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HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots:China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapyNDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
June 5, 2025

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Innovent Reports the NMPA’s NDA Acceptance & Priority Review of Neoadjuvant Ipilimumab + Sintilimab for Colon Cancer

Shots:China’s NMPA has accepted NDA & granted priority review to ipilimumab (IBI310) + sintilimab as neoadj. treatment of operable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer Submission was based on P-III (NeoShot) trial assessing safety & efficacy of ipilimumab + sintilimab vs direct radical surgery in MSI-H/dMMR colon cancer pts …
February 24, 2025

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