Keymed Biosciences Inc. announced that the Phase IIb clinical study of its self-developed Class 1 innovative drug CM310 recombinant humanized monoclonal antibody injection (CM310AD002) has completed the analysis of unblinded data and preliminary statistics, and obtained positive results. CM310AD002 is a multi-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy, safety, pharmacokinetics (PK) characteristics, pharmacodynamics (PD) effects and immunogenicity of CM310 with different dosages in subjects with moderate-to-severe atopic dermatitis (AD). The subjects meeting the study eligibility requirements were randomly assigned in a 1:1:1 ratio, and received 8 treatments with high-dose (CM310 600-300mg, Q2W), low-dose (CM310 300-150mg, Q2W) and placebo. The primary endpoint is to assess the proportion of subjects with EASI-75 at week 16 (Eczema Area and Severity Index (EASI) 75% improvement from baseline). The results of the Phase IIb study showed that the primary endpoint of each CM310 group was fully achieved. The proportion of subjects with EASI-75 at week 16 was 73.1% in the high-dose group and 70.6% in the low-dose group, which was significantly higher than that in the placebo group (18.2%), with both of the P values <0.0001. In terms of Investigator's Global Assessment (IGA), the proportion of subjects with both IGA 0/1 and a reduction from baseline of 2 points at week 16 in the high-dose group, low-dose group and placebo group was 34.6%, 32.4% and 9.1%, respectively, with the P values of 0.023 and 0.033 respectively in comparison to placebo group. The proportion of subjects with an IGA reduction from baseline of 2 points at week 16 in the high-dose group, low-dose group and placebo group was 53.8%, 61.8% and 9.1%, respectively, with both of the P values <0.0001 in comparison to the placebo group. Other efficacy endpoints such as EASI-90, EASI-50, Pruritus Numeric Rating Scale (NRS), Affected Body Surface Area (BSA) and Dermatological Life Quality Index (DLQI) were observed to be significantly better in the two CM310 groups than in the placebo group at week 16. At the same time, it was also observed that CM310 had a promising safety profile in this study. The incidences of drug-related treatment-emergent adverse events (TEAE) in the high-dose group, low-dose group and placebo group were 20.0%, 12.5% and 12.5%, respectively, all being of grade 1 or 2 in severity.