Zhitong Finance App News, Goli Pharmaceutical-B (01672) issued an announcement. The company has submitted an ASC30_39 FDC clinical trial application (IND) for the new drug for the treatment of obesity to the US Food and Drug Administration (FDA). ASC30_39 FDC is a once-daily oral fixed-dose combination preparation (FDC) tablet of the small molecule GLP-1R agonist ASC30 and the small molecule selective pancreatin receptor agonist (SARA) ASC39.

“ASC30_39 FDC is the first combination of oral GLP-1 and oral insulin to be submitted to IND, combining two proven and complementary weight management mechanisms in a single daily tablet.” Dr. Wu Jinzi, founder, chairman of the board of directors and CEO of Geli said, “By combining the potential best-in-class efficacy and gastrointestinal tolerability of ASC30 with the first oral small molecule insulin similar to eloralintide, we believe ASC30_39 FDC can provide a highly differentiated and convenient oral treatment option for people with obesity.”

This IND submission is based on recent milestones in the Geli Oral Small Molecule Pipeline. ASC30 is currently conducting two key global phase III studies (AURORA-1 and AURORA-2), enrolling approximately 4,600 obese or overweight subjects in the US, Europe, and Canada. Curie is expected to release top-line data for the AURORA phase III clinical program in the third quarter of 2028. Curie recently announced that it has submitted its IND for the treatment of obesity with ASC39, an oral small molecule selective insulin receptor agonist, to the US FDA.