Hua Medicine
Public · 17 known investors
Shanghai-based, HKEX-listed drug developer commercializing dorzagliatin, the first approved glucokinase activator for type 2 diabetes.
Also known as 2552.HK · Hua Medicine (Shanghai) Ltd. · 华领医药
Investors · 17
Also in the syndicate · 10
Company profile
researched Aug 2026Hua Medicine is an innovative drug development and commercialization company headquartered in Shanghai, China, with divisions in the United States and Hong Kong. Founded in 2011 (the company also cites establishment of Hua Medicine (Shanghai) Ltd. in June 2011), it develops novel therapies for patients with unmet medical needs, with a concentration on diabetes and metabolic disease and a secondary interest in central nervous system disorders. Its registered address is No.2, Lane 36, Xuelin Road, Pudong District, Shanghai.
The company's cornerstone product is HuaTangNing (dorzagliatin tablets, HMS5552), an allosteric glucokinase (GK) full activator that acts on glucokinase in pancreatic islets, intestinal endocrine cells, the liver and other glucose storage and output organs. The stated mechanism is to repair impaired glucose sensing, improve glucose-stimulated insulin and GLP-1 secretion, improve beta-cell function and reduce insulin resistance, thereby restoring glucose homeostasis in type 2 diabetes (T2D) patients. Dorzagliatin was approved by China's National Medical Products Administration on September 30, 2022, for use alone or in combination with metformin in metformin-tolerated T2D patients, with no dose adjustment required in chronic kidney disease. It is described as the first glucokinase activator approved and marketed globally and the first GKA to complete Phase 3 trials for T2D.
Beyond dorzagliatin in T2D, the pipeline includes dorzagliatin in additional indications and combinations (MODY-2, diabetes prevention IGT2NGT, frailty, early Alzheimer's disease, cystic fibrosis-related diabetes, a dorzagliatin/metformin fixed-dose combination, and combinations with GLP-1 receptor agonists, small-molecule GLP-1, empagliflozin, sitagliptin and insulin), a second-generation GKA for metabolic disease, a GK negative allosteric modulator, and mGluR5 negative allosteric modulators for levodopa-induced dyskinesia in Parkinson's disease and drug addiction.
Founding story
According to a 2014 Nature careers item, Dr. Li Chen, who received a PhD in chemistry from Iowa State University in 1992, worked at Roche's R&D centre in New Jersey and returned to China in 2004 as Roche's Chief Scientific Officer to help establish its China R&D Center. In 2011 he founded Hua Medicine together with Ge Li and Jack Baldwin, with $50 million in start-up funding from Arch Venture Partners, Fidelity, Verock [sic], Sino-Alliance International Ltd. and WuXi PharmaTech Corporate Venture, with the aim of using Shanghai's drug development ecosystem to develop novel drugs for China. A 2024 press release states Dr. Chen founded Hua Medicine in Shanghai in 2010; the company's own history page dates establishment to June 2011.
Business model
Hua Medicine develops proprietary small-molecule drugs and commercializes them, initially through partners and more recently directly. The company states it fully took over commercialization of HuaTangNing in China in 2025 and built a dedicated sales team; previously it worked with Bayer Healthcare Company Limited as commercial partner in China. It also uses distribution partnerships, such as with DKSH Hong Kong, for market expansion.
Revenue derives from sales of approved prescription pharmaceuticals, principally HuaTangNing (dorzagliatin) in China, previously through a commercial partnership with Bayer Healthcare and, from 2025, through the company's own sales organization; distribution partners such as DKSH support other markets.
Traction
Dorzagliatin has completed Phase 3 trials (SEED/HMM0301 and DAWN/HMM0302) and is approved and marketed in mainland China (September 2022), Hong Kong (2026) and Macao (June 2026), with the first Hong Kong prescription dispensed in August 2026. It is listed in China's National Reimbursement Drug List, renewed at its original price at the end of 2025. As of an October 2024 press release, HuaTangNing revenue with commercial partner Bayer had reached nearly RMB 200 million. The company reports over 100 clinical centers and states that R&D staff make up 30% of its team. In a post-SEED remission study, drug-free diabetes remission probability was reported at 65.2% at week 52.
Latest developments
In 2026 the company reported Hong Kong marketing approval of dorzagliatin under the '1+' mechanism, approval in Macao (MYHOMSIS®, 華領片®) on June 30, 2026, the first Hong Kong prescription dispensed in August 2026, an expanded DKSH Hong Kong partnership and a real-world evidence collaboration with GemVCare, presentations at the ADA 86th Scientific Sessions in June 2026, approval of a patent term extension extending core dorzagliatin patent protection to April 2034 with an additional five-year market exclusivity, and publication of unaudited interim results for the six months ended June 30, 2026.
▸Full profile — market position, technology, go-to-market, geography, history
Market position
The company positions dorzagliatin as the world's first-in-class and first approved glucokinase activator, described as the tenth class of diabetes therapeutic drugs, and as the first innovative drug for chronic metabolic diseases approved under Hong Kong's '1+' mechanism. Prior attempts at GKA development by several multinational pharmaceutical companies are described as having failed; at the time of a 2020 award to GK researcher Franz Matschinsky, Hua Medicine was described as the only company to have advanced a GKA into Phase III.
