BrightGene subsidiary gets approval for oral obesity drug trial

BrightGene Bio-Medical Technology announced that its wholly-owned subsidiary, BrightGene Pharmaceutical (Suzhou) Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its BGM0504 tablets. This approval allows BGM0504 tablets to proceed with clinical trials in adult overweight and obese patients.

BGM0504 is an independently developed dual GLP-1 and GIP receptor agonist, which holds potential for treating various metabolic diseases by controlling blood sugar, reducing weight, and treating non-alcoholic steatohepatitis (NASH). The BGM0504 injectable form is currently in Phase III clinical trials in China for Type 2 diabetes and weight loss.

As of the disclosure date, BGM0504 tablets represent an oral dosage form of BGM0504, and there are currently no approved oral formulations for similar targets globally. The company cautioned investors that drug development involves long cycles and significant investment, with outcomes subject to multiple factors and inherent uncertainties.