange (the “Hong Kong Listing Rules”) (the “Relevant Rules”) to the Company. As a result of the dis-application of the Relevant Rules, the “B” marker ceased to be affixed to the Company’s stock name and stock short name from 15 July 2020.

– The Company completed the issue of A shares. The A shares of the Company were listed and commenced trading on the STAR Market of the Shanghai Stock Exchange on 15 July 2020.

– The Company entered into a research collaboration and license agreement with Revitope Oncology, Inc. to develop next generation of T-cell engaging cancer immunotherapies that utilize Revitope’s proprietary dual-antigen targeting technology platform together with the Company’s antibody technology platform. Revitope will be responsible for designing up to 5 unique T-cell immunotherapeutic drugs against targets selected by the Company. The Company will be granted a world-wide exclusive license on products that result from such agreement.

– The Company’s recombinant humanized anti-Trop2 monoclonal antibody – Tub196 conjugate for injection (product code: JS108), obtained the Clinical Trial Approval issued by the NMPA.

– The Company and IMPACT Therapeutics entered into a joint venture agreement for the formation of a joint venture company (the “JV Company”). The JV Company will mainly engage in the R&D and commercialization of small molecule anti-tumor drugs. IMPACT Therapeutics will contribute for its equity interests by way of injection of a PARP inhibitor Senaparib (IMP4297) as an asset within mainland China, Hong Kong and the Macau Special Administrative Regions. The Company and IMPACT Therapeutics will each own 50% equity interests in the JV Company. Both parties will cooperate in conducting clinical trials, manufacturing, and commercialization preparations for various indications of the IMP4297 project within the above territory.

About Junshi Biosciences
Junshi Biosciences (HKEX: 1877; SSE: 688180) was co-established in December 2012 by alumni of famous universities of China and the United States. The founding team has extensive and solid experience in the cross-border transformation of scientific and technological achievements and substantial expertise in the pharmaceutical industry.

Our priority is researching and developing therapeutic antibodies. We are committed to researching, developing, and industrializing innovative monoclonal antibody drugs and other therapeutic protein drugs. The company has established a diversified R & D pipeline comprising 19 innovative candidate drugs and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune diseases, metabolic diseases, neurologic diseases, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for PD-1 monoclonal antibody and clinical trial approval for anti PCSK9 monoclonal antibody from NMPA. The world’s first in human anti-BTLA antibody for solid tumors was officially approved for drug clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences pooled its efforts with Chinese science institutions to co-develop JS016, China’s first neutralizing human monoclonal antibodies against SARS-Cov-2, that has entered clinical trial, part of our continuous innovation for disease control and prevention in China and beyond. We have about 2,000 employees in San Francisco and across Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou, China. For more information, please visit: http://junshipharma.com.

Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Lee’s Pharm Announces 2020 Interim Results

Profit Attributable to the Owners of the Company Increased by 153.3%
Actively Develop New Products
Reform and Replenish the Sales Organisation

Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm” or the “Group”, Stock Code: 950), an integrated research-driven and market-oriented pharmaceutical group in China, today announced its interim results for the six months ended 30 June 2020 (the “period under review”).

The Group’s revenue for the second quarter of this year was HK$283,732,000, represented a decrease of 12.6% over the same quarter last year but a sequential increase of 3.9% over the first quarter of 2020. Revenue for the first half of 2020 was HK$556,716,000, represented a decrease of 8.4% over same period last year when Renminbi currency has been weakened by 5.1% year on- year. Sales of licensed-in products accounted for 60.9% (1H 2019: 55.4%) of the Group’s revenue while sales of proprietary and generic products contributed 39.1% (1H 2019: 44.6%) of the Group’s revenue.

Drugs for surgical use such as Livaracine and Slounase have been affected most as the hospitals were still inclined to postpone elective surgeries amid novel coronavirus (“COVID-19”) resurgence fears during the quarter under review but began to show improvement on a quarter-to-quarter comparison. The sales of Livaracine and Slounase dropped 31.8% and 23.5%, respectively, during the period under review as compared to the same period last year, and were improved from decrease in the first quarter of 33.1% and 34.8%, respectively. Yallaferon was categorised by the Department of Economic and Information Technology of Anhui Province as one of the critical materials for the COVID-19 pandemic prevention and control during the period under review, and the sale thereof was comparatively less affected, declined by 13.4% as compared to the same period last year. On the other hand, the demand for chronic disease medications remains intact during the period under review. Revenue of Carnitene and Zanidip recorded a growth of 18.6% and 1.6%, respectively, and revenue of Ferplex decreased by 14.0%. The timely approved generic Treprostinil Injection in March 2020 has instantly made contribution to the revenue since the end of first quarter of this year and partially compensated for the loss of revenue following the termination of distribution of Remodulin by end of 2019.

