Keymed Biosciences Inc. announced that the new drug application of Stapokibart injection (an anti-IL-4Ra monoclonal antibody, R&D codename: CM310) was accepted by the National Medical Products Administration (" NMPA") and granted priority review on December 7, 2023. Drug name: Stapokibart injection. Dosage form: Injection.

Application matter: New drug application for registration and marketing of domestically manufactured drugs. Registration classification: Therapeutic biologics products, Class 1. Applicant: Chengdu Kangnuoxing Biopharma Inc. (Cheng Du Kang Nuo Xing Sheng Wu Yi Yao Ke Ji You Xian Gong Si), a wholly-owned subsidiary of the Company. Acceptance No.: CXSS2300090.

Proposed indication: For the treatment of moderate-to-severe atopic dermatitis in adults who are poorly controlled or unsuitable for topical therapy. The application is based on a multi-center, randomized, double-blind, placebo-controlled phase III study (CM310AD005), with achieving at least a 75% improvement of Eczema Area and Severity Index (EASI-75) from baseline and an Investigator's Global Assessment (IGA) score of 0 or 1 with a reduction of 2 points from baseline at week 16 as the co-primary endpoints. Results showed that the trial met its co-primary endpoints at week 16, and long-term treatment could produce sustained clinical benefits with a good safety profile.