Ascletis Pharma-B (01672) shares rose more than 5% in early trading, recently gaining 4.89% to HK$9.44, with a turnover of approximately HK$20.63 million. On August 3, the company announced that its once-daily oral small molecule GLP-1 drug, ASC30, received approval from the U.S. Food and Drug Administration (FDA) for Phase 3 clinical trials.

ASC30 is a core component of Ascletis's oral small molecule obesity treatment pipeline. The company has initiated a global Phase 3 clinical program for long-term weight management, encompassing two key trials in the United States, Europe, and Canada, targeting enrollment of about 4,600 obese or overweight subjects.

Topline data from the ASC30 Phase 3 program is expected to be released in the third quarter of 2028. Ascletis plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2028, followed by a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by regulators in the U.S. and Europe, ASC30 is poised to become the second oral small molecule GLP-1 approved in those regions, following orforglipron.