Core Insights - The company reported significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting, indicating its potential clinical importance [1] - Denifanstat (ASC40) demonstrated statistically significant and clinically meaningful improvements compared to placebo across all primary and secondary endpoints, along with good safety and tolerability profiles [1] - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) process, with positive feedback received [1] Group 1 - Denifanstat (ASC40) is an innovative therapy in the acne treatment field [1] - The company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne after completing pre-NDA communications with NMPA [1] Group 2 - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]
歌礼制药-B(01672)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