Innovent's PECONDLE® approved for moderate-to-severe plaque psoriasis in China

Innovent Biologics, Inc. announced that its new drug application for PECONDLE® (picankibart injection) has been approved by China’s National Medical Products Administration (NMPA). The approval is for treating moderate-to-severe plaque psoriasis in adult patients eligible for systemic therapy. PECONDLE® is the first domestically developed IL-23p19 monoclonal antibody approved in China, offering a maintenance dosing interval of once every 12 weeks, the longest among comparable biologics.

The approval is based on positive results from the pivotal Phase 3 registrational clinical study CLEAR-1. At week 16, 80.3% of subjects in the picankibart group achieved PASI 90 and 93.5% achieved sPGA 0/1, significantly higher than the placebo group (2.0% and 13.1%, respectively, p < 0.0001 for both). These high levels of PASI 90 and sPGA 0/1 were maintained in both 100mg and 200mg picankibart maintenance groups.

Picankibart also demonstrated significantly higher proportions of participants achieving PASI 75, PASI 100, sPGA 0, and DLQI 0/1 compared to placebo (p < 0.0001). Improvements were observed in special psoriasis areas such as the scalp, nails, palmoplantar, and perineal regions. The safety profile was favorable, with upper respiratory tract infection being the most common adverse event, consistent with other IL-23p19 agents and without new safety signals.