Kintor Pharmaceutical-B (09939) announced that its self-developed, potential first-in-class KX-826 1.0% Tincture has produced positive topline results in the Phase III segment of a pivotal clinical trial for treating hair loss. The data indicated that this phase successfully met its primary endpoint, demonstrating statistically significant and clinically meaningful outcomes, along with excellent efficacy and safety profiles.
The pivotal trial is a multicenter, randomized, double-blind, vehicle-controlled adaptive design study evaluating the efficacy and safety of topical KX-826 at 1.0% and 0.5% concentrations in Chinese adult male patients with androgenetic alopecia (AGA). Utilizing a seamless Phase II/III operational design, the study was led by Principal Investigators Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People's Hospital. The Phase III stage was conducted across 26 clinical research centers in China, involving 24 weeks of treatment at specified doses followed by a 14-day safety observation period.
Analysis of 666 enrolled patients in the Phase III segment revealed the following results: - Efficacy: Both the 1.0% BID (twice daily) and 0.5% BID groups showed statistically significant and clinically meaningful improvements compared to the placebo group. The target area hair count (TAHC) increased by 15.33 hairs/cm² from baseline in the 1.0% BID group and by 14.46 hairs/cm² in the 0.5% BID group, versus an increase of 4.68 hairs/cm² in the placebo group. The 1.0% BID group demonstrated a TAHC increase of 10.65 hairs/cm² over placebo, with statistical significance (P<0.0001). The 0.5% BID group showed a 9.78 hairs/cm² increase over placebo, also statistically significant (P<0.0001). - Safety: Both the 1.0% BID and 0.5% BID groups exhibited excellent safety and tolerability, with no drug-related serious adverse events reported. The incidence of adverse events showed no clinically significant difference between the treatment groups and the placebo group.
KX-826, one of the company's most advanced topical innovative drug candidates, has completed multiple clinical trials for hair loss in both male and female patients in China and the United States, consistently demonstrating strong efficacy and safety. As a topical agent, KX-826 works by competitively binding to androgen receptors in target tissues, directly blocking androgen signaling pathways. Due to its localized action and low skin penetration, KX-826 is rapidly metabolized into low-activity compounds in the body, effectively minimizing associated safety risks.
Based on the preceding clinical trial results, the company plans to initiate communication with Chinese drug regulatory authorities shortly to submit a marketing authorization application for KX-826 1.0%. The company also noted that Cosmo Pharmaceuticals recently reported positive Phase III trial results in early December 2025 for a topical innovative drug targeting the same pathway, which is seeking regulatory approval in the United States and the European Union. Both this drug and KX-826 are expected to offer novel treatment options for androgenetic alopecia, providing patients with safer and more effective alternatives.
Kintor Pharmaceutical aims to secure KX-826's approval as the first-in-class drug for hair loss treatment in China and globally. If approved, KX-826 is poised to address the unmet clinical need in the current hair loss treatment landscape, breaking the decades-long reliance on minoxidil and finasteride as the primary therapeutic options.
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