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Phase III KX-826 Tincture 1.0% For AGA Completed Enrollment

2025/07/31
Kintor Pharma fort TS

Suzhou, 31 July, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the enrollment of 666 patients has been completed for the Phase III 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. The Pivotal Clinical Trial adopts a phase II/III operational seamless  design, and 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 Phase III  Stage involved 25 clinical research centers in China and a 24-week treatment period at the prescribed dosages, followed by a 2-week safety observation period. The Phase III Stage is expected to be completed by the beginning of 2026. 

    About Kintor Pharmaceutical Limited

    Founded in 2009, Kintor Pharmaceutical Limited focuses on developing and commercializing potential "first-in-class" and "best-in-class" innovative drugs and functional cosmetics, aiming to be a leading enterprise in such areas, and establish a “troika” business model formed by R&D business of innovative topical drugs, B2B business of functional cosmetic raw materials and B2C business of functional cosmetic products. After several years' development, the Company has developed diverse product pipeline built on dermatology and oncology related diseases. The products cover diseases with high incidence rate globally and extend to functional cosmetics, which can meet the needs of clinical dermatology and cosmetics consumers worldwide. Kintor Pharma's layout includes innovative small molecule and biologic drugs, consisting of five productsunder clinical development and several preclinical research programs. Kintor Pharma has been granted more than 100 patents worldwide. On 22 May 2020, Kintor Pharma was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK. For more information, please visit www.kintor.com.cn.


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