China’s National Medical Products Administration (NMPA) issued a first market approval to Innovent Biologics’ Pecondle (picankibart), the country’s first domestically developed IL-23p19 monoclonal antibody for moderate-to-severe plaque psoriasis. Innovent joins a select group of companies globally to successfully advance a selective IL-23p19 inhibitor to the market.
While the IL-23 pathway is well established as a therapeutic target internationally over the past decade, Innovent’s approval represents the first time a Chinese developer has delivered a home-grown biologic from this cytokine class.
Innovent’s biologic engineered for precision
Picankibart (IBI112) is a fully human monoclonal antibody targeting the p19 subunit of interleukin-23, a cytokine central to the differentiation, maintenance, and expansion of Th17 cells. By selectively blocking IL-23 without affecting IL-12 (which shares the p40 subunit), IL-23p19 antibodies offer a precise immunological footprint. This precision has become a hallmark of the newer psoriasis biologics that aim to maintain efficacy while reducing systemic immune suppression and infection risk.
Innovent’s engineering work includes Fc region optimization to extend half-life, enabling picankibart’s 12-week maintenance dosing, an interval matching or exceeding the longest of currently approved IL-23p19 agents globally. In Innovent’s Phase 3 CLEAR-1 study (NCT05645627), the molecule delivered rapid and durable clinical clearance, with 80.3% of patients achieving Psoriasis Area and Severity Index 90 (PASI 90) at week 16 and 93.5% reaching static Physician’s Global Assessment (sPGA) 0/1 at week 16. These outcomes compare favorably with other IL-23p19 biologics.
China joins global cohort of IL-23p19 innovators
Prior to Innovent’s approval, the multinational players with IL-23p19 inhibitor approvals globally were:
- Janssen’s guselkumab (Tremfya) – the first IL-23p19 approved globally, set benchmarks for the class with robust head-to-head superiority over TNF (adalimumab) and IL-17 inhibitors (secukinumab);
- AbbVie’s risankizumab (Skyrizi) – Risankizumab’s high-level PASI 90/100 performance and long durability through 52–128 weeks have made it the most clinically dominant IL-23p19 antibody globally;
- Eli Lilly’s mirikizumab (Omvoh) – Although late to the market, mirikizumab’s first approval for the class in ulcerative colitis (UC) reinforced interest in IL-23p19 inhibition beyond dermatology; and
- Almirall/Sun Pharma’s tildrakizumab (Ilumya) – with a more traditional antibody architecture.
Innovent’s success with picankibart means China now has an indigenous molecule operating in the same mechanistic and performance space as these global agents. This reflects the country’s growing domestic R&D capabilities, given that IL-23p19 programs require sophisticated epitope mapping, precise affinity tuning to balance potency with safety, and long-term PK/PD optimization for extended dosing intervals.
Picankibart’s efficacy data in terms of the CLEAR-1 study’s PASI 90 results are consistent with global class norms, placing it near the guselkumab–risankizumab tier. The12-week dosing schedule matches or exceeds global competitors, placing it in the long-acting category. Innovent is studying additional indications for the molecule, including UC, adolescent psoriasis, and psoriatic arthritis, mirroring the lifecycle planning of multinational biologics leaders. Notably, although Innovent has restricted clinical studies for picankibar to China sites at present, the firm’s strong record of global partnering means the molecule could be a potential future candidate for cross-border development, depending on data in broader indications.