Following the slowdown in the first quarter amid COVID-19 pandemic, the Group’s research and development (“R&D”) activities for new drugs have been resumed gradually in the second quarter and HK$151,136,000 was spent in R&D activities during the first half of 2020, representing 27.1% to the corresponding revenue during the period under review.

During the period under review, the product license of Zanidip which would be originally expired on 31 December 2021 was early terminated in return for compensation. Given the availability of several generic lercanidipines in China, the Group believes that the early termination of this product at this juncture not only brings short term financial benefit but also paves the way for the Group to launch its generic version in the near future for long term prosperity. Net profit attributable to the owners of the Company in the first half of 2020 was HK$96,982,000, increased by 153.3% over the same period last year.

Dr. Benjamin Li, Executive Director and Chief Executive Officer of the Group, said, “Given the backdrop of the volatile global macro environment, 2020 was the year not without its challenges. The market was in a slowing growth situation but inflationary pressure in raw material costs, manufacturing and administrative overhead remained high during the period under review. Together with the tensions between China and the U.S. attained an all-time high and the negative impact arising from the outbreak of a COVID-19 persisted, the business operating environment was stayed tough in China during the period under review. The Group continued to impose stringent cost-control measures in order to mitigate cost pressures in other areas. The Group has allocated more resources to the sales and marketing team during the period under review in order to explore new distribution channels and to prepare for the roll-out of new products.”

From the aspect of manufacturing facilities and production capabilities, following the completion of the upgrading of facilities for APIs such as Nadroparin Calcium, there are more upgrading works in progress in Hefei site such as the upgrading of Yallaferon production facilities and pre-filled syringe production facilities in order to improve the capacity and efficiency. In Nansha site, the manufacturing of Tecarfarin tablet batch samples for GMP application and clinical trials is actively moving forward in good progress. In addition, the three new manufacturing facilities in the Nansha premise for Staccato fentanyl, oral cytotoxic drugs and continuous glucose monitor have been erected. Clinical sample of Staccato fentanyl for inhalation for the treatment of cancer breakthrough pain has been successfully produced and the submission of Investigational New Drug (“IND”) will be made in September 2020. The equipment installation for the production of oral cytotoxic drugs and continuous glucose monitor is ongoing and full commission is expected during the second half of 2020.

With respect to New Drug Application (“NDA”), the Group’s R&D pipeline includes over 60 projects from early-to late-stage development in various therapeutics areas. The Group’s commitment to R&D persisted and measurable progress has been made during the period and up to date. The Group’s applications for Import Drug License (“IDL”), namely Trazodone, INOmax, Zingo and Teglutik, were under review by the Centre for Drug Evaluation (the “CDE”). The New Drug Application (“NDA”) of INOmax has been granted priority review for pediatric orphan disease by China’s National Medical Products Administration (“NMPA”). The Group’s applications for Abbreviated New Drug Application (“ANDA”), namely Fondaparinux, Sodium Phenylbutyrate Granule, Sodium Phenylbutyrate Tablet and Bimatoprost, were also in good progress during the period under review and up to date.

