BrightGene subsidiary gets NMPA nod for obesity drug clinical trials

BrightGene Bio-Medical Technology Co., Ltd. announced its wholly-owned subsidiary, BrightGene Pharmaceutical (Suzhou) Co., Ltd., has received a Clinical Trial Approval Notice from the National Medical Products Administration (NMPA) for its BGM1812 injection. The approval allows BrightGene Pharmaceutical to conduct clinical trials for BGM1812 injection for the treatment of overweight or obesity.

BGM1812 injection is a novel, long-acting Amylin analog designed for weight reduction, possessing good molecular activity and pharmaceutical stability. The drug for the weight loss indication has already received FDA approval for clinical trials in the United States, with the first patient already enrolled. As of the announcement date, there are no other drugs with the same target approved for weight loss globally.

The company cautions that the drug will undergo further clinical trials before it can be produced and marketed, which will not significantly impact the company's operating performance in the short term. Drug development is a lengthy process with multiple approval stages, substantial R&D investment, and inherent risks.