According to the Zhitong Finance App, Goli Pharmaceutical-B (01672.HK) announced that oral administration of the small molecule GLP-1 (ASC30) once a day has obtained phase III clinical study approval from the US Food and Drug Administration (FDA). ASC30 is the core pillar of Geli's oral small molecule obesity treatment pipeline. The company has initiated a global phase III clinical program for long-term weight management indications for ASC30. The program consists of two key multicenter, randomized, double-blind, placebo-controlled global phase III trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450), which will enroll approximately 4,600 obese or overweight subjects in the US, Europe and Canada. These two key studies will evaluate the long-term efficacy, safety, and tolerability of taking three oral maintenance doses (20 mg, 40 mg, and 60 mg) of ASC30 versus placebo once daily in non-type 2 diabetic obese or overweight subjects (AURORA-1) and obese or overweight subjects with type 2 diabetes (AURORA-2). The treatment cycle for AURORA-1 and AURORA-2 was 72 weeks, and the titrations (titrations) for the 20 mg, 40 mg, and 60 mg maintenance dose groups were 12 weeks, 16 weeks, and 20 weeks, respectively. The company is expected to release top-line data for the ASC30 phase III clinical program in the third quarter of 2028, and plans to submit a new drug marketing application (NDA) to the US FDA at the end of 2028 and a marketing license application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by relevant regulators in the US and Europe, ASC30 is expected to become the second oral small molecule GLP-1 approved in the US and Europe after Orforglipron. The company has sufficient cash on hand to cover the expected submission of ASC30 NDAs and MAAs, and to support the company's operations until 2029.

According to the Zhitong Finance App, Goli Pharmaceutical-B (01672.HK) announced that oral administration of the small molecule GLP-1 (ASC30) once a day has obtained phase III clinical study approval from the US Food and Drug Administration (FDA). ASC30 is the core pillar of Geli's oral small molecule obesity treatment pipeline. The company has initiated a global phase III clinical program for long-term weight management indications for ASC30. The program consists of two key multicenter, randomized, double-blind, placebo-controlled global phase III trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450), which will enroll approximately 4,600 obese or overweight subjects in the US, Europe and Canada. These two key studies will evaluate the long-term efficacy, safety, and tolerability of taking three oral maintenance doses (20 mg, 40 mg, and 60 mg) of ASC30 versus placebo once daily in non-type 2 diabetic obese or overweight subjects (AURORA-1) and obese or overweight subjects with type 2 diabetes (AURORA-2). The treatment cycle for AURORA-1 and AURORA-2 was 72 weeks, and the titrations (titrations) for the 20 mg, 40 mg, and 60 mg maintenance dose groups were 12 weeks, 16 weeks, and 20 weeks, respectively. The company is expected to release top-line data for the ASC30 phase III clinical program in the third quarter of 2028, and plans to submit a new drug marketing application (NDA) to the US FDA at the end of 2028 and a marketing license application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by relevant regulators in the US and Europe, ASC30 is expected to become the second oral small molecule GLP-1 approved in the US and Europe after Orforglipron. The company has sufficient cash on hand to cover the expected submission of ASC30 NDAs and MAAs, and to support the company's operations until 2029.