#Hong Kong #Ascletis #ASC35 #ASC36

Ascletis Unveils Innovative Co-formulation for Weight Management

Ascletis Pharma Inc., a leader in biotechnology innovation, has recently announced the co-formulation of two groundbreaking drugs: ASC36, a next-generation amylin receptor agonist, and ASC35, a dual agonist targeting GLP-1R/GIPR. Both are designed for once-monthly subcutaneous administration, catering to individuals living with obesity. This co-formulation has emerged from Ascletis' Ultra-Long-Acting Platform technology, showcasing impressive stability and the potential for improved therapeutic outcomes.

In a pivotal development, the co-formulation of ASC36 and ASC35 demonstrated an encouraging pharmacokinetic profile in non-human primate studies, closely matching the individual profiles of these agents when administered separately. This finding is crucial as it supports the practicality and efficacy of the combined treatment approach, reinforcing Ascletis' commitment to advancing solutions for cardio-metabolic diseases.

In comparative studies, ASC36 as a monotherapy exhibited approximately 32% greater weight reduction compared to eloralintide. Meanwhile, ASC35 achieved a staggering 71% greater relative body weight reduction over tirzepatide. When combined, the effects were even more pronounced—yielding roughly 51% greater weight loss compared to the combination of eloralintide and tirzepatide in diet-induced obese rat studies. These compelling results position the co-formulation as a potentially game-changing option for those struggling with weight management.

Unique Advantages of Co-formulation

The successful co-formulation showcases excellent chemical and physical stability, with no adverse aggregation or precipitation issues at neutral pH. Many amylin receptor peptide agonists suffer from stability problems which compromise their effectiveness. Ascletis has mitigated these risks, thereby enhancing the potency and reliability of both agents. The design phase utilized Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery technology, paving the way for precision medication development.

Ascletis plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026, linking this groundbreaking effort to an urgent need for effective obesity treatments in the U.S. market. As the world grapples with obesity—often considered an epidemic—Ascletis' developments are timely and promising.

Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, expressed strong optimism regarding the new formulation, stating, "Based on these encouraging preclinical data, we believe the co-formulation of ASC36 and ASC35 offers significantly enhanced weight loss outcomes compared to existing treatments."

Future Directions

Ascletis is laying the groundwork for ASC36 to serve as the central element of a new class of monthly therapies targeting cardio-metabolic conditions, particularly obesity. The company continues to explore combinatory approaches, potentially pairing ASC36 with additional agents like ASC47, aimed at enhancing metabolic regulation via thyroid hormone mechanisms.

As anticipation mounts for these revolutionary treatments, Ascletis invites the scientific community and the public to follow its progress. A conference call is scheduled for November 13, 2025, where Dr. Wu will elaborate on the co-formulation's implications and future developments.

In conclusion, the innovative work by Ascletis Pharma reflects a significant leap in the pharmaceutical landscape for obesity treatment, promising better patient adherence and outcomes through advanced drug delivery systems. Their commitment to harnessing artificial intelligence and long-acting therapeutic models embodies the future of effective metabolic healthcare. For more details, you can visit Ascletis' official website or contact their PR and IR teams for further insights.