Announcement • Jul 27
Ascletis Pharma Inc. Announces Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, Demonstrates Superior Weight Loss in Diet-Induced Obese Mouse Model Ascletis Pharma Inc. announced that ASC37, a next-generation GLP-1R/GIPR/GCGR triple peptide agonist, demonstrated superior weight loss to tirzepatide in a diet-induced obese (DIO) mouse model. Following 11-day administration of ASC37 and tirzepatide at the same dose of 1 nmol/kg in DIO mice, ASC37 had statistically significant 88% greater relative body weight reduction compared to tirzepatide (Table 1). Furthermore, ASC37 demonstrated up to 41.5% weight loss in a dose-dependent fashion in the DIO mice (Table 1). Table 1. ASC37 demonstrated statistically and significantly more weight loss than tirzepatide in DIO mice following 11-day administration Dosing Total body weight change from baseline Greater relative weight loss versus tirzepatide 1 nmol/kg tirzepatide SQ, QD -7.5% – 1 nmol/kg ASC37 SQ, QD -14.1% 88% (p = 0.0279 vs tirzepatide) 10 nmol/kg ASC37 SQ, QD -30.1% 301% (p < 0.0001 vs tirzepatide) 30 nmol/kg ASC37 SQ, QD -41.5% 453% (p < 0.0001 vs tirzepatide) Note: DIO mice: diet-induced obese mice; SQ: subcutaneous; QD: once daily. ASC37 was engineered to have 41 alpha amino acids, which qualifies it as a biologic. The Investigational New Drug (IND) application of both ASC37 once-monthly subcutaneous (SQ) formulation and oral formulation will be submitted in the third quarter of 2026. Biologics license applications (BLAs) for both ASC37 once-monthly SQ formulation and oral formulation will be submitted to the FDA after Phase III completion. ASC35, a next-generation GLP-1R/GIPR dual peptide agonist, also has 41 alpha amino acids and will be submitted as a BLA as well. Compared to retatrutide, another triple peptide agonist, in non-human primate (NHP) studies, ASC37 SQ Self Assembly Lipid Depot (SALD) formulation had an average observed half-life of approximately 17 days compared to 2.5 days for retatrutide. This approximately 7-fold longer half-life for ASC37 confirms once-monthly or less dosing frequency. ASC37 qualifies as a biologic, offering a number of benefits, including longer statutory exclusivity periods and extended protection from government price negotiation compared to small molecules. Under the Inflation Reduction Act, biologics benefit from a longer exemption period of 13 years following FDA approval, instead of nine years for small molecules, before being subject to government price negotiations. There is also no regulatory path for biologics to be compounded by third-party pharmacies. This limits the ability of compounding pharmacies from potentially offering a lower-price version of ASC37 and ASC35. Live News • Jul 24
Ascletis Pharma Reports ASC36_35 Preclinical Data Surpassing Tirzepatide Combo in Obesity Model Ascletis Pharma reported preclinical data for its once-monthly ASC36_35 fixed-dose combination (FDC) for obesity, showing greater weight loss than an eloralintide and tirzepatide combination in a diet-induced obese animal model, with the results set for oral discussion at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting.
The company views ASC36_35 FDC as a potential advancement in obesity treatment, which, if supported by future clinical data, could influence how it approaches partnerships, pricing power and the size of its target market in metabolic disease.
Ascletis Pharma’s share price is HK$8.84, with the stock down 53.8% over the past 90 days. This suggests the market is not yet assigning clear value to this obesity program despite the positive preclinical signal.
The key question is whether Ascletis Pharma can convert this preclinical advantage into robust human data, since any setback or delay in clinical trials would materially affect the investment case around its obesity pipeline. New Risk • Jul 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Hong Kong stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Revenue is less than US$1m (CN¥2.0m revenue, or US$299k). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). 
