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Hutchmed
NEWS

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots:HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…
October 13, 2025

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NEWS

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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Takeda
NEWS

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Shots: The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…
April 26, 2024

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New Drug Designations - July 2023
INSIGHTS+

New Drug Designations – July 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…
August 21, 2023

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