Category: BioTech

Hua Medicine Announces Successful U.S. Phase I Results on Its 2nd Generation GKA Candidate

Hua Medicine (the Company, HKG: 2552) announced today that the Company has successfully completed a Phase I clinical trial on its 2nd generation GKA candidate in U.S. at the 9th China BioMed Innovation and Investment Conference (CBIIC).

The Phase Ia clinical trial of the second-generation GKA (HM-002-1005) was conducted in the United States in 40 subjects with Type 2 diabetes (T2D). This trial was randomized, double-blind, placebo-controlled, single-dose, focusing on safety, tolerability, and pharmacokinetics. The second-generation GKA is a novel molecular entity with optimized physicochemical properties, holding new patents, and serving as the prodrug of dorzagliatin (HMS5552). This study designed for once-daily oral administration. Its aim is to extend the drug’s action duration in the body through sustained-release technology, enhance patient compliance, and prolong the stimulation of GLP-1 secretion in the intestines.

The Single Ascending Dose (SAD) study demonstrates that HM-002-1005 tablets can be rapidly converted to HMS5552 in the human body, with minimal exposure level of prodrug in both blood and urine. The t1/2 (biological half-life) after a single dose of HM-002-1005 tablets was prolonged compared to dorzagliatin tablets. The Cmax of HMS5552 in plasma after a 184.5mg single dose is comparable to the plasma concentration of HMS5552 after a 75mg single dose of dorzagliatin tablet; likewise, the daily AUC of HMS5552 in plasma after a single dose of HM-002-1005 tablets is comparable to the exposure level of HMS5552 after a 75mg BID dose of dorzagliatin tablets. The research indicates that HM-002-1005 tablets are near-completely converted to HMS5552 in human, and its pharmacokinetic characteristics support for once-daily oral administration. The development of HM-002-1005 tablets not only contributes to enhancing patient medication adherence and effectively control blood glucose levels within 24 hours; meanwhile, it also offers the opportunity to explore the Maximum Tolerated Dose above 150mg daily to achieve better efficacy. The 75 mg BID dose regiment was developed under the concept of Minimum Therapeutic Effective Dose in Chinese T2D patients who suffered from an impairment of insulin secretion and significant reduction of early phase insulin. The different disease characters of T2D with obesity in western patient population would benefit dorzagliatin from its effects on GLP-1 secretion and improvement of insulin sensitivity.

With the confirmation that the exposure level of HM-002-1005 tablets at 184.5mg is comparable to dorzagliatin tablets at 75mg (BID), we will further optimize the dosage form followed by a Multiple Ascending Dose (MAD) clinical development of the 2nd generation GKA in China and the United States.

Dr. Li CHEN, founder and CEO of Hua Medicine, stated, “Hua Medicine has always been committed to treating Type 2 diabetes at its root cause by restoring patients’ ability to autonomously regulate blood glucose levels. Over the course of a decade, the Company has selected dosing and clinical research protocols that are safe and effective for the majority of Chinese diabetes patients, leading to the successful development of GKA and the clinical application of dorzagliatin. Building on this foundation, the Company will undergo a strategic upgrade by further exploring the therapeutic potential of GKA, enriching its product pipeline and seeking partners both domestically and internationally, in order to benefit a broader range of patients, expand into global markets, and effectively establish the brand identity of GKA medications while maximizing the commercial potential of our global first-in-class drugs.”

About Hua Medicine
Hua Medicine (The Company) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (Dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.

For more information
Hua Medicine
Website: www.huamedicine.com
Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

Hua Medicine Announces Successful H.K. SENSITIZE Study Results at the CBIIC

Hua Medicine (the Company, HKG: 2552) announced today that the Company has successfully completed its SENSITIZE study on the mechanism by which dorzagliatin improves the β-cell glucose sensitivity at the 9th China BioMed Innovation and Investment Conference (CBIIC).

The SENSITIZE study was initiated by Professor Juliana Chan, an international endocrinology specialist at The Chinese University of Hong Kong, as the lead researcher. It is the first clinical study in Asian populations to evaluate the impact of GKA on β-cell glucose sensitivity in the populations with varying degrees of impaired glucose tolerance using the technology of hyperglycemic clamp. The study aims to explore the impairment of glucokinase (GK) function and clinical characteristics in different types of glucose dysregulation, providing new scientific evidence on the pathophysiology of Asian Type 2 diabetes and the central role of GK in blood glucose regulation.

The SENSITIZE 2 study results announced at CBIIC demonstrate that a single dose of dorzagliatin restores GK enzyme activity, significantly improving the second-phase insulin secretion and β-cell glucose sensitivity in individuals with impaired glucose tolerance (IGT) in hyperglycemic clamp study. In addition, the SENSITIZE 1 study previously reported at the 2022 ADA annual meeting showed that dorzagliatin directly restores the activity of GK mutants, leading to significant improvements in the second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (GCK-MODY or MODY-2), and significantly enhance basal insulin secretion in newly diagnosed type 2 diabetes patients.