In the area of ophthalmology, China Ophthalmology Focus Limited (“COPFL”), the Company’s indirect non-wholly owned subsidiary, has agreed the Phase III protocol of the Cyclosporine A Ophthalmic Gel trial with CDE for the treatment of dry eye in China. The application of ethical clearance is currently in progress and the pivotal Phase III study is expected to initiate patient recruitment in September 2020. In-licensing strategy is the Group’s preferred mode of its business development, and here are two in-licensing deals which involve three new ophthalmic products. On 25 June 2020, Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited (“ZKO”), an indirectly non-wholly owned subsidiary of the Company, and PanOptica, Inc. (“PAN”), a U.S.-based ophthalmology focused pharmaceutical company developing a topical eye drop for the treatment of sight-threatening eye diseases caused by abnormal or leaky blood vessels, entered into a binding letter of intent for exclusive rights to develop, manufacture and commercialise PAN-90806 in China, Hong Kong, Macau, South Korea and other countries of Southeast Asia. On 24 July 2020, following the binding letter of intent signed in May 2020, ZKO, and IACTA Pharmaceuticals, Inc. (“IACTA”), a U.S.-based ophthalmology focused pharmaceutical company developing drugs with novel mechanisms of action that treat diseases in areas of significant unmet medical need, entered into a license agreement for exclusive rights to develop, manufacture and commercialise IC-265 and IC-270 in China and other countries of Southeast Asia.

One of the Group’s strategic investments has reached a milestone during the period under review. On 20 May 2020, Windtree Therapeutics, Inc. (“Windtree”) has successfully uplisted its common shares from the OTC Markets to the Nasdaq Capital Market after the completion of financing via public offering. The proceeds therefrom provide additional resources for Windtree to advance its clinical studies and create value.

Regarding corporate development, in view of the spread of the COVID-19 worldwide and the demand for masks has surged significantly, Powder Pharmaceuticals Incorporated, an associated company of the Group, is currently operating two fully automatic face mask production machines in its cleanroom which meets the ISO-8 class 100,000 requirements. To date, the production volume of masks has been ramped up to approximately 40,000 pieces daily, and is selling online at vmask.com.hk.

Looking forward, Dr. Benjamin Li, Executive Director and Chief Executive Officer of the Group said, “the tensions arising from inflationary, the challenging situations may continue for an extended period, and the Group foresees the tough environment will be persisted throughout this year. Nevertheless, the Group will continue to stay focus on its new drug development, sales organisation reform and expansion, and cost containment. With the good progress is being made on the development of new drugs, evidenced by the encouraging results from clinical trials achieved and the number of NDA approvals obtained during the period under review and up to date, the Group is confident that all these works to be done will eventually drive growth therefor. In addition, with the increasing maturity of the Chapter 18A regime introduced by The Stock Exchange of Hong Kong Limited since 2018 which support biotech companies to go public and raise capital in their pre-revenue stage, the Group is actively considering a possible spin-off and separate listing of its ophthalmology project in the near future. The Group believes that the spin-off of R&D arms, such as ophthalmology and oncology projects, into standalone companies will in turn drive the market to recognise the value of its robust R&D pipelines. Beyond the present headwinds, the Group will continuously monitor the changing situations and make timely responses and adjustments as needed. As always, the operation and management team will continue to make its unremitting efforts to achieve additional uplift on the performance in the upcoming quarters.”

About Lee’s Pharmaceutical Holdings Limited
Lee’s Pharm is a research-based and market-oriental biopharmaceutical company listed in Hong Kong with over 25 years’ operation in China’s pharmaceutical industry. It is fully integrated with solid infrastructures in drug development, manufacturing, sales and marketing. It has established extensive partnerships with over 20 international companies and currently has 23 products in the market place. Lee’s Pharm focuses on several key disease areas such as cardiovascular, woman health, pediatrics, rare diseases, oncology, ophthalmology, dermatology, obstetrics and urology. Lee’s Pharm more than 60 products under different development stages stemming from both internal research and development as well as from the licensing of development, commercialisation, and manufacturing rights from various United States, European and Japanese companies. The mission of Lee’s Pharm is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life.

Additional information about Lee’s Pharm is available at www.leespharm.com.

Sihuan Pharmaceutical Launched an Equity Incentive Plan to Inject New Impetus for the Company’s Growth

Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460 “Sihuan Pharmaceutical” or the “Company”, together with its subsidiaries, the “Group”) announced that on 26 August 2020, the Company granted a total of 94,656,000 share options (the “Share Options”) to the eligible participants of the Company (the “Grantees”) to subscribe for a total of 94,656,000 ordinary shares of HK$0.01 each in the share capital of the Company (the “Shares”) pursuant to the share option scheme of the Company adopted on 24 October 2017, subject to the acceptance by the Grantees.

