15 Major Events of Hua Medicine in 2025
01
Hua Medicine launched the "Hundred People, Hundred Days Action" for dorzagliatin commercialization, opening up a new way to market the innovative drug in China.
02
Hua Medicine independently carried out commercialization of HuaTangNing(华堂宁®) in China, building an in-house sales team of over 100 people. With the continuous expansion of medical insurance coverage, HuaTangNing(华堂宁®)'s sales volume and sales revenue both doubled in the first half of the year, and the annual performance achieved rapid growth, demonstrating remarkable results in fully independent commercialization.
Source: https://www.huamedicine.com/news-188
03
Hua Medicine successfully explored Hong Kong's innovative drug registration policy. In September, the Department of Health of the Hong Kong Special Administrative Region of China officially accepted the New Drug Application (NDA) for dorzagliatin. Hong Kong will become an important pivot for the company to expand into Southeast Asian and global markets, exploring a new path for Chinese innovative drugs to go global.
Source: https://www.huamedicine.com/news-192
04
At the 85th Scientific Sessions of the American Diabetes Association (ADA), a study conducted by the team of Professor Basu, a tenured professor in the Division of Endocrinology, Diabetes, and Metabolism at the University of Alabama at Birmingham, demonstrated that dorzagliatin can increase total UDP-glucose flux through the direct pathway of glycogen synthesis. This finding suggests that dorzagliatin is capable of improving impaired hepatic glycogen metabolism, and possesses a mechanism that restores hepatic glycogen production or storage in patients with type 2 diabetes and effectively reduces postprandial blood glucose levels.
Source: https://doi.org/10.2337/db25-855-P
05
The Investigator-Initiated Trial (IIT) of dorzagliatin for the treatment of Cystic Fibrosis-related Diabetes (CFRD), conducted by the University of Pennsylvania in the United States, has completed the Investigational New Drug (IND) application and clinical center initiation in the United States, laying the foundation for the development of dorzagliatin's rare disease indication.
Source: https://clinicaltrials.gov/study/NCT06995651?cond=Cystic%20Fibrosis-related%20Diabetes&term=dorzagliatin&rank=1
06
At the 85th Scientific Sessions of the American Diabetes Association (ADA), an oral presentation by the team of Basu pointed out that compared with metformin and insulin glargine, dorzagliatin reduces nocturnal glucose production by lowering glycogenolysis and gluconeogenesis, further confirming its unique mechanism of action in controlling diabetes from the root.
Source: https://doi.org/10.2337/db25-38-OR
07
The fixed-dose combination of dorzagliatin and metformin completed the IND application in China, with registration clinical trials expected to be completed in 2026.
08
In December, Hua Medicine initiated the Phase Ib Multiple Ascending Dose (MAD) clinical trial of the second-generation GKA in the United States and successfully administered the first dose to a trial participant. The company continues to explore the feasibility of a once-daily oral administration regimen for the treatment of patients with type 2 diabetes mellitus combined with obesity.
Source: https://www.huamedicine.com/news-195
09
Hua Medicine conducted a real-world study of dorzagliatin (BLOOM Study) covering a broader population to evaluate the long-term safety, efficacy, and combination medication value of dorzagliatin, as well as to expand its indication potential. Currently, the study has completed the last patient enrollment.
10
Dorzagliatin has completed the marketing registration application in the Macao Special Administrative Region of China and will use this as an export base to cover 9 Portuguese-speaking countries.
11
Dorzagliatin Tablets successfully renewed its listing in the new version of the National Medical Insurance Catalog at the original price and was selected by the National Healthcare Security Administration as a representative of high-quality innovative products for exhibition.
Source: https://www.nhsa.gov.cn/art/2025/12/7/art_104_18970.html
12
Dorzagliatin tablets successfully complete process scale-up, new production capacity goes into operation in shanghai.
13
Hua Medicine actively uses artificial intelligence to engage the innovation of scientific promotion models for innovative drugs and delivered a report at the 27th Academic Conference of the Chinese Diabetes Society (CDS). The company is launching a chronic disease education intelligent platform—GK Charger—based on large language models and knowledge graphs, providing AI technical tools for auxiliary decision-making in the diagnosis and treatment of related diseases.
Source: Oral Presentation at CDS 2025: Intelligent Q&A Platform Based on Large Language Model and Knowledge Graph – GK Charger, Paper ID: 863
14
Researchers from the Diabetes and Metabolic Diseases Center of The Chinese University of Hong Kong published a paper in a top medical journal Diabetes Obesity and Metabolism, pointing out that using Mendelian randomization research methods, GK gene activation has the potential to reduce the body's frailty index and extend telomere length. Another prediction indicates that dorzagliatin may benefit major diabetes-related complications, such as reducing the risk of heart failure, coronary artery disease, memory loss, and dyslipidemia.
Source: https://doi.org/10.1111/dom.16312
15
A Chinese scientific team reported a case of dorzagliatin in the treatment of hyperglycemia induced by the anti-tumor drug PI3K inhibitor in Molecules Medicine, indicating that dorzagliatin has good application prospects in addressing PI3K inhibitor-related hyperglycemia, thereby improving the therapeutic effect of the drug class.
Source: https://doi.org/10.1016/j.molmet.2025.102151