Hua Medicine will continue to investigate β-cell glucose sensitivity improvement and incretin effect in response of repeated dose of dorzagliatin in individuals with intermediate hyperglycemia (IH) and Type 2 diabetes, in order to establish personalized intervention and treatment management plans for prediabetic and Type 2 diabetes patients.

About Hua Medicine
Hua Medicine (The Company) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (Dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

NEFECON(R) Included in National Reimbursement Drug List (NRDL)

  • Significantly Boosting Market Penetration and Driving Valuation Reassessment

On November 28, the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security announced the “National Reimbursement Drug List (2024)” (NRDL), which will officially take effect on January 1, 2025. NEFECON(R), the first etiological treatment for IgA nephropathy developed by Everest Medicines, was successfully included in the NRDL. This milestone signifies a breakthrough in advancing the standardization of IgAN treatment and improving accessibility and affordability, offering hope for millions of IgAN patients in China. NEFECON(R) has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong, Taiwan, China, South Korea and in Singapore under the trade name Nefegan(R).

NEFECON(R) is the first ever treatment for IgAN to receive full approval from the U.S. Food and Drug Administration (FDA) and the first non-oncology therapeutic to receive breakthrough therapy designation in China by the China National Medical Products Administration (NMPA), underscoring its globally leading position and exceptional clinical value. Recently, at the 2024 American Society of Nephrology (ASN) Annual Meeting, data from the open-label extension (OLE) phase of the NefIgArd Phase 3 trial demonstrated that patients undergoing a second course of NEFECON(R) treatment experienced similar benefits in estimated glomerular filtration rate (eGFR) preservation and proteinuria reduction as observed after the initial treatment, with good tolerance. These findings further validate the feasibility and efficacy of long-term treatment strategies, aligning with recommendations from the “KDIGO 2024 Clinical Practice Guideline for The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV)”, highlighting NEFECON(R)’s innovation and clinical value in IgAN treatment. NEFECON(R) was also listed as the only treatment proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes.

IgAN is highly prevalent in Asia and is one of the main causes of kidney failure in young adults in China. Statistics show that with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. Since NEFECON(R)’s first prescription was issued in Mainland China in May 2024, the product has demonstrated strong market performance. According to Everest Medicines’ interim report, NEFECON(R) achieved RMB1.673 billion in sales within its first month, reflecting widespread recognition of its therapeutic benefits and the significant demand for innovative therapies among Chinese patients.

With NEFECON(R)’s successful inclusion in the NRDL, its accessibility and coverage in China are expected to increase significantly, driving sustained and robust commercial revenue growth for Everest Medicines. This milestone not only strengthens the company’s leadership in nephrology but also injects new momentum into optimizing resource allocation and promoting synergistic development. As reimbursement coverage leads to expanded market penetration, this development is poised to be a key catalyst in unlocking the full value of the company’s core products, further accelerating the reevaluation of its market potential.

NEFECON(R) included in the NRDL is a testament to Everest Medicines’ differentiated commercial strategy. Another core product, XERAVA(R) (eravacycline) is the world’s first fluorocycline antibiotic for the treatment of complicated intra-abdominal infections, continues to excel in the field of complicated intra-abdominal infections. According to the recently released final report of the “Comprehensive Evaluation Project on the Clinical Application of Eravacycline”, the drug demonstrated an impressive overall treatment effectiveness rate of 90.1%, further affirming its clinical value and safety. As of the first half of 2024, XERAVA(R) achieved cumulative sales of RMB2.33 billion, underscoring its strong market acceptance and potential.

In the autoimmune disease portfolio, VELSIPITY(R) continues to make steady progress in its commercialization journey. In October, under the “Hong Kong and Macau Medicine and Equipment Connect” policy, VELSIPITY(R) received approval from the Guangdong Provincial Medical Products Administration and is now available for use in three designated medical institutions within the Greater Bay Area. Earlier this year, VELSIPITY(R) was also approved for use in Macau and Singapore. In addition, Everest Medicines recently submitted a new drug application (NDA) for VELSIPITY(R) in Hong Kong and plans to submit an NDA in Mainland China by the end of the year. As Everest Medicines’ third commercialized product, VELSIPITY(R) is poised to become a key growth driver, with significant market potential expected to unfold as its adoption expands further.

Everest Medicines continues to make significant strides in innovative R&D, with its proprietary mRNA development platform now fully localized. The company’s first personalized mRNA cancer vaccine, EVM16, has Initiated an Investigator-Initiated Clinical Trial (IIT). Additionally, EVER001, a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor being developed globally for the treatment of renal diseases, marks another important advancement. Everest Medicines will host an investor call on December 4th to discuss the results of the Phase 1b/2a clinical study of EVER001 in primary membranous nephropathy, highlighting its potential to drive future growth.

