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Starting Again! Pioneer Pharmaceuticals KX-826 Tincture Registrational Clinical Trial Investigators Meeting Successfully Held

Release time：2024-08-05 00:00

BEIJING, Aug. 5, 2024 - Pioneering Pharmaceuticals (HKEx: 9939.HK), a biopharmaceutical company focusing on the research, development and industrialization of potentially first-of-its-kind and best-of-breed innovative medicines, announced that the investigators' meeting of the Registered Phase II/III Clinical Trial of KX-826 Tincture for the Topical Treatment of Androgenetic Alopecia in Chinese Adult Males (AGA), which is being conducted by Prof. Zhang Jianzhong and Prof. Zhou Cheng of Peking University People's Hospital as Leading PIs, was successfully held in Beijing, China, on Aug. 4th. The clinical trial was conducted by Prof. Zhang Jianzhong and Prof. Zhou Cheng of Peking University People's Hospital (PUPRH) as Leading PIs, with the participation of dermatology research teams from more than 20 domestic hospitals. 756 subjects are expected to be enrolled, and the patient recruitment program will be completed at the beginning of next year. The meeting was attended by specialists and heads of clinical organizations from several hospitals across China, including Beida People's University, as well as representatives from Pioneer Pharma's team, CROs, and Numerical Systems.

 

The clinical trial, which was officially licensed by the National Drug Administration (NMPA) on May 22, 2024, is designed to evaluate the efficacy and safety of KX-826 tincture for topical treatment of Chinese adult male AGA patients. The trial passed the ethical review of the group leader, Peking University People's Hospital, in July this year. The investigator meeting focused on the research background of the KX-826 project, the clinical trial study protocol and evaluation of the consistency points, the operation of the project was introduced, and the details of the project operation process and other issues were fully discussed, while the meeting also summarized in detail the results and experience of the past clinical trials of KX-826, and put forward the requirements and measures for further improvement of the large-scale registry-based clinical trial that was formally initiated. Measures

 

Dr. Tong Youzhi, Founder, Chairman and Chief Executive Officer of Pioneering Pharmaceuticals, said, “KX-826 is under continuous development as a core innovative product of the Group. The topical innovative drug has completed a number of clinical trials in China and the United States targeting both men and women for the treatment of hair loss and has demonstrated an excellent trend of safety and efficacy. The Company's preclinical studies have shown that the new registrational clinic will utilize KX-826 tincture in the 1.0% dosage form as compared to the 0.5% dosage form of KX-826 tincture used in the previous Phase III clinical trial. With a seven-fold increase in topical drug concentration in the skin without altering the animals' in vivo exposure, it is expected to maintain a favorable safety profile in the clinical trial while significantly enhancing clinical efficacy. The Company believes that it is expected to strive for the success of the registrational clinical trial based on the elimination of the interfering factors of the new crown and the improvement of clinical quality control and subject compliance, and to strive for KX-826 to become the first innovative drug marketed globally for the treatment of AGA with an AR inhibitor.”

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