- CEO
- Li Chen
- Full Time Employees
- 168
- Sector
- Healthcare
- Industry
- Drug Manufacturers - Specialty & Generic
- Address
- Building A Shanghai People's Republic of China
- IPO Date
- Mar 15, 2021
- Business
- Hua Medicine (Shanghai) Ltd. (HUMDF) is an innovative biopharmaceutical company focused on the research, development, and commercialization of novel therapies targeting glucokinase activators (GKA) for type 2 diabetes (T2D) and related metabolic disorders. The company offers its cornerstone product, HuaTangNing (dorzagliatin tablets, HMS5552), an oral allosteric glucokinase full activator approved by China's National Medical Products Administration (NMPA) in September 2022 for adult T2D patients as monotherapy or in combination with metformin; it requires no dose adjustment for patients with chronic kidney disease and restores glucose homeostasis by improving beta-cell function and insulin sensitivity in pancreatic islets, liver, and other glucose-regulating organs. Its pipeline includes fixed-dose combinations such as dorzagliatin-metformin, dorzagliatin-DPPIV inhibitor, dorzagliatin-SGLT-2 inhibitor, dorzagliatin-insulin, and dorzagliatin-GLP-1; a second-generation GKA (HM-002-1005) advancing toward once-daily dosing following U.S. Phase I single-ascending dose completion; and exploratory indications in prediabetes, maturity-onset diabetes of the young (MODY-2), cystic fibrosis-related diabetes, obesity, and non-alcoholic steatohepatitis (MASH). Founded in 2011 and headquartered in Shanghai, China, with divisions in the United States and Hong Kong, Hua Medicine operates primarily in China while pursuing global expansion, including Southeast Asia, Greater China, and the U.S.
In recent developments, the company terminated its exclusive promotion service agreement with Bayer effective January 1, 2025, assuming full independent commercialization of HuaTangNing in China, which drove HuaTangNing sales volume to 1,764,000 packs (up 108% year-on-year) and net sales to RMB217.4 million (up 112%) in the first half of 2025, alongside a first-time pre-tax profit of RMB1,183.9 million from released deferred income. Hua Medicine submitted a new drug registration application in Hong Kong for dorzagliatin 75mg (branded MYHOMSIS, 华领片) to support expansion into Greater China and Southeast Asia; expanded manufacturing capacity and gross margins to 54.2%; and advanced real-world evidence through the BLOOM study across 80 Chinese centers involving 2,000 T2D patients, confirming safety in diverse comorbidities and combinations with SGLT-2 inhibitors, insulin, GLP-1 agonists, and DPP-IV inhibitors. Additional progress includes U.S. FDA clearance for a Phase I investigator-initiated trial in cystic fibrosis-related diabetes, pre-IND submission for dorzagliatin-metformin fixed-dose combination with bioequivalence studies planned for 2026, new data presented at the 2025 American Diabetes Association conference on dorzagliatin's disease-modifying potential including remission (65.2% drug-free at week 52 in SEED extension), cognitive/lipid/muscle benefits, and Mendelian randomization evidence for diabetic complications. The company maintains 168 employees, over 200 global patents, and cash reserves of RMB1,022.8 million as of June 30, 2025, targeting diabetes prevention, longevity, and neural homeostasis through AI-enhanced platforms and partnerships.