KINTOR PHARMA-B (09939): KX-826 1.0% solution achieves the main endpoint in Phase III critical clinical trial for treating male androgenetic alopecia in Chinese adult males.

KINTOR PHARMA-B(09939) announced that the key clinical trial Phase III of their self-developed and potentially first-in-class KX-826 lotion 1.0% for the treatment of hair loss has achieved top-line data. The data shows that the Phase III trial has met its primary endpoint with statistically significant and clinically meaningful results, demonstrating excellent efficacy and safety. This key clinical trial is a multicenter, randomized, double-blind, placebo-controlled adaptive design study in Phase II/III to evaluate the efficacy and safety of KX-826 lotion 1.0% and 0.5% for the treatment of Chinese adult male AGA patients. The trial is seamlessly designed from Phase II to Phase III and led by Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People's Hospital. The Phase III trial was conducted in 26 clinical research centers nationwide, with a 24-week treatment period and a 14-day safety observation period following the specified dosing. The analysis of the 666 patients enrolled in the Phase III trial showed: In terms of efficacy, both the 1.0% BID (twice daily) group and the 0.5% BID group demonstrated statistically significant efficacy advantages and clinical significance compared to the placebo group. The target area hair count (TAHC) increased by 15.33 hairs/cm2 in the 1.0% BID group and by 14.46 hairs/cm2 in the 0.5% BID group, compared to an increase of 4.68 hairs/cm2 in the placebo group. The increase in TAHC in the 1.0% BID group compared to the placebo group was significant (P<0.0001). The increase in TAHC in the 0.5% BID group compared to the placebo group was also significant (P<0.0001). In terms of safety, both the 1.0% BID group and the 0.5% BID group demonstrated excellent safety and tolerability in the clinical trial, with no drug-related serious adverse events reported. The incidence of adverse events between the 1.0% BID group, 0.5% BID group, and placebo group showed no significant difference in clinical practice. KX-826, as one of the company's fastest progressing topical innovative drugs, has completed multiple clinical trials for the treatment of hair loss in both men and women in China and the United States, showing excellent efficacy and safety. KX-826, as a topical medication, competes with androgen receptors in target tissues, directly blocking the signaling pathway of androgens. Due to its limited action to the local skin and low transdermal absorption rate, the metabolites of KX-826 in the body are inactive, effectively avoiding safety risks. Based on the results of previous clinical trials, the company plans to initiate communication with Chinese regulatory authorities to submit an application for market approval of KX-826 1.0% in the near future. The company also notes that Cosmo Pharmaceuticals announced positive results from the Phase III clinical trial of their topical innovative drug targeting the same pathway in December 2025, and is seeking market approval from regulatory authorities in the United States and the European Union. Both drugs, KX-826 and the one from Cosmo Pharmaceuticals, are expected to provide a new treatment option for androgenic hair loss, offering a safer and more effective choice for a wide range of hair loss patients. The company will strive for KX-826 to become the first-in-class drug approved by regulatory authorities for the treatment of hair loss domestically and globally. Once approved, KX-826 is expected to fill the clinical drug gap in the field of hair loss treatment, breaking the pattern of treatment relying solely on minoxidil and finasteride for nearly 40 years.