Dorzagliatin is presented as the first and only approved glucokinase activator worldwide, targeting the underlying glucose-sensing defect in type 2 diabetes rather than downstream pathways, developed entirely in China from preclinical through late-stage clinical work, with reported low hypoglycemia incidence, no dose adjustment required in chronic kidney disease, and evidence of drug-free diabetes remission after treatment.
Technology
The core technology is allosteric activation of glucokinase, the body's glucose sensor. In healthy individuals glucose is maintained within roughly 4-6.5 mM; impaired GK activity in T2D disrupts glucose sensing, and a GKA is intended to repair defective GK function and restore glucose homeostasis. Dorzagliatin (HMS5552) is described as a fourth-generation, first-in-class oral GKA with a novel mechanism and structure. A second-generation GKA and a GK negative allosteric modulator are in development, alongside mGluR5 negative allosteric modulators for CNS indications, the first generation of which was filed for PCT patent protection in 2013.
Go-to-market
Commercialization in mainland China is now conducted with the company's own professional sales team following its 2025 takeover of HuaTangNing commercialization from partner Bayer Healthcare. In Hong Kong the company expanded a strategic partnership with DKSH Hong Kong in June 2026 to broaden patient access, and entered a research collaboration with GemVCare to generate real-world evidence. Product access is supported by inclusion in China's National Reimbursement Drug List, and scientific data are disseminated through peer-reviewed publications (Lancet Diabetes and Endocrinology, Nature Medicine) and conference presentations such as the ADA Scientific Sessions.
Adults with type 2 diabetes, including drug-naive patients, metformin-tolerated patients and patients with renal function impairment; pipeline programs also target obesity, diabetic kidney disease, MODY-2, cystic fibrosis-related diabetes, frailty, early Alzheimer's disease, Parkinson's disease levodopa-induced dyskinesia and drug addiction.
Geography
Headquarters in Shanghai (Zhangjiang/Pudong), with divisions in the United States and Hong Kong, and offices previously launched in Beijing (2017) and Wuhan (2018). Products are approved in mainland China, Hong Kong and Macao; clinical work has been conducted in China and the United States.
History
Hua Medicine (Shanghai) Ltd. was established in June 2011 and in December 2011 in-licensed an innovative medicine from a multinational company. The diabetes program launched in Zhangjiang, Pudong, Shanghai in February 2012 and HMS5552 entered Phase I in China in 2013, with Phase Ia-Id studies completed through 2015 including US trials. Phase II completed in September 2016; Phase III began in 2017 and HMS5552 was approved as a pilot drug under China's Marketing Authorization Holder system in April 2017. The company opened a Beijing office in 2017 and a Wuhan office in 2018, published Phase II proof-of-concept results in Lancet Diabetes and Endocrinology in May 2018, and listed on HKEX in September 2018. Phase III registration trials SEED/HMM0301 and DAWN/HMM0302 read out in 2019-2020, Nature Medicine published two Phase III papers in May 2022, and NMPA approved the NDA in September 2022. Dorzagliatin entered China's National Reimbursement Drug List in December 2023 and was renewed at its original price at the end of 2025. In 2023 the company filed an FDA IND for a second-generation GKA, completing its Phase Ia single-ascending-dose study in the US in 2024. In 2026 dorzagliatin received Hong Kong marketing approval and a Chinese patent term extension.
Compiled by commissioned research from 8 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Timeline · 26
launches, deals, and filingsUnaudited consolidated results for the six months ended June 30, 2026 announced together with business progress and outlook.
Approved for marketing by the Pharmaceutical Administration Bureau of Macao SAR for treatment of type 2 diabetes in adults under the trade name MYHOMSIS®/華領片®.
Hua Medicine and DKSH Hong Kong expanded their partnership to accelerate patient access to innovative drug therapies in Hong Kong.
Approved for adult type 2 diabetes under Hong Kong brand names MYHOMSIS®/華領片®; described as the first innovative drug for chronic metabolic diseases approved under Hong Kong's 1+ mechanism.
China National Intellectual Property Administration approved a PTE extending core patent protection to April 2034, with an additional 5-year market exclusivity.
Price remains unchanged for 2026-2027.
Company fully took over commercialization of HuaTangNing in China and built a professional sales team.
Dr. Li Chen, founder and CEO of Hua Medicine, received the award at the 17th C.C. Tan Life Science Award ceremony in Shenyang, China.
China's National Medical Products Administration approved the New Drug Application for HuaTangNing (dorzagliatin tablets, HMS5552), the first glucokinase activator approved and marketed globally.
Hua Medicine listed on HKEX; shares trade under stock code 2552.HK.
Combined USD- and RMB-denominated Series C of approximately $50 million led by Harvest Investments, with Frontline BioVentures leading existing-investor participation; round was more than 3x oversubscribed and China Renaissance acted as financial advisor. Proceeds to complete Phase 2 trials and accelerate Phase 3 development of HMS5552.
$50M source ↗
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
In the news
▸Research sources · 8
primary sources listed
- Hua Medicine: Homehuamedicine.com · web
8 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Hua Medicine do?
- Shanghai-based, HKEX-listed drug developer commercializing dorzagliatin, the first approved glucokinase activator for type 2 diabetes.
- Who are Hua Medicine's investors?
- Hua Medicine's investors include ARCH Venture Partners, F-Prime Capital, Venrock, 6 Dimensions Capital, Blue Pool Capital, Eight Roads Ventures, Ping An.