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开拓药业-B:KX-826酊 1.0%治疗中国成年男性雄激素脱发关键性临床试验III期阶段达完成全部患者入组

Core Viewpoint - The company has completed the enrollment of 666 patients in the pivotal Phase III clinical trial for KX-826 topical solution 1.0% for the treatment of hair loss, which is a potential first-in-class product [1] Group 1: Clinical Trial Details - The pivotal clinical trial employs a seamless II/III phase design, with the Phase II stage achieving its primary endpoint with statistical significance and clinical relevance [1] - The trial is a multi-center, randomized, double-blind, placebo-controlled adaptive design study aimed at evaluating the efficacy and safety of KX-826 topical solutions 1.0% and 0.5% in treating androgenetic alopecia (AGA) in adult males in China [1] - The Phase III trial is being conducted at 25 clinical research centers nationwide, with a treatment duration of 24 weeks followed by a 2-week safety observation period, expected to complete by early 2026 [1] Group 2: Product Development and Market Considerations - Besides KX-826 topical solution and other cosmetic products, the company cannot ensure the successful development and eventual commercialization of other products related to KX-826 [1] - Shareholders and potential investors are advised to act cautiously when trading the company's shares [1]