According to the Zhitong Finance App, Kaituo Pharmaceutical-B (09939) announced that its self-developed long-term safety clinical trial of 1.0% KX-826 tincture to treat androgen alopecia (“AGA” or “alopecia”) (“this long-term safety clinical trial”) has completed all follow-up of subjects, showing good safety.
According to the ICH-E1 guidelines and the requirements of the China National Drug Administration (“State Drug Administration”) on the application of the “E1: Population Exposure Level: Assessing Clinical Safety of Drugs for the Long-term Treatment of Non-Life-threatening Diseases” (No. 88 of 2019), KX-826 tincture 1.0% as a drug for long-term treatment of non-life-threatening diseases (chronic or intermittent use over 6 months) is required to evaluate its safety. To meet these requirements, this long-term safety clinical trial uses a multi-center, open-label design to evaluate the long-term safety of 1.0% of KX-826 tincture for the treatment of Chinese alopecia patients (treatment time of one year).
The long-term safety clinical trial was conducted at 12 clinical research centers across the country, with Professor Zhang Jianzhong and Professor Zhou Cheng of Peking University People's Hospital as the main researchers. The primary endpoints of this trial were the occurrence of adverse events (“TEAE”) that occurred during treatment during the study and other safety indicators. The test used KX-826 tincture of 1.0% BID (i.e. twice daily) as the dosage of the study drug. Clinical trial results have shown good safety.
As a necessary test for KX-826 to submit a New Drug Marketing Application (NDA), the results of this long-term safety clinical trial further confirm the safety and efficacy of the long-term use of KX-826. The above results will be included in the main NDA reporting materials along with materials such as the positive results of the phase III clinical trial announced in March 2026, and will be submitted to the National Drug Administration in the near future.