Among the total of 94,656,000 Share Options granted, 19,000,000 Share Options were granted to five Directors, and the remaining 75,656,000 Share Options were granted to eligible participants who are employees of the Company. The exercise price of the share options granted HK$0.972 per share, closing price of the shares on the date of grant was HK$0.900 per share, average closing price of the shares for the five business days immediately preceding the date of grant was HK$0.972 per share. Validity period of the options start from 26 August 2020 to 25 August 2030 (both days inclusive).

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. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed 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/.

Jacobson Pharma Collaborates with Fosun Pharma Group to Supply Potentially 10 Million Doses of BioNTech SE’s COVID-19 Vaccine Candidate in Hong Kong and Macau

Jacobson Pharma Corporation Limited (“Jacobson Pharma” or “the Group”; Stock Code: 2633.HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, today announced the signing of a letter of intent (“Letter of Intent”) with Fosun Industrial Co. Ltd., a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma Group”; Stock Code: 600196.SH, 02196.HK) to market and supply potentially 10 million doses of BioNTech SE’s BNT162 mRNA-based vaccine candidate (the “COVID-19 Vaccine”) against SARS-CoV-2 in Hong Kong Special Administrative Region (SAR) and Macau SAR (the “Region”).

In the collaboration, Jacobson Pharma will provide all relevant support services to Fosun Pharma Group for the marketing, sales and distribution of the COVID-19 Vaccine in Hong Kong and Macau SAR regions through its extensive sales and distribution network amongst the hospital and medical clinic sectors in the region.

Mr Derek Sum, Chairman and Chief Executive Officer of Jacobson Pharma, said, “We much look forward to joining forces with Fosun Pharma Group to market and supply a potentially safe and effective COVID-19 vaccine product to effectively turn the tide of this pandemic in Hong Kong and Macau SAR regions. We will leverage our distribution network and technical resources to ensure swift accessibility of this novel mRNA-based vaccine product to answer the needs of healthcare professionals and the general public. Jacobson is particularly gratified with the opportunity to contribute and play a part in the fight against this COVID-19 pandemic.”

BioNtech SE is one of the leading mRNA-based biopharmaceutical companies in the world and is currently listed in US Nasdaq (NASDAQ: BNTX). BioNTech SE will supply the vaccines from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech SE and Fosun Pharma Group announced their strategic collaboration on March 13, 2020. Based on the agreement, the two companies are working jointly on the development and commercialization of potential COVID-19 vaccine products based on BioNTech SE’s mRNA technology platform in Greater China i.e. Mainland China, Hong Kong and Macau Special Administration Regions as well as Taiwan. The vaccine candidate is a prophylactic biological product, aiming to prevent COVID-19 in adults. A phase 1 trial has already been initiated in China and the treatment of the first participants with one of the vaccine candidates from the BNT162 program, BNT162b1, was announced on August 5, 2020. All 144 participants have already been enrolled in the Phase 1 study.

About Jacobson Pharma Corporation Limited (Stock Code: 2633)
Jacobson Pharma is a leading generic drug company in Hong Kong. The Group also carries a portfolio of proprietary brands, notably Po Chai Pills, Ho Chai Kung TjiThung San, Contractubex Scar Gel, Flying Eagle Woodlok Oil, Tong Tai Chung Woodlok Oil, Doan’s Ointment, Saplingtan, Shiling Oil and Col-gan Tablet, which have been widely recognised by the market. In the strategic expansion of its branded healthcare business platform, the Group has introduced health and wellness brands and products such as Dr. FreemanFlu/RSV Combo, SmartfishHealth Nutrition Products, Dr.Freeman Infection Control Product Series and Dr Freeman COVID-19 Rapid Test Kit, among other reputable brands represented in overseas markets such as Excilor and Weisen-U.

The Group aims at the continued strategic enrichment of both of its generic drug and branded healthcare portfolios through the addition of high value-added products. With its corporate headquarters based in Hong Kong, the Group has also established its operating subsidiaries in China, Macau, Taiwan, Singapore and Cambodia forming a regional commercial platform to tap the market potential in the Asia Pacific and Greater China region. Jacobson Pharma has been a constituent stock of MSCI Hong Kong Micro Cap Index since 1 June 2017. For more details about Jacobson Pharma, please visit the Group’s website: http://www.jacobsonpharma.com

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