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, indicating significant progress in its development pipeline [1] Group 1: Clinical Trial Details - The pivotal clinical trial employs a seamless II/III phase design, with the II phase achieving primary endpoints that are statistically significant and clinically meaningful [1] - The study is a multicenter, randomized, double-blind, placebo-controlled adaptive design aimed at evaluating the efficacy and safety of KX-826 1.0% and 0.5% in treating adult male AGA patients 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 Risks - Apart from 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]
开拓药业-B(09939):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