By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that a supplementary Biologics License Application (sBLA) for its PD‑1 monoclonal antibody camrelizumab has been accepted for review by the National Medical Products Administration (NMPA). The company seeks approval for camrelizumab combined with apatinib and transarterial chemoembolization (TACE) for the treatment of unresectable hepatocellular carcinoma (HCC).
Regulatory Milestone & Combination Strategy
| Item | Detail |
|---|---|
| Company | Jiangsu Hengrui Medicine Co., Ltd (600276.SH) |
| Drug | Camrelizumab (PD‑1 mAb) |
| Combination | Camrelizumab + apatinib + TACE |
| Indication | Unresectable hepatocellular carcinoma (HCC) |
| Application Type | Supplementary Biologics License Application (sBLA) |
| Status | Accepted for review by NMPA |
| Camrelizumab Launch | First approved in China May 2019 |
| Prior Approvals | Liver cancer, lung cancer, ESCC, NPC, lymphoma |
Drug Profile & Mechanism of Action
- Camrelizumab: PD‑1 checkpoint inhibitor that restores T‑cell mediated anti‑tumor immunity; Hengrui’s flagship immuno‑oncology asset with 5+ approved indications in China
- Apatinib: Selective VEGFR‑2 tyrosine kinase inhibitor (TKI) that blocks tumor angiogenesis; first approved in 2014 for advanced gastric cancer, now with 4 total indications
- TACE: Standard interventional radiology procedure delivering localized chemotherapy to liver tumors
- Synergistic Rationale: Triple combination aims to maximize anti‑tumor efficacy through immune activation (PD‑1), anti‑angiogenesis (VEGFR‑2), and locoregional cytotoxicity (TACE) in HCC, a highly vascular and immunosuppressive tumor microenvironment
Market Impact & Commercial Outlook
- China HCC Burden: ~400,000 new HCC cases annually; unresectable disease represents 70% of diagnoses with 5‑year survival <15%
- Standard of Care: Limited to sorafenib/lenvatinib and PD‑1/VEGF combos; no approved triplet regimens exist
- Competitive Landscape: Competes with BeiGene’s tislelizumab + lenvatinib and Innovent’s sintilimab + bevacizumab biosimilar; Hengrui’s TACE integration offers differentiation
- Revenue Potential: Analysts project ¥1.5–2.0 billion (US$210–280 million) peak annual sales potential if approved, leveraging Hengrui’s established oncology sales force
- Strategic Value: sBLA acceptance demonstrates regulatory confidence; positions Hengrui as leader in HCC combination therapy innovation
- Next Steps: NMPA priority review possible given unmet need; approval anticipated H2 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, clinical outcomes, and commercial expectations for the camrelizumab combination. Actual results may differ due to NMPA review processes, competitive dynamics, and market adoption rates.-Fineline Info & Tech