Zhitong Finance App News, Goli Pharmaceutical-B (01672) announced that the new generation GLP-1R/GIPR/GCGR [1] tri-target agonist polypeptide ASC37 has shown superior weight loss effects compared to tiverpotide in diet-induced obesity (DIO) mouse models. In DIO mice, after 11 days of administration at the same dose of 1 nmol/kg, the weight loss effect of ASC37 was relatively increased by 88% compared to tiverpotide, and the differences were statistically significant (Table 1). Furthermore, in DIO mice, ASC37 achieved up to 41.5% weight loss and was dose-dependent.
After 11 days of administration, the weight loss effect of ASC37 was superior to terpotide in DIO mice, and the differences were statistically significant.
Through precise targeted design, ASC37 contains 41 α-amino acids and is eligible as a biological product. ASC37 will submit monthly New Drug Clinical Trial Applications (INDs) for subcutaneous preparations and oral formulations in the third quarter of 2026. ASC37 will submit monthly biological product licensing applications (BLA) for subcutaneous preparations and oral formulations to the FDA after completion of phase III clinical trials. The new-generation GLP-1r/GIPR dual-target agonist polypeptide ASC35 also contains 41 alpha amino acids, and will also be declared for marketing through the Biological Product License Application (BLA) channel.
Compared with retatrutide, another tri-target agonist, the average apparent half-life (apparent half-life) of the ASC37 subcutaneous self-assembled lipid reservoir (SALD) preparation in non-human primates (NHP) studies was about 17 days, while retatrutide was 2.5 days. Asc37, which has a half-life of about 7 times that of retatrutide, supports dosing once a month or less.
“Based on these encouraging preclinical data, we believe ASC37 has the potential to be the first-in-class (first-in-class) subcutaneous triple-target agonist peptide for patients with severe obesity, and also has the added advantage of being declared through the BLA registration path,” said Dr. Wu Jinzi, founder, chairman of the board and CEO of Geli. “Obtaining biological product qualifications provides ASC37 with many advantages, including a longer legal market monopoly period and a longer protection period from government price negotiations compared to small-molecule drugs.”
According to the Inflation Reduction Act (Inflation Reduction Act), biological products enjoy a price negotiation exemption period of up to 13 years (not 9 years for small molecule drugs) after approval by the FDA, before being bound by government price negotiations. Furthermore, the regulatory path does not allow third-party pharmacies to make generic compounds (compounds) of biological products. This limits the possibility for compounding pharmacies (compounding pharmacies) to offer lower cost versions of ASC37 and ASC35.