BrightGene：BGM0504 has been formally accepted for review.

On June 11, the CDE official website showed that a New Drug Application (NDA) for BrightGene Pharmaceutical’s BGM0504 Injection has been accepted. According to the Insight database, the proposed indication is for overweight or obesity.

BGM0504 is a GLP-1 and GIP receptor dual agonist independently developed by BrightGene Pharmaceutical. It simultaneously activates downstream signaling pathways of both GLP-1 and GIP, producing biological effects including blood glucose control, body weight reduction, and improvement of multiple metabolic parameters.

In May of this year, BrightGene Pharmaceutical announced that BGM0504 had achieved positive topline results in a Phase III clinical study (Project No.: BGM0504-III-WL) designed to evaluate its efficacy and safety in overweight or obese subjects.

BGM0504-III-WL was a randomized, double-blind, placebo-controlled Phase III study enrolling 652 overweight or obese participants, including a subset with baseline hypertension whose blood pressure was not at target. During the study, these subjects generally did not use other antihypertensive medications. The mean baseline body weight of all enrolled participants was 96.2 kg, with a mean baseline BMI of 33.9 kg/m². Baseline characteristics were generally balanced across all dose groups. All subjects received BGM0504 Injection at doses of 5 mg, 10 mg, and 15 mg, or placebo, according to the protocol, with a treatment period of 52 weeks.

The results showed that the study met its primary endpoint and all key secondary endpoints. The product achieved a mean body weight reduction of 19.3% and a waist circumference reduction of 16.5 cm. In the hypertensive population, after 36 weeks of treatment, mean systolic blood pressure and diastolic blood pressure decreased by 22.9 mmHg and 12.9 mmHg from baseline, respectively. Additionally, mean uric acid decreased by 70.7 μmol/L, while whole-body bone mineral density, lumbar spine bone mineral density, and hip bone mineral density increased by 0.3%, 1.4%, and 3.9%, respectively. Prominent comprehensive improvements were also observed in other cardiometabolic parameters, including blood lipids and blood glucose.

Moreover, while achieving robust efficacy, BGM0504 demonstrated a favorable overall safety and tolerability profile. The treatment discontinuation rates due to adverse events at 52 weeks in the 5 mg, 10 mg, and 15 mg dose groups were 1.7%, 1.2%, and 0.7%, respectively.

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