By Fineline Cube Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted Biologics License Application (BLA) for the combination therapy of camrelizumab and apatinib as first‑line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The FDA is expected to act on the filing by July 23, 2026.
Drug Profile & Regulatory History
| Item | Detail |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals (SHA: 600276, HKG: 1276) |
| Combination | Camrelizumab (anti‑PD‑1 mAb) + Apatinib (VEGFR TKI) |
| Indication | Unresectable/metastatic HCC (first‑line) |
| Regulatory Status | FDA accepted resubmitted BLA (January 2026) |
| Previous Status | Complete Response Letter (CRL) issued March 2025 (manufacturing site issues) |
| Clinical Basis | Phase III SHR‑1210‑III‑310 study |
| PDUFA Date | July 23, 2026 |
Clinical Data & Study Results
- Trial Design: Phase III SHR‑1210‑III‑310 study in previously untreated advanced HCC patients
- Comparator: Standard therapy sorafenib
- Primary Endpoints: Significantly extended both progression‑free survival (PFS) and overall survival (OS) vs. sorafenib
- CRL Resolution: Resubmission addresses FDA’s manufacturing site inspection concerns; no clinical deficiencies cited
Market Impact & Commercial Outlook
- Global HCC Market: Valued at $3 billion : in 2025, with first‑line systemic therapy representing ~60% : of treatable patients
- Competitive Landscape: Competition from Tecentriq + Avastin (Roche), Opdivo + Yervoy (BMS); camrelizumab‑apatinib offers all‑oral combination advantage
- Revenue Potential: Analysts project $500–800 million : peak annual global sales if approved, based on China market dominance and potential ex‑China expansion
- Strategic Value: US approval would validate Hengrui’s innovation platform and enable global partnerships; China sales already exceed ¥2 billion : annually
- Next Steps: FDA review underway; potential approval Q3 2026; ex‑China commercialization partnerships under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approval timelines, commercial expectations, and revenue projections for the camrelizumab‑apatinib combination. Actual results may differ due to FDA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech