On September 26, BioInnovent (01801.HK) announced that the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has officially accepted the new drug marketing application (NDA) for Pykangzhibai monoclonal antibody injection (recombinant anti-interleukin 23p19 subunit ("IL-23p19") antibody, R&D code: IBI112), for the treatment of moderate to severe plaque psoriasis.

This NDA acceptance is based on the positive results of a Phase III registration clinical study CLEAR-1 (NCT05645627) conducted in Chinese moderate to severe plaque psoriasis subjects. The study successfully achieved the primary and all key secondary endpoints in May 2024, showing that the proportion of subjects achieving PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0 in the Pykangzhibai monoclonal antibody group was significantly better than the placebo group. During the study treatment, Pykangzhibai monoclonal antibody demonstrated overall good safety, with no new safety signals identified. Detailed data from the CLEAR-1 study will be presented at future scientific conferences and academic journals.

Pykangzhibai monoclonal antibody is the first IL-23p19 antibody drug to achieve a proportion of subjects exceeding 80% reaching PASI 90 at week 16, the primary endpoint of Phase III registration study. It also has the longest dosing interval (every 12 weeks) among similar biologic drugs. Pykangzhibai monoclonal antibody is expected to bring comprehensive benefits such as skin lesion clearance, improvement in quality of life, and enhanced dosing convenience to Chinese patients with moderate to severe plaque psoriasis. The company will actively cooperate with regulatory authorities, looking forward to providing better treatment options for psoriasis patients in China soon.