Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor

Innovent's Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor

Innovent Biologics, Inc. (HKG: 1801) announced that Picankibart Monoclonal Antibody Injection (IBI112), branded XINMEIYUE, received National Medical Products Administration (NMPA) marketing approval for adult patients with moderate‑to‑severe plaque psoriasis, becoming the latest IL‑23p19 inhibitor to enter China’s dermatology market.

Regulatory Milestone

ItemDetail
ProductPicankibart (IBI112) – XINMEIYUE
CompanyInnovent Biologics (HKG: 1801)
AgencyNMPA (China)
Approval TypeMarketing authorization (Category 1 innovative drug)
IndicationModerate‑to‑severe plaque psoriasis (adult systemic therapy candidates)
MechanismIL‑23p19 subunit inhibitor (blocks IL‑23 receptor signaling)
Study BasisCLEAR‑1 Phase III trial (NCT05645627)

Clinical Evidence – CLEAR‑1 Trial

EndpointWeek 16 (Picankibart vs. Placebo)Week 52 (Maintenance)
PASI 9080.3% vs. 2.0% (P < 0.0001)Sustained high response (100 mg/200 mg q12w)
sPGA 0/193.5% vs. 13.1% (P < 0.0001)Sustained clearance
PASI 75/100Significantly higher vs. placebo (P < 0.0001)Maintained efficacy
Special SitesImproved scalp, nail, palmoplantar, perineal psoriasis
SafetyMost common: upper respiratory tract infection; no new signalsFavorable long‑term profile

Market Context & Outlook

MetricValue
China Psoriasis Patients~6.5 million (moderate‑to‑severe: 2.1 million)
Biologics Penetration~25% (525,000 patients)
IL‑23 Inhibitor Market Size¥4.8 billion (~US$660 million)
Growth CAGR22% (2024‑2030)
Peak Sales Forecast (Picankibart)¥2.5‑3.2 billion (~US$340‑440 million) by 2031
Market Share Target15‑20% of IL‑23 class (competing with Janssen’s Tremfya, AbbVie’s Skyrizi)
  • Pricing Strategy: Expected at ¥15,000‑18,000 per dose (q12w dosing), 20‑30% discount vs. imported IL‑23 inhibitors
  • Reimbursement Path: NMPA approval triggers Priority Review for National Reimbursement Drug List (NRDL) inclusion Q2 2026
  • Strategic Value: Strengthens Innovent’s immunology franchise, building on its anti‑PD‑1 leadership (sintilimab)

Forward‑Looking Statements
This brief contains forward‑looking statements regarding Picankibart’s commercial launch, market penetration, and reimbursement outcomes. Actual results may differ materially due to risks including competitive responses, market adoption rates, and NRDL negotiation outcomes.-Fineline Info & Tech