G Sight Pharma-B (01672) announced the initiation of its global Phase III clinical trial for the oral small molecule ASC30 targeting GLP-1 and released positive preclinical data for its first-in-class oral small molecule GLP-1/GIP and fixed-dose combination formulation of amylin.

Zhitong Finance APP reported that Ganyuan Pharmaceutical-B (01672) announced that its oral small molecule GLP-1 (ASC30) has received approval from the U.S. Food and Drug Administration (FDA) for a Phase III clinical study. ASC30 is the cornerstone of Ganyuan's oral small molecule obesity treatment pipeline. The company has launched a global Phase III clinical program targeting ASC30 for long-term weight management indications, which consists of two key multicenter, randomized, double-blind, placebo-controlled global Phase III trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450), aiming to enroll approximately 4,600 obese or overweight subjects across the United States, Europe, and Canada. These two pivotal studies will evaluate the long-term efficacy, safety, and tolerability of ASC30 administered once daily at three maintenance doses (20 mg, 40 mg, and 60 mg) compared to placebo, in obese or overweight subjects without type 2 diabetes (AURORA-1) and in obese or overweight subjects with type 2 diabetes (AURORA-2). The treatment period for both AURORA-1 and AURORA-2 is 72 weeks, with titration periods of 12 weeks, 16 weeks, and 20 weeks for the 20 mg, 40 mg, and 60 mg maintenance dose groups, respectively. The company expects to announce the top-line data from the ASC30 Phase III clinical program in the third quarter of 2028 and plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2028, as well as a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by the relevant regulatory authorities in the U.S. and Europe, ASC30 is expected to become the second oral small molecule GLP-1 approved in the U.S. and Europe, following orforglipron. The company has ample cash on hand to cover the anticipated ASC30 NDA and MAA submissions and support its operations until 2029.