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First Subject Enrollment In Phase 3 Stage Of KX-826 1.0% For AGA

Release time：2024-12-30 10:30

Suzhou, 30 December, 2024-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the Company has successfully completed the first subject enrollment recently in the phase III stage (the “Phase III Stage”) pivotal clinical trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of male adult AGA in China.

 

The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-826 tincture 1.0% for the topical treatment of male adults with AGA in China. The Pivotal Clinical Trial adopts a phase II/III operational seamless design, namely 2-in-1 design, with Professor Jianzhong Zhang (張建中) and Professor Cheng Zhou (周城) from Peking University People’s Hospital as the lead principal investigator. The Phase III Stage is expected to involve 25 clinical research centers in China and enroll 666 patients within 5 months. The patients will receive treatment with the stipulated dosages over a period of 24 weeks, followed by a 1-month safety observation. The Phase III Stage is expected to be completed by the end of 2025.

 

The Company’s preclinical studies have shown that KX-826 tincture 1.0% has significantly increased the retention concentration of the tincture on human scalp cells compared to KX-826 tincture 0.5% used in the previous phase III clinical trial, and is expected to enhance the clinical efficacy. The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety profile and present superior efficacy compared to KX-826 tincture 0.5%.

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