Driven by the inclusion of NEFECON(R) in the NRDL and the continued progress of its core pipeline, Everest Medicines’ business model demonstrates its resilience and strength. The company remains steadfast in fulfilling its commitments to investors while strengthening market confidence in its innovation and long-term growth potential. With a diversified focus on renal, infectious, and autoimmune diseases, Everest Medicines is harnessing its robust commercialization platform to fuel growth, steadily advancing toward its vision of becoming Asia’s leading global biopharmaceutical company.

Everest Medicines Announces NEFECON(R)’s Full Approval in South Korea

  • Marking Another Milestone in Commercialization

Today, Everest Medicines announced that NEFECON(R) has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). This approval further expands NEFECON(R)’s footprint in Asia and provides Asian patients with a groundbreaking etiological treatment option for IgAN.

Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, expressed his excitement about the approval: “As the world’s first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), NEFECON(R) will provide a new treatment option for patients in South Korea. We will continue to work on enhancing the accessibility and affordability of NEFECON(R) across Asia to meet the urgent needs of more IgAN patients for this innovative therapy.”

NEFECON(R) is the first and only fully approved etiological treatment for IgAN, with its clinical value widely recognized by the global medical community. The approval of NEFECON(R) in South Korea is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, NEFECON(R) not only brought about a sustained reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR). The study further revealed that NEFECON(R) reduces the decline in kidney function by 50%, over a period of 2 years, comprising 9 months of treatment and 15 months of observation, and potentially delay the progression to dialysis or kidney transplantation by 12.8 years.

Studies have shown that IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups, and often progresses more rapidly. The approval of NEFECON(R) in South Korea provides a breakthrough treatment option for IgAN patients in Asia and highlights its significant commercial potential in the region.

This milestone is further evidence of Everest Medicines’ robust global commercialization capabilities. Earlier this year, NEFECON(R) issued its first prescription in mainland China, with subsequent approvals in Macau, Hong Kong, Singapore (marketed as Nefegan(R)), and Taiwan China. According to the company’s interim report, NEFECON(R) achieved RMB 167.3 million in sales within just over a month of its commercial launch in China, demonstrating strong market performance. The approval in South Korea further validates NEFECON(R)’s clinical value and commercial potential, opening new market opportunities and creating an important revenue growth driver for the company.

Notably, NEFECON(R) participated in China’s National Reimbursement Drug List (NRDL) negotiations this year for the first time. Inclusion in the NRDL would significantly enhance its market penetration and affordability, accelerating its sales growth in China. Industry experts widely view NEFECON(R) as a potential blockbuster drug in the Chinese market, with the ability to drive Everest Medicines’ commercialization strategy while strengthening its competitive edge in both domestic and international markets.

Founder of Hua Medicine Dr. Chen Li was awarded the ‘C.C. Tan Life Science Industrialization Award’

The 17th “C.C. Tan Life Science Award” ceremony was held at Shenyang Pharmaceutical University on October 9th. Dr. Chen Li, Founder and Chief Executive Officer of Hua Medicine, was awarded the “C.C. Tan Life Science Industrialization Award”. C.C. Tan Life Science Award has the highest honor as “the Chinese Nobel” in life science. In the context of the comprehensive construction of Chinese-style modernization and the development of new productivity, this award is a high recognition of Dr. Chen Li’s outstanding contributions to the industrialization of life science achievements, and a full affirmation of his decades-long efforts to promote conceptual, technological and institutional innovations in biopharmaceutical industry.

Dr. Chen Li participated in the award ceremony and received the “C.C. Tan Life Science Industrialization Award”.

“C.C. Tan Life Science Award” was proposed by Mr. Tan Jiazhen, one of the founders of modern genetics in China and an outstanding scientist and educator in modern China, which was approved by the Ministry of Science and Technology of the People’s Republic of China, aims to promote the industrialization of China’s life sciences research results and stimulate life scientists to make innovations. Since its establishment in 2008, C.C. Tan Life Science Award has been awarded annually to scientists, professors and young scholars who have made achievements in life science in the People’s Republic of China and have made outstanding contributions to the industrialization of scientific and technological achievements in life science.

With more than 30 years of experience in new drug R&D and management, Dr. Chen Li returned to Shanghai from the U.S. in 2004, and participated in the establishment of Roche R&D Center, the first R&D center of a multinational company in Shanghai, bringing the advanced experience, talent concept, technical standards and quality management system of international new drug R&D to China, and contributing to the establishment of the environment of China’s biopharmaceutical industry. Dr. Chen Li has contributed to the establishment of China’s biopharmaceutical industry environment.

In 2010, Dr. Chen Li founded Hua Medicine in Zhangjiang, Shanghai, with the original intention of “China leads the way in pharmaceutical innovation”, adhering to the tenet of “patients first, innovation first, and good medicines for the people”, focusing on the unmet clinical needs, and concentrating on the research and development of first-of-its-kind new medicines for diabetes. Dr. Chen Li is not only one of the earliest pioneers to leave his executive position at a multinational pharmaceutical company to start a local innovative drug company, but also a leader in developing First-in-Class drugs in China.

