KEYMED BIO-B(02162): CM512 (TSLP x IL-13 dual antibody) injection has achieved all study endpoints in the Phase II clinical trial for patients with chronic rhinosinusitis with nasal polyps.

KEYMED BIO-B (02162) announced that the phase II clinical study of its self-developed class I new drug CM512 injection for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) has completed data unblinding and preliminary statistical analysis. The results show that: 1. CM512 achieved all the study endpoints, with comparable efficacy across all dosage groups. CM512 acted quickly, significantly reducing nasal polyps and alleviating nasal congestion by the fourth week of treatment, while also promoting the recovery of olfactory function. The efficacy of a single injection can last for six months, with a significant improvement in the nasal polyps score (NPS) at 24 weeks compared to baseline, outperforming the control group, and significantly alleviating overall sinonasal inflammation. 2. Among CRSwNP patients, all dosage groups of CM512 demonstrated good safety and tolerability, with an extremely low incidence of anti-drug antibodies (ADA). The incidence of treatment-emergent adverse events (TEAEs) was comparable to that of the placebo group, and no serious adverse events occurred in the CM512 group. Detailed data will be further published in international academic journals or at academic conferences. Based on these phase II results, the company is rapidly initiating the phase III clinical study of CM512 injection for the treatment of CRSwNP, confirming a dosing regimen of 300mg, once every six months (Q24W).