An announcement has been made by KEYMED BIO-B (ASX: 02162) regarding its key research and development product, CM512 (TSLP/IL-13 bispecific antibody).

The product has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of the National Medical Products Administration for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

CM512 is a novel recombinant bispecific antibody that targets both thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), developed independently by the company.

It is recognized as the world's first IgG-like long-acting dual blocker of TSLP and IL-13.

A Phase I clinical study involving healthy subjects and adult patients with moderate-to-severe Atopic Dermatitis (AD) has been completed.

This study, which assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512, also provided preliminary insights into its efficacy for treating moderate-to-severe AD patients, reaching all primary endpoints in November 2025.

In April 2026, the Phase I clinical results were published in the Journal of Translational Medicine through a collaboration between the company and West China Hospital of Sichuan University.

As of the date of this announcement, a randomized, double-blind, placebo-controlled Phase II clinical study is actively underway.

This trial is evaluating the safety and efficacy of CM512 injection in subjects with CRSwNP, and its results will be announced in due course.

Furthermore, the company is advancing multiple other Phase II clinical studies for CM512, targeting indications such as moderate-to-severe asthma, moderate-to-severe chronic obstructive pulmonary disease, adult moderate-to-severe AD, and chronic spontaneous urticaria.