By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that its Phase 3 trial JS001sc-002-III-NSCLC met the primary endpoint, demonstrating that the subcutaneous formulation JS001sc achieved non‑inferior drug exposure to intravenous toripalimab (JS001) in first‑line recurrent/metastatic non‑squamous NSCLC, with comparable efficacy and safety.
Clinical Trial Milestone
| Item | Detail |
|---|---|
| Product | JS001sc (toripalimab subcutaneous injection) |
| Company | Shanghai Junshi Biosciences (1877.HK; 688180.SH) |
| Trial | JS001sc-002-III-NSCLC (NCT06505837) |
| Study Design | Multicenter, open‑label, randomized Phase 3 |
| Comparator | Toripalimab (JS001) IV + chemotherapy |
| Primary Endpoint | Drug exposure non‑inferiority |
| Key Results | JS001sc exposure non‑inferior to JS001; similar efficacy and safety profiles |
| Significance | First domestically developed anti‑PD‑1 subcutaneous formulation in Phase 3 |
| Next Step | Marketing authorization application (MAA) submission planned |
Drug Profile
- Mechanism: Anti‑PD‑1 monoclonal antibody (subcutaneous formulation of marketed toripalimab/LOQTORZI)
- Innovation: Subcutaneous delivery offers patient convenience and reduced infusion center burden vs. IV administration
- Differentiation: Only domestic subcutaneous PD‑1 inhibitor in late‑stage development; addresses growing demand for outpatient‑friendly oncology therapies
- Pipeline: Expands toripalimab franchise beyond approved IV indications (nasopharyngeal carcinoma, melanoma)
Market Context & Outlook
| Metric | Value |
|---|---|
| China NSCLC Incidence | ~800,000 new cases (2024) |
| Recurrent/Metastatic ns‑NSCLC Share | ~40% of total NSCLC cases |
| PD‑1/PD‑L1 Market Size | ¥18 billion (US$2.5 billion) in China |
| Subcutaneous Penetration | <5% of PD‑1/PD‑L1 market; high growth potential |
| Peak Sales Forecast (JS001sc) | ¥2.5‑3.5 billion (US$340‑470 million) by 2031 |
| Competitive Landscape: Merck’s Keytruda SC approved globally but not yet in China; JS001sc could be first‑to‑market subcutaneous anti‑PD‑1 in China | |
| Reimbursement Path: Subcutaneous formulations typically receive favorable NRDL evaluation due to reduced healthcare resource utilization |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding JS001sc’s regulatory submission, market potential, and commercial launch timeline. Actual results may differ materially due to risks including NMPA review outcomes, competitive responses, and market adoption rates.-Fineline Info & Tech