By Fineline Cube 
BioRay Biopharmaceutical (SHA: 688166) announced today that its dual‑agonist drug BGM0504 has received National Medical Products Administration (NMPA) approval to commence clinical trials in adults with overweight or obesity. The approval marks a significant milestone for the company’s metabolic‑disease pipeline and positions BGM0504 as a promising candidate for both weight management and type‑2 diabetes treatment.
What Is BGM0504?
- Dual GLP‑1/GIP Agonist – BGM0504 simultaneously targets glucagon‑like peptide‑1 (GLP‑1) and glucose‑dependent insulinotropic polypeptide (GIP) receptors, activating downstream pathways that regulate glucose homeostasis, appetite, and lipid metabolism.
- Broad Therapeutic Potential – Preclinical data indicate that BGM0504 can lower blood sugar, induce weight loss, and ameliorate non‑alcoholic steatohepatitis (NASH), suggesting utility across a spectrum of metabolic disorders.
- Injectable Formulation – The drug is administered via subcutaneous injection and is currently in Phase III trials in China for both type‑2 diabetes and weight loss.
Clinical Development Roadmap
| Phase | Status | Key Milestones |
|---|---|---|
| Phase III (China) | Ongoing | 1‑Year enrollment of 1,200+ adults with overweight/obesity; primary endpoints: % body‑weight loss, HbA1c reduction. |
| Global Expansion | Planned | Pending positive Phase III outcomes, BioRay will seek regulatory approval in the United States and EU. |
Market Context
The global obesity market is projected to exceed $300 billion by 2030, driven by rising prevalence and expanding indications for metabolic drugs. BGM0504’s dual‑agonist mechanism offers a differentiated profile relative to existing GLP‑1 monotherapies, potentially improving efficacy while maintaining a favorable safety profile.
Company Outlook
BioRay’s strategic focus on metabolic diseases aligns with its broader pipeline, which includes candidates for diabetes, NASH, and other obesity‑related conditions. The NMPA approval for BGM0504 enhances the company’s valuation prospects and strengthens its position as a leading biopharma player in China’s rapidly growing metabolic‑disease sector.-Fineline Info & Tech