Hong Kong-listed Kintor Pharmaceutical Limited (Kintor Pharma-B, 09939) announced top-line data showing that the Phase III stage of its pivotal clinical trial for KX-826 tincture 1.0 % met the primary efficacy endpoint in treating male adult androgenetic alopecia (AGA) in China.
The randomized, double-blind, vehicle-controlled Phase II/III trial enrolled 666 patients across 26 mainland research centers. After a 24-week dosing period followed by a 14-day safety follow-up, key findings were:
• Efficacy: – 1.0 % BID group increased target-area non-vellus hair count (TAHC) by 15.33 hairs/cm² from baseline. – 0.5 % BID group increased TAHC by 14.46 hairs/cm² from baseline. – Placebo group increased TAHC by 4.68 hairs/cm² from baseline. – The 1.0 % BID regimen delivered a 10.65 hairs/cm² advantage over placebo (P<0.0001), while the 0.5 % BID arm beat placebo by 9.78 hairs/cm² (P<0.0001).
• Safety: No drug-related serious adverse events were reported; overall adverse-event incidence showed no clinically significant difference among active and placebo cohorts.
KX-826, a topical androgen-receptor antagonist with minimal systemic exposure, has completed multiple trials in China and the United States for both male and female AGA. Based on accumulated data, the company intends to initiate a New Drug Application in the PRC “in the near term.” Management also highlighted that another topical agent targeting the same receptor from Cosmo Pharmaceuticals recently produced positive Phase III results, underscoring growing clinical interest in novel AGA treatments.
Kintor aims to position KX-826 as the first-in-class therapy approved for AGA in China and potentially worldwide, addressing a market that has relied largely on minoxidil and finasteride for nearly four decades.
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