CHENGDU, China, June 15, 2022 – Keymed Biosciences (HKEX: 02162) is pleased to announce that the Center for Drug Evaluation of the National Medical Products Administration (the “CDE”) has granted CM310 recombinant humanized monoclonal antibody injection, a Class 1 innovative drug self-developed by the Group, breakthrough therapy designation for the treatment of moderate to severe atopic dermatitis. Phase III clinical trial is currently carried out in the PRC for this indication.
According to the announcement of the NMPA in relation to the publication of three documents including the Working Procedures for Review of Breakthrough Therapeutics (Trial) (No. 82 of 2020), drugs that have been granted the breakthrough therapy designation are prioritized by the CDE in communications and exchange, and in receiving guidance to promote the drug development progress.
CM310 recombinant humanized monoclonal antibody injection is an innovative humanized monoclonal antibody self-developed by Keymed Biosciences (Chengdu) Co., Ltd., targeting human IL-4 receptor alpha subunit (IL-4Rα). CM310 can selectively combine with IL-4Rα to block out the combination of IL-4Rα and IL-4 as well as IL-13, thus suppressing its bioactivity.
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