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% for the topical treatment of male adults with AGA in China. The Pivotal Clinical Trial adopts a phase II/III operational seamless design, namely 2-in-1 design, with Professor Jianzhong Zhang (張建中) and Professor Cheng Zhou (周城) from Peking University People’s Hospital as the lead principal investigator. The Phase III Stage is expected to involve 25 clinical research centers in China and enroll 666 patients within 5 months. The patients will receive treatment with the stipulated dosages over a period of 24 weeks, followed by a 1-month safety observation. The Phase III Stage is expected to be completed by the end of 2025.

The Company’s preclinical studies have shown that KX-826 tincture 1.0% has significantly increased the retention concentration of the tincture on human scalp cells compared to KX-826 tincture 0.5% used in the previous phase III clinical trial, and is expected to enhance the clinical efficacy. The clinical trial of KX-826 tincture 1.0% is expected to maintain excellent safety profile and present superior efficacy compared to KX-826 tincture 0.5%.

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. 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 six products under 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.