China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This marks the first approval of its kind for this indication in China.
Approval Based on Global Phase III Study
The approval is based on the SHR-1210-III-310 study, a global, multi-center Phase III clinical trial involving 95 centers across 13 countries. The results demonstrated significant survival benefits and tolerable safety for the camrelizumab-apatinib combination. Specifically, the median overall survival (OS) was 22.1 months, the median progression-free survival (mPFS) was 5.6 months, the risk of disease progression or death was reduced by 48%, and the risk of death was reduced by 38%. This combination offers the longest OS benefit among all first-line treatments for advanced liver cancer currently available.
Camrelizumab’s Regulatory Milestones
Camrelizumab was first approved in China in May 2019 and has since received eight indication approvals, including for liver cancer, lung cancer, esophageal squamous cell carcinoma (ESCC), nasopharyngeal cancer (NPC), and lymphoma. All these indications are covered by China’s National Reimbursement Drug List (NRDL). Today’s approval marks the ninth indication for camrelizumab, further solidifying its position in oncology treatment options.-Fineline Info & Tech
