On December 30, KINTOR PHARMA-B (09939.HK) announced that its independently developed, potential first-in-class KX-826 topical solution 1.0% for the treatment of androgenetic alopecia in adult men in China has recently successfully completed the Phase III stage with the enrollment of the first subject.

This critical clinical trial is a multicenter, randomized, double-blind, placebo-controlled adaptive design study to evaluate the efficacy and safety of the KX-826 topical solution 1.0% in treating adult male patients with androgenetic alopecia in China. The trial employs a seamless Phase II/III design, a 2-in-1 design, with Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People's Hospital serving as the principal investigators. The Phase III trial is planned to be conducted at 25 clinical research centers nationwide, aiming to enroll 666 patients, with an anticipated enrollment period of 5 months, followed by a treatment duration of 24 weeks at the specified dosage and 1 month of safety observation, expected to complete the Phase III clinical trial by the end of 2025.

The company's preclinical research indicates that relative to the KX-826 topical solution 0.5% used in previous Phase III clinical trials, the 1.0% formulation has a significantly increased retention concentration in human scalp cells, which is expected to enhance the clinical effectiveness. It is anticipated that the clinical trial of KX-826 topical solution 1.0% will maintain excellent safety while demonstrating more significant efficacy compared to KX-826 topical solution 0.5%.