In September 2022, under the leadership of Dr. Chen Li, Hua Medicine’s world’s first, China’s first, Class I National New Drug, Dorzagliatin (trade name: HuaTangNing®), which took ten years to develop independently, received marketing approval from the State Food and Drug Administration (SFDA), making it the first Glucose Kinesin Activator (GKA) approved and marketed globally, and the tenth class of diabetes therapeutic drugs.

As the world’s first GKA drug, Dorzagliatin utilizes the new concept of “repairing sensing, reshaping homeostasis, and treating diabetes at the source” to achieve the improvement of blood glucose homeostasis dysregulation in patients with type 2 diabetes mellitus, and to bring a brand-new treatment for diabetes mellitus patients, which is a major breakthrough in the history of drug research and development of China in the field of major chronic diseases.  

During the development of Hua Medicine, Dr. Chen Li has actively contributed to the development of China’s biopharmaceutical industry. He has provided constructive opinions and suggestions for the system of marketing license holders and the system of patent linkage and patent protection, etc. He has cooperated with enterprises in the industry chain in the R&D and production of dorzagliatin to establish a joint innovation model, which has led to the development of the ecological development of the biopharmaceutical industry. In early 2024, Dr. Chen Li was awarded the first “Shanghai Outstanding Talent”. He is also the inventor of 119 granted invention patents and 270 invention patent applications and has been published more than 70 scientific papers in Nature Medicine, Lancet Diabetes Endocrinology, Nature Communication, PNAS, Diabetes, Obesity Metabolism, and the Journal of Biomedicine. PNAS, Diabetes, Obesity Metabolism, JACS, JOC and other international academic journals.

About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin on hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.

For more information
Hua Medicine
Website:  www.huamedicine.com
Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

HighTide Therapeutics to Present Analyses of Phase 2 MASH Study at AASLD’s The Liver Meeting 2024

– Demonstrating Benefits of Berberine Ursodeoxycholate (HTD1801)

HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, will present at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting®, taking place from November 15-19, 2024 in San Diego, California. The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744).

“These data provide additional characterization of the efficacy and safety of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with MASH and T2DM. If further studies confirm these findings, HTD1801 could potentially offer a more effective solution for patients who do not respond adequately to GLP-1 receptor agonists.  In addition, the observations of improved GI tolerance over time suggests that HTD1801 may be an attractive option for long-term management of chronic conditions such as MASH and T2DM. The ongoing Phase 2b study (CENTRICITY, NCT05623189), fully enrolled in 1Q 2024, evaluates the histological benefit of HTD1801 in patients with MASH and T2DM. We look forward to announcing the CENTRICITY results which we expect in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract 3218, Poster Presented November 17th)

About the Abstract: As GLP-1 Receptor Agonists (GLP-1RAs) are prominently used in patients with T2DM and gaining attention as a potential treatment for MASH, this post-hoc comparative efficacy analysis evaluated ongoing GLP-1RA use compared to newly initiated HTD1801 treatment. This analysis suggests that HTD1801 provides greater improvements in markers of liver injury and inflammation, glycemic control, weight loss, and lipid metabolism compared to ongoing GLP-1RA use. These findings are important as they suggest that HTD1801 could provide additional benefit to patients with MASH and T2DM, on concomitant GLP-1RA treatment.

“Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM” (Abstract 3219, Poster Presented November 17th)

About the Abstract: Across several indications, the most commonly occurring adverse events (AEs) in studies of HTD1801 have been mild to moderate gastrointestinal (GI) AEs, primarily diarrhea and nausea. The purpose of this post-hoc analysis was to characterize the time course and severity of GI AEs in patients with MASH and T2DM treated with HTD1801 for 18 weeks. Based on this analysis, the incidence of GI-related AEs peaks within the first 4 weeks of treatment, was mild to moderate in severity, and importantly, showed a decreasing incidence and prevalence over the course of treatment. These data demonstrate that HTD1801 is generally well-tolerated and with continued treatment, GI tolerance improves supporting its potential long-term use in chronic diseases, such as MASH.

About HighTide Therapeutics
HighTide Therapeutics, Inc. (HKG: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both MASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

For more information, please visit www.hightidetx.com

T.MAN Pharmaceutical PCL (SET: TMAN) Showcases Leadership in Health Innovation, Aiming for Sustainable Growth Following Listing on SET

T.MAN Pharmaceutical PCL (SET: TMAN), a leader in the production and distribution of pharmaceuticals and healthcare products in Thailand for over 50 years, debuts on the Stock Exchange of Thailand (SET) under the Personal Products & Pharmaceuticals sector. The company has showcased its commitment to investing in technology to enhance production and efficiency, focusing on the research, development, and innovation of pharmaceuticals and healthcare products. Aiming to expand its market presence both domestically and internationally, the company strives to be a leader in health innovation that enhances the quality of life for all.


