ASCLETIS-B (01672.HK): files IND with US FDA for ASC30_39 FDC in obesity, a first-in-class oral combo

NewTimeSpace News: On 11 November 2026, Ascletis Pharma Inc. (01672.HK) announced voluntarily that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC for the treatment of obesity. The product is a once-daily oral fixed-dose combination (FDC) tablet of ASC30, a small molecule GLP-1R agonist, and ASC39, a small molecule selective amylin receptor agonist (SARA), and is the first oral GLP-1 and oral amylin combination for which an IND has been filed.

Both ASC30 and ASC39 were discovered and developed in-house using the Company's structure-based AI-assisted drug discovery (AISBDD) technology, while the FDC was developed with the Company's proprietary formulation technology, demonstrating good compatibility between the two components, room-temperature stability and a small tablet size. Following oral administration in dogs, ASC30_39 FDC showed excellent oral bioavailability, high drug exposure and a half-life of up to 12 hours; in a head-to-head dog study, these key pharmacokinetic parameters were consistent with those observed for ASC30 and ASC39 as monotherapies. ASC30 is currently being evaluated in two global pivotal Phase III studies (AURORA-1 and AURORA-2), which are enrolling about 4,600 subjects with obesity or overweight in the United States, Europe and Canada, with topline data from the AURORA Phase III programme expected in the third quarter of 2028. The Company recently also filed an IND with the FDA for ASC39 monotherapy in obesity.

Monotherapy data show that ASC30 has a favourable gastrointestinal tolerability profile, with the incidence of vomiting being half that of orforglipron in a non-head-to-head study in which both drugs were titrated weekly; ASC39 is 40 times more selective for the human amylin type 1 receptor (hAMY1R) than for the human calcitonin receptor (hCTR), and after six consecutive days of once-daily oral dosing in diet-induced obese (DIO) rats achieved placebo-adjusted weight loss of 6.6%, comparable to 5.6% for eloralintide. Pursuant to Rule 18A.05 of the Listing Rules, the Company cannot guarantee that it will ultimately be able to successfully develop, market and/or commercialise ASC30, ASC39 and/or ASC30_39 FDC.