Ascletis Submits Groundbreaking Acne Drug for Approval in China

Ascletis Pharma has taken a major step forward in treating moderate-to-severe acne vulgaris in China. The company recently submitted a New Drug Application (NDA) for denifanstat (ASC40) to the National Medical Products Administration (NMPA). This follows years of clinical trials and a licensing deal with Sagimet Biosciences for exclusive rights in Greater China.

The drug’s journey began with Ascletis licensing denifanstat from Sagimet Biosciences, securing exclusive development and commercialisation rights across Greater China. The company then completed both Phase II and Phase III clinical trials, testing the drug’s effectiveness against moderate-to-severe acne.

The Phase III results, presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, showed clear success. Denifanstat met all primary and secondary goals, outperforming placebo with significant improvements in acne symptoms. Patients also tolerated the treatment well, with no severe side effects or early discontinuations reported.

Before submitting the NDA, Ascletis held a pre-application consultation with the NMPA, receiving positive feedback. The agency’s acceptance of the NDA marks a key milestone in bringing this new therapy to Chinese patients.

With the NDA now under review, Ascletis moves closer to offering a novel treatment option for those with moderate-to-severe acne. The drug’s strong clinical performance and regulatory progress suggest it could soon become available to patients in China. If approved, denifanstat would expand the limited range of effective therapies for this common skin condition.