KINTOR PHARMA-B (09939.HK): long-term safety trial of KX-826 tincture 1.0% for AGA completed

NewTimeSpace News: On 3 November 2026, Kintor Pharmaceutical Limited (09939.HK) announced voluntarily that the long-term safety clinical trial of its self-developed, potentially first-in-class KX-826 tincture 1.0% for the treatment of androgenetic alopecia (AGA) had completed all subject follow-ups, demonstrating a good safety profile.

To meet the ICH-E1 guideline and the requirements of the National Medical Products Administration (NMPA), the trial adopted a multi-center, open-label design and was conducted at 12 clinical research centers across China, with Professor Zhang Jianzhong and Professor Zhou Cheng of Peking University People's Hospital as principal investigators, evaluating the one-year long-term safety of topical KX-826 tincture 1.0% in Chinese patients, with the primary endpoint being the incidence of treatment-emergent adverse events (TEAE) and other safety indicators.

As a necessary trial for the NDA submission of KX-826, the results further confirm the long-term safety and efficacy of KX-826, and will be included in the key NDA filing materials together with the positive Phase III results announced in March 2026 for submission to the NMPA in the near future.