Wedoany.com Report-Nov. 29, Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for Pecondle (picankibart), a fully home-grown anti-IL-23p19 monoclonal antibody, for the treatment of adults with moderate-to-severe plaque psoriasis.

Pecondle is the first domestically developed IL-23p19 inhibitor to gain NMPA approval. It offers a convenient maintenance regimen of one subcutaneous injection every 12 weeks — the longest dosing interval currently available among biologic therapies for psoriasis in China.

Approval was based on the CLEAR-1 Phase 3 study involving approximately 500 Chinese patients. Participants received a 200 mg induction dose monthly for the first 12 weeks, followed by maintenance dosing of either 200 mg or 100 mg every 12 weeks.

At week 16, 80% of patients treated with Pecondle achieved at least 90% improvement in Psoriasis Area and Severity Index score (PASI 90), compared with only 2% in the placebo group. Additionally, 93.5% reached a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear), versus 13.1% on placebo. Long-term efficacy remained strong, with 84.9% of patients on the 200 mg maintenance dose sustaining PASI 90 and 85.9% maintaining sPGA 0/1 at week 52.

Innovent estimates that around seven million people in China live with psoriasis. Recent advances in biologic treatments have raised clinical expectations from PASI 75 to the more stringent PASI 90 standard for moderate-to-severe cases.

Dr Lei Qian, Innovent's Chief R&D Officer for General Biomedicine, stated: "With its balance of efficacy and safety and convenient long-interval maintenance dosing, picankibart demonstrates strong potential as a best-in-class treatment."

Beyond psoriasis, Pecondle is being evaluated in multiple inflammatory conditions. A Phase 2 trial in ulcerative colitis has already delivered positive results, and further studies in additional indications are planned, positioning the drug as a core asset in Innovent’s growing immunology franchise.

The approval marks another milestone for China's domestic biopharmaceutical innovation in the field of immune-mediated diseases. Earlier this year, Akeso also secured NMPA approval for ebdarokimab, a dual IL-12/IL-23 inhibitor, for the same indication.