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A Chinese immunotherapy-plus-anti-angiogenic pill combination that clearly beat sorafenib in liver cancer, yet remains unapproved in the US after three manufacturing-related rejections.
CARES-310: median OS 23.8 vs 15.2 months (HR 0.62) and PFS 5.6 vs 3.7 months versus sorafenib in first-line unresectable HCC; approved in China (2023). FDA complete response letters in May 2024, March 2025 and July 2026, each on cGMP inspection deficiencies at the rivoceranib manufacturing site, not on clinical data. Rivoceranib (apatinib) is a selective VEGFR2 TKI; camrelizumab is a PD-1 antibody notable for reactive cutaneous capillary endothelial proliferation, which the TKI suppresses.
PD-1 blockade plus VEGFR2 inhibition (vascular normalisation and reduced immunosuppression). Connects to PD-1 and VEGF / VEGFR.
1.Camrelizumab + rivoceranib binds PD-1.
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First CRL: manufacturing inspection findings
Second CRL
Resubmission accepted; PDUFA 23 July 2026 source
Third CRL, again cGMP source
| Region | Year | Indication |
|---|---|---|
| China | 2023 | First-line unresectable HCC |
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Query for this drug: (TITLE:"Camrelizumab + rivoceranib" OR ABSTRACT:"Camrelizumab + rivoceranib" OR TITLE:"SHR-1210 + apatinib" OR ABSTRACT:"SHR-1210 + apatinib") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Camrelizumab + rivoceranib, not a curated reading list.
Shares Rivoceranib (apatinib), Jiangsu Hengrui Pharmaceuticals, Anti-angiogenic therapy, Hepatocellular carcinoma.
Shares Rivoceranib (apatinib), Jiangsu Hengrui Pharmaceuticals, Anti-angiogenic therapy, Hepatocellular carcinoma.
Shares Rivoceranib (apatinib), Jiangsu Hengrui Pharmaceuticals, Anti-angiogenic therapy, Immune checkpoint inhibitors.
Shares Rivoceranib (apatinib), Jiangsu Hengrui Pharmaceuticals, Anti-angiogenic therapy, Immune checkpoint inhibitors.
Shares Advanced hepatocellular carcinoma (BCLC C), Anti-angiogenic therapy, Hepatocellular carcinoma, Immune checkpoint inhibitors.
Shares Advanced hepatocellular carcinoma (BCLC C), Anti-angiogenic therapy, Hepatocellular carcinoma, Immune checkpoint inhibitors.
Shares Advanced hepatocellular carcinoma (BCLC C), Anti-angiogenic therapy, Hepatocellular carcinoma, Immune checkpoint inhibitors.
Shares Advanced hepatocellular carcinoma (BCLC C), Anti-angiogenic therapy, Hepatocellular carcinoma, Immune checkpoint inhibitors.