Mr. Prapon Thanachotipan, Chief Executive Officer of T.MAN Pharmaceutical PCL (“the company” or “TMAN”), announces that the company starts trading its shares on the SET on October 22, 2024, under the consumer products industry group, specifically in the personal products and pharmaceuticals category, using the ticker symbol “TMAN”. He expresses confidence that the company’s strong foundation in health innovation, from research and development of pharmaceuticals and healthcare products to enhancing production standards with modern technology and effective marketing strategies, will make TMAN a quality stock that attracts investors. The company aims to be a leader in health innovation, helping to improve the quality of life for everyone.

Following its listing, the company has allocated a short-to-medium-term investment budget not exceeding 777.5 million THB, divided as follows:

1) Ongoing projects involving construction and machinery installation, totaling up to 298.5 million THB. These include:

1.1) Projects to improve the efficiency of herbal product manufacturing,

1.2) Projects to enhance the efficiency of modern medicine production,

1.3) Expansion of research and development,

1.4) Increased production capacity for dietary supplements,

1.5) Development of sales systems using information technology,

1.6) Procurement of quality control equipment for modern medicine,

1.7) Procurement of quality control equipment for dietary supplements, and

1.8) Construction of warehouses and office buildings, with several projects already underway.

2) The company has also planned future investments for business expansion in 5 projects, with a budget not exceeding 479.0 million THB. These include:

2.1) Construction of a new headquarters building,

2.2) The first phase of expanding production capacity for modern medicine,

2.3) Investment in the installation of solar panels (Solar Rooftop),

2.4) Upgrading production areas for modern medicine, and

2.5) The second phase of expanding production capacity for modern medicine.

Mr. Prapon states that after being listed on the stock exchange, the company has strategized for sustainable growth by focusing on building brand recognition and acceptance for its products. It aims to develop pharmaceuticals for chronic non-communicable diseases (NCDs) and respiratory conditions to expand its customer base among hospitals, a major segment in the pharmaceutical industry. Currently, the company has over 226 brands. Additionally, it will continue to research and develop diverse and high-quality health innovations to fully meet customer needs. The company also plans to increase its contract manufacturing (OEM/ODM) and distribution services, while boosting revenue growth by expanding product distribution to over 22 countries worldwide, aiming to become a global brand in the future.

Mr. Thinnaphan Wanglee, Deputy Managing Director of Kasikorn Securities Public Company Limited, acting as the financial advisor and lead underwriter, states that TMAN is a leading group in the production and distribution of pharmaceuticals and health products in Thailand. It is at the forefront of inventing, researching, and developing pharmaceuticals and healthcare products that fit current trends in preventive and therapeutic healthcare. TMAN has enhanced its R&D centers and production facilities with modern technology, improving its competitiveness as well as aggressively expanding its business both domestically and internationally, driven by strong business strategies that will enable sustainable growth.

Analysts from leading securities firms view TMAN shares as having a solid foundation, with a diverse range of over 842 SKUs in pharmaceuticals and healthcare products, many of which are popular in the market with strong brand presence. The company plans to launch 10-12 new products annually, backed by research and development that swiftly addresses consumer needs. Strategies to expand its customer base among hospitals and penetrate international markets are expected to drive continuous sales growth both domestically and abroad. Effective cost management through direct distribution to customers also contributes to its growth. Analysts have assessed the fundamental value of TMAN shares to be in the range of 24.0-29.5 THB per share, with a positive outlook driven by the following factors: 1) Expanding product lines under existing brands, 2) Launching new products under the TMAN brand, 3) Expanding the customer base among hospitals, 4) Continuously growing distribution channels, and 5) Boosting international sales to move towards becoming a global brand.

Additionally, TMAN engages in third-party distribution, which provides in-depth market and consumer behavior insights that support the company’s growth. The current consumer trend toward health consciousness, which is a global megatrend, further drives this growth.

Released by Public Relations Dept, MT Multimedia Co., Ltd for T.MAN Pharmaceutical PCL or TMAN

For more information, please contact: Pipop (Top)
Tel. +66 81-929-8864; Email: pipop.k@mtmultimedia.com 

T.MAN Pharmaceutical PCL [SET: TMAN; TMAN/F; TMAN-R] https://www.tmanpharma.in.th/en/home-en/

Everest Medicines Announces Positive Results of Complete Chinese Subpopulation Data from the NEFECON Global Phase 3 NefIgArd Clinical Trial

– Published in “Kidney 360” Magazine

Everest Medicines (HKG: 1952, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the “Kidney 360” magazine has published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON® under the title “Efficacy and Safety of Nefecon in Patients With Immunoglobulin A Nephropathy From Mainland China: 2-Year NefIgArd Trial Results”. 

The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the same outcomes in the global trial. Compared with the placebo, NEFECON® treated patients showed greater preservation of estimated glomerular filtration rate (eGFR) within 9 months and over 2 years, and the treatment benefits observed in Chinese patients were numerically larger, with good tolerability and no new safety signals observed. Previously, the Chinese subpopulation data were published at the American Society of Nephrology (ASN) Kidney Week held in November 2023.

