China Resources Pharma's BGM0504 Injection, a GLP-1/GIP dual receptor agonist for weight loss, has received NDA acceptance from China's NMPA. The drug, developed with BrightGene Bio-Medical Technology, is also in Phase III trials for type 2 diabetes. The stock fell 1.4% on the session.
China Resources Pharma fell 1.4% even as its BGM0504 weight-loss drug received NDA acceptance from China's drug regulator.
"The NDA acceptance marks the product's transition from clinical development to the filing stage, taking a critical step toward commercialization," the company said in a statement.
BGM0504 Injection is a GLP-1/GIP dual receptor agonist developed jointly by China Resources Sanjiu Medical & Pharmaceutical, a subsidiary of China Resources Pharma, and BrightGene Bio-Medical Technology. Unlike single-target GLP-1 drugs such as Novo Nordisk's semaglutide, dual agonists target both the GLP-1 and GIP receptors, potentially offering greater weight reduction and improved metabolic benefits. The drug activates downstream pathways to produce biological effects including blood glucose control, weight reduction, and treatment of metabolic dysfunction-associated steatotic liver disease.
The drug is being developed for multiple indications in parallel. Its type 2 diabetes indication has entered Phase III clinical trials in China, while the weight-loss program has now reached the NDA filing stage. The company has not disclosed a timeline for the MASLD indication.
The NDA acceptance positions China Resources Pharma to compete in China's weight-loss drug market, where demand for GLP-1-based therapies has grown rapidly. Global leaders Novo Nordisk and Eli Lilly have dominated the category with semaglutide and tirzepatide, respectively, while domestic players including Shanghai Junshi Biosciences and Hangzhou Zhongmei Huadong Pharmaceutical are advancing their own candidates.
China has one of the world's largest obese populations, with more than 180 million adults classified as obese, according to the National Health Commission. The domestic GLP-1 market could reach 50 billion yuan ($6.9 billion) by 2030, analysts at CITIC Securities have estimated. For context, Novo Nordisk's Wegovy generated about 5.7 billion yuan in global sales in 2024, highlighting the revenue potential for approved therapies in China.
The stock saw short selling of HK$5.79 million, representing 16.8% of its trading volume, as of the latest session.
China Resources Pharma, a unit of state-owned China Resources Group, has been expanding its presence in innovative drugs beyond traditional Chinese medicine. The company's R&D spending has increased as it seeks to build a pipeline of novel therapies, with BGM0504 representing its most advanced internally developed drug candidate.
The NMPA's Center for Drug Evaluation will now review the BGM0504 submission, a process that typically takes six to 12 months for priority review candidates. The agency has been accelerating approvals for weight-loss drugs as obesity rates rise and public health concerns grow.
If approved, BGM0504 would be among the first domestically developed GLP-1/GIP dual agonists to reach the Chinese market, competing with imported drugs that currently command premium pricing.
The regulatory milestone reduces uncertainty around BGM0504's path to market and shows confidence in its clinical profile. Investors will watch for the NMPA's approval decision and the progress of the drug's Phase III diabetes trial in the coming months.
This article is for informational purposes only and does not constitute investment advice.
