{"entity":{"id":"camrelizumab-rivoceranib","kind":"drug","name":"Camrelizumab + rivoceranib","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03764293 (CARES-310)","url":"https://clinicaltrials.gov/study/NCT03764293"}],"tags":[],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor","antiangiogenic"],"targets":["pd1","vegf"],"drugs":[],"companies":["hengrui","elevar-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["cares-310"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"SHR-1210 + apatinib","modality":"PD-1 antibody + oral VEGFR2 inhibitor","mechanism":"PD-1 blockade plus VEGFR2 inhibition (vascular normalisation and reduced immunosuppression).","approvals":[{"region":"China","year":2023,"indication":"First-line unresectable HCC"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2024-05","type":"crl","region":"US","note":"First CRL: manufacturing inspection findings"},{"date":"2025-03","type":"crl","region":"US","note":"Second CRL"},{"date":"2026-01-30","type":"filing","region":"US","note":"Resubmission accepted; PDUFA 23 July 2026","source":"https://www.globenewswire.com/news-release/2026/01/30/3229623/0/en/elevar-therapeutics-announces-fda-acceptance-of-new-drug-application-resubmission-for-rivoceranib-in-combination-with-camrelizumab-as-a-first-line-systemic-treatment-for-unresectab.html"},{"date":"2026-07-23","type":"crl","region":"US","note":"Third CRL, again cGMP","source":"https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc"}]},"route":"/drugs/camrelizumab-rivoceranib/","neighbours":{"cancer":[{"id":"hcc-advanced","kind":"cancer","name":"Advanced hepatocellular carcinoma (BCLC C)","route":"/cancers/hcc-advanced/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"elevar-therapeutics","kind":"company","name":"Elevar Therapeutics (HLB)","route":"/companies/elevar-therapeutics/"},{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"trial":[{"id":"cares-310","kind":"trial","name":"CARES-310","route":"/trials/cares-310/"}],"person":[{"id":"qin-shukui","kind":"person","name":"Shukui Qin","route":"/people/qin-shukui/"}],"drug":[{"id":"rivoceranib","kind":"drug","name":"Rivoceranib (apatinib)","route":"/drugs/rivoceranib/"}]}}