HUTCHMED

HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China

22 April 2025 -- Hong Kong, Shanghai and New Jersey, US -- HUTCHMED today announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification. This clinical trial is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and...

HUTCHMED Announces NMPA Conditional Approval for TAZVERIK (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma

First and only EZH2 inhibitor approved by the NMPA HUTCHMED’s fourth product, and its first approval in hematological malignancies. 21 March 2025 -- Hong Kong, Shanghai & New Jersey, US -- HUTCHMED (China) Limited today announces that the New Drug Application (“NDA”) for TAZVERIK (tazemetostat) has been granted conditional approval in China for the treatment...

HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025

SAVANNAH Phase II trial demonstrated high and durable response rates with savolitinib plus TAGRISSO® in MET-high lung cancer, representing a promising chemo-free oral treatment strategy to address mechanisms of resistance in the advanced setting Long-term survival benefit and safety observed in savolitinib Phase IIIb study in METex14 NSCLC. 20 March 2025 -- Hong Kong, Shanghai...

HUTCHMED and Innovent Jointly Announce that the FRUSICA-2 Phase II/III Study of Fruquintinib and Sintilimab Combination Has Met its Primary Endpoint in Advanced Renal Cell Carcinoma in China

19 March 2025 -- Hong Kong, Shanghai & New Jersey, US -- HUTCHMED (China) Limited and Innovent Biologics, Inc, today jointly announce that the FRUSICA-2 Phase II/III clinical trial evaluating fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China has met its primary endpoint of...

HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China

6 March 2025 -- Hong Kong, Shanghai and New Jersey, US -- HUTCHMED (China) Limitedtoday announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement. The study is a single-arm, multi-center, open-label, Phase II registration study to evaluate...

HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval. 14 January 2025 -- Hong Kong, Shanghai, and New Jersey, US -- HUTCHMED (China) Limited today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China National Medical Products Administration (“NMPA”)...

HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer

First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor 3 December 2024 -- Hong Kong, Shanghai and New Jersey, US — HUTCHMED (China) and Innovent Biologics, Inc today jointly announce that the New Drug Application (“NDA”) for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in...
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