“The publication of the Chinese subpopulation data from the NEFECON® global Phase 3 NefIgArd clinical trial in the ‘Kidney 360’ magazine further supports the clinical evidence of NEFECON® in the clinical application for Chinese IgA nephropathy (IgAN) patients. Compared with the European and American populations, the disease progression in the Chinese population with IgAN is faster, and the prognosis is poorer, bringing a heavy disease burden to patients and society.” Said Professor Zhang Hong with Peking University First Hospital, a member of the global steering committee for the Phase 3 clinical trial NefIgArd, chairman of the Chinese Collaborative Group of the International IgA Nephropathy Federation. “The data analysis of the Chinese subpopulation in the NefIgArd trial shows a clear benefit of treatment with NEFECON® in Chinese patients. After a 9-month treatment period with NEFECON® and 15 months of follow-up off drug, significant kidney function protection was achieved within 2 years, reducing the decline in kidney function by 66% over 2 years, and a continuous decrease in proteinuria was observed. At 9 months, the urine protein to creatinine ratio (UPCR) significantly decreased by 37.6% from the baseline, and the decline was well maintained during the 15-month follow-up period off drug, with numerical benefits superior to global patients. Currently, there are many IgAN patients in China, and we look forward to more Chinese patients starting etiological treatment earlier in the future.”

“The recently published Chinese subpopulation data from the global Phase 3 NefIgArd clinical trial for NEFECON® in Kidney 360 further validates the significant clinical benefits NEFECON® offers to Chinese patients, solidifying its position as the first-line cornerstone treatment for IgAN.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “With IgAN incidence rates notably higher in Asia compared to other regions, and its high prevalence in the Asian population – where there is a 56% higher risk of progression to end-stage renal disease and faster disease progression, there is a clear indication of significant unmet clinical needs. As the world’s first etiological treatment for IgAN, NEFECON® directly addresses the cause of the disease, filling a crucial gap in treatment. Moving forward, we are committed to enhancing NEFECON®’s accessibility and advancing its commercialization across Asia to benefit more patients as soon as possible.”

The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy. Patients were randomly assigned in a 1:1 ratio to receive NEFECON® or matched placebo for 9 months, followed by a 15-month off drug follow-up period. The NEFECON® global Phase 3 NefIgArd clinical trial achieved its primary and key secondary endpoints, and the complete data have been published in The Lancet magazine. The FDA fully approved NEFECON® for the treatment of adult patients with IgAN at risk of progression in December 2023 based on the results of this study, irrespective of proteinuria levels.

Currently, NEFECON® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong, China, Singapore and Taiwan, China. In July this year, the National Medical Products Administration officially accepted the supplementary application for the complete data of the final clinical trial stage of NEFECON®, and NEFECON® is expected to become the first and only fully approved etiological treatment for IgAN in China. In addition, NEFECON® was recently included in the latest draft for public review, “KDIGO 2024 Clinical Practice Guideline for The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) ” and was listed in the guideline draft as the only treatment proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes.

About Phase 3 NefIgArd Clinical Trial
The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy. This study lasted for 2 years, including a 9-month treatment period with NEFECON® or placebo, followed by a 15-month off drug follow-up period. The global study results showed that compared with the placebo, NEFECON® not only brought a lasting decrease in proteinuria and reduced the risk of microscopic hematuria, but more importantly, it showed a clinically significant and statistically significant advantage (p<0.0001) in estimated glomerular filtration rate (eGFR), delaying the decline of kidney function by 50%.

The Chinese subpopulation data showed better efficacy in kidney function protection, proteinuria reduction, and improvement of microscopic hematuria compared to the global study in numerical values, and a faster disease progression was also observed in the Chinese patient control group using only supportive treatment. During the 2-year treatment and observation period, the time-weighted average decline in eGFR in the NEFECON® treatment group was 3.7 ml/min/1.73m2, while the time-weighted average decline in eGFR in the placebo group was 13.3 ml/min/1.73m2. NEFECON® treatment could bring a benefit of 9.6 ml/min/1.73m2 in eGFR, a value greater than the treatment benefit in the global population (5.1 ml/min/1.73m2). The average absolute change in eGFR at 24 months compared to the baseline in the Chinese population indicated that the degree of kidney function deterioration in patients treated with NEFECON® was reduced by about 66% compared to the placebo, a value of about 50% in the global population. Additionally, a sustained reduction in proteinuria was observed in the NEFECON® group over the course of two years. Compared with the placebo, the 9-month NEFECON® treatment in the Chinese population reduced the urine protein creatinine ratio (UPCR) by 31% and 43% at 9 months and 24 months, respectively, while the global population decreased by about 30% at 9 months and 24 months. In addition, in the placebo group, the average UPCR in the Chinese subpopulation increased by 18.6% from the baseline at 24 months, while the global population had a slight decrease, indicating that the disease progression in the Chinese population is faster than in the global population. In the Chinese population, the proportion of patients without microscopic hematuria in the NEFECON® group significantly improved from 26.9% at baseline to 57.7% within 2 years, while there was no change in the placebo group. 

