China NDA Acceptance-Savolitinib in Gastric Cancer

HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Savolitinib for the treatment of Gastric Cancer Patients with MET Amplification

• NDA supported by positive Phase II registration study data in Chinese patients; follows Breakthrough Therapy Designation granted in 2023 -
• Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer -

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, December 30, 2025: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application ("NDA") for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments has been accepted and granted priority review by the China National Medical Products Administration ("NMPA").

This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study of savolitinib in gastric cancer patients with MET amplification in China. The study has met its primary endpoint of objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1). Additional details may be found at clinicaltrials.gov using identifier NCT04923932.

Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis.[1] It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.[2],[3] The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.[4]

The NMPA has granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023. The NMPA granted this designation to this new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.[5] Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

Medical Information

[1] Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070. doi:10.1002/cncr.30437

[2] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044

[3] Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter Phase II Study of AMG 337 in Patients with MET-Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337

[4] Global Cancer Observatory. China Fact Sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed April 7, 2025.