SAN FRANCISCO & SUZHOU, China — November 28, 2025. Innovent Biologics has announced that PECONDLE® (picankibart injection), a recombinant IL-23p19 monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA) for adults with moderate-to-severe plaque psoriasis requiring systemic therapy. The approval is based on a pivotal Phase 3 trial showing over 80% of patients achieving PASI 90 at Week 16, making PECONDLE the world’s first IL-23p19 antibody whose registrational trial reached this level of efficacy. Offering the longest maintenance dosing interval among comparable biologics in China (once every 12 weeks), PECONDLE marks a major advancement in autoimmune disease therapeutics.
Science Significance
The scientific impact of PECONDLE lies in its selective IL-23p19 inhibition, a key cytokine driver of psoriatic inflammation and immune dysregulation. With an engineered Fc region that extends half-life, picankibart delivers durable suppression of disease activity and consistent lesion clearance across difficult-to-treat regions such as scalp, nails, palmoplantar skin and perineal areas. CLEAR-1 Phase 3 data demonstrated PASI 90 in 80.3% and sPGA 0/1 in 93.5% of patients at Week 16, alongside stable long-term efficacy through Week 52. These findings position PECONDLE as a best-in-class immunotherapy and a major scientific milestone in China’s rapidly advancing biologics innovation ecosystem.
Regulatory Significance
PECONDLE’s NMPA approval highlights increasing regulatory confidence in domestically developed biologics that meet global standards for quality, efficacy and safety. Picankibart’s regulatory success follows a rigorous evaluation of its Phase 3 dataset, which showed high clinical response rates, meaningful quality-of-life improvement and no new safety signals beyond expected IL-23p19 class effects. As the first IL-23p19 antibody developed in China, PECONDLE sets a new regulatory precedent and strengthens the country’s capabilities in advanced immunology drug approvals, supporting future pathways for autoimmune and inflammatory disease innovation.
Business Significance
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This approval significantly reinforces Innovent’s position as a leading biopharmaceutical company with a growing global-standard pipeline across oncology, autoimmunity, ophthalmology and cardiovascular disease. PECONDLE adds to Innovent’s expanding portfolio of 17 launched products, multiple Phase 3 assets and over 15 early-stage candidates, solidifying its competitiveness in China’s biologics market—one of the fastest-growing immunology markets in the world. The extended maintenance interval (every 12 weeks) creates a strong differentiation opportunity versus imported biologics, providing commercial leverage and supporting Innovent’s broader growth strategy in autoimmune disease management and lifecycle-management clinical programs.
Patients’ Significance
For more than 7 million psoriasis patients in China, PECONDLE introduces a high-efficacy, long-duration, and well-tolerated treatment option that addresses the limitations of traditional systemic therapies. Picankibart helps patients achieve rapid lesion clearance, reduces recurrence, improves skin appearance and decreases long-term health complications associated with chronic inflammation—such as cardiometabolic dysfunction, depression and anxiety. With improved dosing convenience and the ability to maintain efficacy in difficult anatomic areas, PECONDLE has the potential to transform quality of life, enhance treatment adherence and reduce long-term healthcare burdens on families and health systems.
Policy Significance
The approval aligns with national health-policy priorities encouraging indigenous biologics innovation, improved patient access to high-value therapies and reduced dependence on imported immunomodulators. PECONDLE’s success demonstrates the effectiveness of China’s strategic initiatives to strengthen biopharmaceutical R&D capabilities, expand domestic manufacturing of complex monoclonal antibodies and support precision-medicine frameworks. As a homegrown, high-efficacy biologic, picankibart reinforces policy momentum toward self-sufficiency, affordable innovation and accelerated availability of advanced therapies across China’s healthcare system.
With PECONDLE, Innovent Biologics achieves a landmark scientific and regulatory milestone, delivering the first domestically developed IL-23p19 monoclonal antibody for psoriasis in China. Combining best-in-class efficacy, extended dosing intervals, strong safety performance and regulatory recognition, picankibart strengthens Innovent’s leadership in immunology and provides patients with a transformative new therapeutic option. As the company advances multiple Phase 3 and Phase 2 studies across autoimmune and inflammatory diseases, PECONDLE stands as a major achievement in China’s evolution as a global force in biopharmaceutical innovation.
Source: Innovent Biologics press release
