Kintor Pharmaceutical recently announced the first dosing in its phase-III clinical trial of KX-826 Pyrilutamide in China for the treatment of male androgenetic alopecia (AGA) patients on 31st December, 2021. KX-826 is the first Androgen Receptor (AR) antagonist that has entered the phase-III clinical trial for AGA treatment in China and globally, a company statement said.
It also said that on 24th November, 2021, Kintor Pharma announced that China’s National Medical Products Administration (NMPA) greenlighted the protocol for the pivotal phase-III study of KX-826.
On 20th December, 2021, the kickoff meeting among key investigators for the KX-826 phase-III clinical trial was successfully held. Peking University People’s Hospital and Huashan Hospital affiliated to Fudan University led the trial, with 26 hospitals to be participating. After successfully co-leading the phase-II clinical trial of KX-826 in China for the treatment of AGA, Professor Zhang Jianzhong from Peking University People’s Hospital and Professor Yang Qinping from Huashan Hospital affiliated to Fudan University cooperate again to be the leading principal investigators (leading Pls) of the pivotal phase-III clinical trial of KX-826. At the investigator meeting, nearly 100 experts from 26 hospitals across China listened to the report on the efficacy and safety of the KX-826’s phase-II clinical trial, the statement added.
Speaking in this regard, Dr Youzhi Tong, founder, Chairman and Chief Executive Officer, Kintor Pharma, commented, “Kintor’s team has executed with high efficiency from the NMPA’s clearance to the first dosing of this phase-III clinical trial with around one month. This phase-III clinical trial will be carried out in 26 top dermatology medical institutions across China. We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation (six months study + one month follow-up) within the year. With the goal of completing the phase-III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible.”