Ascletis Pharma Finalizes Pre-NDA Consultation for Denifanstat in China

Ascletis Completes Pre-NDA Consultation for Denifanstat

Ascletis Pharma Inc., a biotechnology company listed on the Hong Kong Stock Exchange, has announced that it has successfully completed its pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat (ASC40). This treatment has shown promise for individuals suffering from moderate-to-severe acne vulgaris. The consultation process began in June 2025 and concluded in October 2025, setting the stage for an impending NDA submission.

Clinical Trial Success

The efficacy of denifanstat (ASC40) was assessed during a Phase III randomized, double-blind, placebo-controlled clinical trial. The results were promising; denifanstat met all primary and secondary efficacy endpoints based on an intention-to-treat (ITT) analysis. When compared to placebo, denifanstat demonstrated significant improvements in treating moderate-to-severe acne vulgaris, thus providing hope for many affected individuals.

Safety was another area where denifanstat excelled; all treatment-emergent adverse events (TEAEs) reported were either mild (Grade 1) or moderate (Grade 2). Notably, there were no severe (Grade 3 or 4) TEAEs linked to denifanstat, nor any serious adverse events (SAEs). The data also indicated that there were no permanent treatment discontinuations or patient withdrawals connected with the drug, underscoring its favorable safety profile.

Presentations and Future Directions

Following the successful trials, results were shared at the European Academy of Dermatology and Venereology (EADV) Congress held in Paris on September 17, 2025. This added another layer of credibility and recognition for denifanstat in the medical community.

Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc., securing exclusive rights to develop the drug for the Greater China region. This partnership is indicative of the strategic alliances Ascletis aims for in its mission to deliver advanced therapies.

About Ascletis Pharma Inc.

Ascletis Pharma is committed to the development and commercialization of innovative therapeutics that target unmet medical needs. Utilizing advanced technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and its Ultra-Long-Acting Platform (ULAP), Ascletis has cultivated a portfolio of drug candidates aimed at metabolic diseases. One of its flagship projects includes ASC30, which serves as both a treatment and maintenance therapy for chronic weight management. The company actively works on developing best-in-class therapies that reflect high standards in safety and efficacy.

For anyone interested in following the progress of denifanstat or Ascletis Pharma, more information can be found on their official website at www.ascletis.com.

Conclusion

With these significant developments in the approval process for denifanstat, Ascletis Pharma is positioning itself as a key player in the biotechnology field. Their commitment to addressing moderate-to-severe acne vulgaris has the potential to greatly enhance the quality of life for millions.

For further inquiries, representatives from Ascletis can be reached for additional information on their ongoing developments.