Orpathys® approved in China to treat gastric cancer patients with MET amplification
China's first selective MET inhibitor for the treatment of MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma
July 2, 2026, Shanghai - AstraZeneca announced today that Orpathys® (English trade name: ORPATHYS®, generic name: savolitinib tablets, hereinafter referred to as "savolitinib") has been conditionally approved by the China National Medical Products Administration for the treatment of adult patients with MET gene amplified locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma who have failed after at least 2 systemic treatments.
Savolitinib is China's first approved selective MET inhibitor, jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Savolitinib has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping, and in combination with osimertinib for the treatment of patients with epidermal growth factor receptor ("EGFR") gene mutation-positive locally advanced or metastatic non-squamous NSCLC with MET amplification that has progressed after treatment with an EGFR tyrosine kinase inhibitor ("TKI"). This new approval is an important milestone in the expansion of the clinical application of savolitinib from lung cancer to gastric cancer, and brings new hope to Chinese MET-amplified gastric cancer patients.
Gastric cancer is one of the most common cancers in China and ranks among the leading causes of cancer death. The prognosis of MET-driven gastric cancer is generally poor1. It is estimated that approximately 4-6% of gastric cancer patients have MET amplification2,3. There are approximately 18,000 new cases of MET-amplified gastric cancer in China every year4.
The approval was based on data from a pivotal Phase II registration study (NCT04923932), the results of which were recently published in Nature Medicine and announced at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO). The study has met its primary endpoint of independent review committee (IRC)-assessed objective response rate (ORR) according to RECIST 1.1 criteria. As of October 8, 2025, the ORR assessed by IRC was 32.3% (95% CI: 21.2%, 45.1%), exceeding the preset efficacy threshold. Secondary endpoints include IRC-assessed disease control rate (DCR) of 63.1%, median time to disease response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 months (95% CI: 3.7, 18.5), and median progression-free survival (PFS) of 4.0 months (95% CI: 2.6, 5.0).
The principal investigator of the registration study, Professor Shen Lin from Peking University Cancer Hospital, said: "This landmark approval marks a key advance in biomarker-oriented precision medicine in the field of gastrointestinal tumors. The clinical data of this pivotal study have recently been published in Nature Medicine, it provides solid evidence-based medical evidence for clinical practice: identifying MET amplification status through timely molecular testing can directly guide patients to match efficient oral targeted treatment options for the clinical treatment of MET-amplified gastric cancer, providing clinicians with a powerful and precise new therapeutic tool to intervene in this aggressive cancer driver 5."
Ms. Guan Dongmei, General Manager of AstraZeneca's China Oncology Business, said: "After its success in the field of lung cancer, savolitinib's approval for gastric cancer indications is not only another important milestone in our joint development with HUTCHMED, but also opens a new chapter in the precision treatment of MET-amplified gastric cancer. In the future, we will continue to work together to advance the full-cycle pipeline layout of savolitinib, continue to expand its boundaries, fully unleash the therapeutic potential of this highly selective MET inhibitor, and bring innovative treatment options to cancer patients in China and around the world to meet the evolving clinical treatment needs."
Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: "The approval of savolitinib for the new indication of MET-amplified advanced gastric cancer is an important development and demonstrates HUTCHMED's long-term and firm commitment to bringing independent research and development innovations to patients. This marks the success of savolitinib in China has ushered in the third approved indication and further verified the strength of our independent research and development platform to solve deep unmet medical needs. We work closely with our partner AstraZeneca to continue to expand the clinical application of this highly selective MET inhibitor and look forward to fully accelerating its commercialization to improve the clinical treatment landscape of gastric cancer in China."
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About savolitinib
Savolitinib is a potent, highly selective, oral TKI for MET, a receptor tyrosine kinase that plays an important role in normal cell development. Savolitinib blocks abnormal activation of the MET receptor tyrosine kinase signaling pathway caused by mutations (such as exon 14 skipping or other point mutations), gene amplification, or protein overexpression.