About NEFECON®
NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. 

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories. 

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Acrometa Group to Divest Its Life Sciences Business, Pursue New Business Opportunities in the Region

– ACROMETA seeks to unlock value from its disposal of Life Science Incubator Holdings Pte. Ltd. following a strategic review.
– ACROMETA’s wholly-owned subsidiary has entered into a non-binding MOU with a Malaysian sand concessionaire to facilitate further collaboration in mineral sand trading.

ACROMETA Group Limited (“ACROMETA”, or the “Company” and together with its subsidiaries, the “Group”), today announced that the Company has entered into a sale and purchase agreement (the “SPA”) for the disposal of all of the shares held by the Company (the “Sale Shares”) in Life Science Incubator Holdings Pte. Ltd. (“LSI”), representing 70% of the issued and paid-up share capital of LSI, for an aggregate consideration of S$2.7 million (the “Proposed Disposal”).

Mr Lawrence Toh, ACROMETA’s Executive Director, said, “The Proposed Disposal follows a strategic review of the Company’s long-term strategy and will enable ACROMETA to unlock value for future growth. We have determined that the Group’s resources and management efforts would be better directed towards other potential business opportunities in mineral sands trading.”   

The Proposed Disposal will be made conditional upon approval by the shareholders of the Company at an Extraordinary General Meeting (“EGM”) to be convened in due course. Upon the completion of the Proposed Disposal, LSI will cease to be a subsidiary of the Group.

Mineral Sands Trading

AcroMeta Minerals Pte. Ltd. (“AcroMeta Minerals”), a wholly-owned subsidiary of the Company, has entered into a non-binding Memorandum of Understanding (“MOU”) with Constance Holding Sdn. Bhd. (“Constance Holding”) to facilitate further collaboration in mineral sands trading.

Constance Holding, a Malaysia-based holding company, operates primarily in the upstream sand industry. It holds exclusive rights to market, sell, and trade sand products from the concession and management rights of the sand concession. Constance Holding is currently involved in supplying sand for major land reclamation projects across major infrastructure developments in Malaysia.

This latest development represents another significant milestone in the Group’s ongoing pursuit of regional opportunities, following an earlier non-binding, non-exclusive MOU with PT Swadaya Buana Makmur for the supply of high-grade silica sand from West Kalimantan, Indonesia. The Group is actively engaged in negotiations with potential international buyers, with formal offtake agreements anticipated in the near future.

ACROMETA remains optimistic about the long-term prospects of AcroMeta Minerals, which are supported by strong demand and strategic local partnerships. With an enhanced cash position following the completion of the Proposed Disposal, the Group is well-positioned to continue exploring suitable new business opportunities that will create value for its shareholders.

This press release should be read in conjunction with the SGXNET announcement issued on the same date.

About ACROMETA Group Limited (SGX Stock Code:43F)

ACROMETA (Previously known as ACROMEC Limited) has been listed on the Catalist Board of the Singapore Exchange since 2016. 

ACROMETA’s business is divided into three main business segments: (i) Maintenance and repair services of facilities and equipment of controlled environments and their supporting infrastructure, (ii) Co-working laboratory business, which currently operates 6,500 square feet of co-working laboratory space at The German Centre in Singapore and a 21,538 square feet coworking laboratory centre at Elementum, One-North, serving SMEs and startups, and (iii) Trading of minerals and sand. For more information, please visit www.acrometa.com .

Media and Analysts Contact:

ACROMETA Group Limited
Ms. Cheah Lai Min
Chief Financial Officer
Tel: +65 6717 0111
Email: laimin.cheah@acrometa.com 

Waterbrooks Consultants Pte Ltd
Mr. Wayne Koo
Tel: +65 6958 8008 / +65 9338 8166
Email: wayne.koo@waterbrooks.com.sg
Email: query@waterbrooks.com.sg 

This media release has been reviewed by the Company’s Sponsor, Evolve Capital Advisory Private Limited (the “Sponsor)”. It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the “SGX-ST”), and the SGX-ST assumes no responsibility for the contents of this media release, including the correctness of any of the statements or opinions made or reports contained in this media release.

The contact person for the Sponsor is Mr Jerry Chua (Tel: (65) 6241 6626), at 138 Robinson Road, Oxley Tower, #13-02, Singapore 068906.

Athos Announces Positive Topline Phase 1 Data for its AI-Generated, Novel, Oral G9A Inhibitor ATH-063, Demonstrating Selective Expansion and Activation of Potent Anti-Inflammatory Regulatory T Cells

ATH-063 significantly increased the number of circulating regulatory T cells (Tregs) across all doses and demonstrated enrichment in six well-described genes related to induced Treg anti-inflammatory activitie
No serious adverse effects or dose limiting toxicities were observed at any dose level, and ATH-063 demonstrated favorable pharmacokinetics (PK) 
The data provides clinical verification for Athos’ Proprietary AI2 (Artificial Intelligence for Autoimmune drug development) computational software platform which generated ATH-063

Athos Therapeutics, Inc. (Athos), a clinical stage biotechnology company pioneering the development of precision small molecule therapeutics for patients with immune-mediated diseases, today announced topline results for the company’s Phase 1 clinical trial of ATH-063, an investigational oral small molecule G9A inhibitor and the company’s lead asset in development for the treatment of inflammatory bowel disease (IBD).

The clinical trial was a randomized, double-blind, placebo-controlled study in healthy volunteers designed to evaluate safety and PK as well as provide pharmacodynamic (PD) data to provide confirmation of ATH-063’s proposed mechanism of action. The trial was conducted as sequential single ascending dose (SAD) (n=32) and multiple ascending dose (MAD) (n=32) arms, and a separate food-effect (FE) (n=12) arm. Four doses (25, 75, 150, and 250 mg) of ATH-063 were administered orally.

  • PD data showed ATH-063 selective expansion and activation of Tregs, consistent with predictions made by Athos’ AI2 platform:
    • Statistically significant increases (p<0.001) in the number of blood Tregs were observed at all ATH-063 dose levels compared to placebo subjects, and demonstrated correlation between ATH-063 blood levels and number of Tregs
      • Blood ATH-063 concentration positively correlated with increase in multiple key biomarkers of Treg activity, including strong correlation with FOXP3 (p=0.003)
    • Induced Tregs demonstrated enrichment of six well-described genes related to Treg anti-inflammatory activities
      • STAT5A, a key signaling molecule related to induced Tregs, was activated in all cohorts and doses (p=0.0003)
  • PD data demonstrated correlation with key biomarkers of IBD disease activity, supporting further development of ATH-063 as a treatment for IBD:
    • Blood ATH-063 concentration correlated (p=0.012)with reduction of OSM, a well-established biomarker related to TNFA resistance
    • Blood ATH-063 concentration correlated with reduction of calprotectin monomers, which is an established biomarker for IBD
  • ATH-063 was well tolerated across all dose groups: No serious adverse effect or dose limiting toxicities were observed at any dose level
  • Robust PK results and dose proportional increases in blood levels: ATH-063 showed favorable PK results with dose-proportional increases in blood ATH-063 concentrations throughout the study

“The results of our first-in-human clinical trial of ATH-063 exceeded our high expectations,” said Dimitrios Iliopoulos, PhD, MBA, Founder, President & CEO, Athos. “We used the Athos AI2 drug development platform to identify a previously unrecognized and novel therapeutic target, to create ATH-063, and to preclinically predict the compound’s proposed mechanisms of action. We are delighted that these Phase 1 results serve as clinical verification for the predictions made by the Athos AI2 computational engine” added Dr. Iliopoulos.

“Our Phase 1 data showed that once daily, oral dosing of ATH-063 was well tolerated and showed expansion of Tregs,” commented Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. “We are excited to move to our next stage of clinical development in subjects with moderately to severely active ulcerative colitis. The rapid pace of the ATH-063 program, from initial target identification to a completed Phase 1 trial, was enabled by the use of our innovative approach to leveraging Artificial Intelligence for drug development.”

About ATH-063
ATH-063 is a novel, investigational, AI-generated, oral, small molecule, G9A inhibitor in development for the treatment of inflammatory bowel disease and other autoimmune diseases. G9A is a central hub on a gene network that was identified by the Athos AI2 platform through the integration of multi-omic and longitudinal clinical data from Athos’ IBD biorepository. ATH-063 is designed to directly target G9A enzymatic activity in human CD4 T cells and GI epithelial cells, acting both by suppressing pro-inflammatory responses through expansion and activation of regulatory T cells and inducing direct mucosal healing through regulation of tight junction proteins.

About Athos Therapeutics
Athos Therapeutics is a clinical stage biotechnology company seeking to develop potential first-in-class therapeutics that significantly impact the lives of patients with autoimmune disorders and chronic inflammatory diseases. The Athos drug development platform begins with over 25,000 high-quality patient samples sourced from premier global hospital systems. Athos’ AI2 platform identifies novel drug targets by integrating multi-omic and longitudinal clinical datasets and matches them to its small molecule computational chemistry platform. The AI2 platform includes the Athos data lake, singular well-established omics workflows, and an integrative deep machine learning engine. The company’s lead drug compound is ATH-063, an investigational, oral small molecule G9A inhibitor for inflammatory bowel disease.

Athos is also developing a pipeline of additional small molecule approaches for various autoimmune diseases.Additional information about Athos Therapeutics can be found at https://athostx.com/

Contact:
Athos Therapeutics, Inc.
Keith Hoffman, PhD, Chief Business Officer
khoffman@athostx.com

SOURCE: Athos Therapeutics, Inc.