Keymed Biosciences Inc. announced that the data unblinding and preliminary statistical analyses for the Phase III confirmatory clinical study of its self-developed Class 1 innovative drug CM310 recombinant humanized monoclonal antibody injection in subjects with moderate to severe atopic dermatitis (AD) (trial protocol number: CM310AD005) has been completed, and both of the co-primary endpoints were achieved successfully. In accordance with the clinical trial protocol, the Group is in the process of pushing ahead with completion of the Phase III confirmatory clinical trial study with collection of other long-term efficacy and safety related data, and there is no need to enroll additional patients for such data collection. The Group will continue to communicate with the Center for Drug Evaluation of the National Medical Products Administration (the " NMPA") of the PRC, and proactively proceed with the marketing application for CM310 for the treatment of moderate to severe AD.

CM310AD005 is a multi-center, randomized, double-blind, placebo-controlled Phase III confirmatory clinical study to evaluate the efficacy, safety, PK/PD and immunogenicity of CM310 in subjects with moderate to severe Atopic dermatitis. The eligible subjects were randomized in a 1:1 ratio to receive CM310 (600mg - 300mg Q2W) or placebo. The co-primary endpoints are the proportion of subjects with EASI-75 (Eczema Area and Severity Index (EASI) =75% improvement from baseline) and the proportion of subjects with IGA score of 0 or 1 and a reduction of =2 points from baseline at Week 16 of treatment.

The results showed that the co-primary endpoints of CM310 were achieved successfully, and the safety profiles were well and consistent with the historical results. The Group is in communication with the NMPA regarding the new drug application (NDA) and it is expected that the NDA will be submitted in 2023.