KEYMED BIO-B (02162): CM512 has been included in the list of breakthrough therapies by the National Medical Products Administration Drug Evaluation Center.

KEYMED BIO-B (02162) announced that the company's key research and development product CM512 (TSLP/IL-13 dual antibody) has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration Drug Evaluation Center for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). CM512 is a recombinant dual-specific antibody against thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13) developed independently by the company, the world's first IgG-like long-acting TSLPxIL-13 dual blocker. Phase I clinical studies involving healthy subjects and adults with severe atopic dermatitis (AD) were conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CM512 in treatment, as well as to explore the preliminary effectiveness of CM512 in severe AD patients. The study reached all research endpoints in November 2025. In April 2026, Sichuan University West China Hospital and the company jointly published the Phase I clinical results in the Journal of Translational Medicine. As of the date of this announcement, a randomized, double-blind, placebo-controlled Phase II clinical study evaluating the safety and effectiveness of CM512 injection in CRSwNP subjects is ongoing, and the results of the trial will be announced in due course. In addition, the company is also advancing multiple Phase II clinical studies of CM512, covering indications such as severe asthma, moderate to severe chronic obstructive pulmonary disease, adults with severe atopic dermatitis, and chronic spontaneous urticaria.