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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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HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

Shots:HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…
August 20, 2025

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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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HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Shots:HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…
March 7, 2025

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HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC

Shots:The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval Approval was based on P-IIIb study, with preliminary data from the first line…
January 15, 2025

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NEWS

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots:The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…
January 2, 2025

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