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开拓药业-B(09939.HK):GT20029凝胶治疗痤疮中国II期临床试验达到主要终点
Ge Long Hui· 2025-08-11 22:40
Group 1 - The core product GT20029 has successfully completed Phase II clinical trials for acne treatment, achieving primary endpoints with statistical significance and clinical relevance [1][2] - The recommended dosage for the upcoming Phase III clinical trial has been established at 0.5% [1] - The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled study conducted at 10 centers across China, led by Professor Xiang Leihong from Huashan Hospital [1] Group 2 - GT20029 is developed based on the company's proprietary PROTAC platform and is positioned as a next-generation treatment for androgenetic alopecia and acne [2] - It is the first topical PROTAC compound globally to complete Phase II clinical trials, maintaining a leading position in the market [2] - The company is planning to initiate Phase III clinical trials for GT20029 in acne treatment to further expand its first-mover advantage in the topical PROTAC field [2] Group 3 - Winlevi® (clascoterone 1%) is the first acne medication approved by the FDA in nearly 40 years with a new mechanism of action, indicating the validation of targeting androgen receptors for acne treatment [2] - Winlevi® has become the most prescribed brand topical acne medication in the U.S., with over 1.3 million prescriptions written by more than 17,900 physicians since its launch [2] - The approval of acne medications targeting AR pathways suggests a promising market for GT20029 as an innovative, safe, and effective treatment option for dermatologists and patients [2]