By Fineline Cube 
BrightGene Bio-Medical Techonology Co., Ltd. (SHA: 688166) disclosed that China’s National Medical Products Administration (NMPA) has approved the conduct of clinical trials for its BGM1812 long‑acting amylin analogue, targeting overweight and obesity. The drug has also received U.S. Food and Drug Administration (FDA) approval to initiate clinical studies, and the first U.S. patient has already been enrolled.
Product Overview
- BGM1812 – a novel, long‑acting amylin analogue engineered for superior molecular potency and pharmaceutical stability.
- Mechanism of Action – amylin is a 37‑amino‑acid satiety peptide co‑released with insulin; it suppresses appetite via central satiety pathways, delays gastric emptying, and inhibits glucagon secretion, yielding a multi‑pathway weight‑loss effect.
- Clinical Indication – overweight or obesity; no other agent with the same target has received global marketing approval for weight‑loss.
Regulatory Milestones
| Region | Authority | License | Date |
|---|---|---|---|
| China | NMPA | Clinical‑trial approval for BGM1812 (obesity) | 14 Nov 2025 |
| U.S. | FDA | Clinical‑trial clearance for BGM1812 (weight‑loss) | 14 Nov 2025 |
| U.S. | – | First patient enrolled in Phase I trial | 24 Nov 2025 |
Clinical Development Roadmap
- Phase I/II (China) – enrollment to begin Q1 2026, focusing on safety, pharmacokinetics, and dosing in adults with BMI ≥ 25 kg/m².
- Phase I (U.S.) – early‑phase study underway; primary objectives: safety, tolerability, dose‑response, and preliminary efficacy in the U.S. obesity population.
- Global Expansion – positive outcomes in both markets could launch a parallel development strategy for later‑phase studies and eventual U.S. approval (FDA), followed by international commercialization.
Market Landscape & Opportunity
The global obesity‑treatment market is estimated to surpass $20 B by 2030. BGM1812’s multi‑mechanistic approach differentiates it from current single‑mechanism therapies such as GLP‑1 receptor agonists and could enhance adherence due to its once‑daily, long‑acting profile.
Forward‑Looking Statements
This report includes forward‑looking information regarding regulatory approvals, trial enrollment, and commercial prospects. Actual results may differ materially from those expressed herein.-Fineline Info & Tech