BrightGene Submits NDA for GLP-1R/GIPR Dual Agonist BGM0504 for Chronic Weight Management

On June 11, the CDE website showed that,Borui Pharma(Rights Protection)ofGLP-1R/GIPR Agonist BGM0504 Files for Marketing Approval,For long-term weight management.

On May 5 this year, the Phase III clinical trial of BGM0504 for weight loss（BGM0504-Ⅲ-WL）Achieved the primary endpoint and all key secondary endpoints.

Full Analysis SetThe results showed that,At Week 52 of treatment, the mean body weight reduction from baseline in the BGM0504 injection trial groups (5 mg, 10 mg, and 15 mg) and the placebo group was 14.3%, 17.3%,19.2%and 3.1%, with body weight reduction of ≥5% from baseline in each treatment groupSubjectThe proportions were 84.7%, 89.8%, and 94.6%, respectively; in the high-dose group, body weight decreased by ≥15% from baselineSubject67.3% of patients with a body weight reduction of ≥20% from baselineSubjectThe proportion was 48.9%. In addition, the high-dose group showed a mean improvement in waist circumference of 16.5 cm from baseline (vs. 3.3 cm in the placebo group).

The per-protocol set results showed that the mean body weight in the BGM0504 injection trial groups (5 mg, 10 mg, and 15 mg) and the placebo group decreased from baseline by 14.6%, 16.9%, respectively.19.3%and 3.3%.

Borui Pharma onBGM0504Initiated multiple Phase III clinical trials, includingBGM0504 Head-to-Head Phase III Clinical Trial Against Semaglutide.

According to statistics from the Medicine Cube Nextpharma database, there are currently three domestically producedGLP-1R/GIPR AgonistsSubmitted for marketing approval, while the other two areRipretinib（Hengrui Pharma) andOleptide(Hansoh Pharma).