UCB：Galvokimig was approved
On June 18, the CDE official website showed that the Category 1 new drug Galvokimig Injection, filed by UCB, has been approved for clinical trial for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).
Galvokimig is a global first-in-class multi-specific antibody therapy designed to inhibit IL-13, IL-17A, and IL-17F, with an extended half-life through albumin binding. By targeting the Th2 pathway (via IL-13) and the Th17 pathway (via IL-17A/F), it achieves combined inhibition of IL-13, IL-17A, and IL-17F with a single drug.
Overseas, UCB has already initiated two clinical trials of Galvokimig for atopic dermatitis. At the 2025 EADV Congress, UCB announced, in an oral presentation, that the first-in-patient trial of Galvokimig in moderate-to-severe atopic dermatitis was successful. In the Phase IIa trial, 47 patients received either Galvokimig (n=33) or placebo (n=14). At Week 12, the proportion of patients achieving ≥75% improvement in Eczema Area and Severity Index from baseline (EASI75) was 64.9% in the Galvokimig group, compared with only 12.3% in the placebo group. Meanwhile, 46.6% of patients in the Galvokimig group achieved EASI90, versus 3.5% in the placebo group. In terms of safety, the most common treatment-emergent adverse events (TEAEs) with Galvokimig treatment were rhinitis, nasopharyngitis, headache, dizziness, and oropharyngeal pain.
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