KEYMED BIO-B (02162.HK): CM512 (TSLP/IL-13 Bispecific Antibody) Granted Breakthrough Therapy Designation by NMPA
NewTimeSpace News: Keymed Biosciences Inc. (02162.HK) announced that its key pipeline asset CM512, a TSLP/IL-13 bispecific antibody, has been included in the Breakthrough Therapy Programme by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). CM512 is the world’s first IgG-like long-acting TSLP × IL-13 dual blocker.
NewTimeSpace News: On 23 July 2026, Keymed Biosciences Inc. (02162.HK) issued a voluntary announcement. CM512, the Company’s core investigational product, has obtained Breakthrough Therapy Designation from the Center for Drug Evaluation under NMPA for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP).
CM512 is a recombinantly engineered bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), developed in-house by the Company. It represents the world’s first IgG-like long-acting TSLP × IL-13 dual blocker. The Breakthrough Therapy Designation covers the treatment of patients with CRSwNP.
A Phase I clinical trial enrolling healthy volunteers and adult patients with moderate-to-severe atopic dermatitis (AD) achieved all study endpoints in November 2025, and relevant data were published in theJournal of Translational Medicinein April 2026.
As at the date of the announcement, a randomised, double-blind, parallel placebo-controlled Phase II trial evaluating the safety and efficacy of CM512 injection in subjects with CRSwNP is ongoing. The Company is also advancing multiple Phase II studies of CM512 across indications including moderate-to-severe asthma, moderate-to-severe chronic obstructive pulmonary disease, adult moderate-to-severe atopic dermatitis and chronic spontaneous urticaria.
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