China Approves First Domestic IL-23p19 Antibody for Psoriasis Treatment
核心洞察
China's NMPA has approved PECONDLE (搜索)® (picankibart injection), the first domestically developed IL-23p19 monoclonal antibody for treating moderate-to-severe plaque psoriasis (搜索) in adults.
The Phase 3 CLEAR-1 trial demonstrated that 80.3% of patients achieved PASI 90 at week 16, significantly outperforming placebo with favorable safety profile.
PECONDLE (搜索)® offers the longest dosing interval among comparable biologics with maintenance dosing every 12 weeks, potentially improving patient compliance and quality of life.
China's National Medical Products Administration (NMPA) has approved PECONDLE (搜索)® (picankibart injection), marking the first domestically developed IL-23p19 monoclonal antibody to receive regulatory approval for treating moderate-to-severe plaque psoriasis (搜索) in adult patients who are candidates for systemic therapy.
The approval represents a significant milestone for Innovent Biologics (搜索), positioning the company as the first Chinese enterprise to successfully develop an IL-23p19 antibody drug. With over 7 million psoriasis (搜索) patients in China, this approval addresses a substantial unmet medical need in the world's second-largest pharmaceutical market.
Clinical Trial Results Demonstrate Superior Efficacy
The approval was based on the pivotal Phase 3 CLEAR-1 trial (NCT05645627), which evaluated picankibart's efficacy and safety in Chinese participants with moderate-to-severe plaque psoriasis (搜索). The study achieved remarkable results, with 80.3% of participants reaching PASI 90 (90% improvement in Psoriasis (搜索) Area and Severity Index) at week 16, compared to only 2.0% in the placebo group (p < 0.0001).
Additional efficacy measures showed equally impressive outcomes. At week 16, 93.5% of participants in the picankibart group achieved static Physician Global Assessment (sPGA) scores of 0/1, compared to 13.1% in the placebo group (p < 0.0001). The drug also demonstrated significant improvements in PASI 75, PASI 100, sPGA 0, and Dermatology Life Quality Index (DLQI) 0/1 scores compared to placebo (p < 0.0001 for all measures).
Long-term efficacy data from week 52 showed sustained responses, with participants in both the 100 mg and 200 mg every-12-weeks maintenance treatment groups maintaining stable and high-level PASI 90 and sPGA 0/1 achievement rates.
Extended Dosing Interval Offers Competitive Advantage
PECONDLE (搜索)® distinguishes itself from other biologics through its extended maintenance dosing schedule of once every 12 weeks, the longest interval among comparable biologics currently available in China. This feature stems from the drug's innovatively engineered Fc region that extends its half-life, potentially improving patient compliance and quality of life.
Professor Shi Yuling, Principal Investigator of CLEAR-1 at Shanghai Skin Disease Hospital (搜索), emphasized the clinical significance: "As the first IL-23 (搜索) p19 monoclonal antibody independently developed by a Chinese enterprise, picankibart has shown significant short-term efficacy and maintained long-term efficacy in CLEAR-1; administration once every 12 weeks during the maintenance period further improves the medication convenience and compliance of patients."
Favorable Safety Profile Consistent with IL-23p19 Class
The safety analysis revealed a favorable profile consistent with other IL-23p19 agents. The most common adverse event was upper respiratory tract infection, and no new safety signals were identified throughout the study period. This safety profile aligns with the established characteristics of the IL-23p19 inhibitor class.
Addressing Evolving Treatment Goals in Psoriasis
The approval comes at a time when psoriasis (搜索) treatment goals have evolved significantly. The therapeutic target has shifted from achieving PASI 75 improvement to more ambitious goals of PASI 90/100, along with marked quality of life improvements measured by DLQI 0/1 scores. Treatment focus has also expanded to include long-term maintenance and efficacy in special areas including scalp, nail, palmoplantar, and perineal regions.
Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics (搜索), highlighted the drug's potential: "The pivotal registration study CLEAR-1 showed that picankibart can rapidly clear skin lesions, significantly improve quality of life, maintain stable efficacy for a long time, and has a favorable safety profile. With its balance of efficacy and safety and convenient long-interval maintenance dosing, picankibart demonstrates strong potential as a best-in-class treatment."
Comprehensive Development Pipeline
Beyond the approved indication, Innovent is advancing multiple clinical studies with picankibart across various patient populations. The company is conducting CLEAR-2, a Phase 3 study examining randomized withdrawal and re-treatment, and CLEAR-3, evaluating the drug in patients previously treated with biologics. Additional Phase 2 studies are exploring efficacy in moderately to severely active ulcerative colitis (搜索).
According to the company, all studies except the ongoing CLEAR-3 have met their primary endpoints. New clinical investigations in adolescent psoriasis (搜索) and adult psoriatic arthritis (搜索) have also been initiated, suggesting potential for expanded indications.
Market Impact and Future Outlook
The approval positions PECONDLE (搜索)® to compete in China's growing biologics market for psoriasis (搜索) treatment. Since 2019, biologics have become central to psoriasis treatment in China, with IL-23 (搜索) inhibitors distinguished by their target precision, rapid onset, robust efficacy, favorable safety profile, and durable effects.
Innovent's achievement represents the first successful domestic development of an IL-23p19 antibody in China, potentially offering cost advantages and improved access for Chinese patients compared to imported biologics. The company plans to continue expanding its autoimmune portfolio while building comprehensive clinical evidence to address unmet needs such as drug resistance and disease recurrence.