Core Viewpoint - The company announced the presentation of significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting, highlighting its innovative mechanism and positive outcomes compared to placebo [1] Group 1: Clinical Research and Results - Denifanstat (ASC40) is positioned as an innovative therapy in the acne treatment field with potential clinical significance [1] - The Phase III study demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to placebo, along with good safety and tolerability profiles [1] Group 2: Regulatory and Market Strategy - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) for denifanstat (ASC40) [1] - Feedback from NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [1] Group 3: Licensing Agreement - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]
歌礼制药-B在2025年欧洲皮肤病与性病学会(EADV)年会最新突破性研究专场报告了同类首创脂肪酸合成酶(FASN)抑制剂地尼法司他(ASC40) 治疗痤疮的III期研究结果