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Phase II Stage Of Pivotal Clinical Trial Of Kx-826 Tincture 1.0% For The Treatment Of Male Adult Aga In China Reached Primary Endpoint

Release time：2025-07-24 09:37

Suzhou, 24 July, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the Phase II Stage of the Pivotal Clinical Trial of its in-house developed and potential first-in-class KX-826 tincture 1.0% for the treatment of AGA has obtained top-line results. Results indicated that the Phase II Stage has reached its primary endpoint with statistically significant and clinically meaningful outcomes, demonstrating excellent efficacy and safety.

 

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% and 0.5% for the topical treatment of male adults with AGA in China. The Pivotal Clinical Trial adopts a phase II/III operational seamless design, with Professor Jianzhong Zhang (張建中) and Professor Cheng Zhou (周城) from Peking University People’s Hospital serving as the lead principal investigators, and  involved a 24-week treatment period at the prescribed dosages, followed by a 1-month safety observation period. Analysis results of the 90 patients enrolled in the Phase II Stage showed that: 

 

regarding efficacy, compared to the placebo group, both 0.5% BID (i.e. twice a day) group and 1.0% BID group demonstrated statistically significant therapeutic efficacy and clinical significance. The target area non-vellus hair counts (“TAHC”) of the 0.5% BID group showed an increase of 22.39 hairs/cm2 from baseline, the TAHC of the 1.0% BID group showed an increase of 21.87 hairs/cm2 from baseline, the TAHC of the placebo group showed an increase of 8.73 hairs/cm2 from baseline. The TAHC of the 0.5% BID group showed an increase of 13.66 hairs/cm2 from placebo group, with statistically significant results (P=0.002). The TAHC of the 1.0% BID group showed an increase of 13.14 hairs/cm2 from placebo group, with statistically significant results (P=0.004).

 

The hair growth assessment (“HGA”) indicators from investigators of 0.5% BID group and 1.0% BID group both experienced significant improvement from placebo group, with a significant therapeutic effect. The results showed that after the treatment of 24 weeks, compared to the placebo group, the HGA indicator of the 0.5% BID group displayed statistically significant results (P=0.000); compared to the placebo group, the HGA indicator of the 1.0% BID group displayed statistically significant results (P=0.013).

 

In terms of safety, KX-826 tincture exhibited satisfactory safety and tolerability in the clinical trial, with a low incidence of overall adverse events. No drug-related sexual dysfunction adverse reactions were observed during the entire study period, which indicated an excellent favorable safety profile without observing any new safety signals.

 

The analysis results were reviewed by the Independent Data Monitoring Committee (IDMC), and its primary recommendation was that the Phase III Stage clinical trial should continue based on the current safety and efficacy data, with no modifications to treatment group or sample size.

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