Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, 01276) and its subsidiary Suzhou Suncadia Biopharmaceuticals have received National Medical Products Administration (NMPA) approval to market camrelizumab for injection in combination with famitinib malate capsules as a first-line (1L) therapy for patients with recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1). The regimen had previously carried a second-line (2L) label; the new approval upgrades it to first-line use in China.
The decision rests on data from the randomised, open-label, multi-centre Phase III trial SHR-1210-III-329, which enrolled 443 patients across 45 Chinese sites. In the PD-L1–positive subgroup, median overall survival reached 35.80 months with camrelizumab + famitinib versus 23.60 months for platinum-based chemotherapy, representing a 36.6% reduction in risk of death (HR = 0.634) at a median follow-up of 19.5 months (cut-off: 10 June 2025). All prespecified primary endpoints were met.
Camrelizumab is a humanised anti-PD-1 monoclonal antibody already cleared in China for nine oncology indications, including hepatocellular carcinoma, non-small cell lung cancer, and nasopharyngeal and esophageal cancers. Cumulative R&D investment in camrelizumab projects stands at approximately RMB 3.49 billion (unaudited).
Famitinib is Hengrui Pharma’s self-developed multi-targeted tyrosine kinase inhibitor. Its combination with camrelizumab received conditional approval in May 2025 for second-line cervical cancer therapy and was converted to full approval in July 2026. Total R&D spending on famitinib projects is about RMB 291.10 million (unaudited).
Cervical cancer remains the most prevalent gynecological malignancy in China, with 150,700 new cases and 55,700 deaths reported in 2022. Existing first-line regimens based on platinum chemotherapy, with or without bevacizumab, deliver limited survival benefits, underscoring the clinical importance of the newly approved immunotherapy-targeted combination.
Global benchmarks highlight the commercial potential of the two drug classes involved. According to EvaluatePharma, worldwide 2025 sales of PD-1 monoclonal antibodies reached USD 44.61 billion, while comparable multi-targeted TKIs such as sorafenib, sunitinib and pazopanib generated USD 503 million.
Hengrui Pharma emphasizes its commitment to stringent quality and safety management across R&D, manufacturing and commercialisation. The company cautions that post-approval production and sales remain subject to market and operational uncertainties.