#China #Hong Kong #Ascletis #ASC35 #ASC36

Ascletis Pharma Expands Obesity Treatment Pipeline

On July 5, 2026, Ascletis Pharma Inc. (HKEX: 1672) announced a significant advancement in the field of obesity treatment with the submission of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA). The applications are for ASC36, a once-monthly injection utilizing a peptide amylin receptor agonist, and ASC36_35 FDC, which is a co-formulation of ASC36 and the peptide GLP-1R/GIPR agonist ASC35.

Children and adults combating obesity often face challenges with traditional weight loss methods, leading to increased reliance on pharmaceutical innovations. Ascletis offers hope through ASC36_35 FDC, which is positioned as a potentially first-in-class treatment that not only simplifies the administration process but also shows promising efficacy in preclinical studies.

Improved Efficacy through Innovation

ASC36_35 FDC is designed as a subcutaneous injection that can be administered monthly. This contrasts with current options like eloralintide and tirzepatide, which require patients to manage two separate weekly injections. Dr. Jinzi Jason Wu, the CEO and founder of Ascletis, emphasized the product's advantages, stating that ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the dual administration of these two traditional treatments in head-to-head studies conducted on diet-induced obese rats.

The underlying efficacy of ASC36 comes from its focus on three validated targets—amylin receptor, GLP-1R, and GIPR. This tripartite approach was established by employing Ascletis' innovative Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) techniques, leading to stronger drug candidates.

Advanced Formulation Technology

Both ASC36 and ASC35 are developed using Ascletis' cutting-edge Ultra-Long-Acting Platform (ULAP) technology and Self-Assembling Lipid Depot (SALD) formulations. In preclinical trials involving non-human primates, ASC36 revealed a half-life approximately six times longer than that of eloralintide. This impressive pharmacokinetic profile supports the potential for once-monthly patient administration, enhancing adherence and efficacy in treatment.

ASC36 alone has shown remarkable results, achieving roughly 91% and 32% greater weight reductions compared to petrelintide and eloralintide, respectively, in targeted studies. Such outcomes reinforce the promise these new treatments hold in ameliorating obesity, specifically in human subjects where outcomes can be expected to mirror those seen in animal models.

Future Prospects

Ascletis is continuously striving to strengthen its obesity treatment portfolio. Following the clearance for ASC35's IND, which allows for the initiation of Phase 1 clinical trials within the U.S., the company plans to build on its momentum with these two latest submissions. Both ASC36 and ASC36_35 FDC have demonstrated excellent stability in formulations, maintaining their effectiveness without aggregation or precipitation over time.

As obesity continues to be a global health concern, innovations like those from Ascletis can play a crucial role in providing accessible and effective treatments for those struggling with weight management issues. The advancements presented by the company provide a refreshing alternative for healthcare providers and patients alike, which could contribute significantly to the future landscape of obesity treatment.

Conclusion

With their recent submissions, Ascletis Pharma positions itself at the forefront of revolutionary obesity therapies, advocating for patients who are often underserved in current healthcare paradigms. The results seen in preliminary studies may ignite a new phase in effective weight management strategies and highlight the role of advanced biotechnology in pharmaceuticals.

For ongoing updates about Ascletis and its groundbreaking research into therapies targeting metabolic diseases, visit Ascletis' official website.