By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announces that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for roconkibart injection (JS005) for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Regulatory Milestone & Study Design
| Attribute | Details |
|---|---|
| Company | Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) |
| Product | Roconkibart injection (JS005) |
| Regulatory Status | NMPA NDA acceptance |
| Indication | Moderate-to-severe plaque psoriasis (adult, systemic/phototherapy candidates) |
| Study Design | Multi-center, randomized, double-blind, parallel, placebo-controlled Phase 3 |
| Study Name | JS005-005-III-PsO (pivotal registrational) |
| Clinical Sites | 60 sites across China |
| Patients Enrolled | 747 patients |
Drug Profile & Mechanism
Roconkibart is a specific anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. The therapy targets the IL-17A cytokine, a key driver of psoriasis pathogenesis, to reduce inflammation and normalize skin cell turnover.
Clinical Efficacy & Safety Data
| Endpoint | Roconkibart Result vs Placebo | Clinical Significance |
|---|---|---|
| PASI 75 | Significantly improved at 12 weeks | Superior skin clearance |
| PASI 90/100 | Significantly improved at 12 weeks | Higher threshold responses |
| sPGA 0 or 1 | Significantly improved at 12 weeks | Physician-assessed clearance |
| Durability | Stable efficacy through 52 weeks | Sustained treatment effect |
| Safety | Overall favorable profile | Supports long-term use |
Key Finding: Treatment demonstrated significantly superior efficacy vs. placebo, with stable results throughout 52-week treatment period.
Market Context & Strategic Outlook
- Psoriasis Market: China has ~6 million psoriasis patients; moderate-to-severe cases represent ~40% (2.4 million patients)
- IL-17 Inhibitors: Growing class with Novartis’ Cosentyx and Eli Lilly’s Taltz dominating the market
- Competitive Advantage: Roconkibart is a domestically developed anti-IL-17A antibody, positioning for favorable reimbursement and pricing
- Commercial Potential: Analysts project ¥2-3 billion (≈ US$280-420 million) peak sales if approved
- Next Steps: NMPA review expected to take 12-18 months; potential launch H2 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the NDA review timeline, clinical outcomes, and market potential for roconkibart. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech