KEYMED BIO-B (02162.HK): Phase II trial of CM512 (TSLP x IL-13 bispecific antibody) for chronic rhinosinusitis with nasal polyps meets all study endpoints; Phase III to advance with 300mg once-half-yearly regimen

NewTimeSpace News: On 10 August 2026, Keymed Biosciences Inc. (stock code: 02162) published an inside information announcement, announcing that the Phase II clinical study of CM512 injection, a self-developed Class 1 innovative drug, for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) has completed data unblinding and preliminary statistical analysis. The results showed that CM512 met all study endpoints with comparable efficacy across dose groups; CM512 demonstrated rapid onset of action, quickly reducing nasal polyps and significantly improving nasal congestion as early as week 4 of dosing while promoting the recovery of olfactory function, with a single dose maintaining efficacy for six months, and the change in nasal polyp score (NPS) from baseline at week 24 being significantly superior to the control group while markedly reducing overall sinonasal inflammation. Among CRSwNP patients, all CM512 dose groups demonstrated a favourable safety and tolerability profile with an extremely low incidence of anti-drug antibodies (ADAs), treatment-emergent adverse events (TEAEs) occurred at rates comparable to the placebo group, and no serious adverse events occurred in the CM512 groups, with detailed data to be further published in international academic journals or at academic conferences in the future.

Based on the Phase II results, the Company is rapidly initiating the Phase III clinical study of CM512 injection for CRSwNP, with the 300mg once-half-yearly (Q24W) regimen confirmed as the dosing schedule. The Phase II trial was a randomised, double-blind, placebo-parallel-controlled study conducted in China to evaluate the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) effects and immunogenicity of CM512 injection in CRSwNP subjects, comprising three treatment groups (300mg every three months Q12W, 300mg every half year Q24W and 600mg every half year Q24W) and one placebo control group, with a 24-week treatment period followed by a 12-week safety follow-up period.

CM512 is a recombinant anti-thymic stromal lymphopoietin (TSLP) and anti-interleukin-13 (IL-13) bispecific antibody, being the world's first IgG-like long-acting TSLP x IL-13 dual blocker, with mechanism-of-action and in vitro pharmacodynamic studies showing that CM512 binds TSLP and IL-13 with high affinity and synergistically inhibits downstream signalling pathways and effector cell activation induced by TSLP and IL-13. The Company completed a Phase I clinical study in 2025 in healthy subjects and adult patients with moderate-to-severe atopic dermatitis (AD), achieving all study endpoints in November 2025, and has continued to advance multiple Phase II clinical studies of CM512 in the second half of 2025 and the first half of 2026, covering indications including CRSwNP, moderate-to-severe asthma, moderate-to-severe COPD, adult moderate-to-severe AD and chronic spontaneous urticaria. On 23 July 2026, CM512 (TSLP x IL-13 bispecific antibody) was included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration for the treatment of CRSwNP. The announcement noted that the Company does not guarantee the eventual successful development, launch and/or commercialisation of CM512, and shareholders and potential investors should exercise caution when dealing in the shares of the Company.

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