Savolitinib is the first selective MET TKI approved in China and has been included in the National Reimbursement Drug List since March 2023. Savolitinib is being developed as monotherapy or in combination with other drugs to treat a variety of tumor types, including lung and gastric cancers.
In 2011, HUTCHMED and AstraZeneca entered into a global licensing agreement to jointly develop and commercialize savolitinib. The collaborative clinical development of savolitinib is led by HUTCHMED in China and AstraZeneca overseas. In addition, HUTCHMED is responsible for the marketing authorization, production and supply of savolitinib in China, while AstraZeneca is responsible for the commercialization of savolitinib in China and globally. Revenue from sales of savolitinib will be recognized by AstraZeneca.
About AstraZeneca’s research in gastrointestinal tumors
AstraZeneca has a broad development program in the treatment of gastrointestinal tumors, covering multiple medicines across multiple tumor types and disease stages. In 2022, there were approximately 5 million new cases of digestive tract tumors, resulting in approximately 3.3 million deaths7.
In this program, the company works to improve the treatment of gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers.
Durvalumab is a PD-L1 monoclonal antibody that has been approved in combination with chemotherapy for the treatment of locally advanced or metastatic biliary cancer (BTC) and with tremelimumab for the treatment of unresectable hepatocellular carcinoma (HCC). In addition, durvalumab has also been approved as a monotherapy for unresectable HCC in Japan, China and the EU. Durvalumab is being evaluated in multiple combination therapy development projects, including in combination with tremelimumab, covering tumor types such as HCC, BTC, esophageal cancer, and gastric cancer, and spanning different treatment scenarios from early to late stages.
Trastuzumab deruxtecan is an antibody-drug conjugate targeting HER2 that is approved in the United States and several other countries for the treatment of previously treated advanced HER2-positive gastric cancer. Trastuzumab deruxtecan is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
Olaparib is a first-in-class PARP inhibitor approved in the United States and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is jointly developed and commercialized by AstraZeneca and Merck & Co. (known as "Merck" in the United States and Canada).
The company is also evaluating the PD-1/TIGIT bispecific antibody rilvegostomig (AZD2936) in combination with chemotherapy as an adjuvant treatment for BTC, in combination with bevacizumab with or without tremelimumab in the first-line treatment of HCC, and in the first-line treatment of HER2-negative, unresectable, recurrent or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Rilvegostomig is also being evaluated in combination with trastuzumab deruxtecan for the first-line treatment of patients with previously untreated locally advanced or metastatic HER2-expressing BTC.
AstraZeneca is advancing multiple treatment modalities with complementary mechanisms against Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class Claudin 18.2-targeting ADC licensed through an agreement with KYM Biosciences Inc. (KYM), currently in Phase III clinical development; AZD5863, a novel Claudin 18.2/CD3-targeting T-cell-engaging bispecific antibody licensed through an agreement with Harbour BioMed, currently in Phase I development; and AZD4360, an antibody–drug conjugate being evaluated in a Phase I/II trial in patients with advanced solid tumors.
In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armored CAR-T therapy for the treatment of HCC.
About AstraZeneca’s research in oncology
AstraZeneca is leading a revolution in the field of oncology and is committed to providing diversified oncology treatment options to scientifically explore the complexity of the oncology field and discover, develop and deliver life-changing medicines to patients.
AstraZeneca's oncology business focuses on the most challenging oncology diseases. Through continuous innovation, AstraZeneca has established an industry-leading diversified product portfolio and channels, continues to promote changes in medical practices and transform patient experience.
AstraZeneca's vision is to redefine cancer treatment with the goal of ending cancer as a leading cause of death in the future.
About AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-first global biopharmaceutical company focused on the research, development, production and marketing of prescription drugs, with a focus on oncology, rare diseases and biopharmaceuticals including cardiovascular kidney and metabolism, respiratory and immunity. AstraZeneca's global headquarters is located in Cambridge, UK, with operations in more than 125 countries, and its innovative medicines benefit millions of patients around the world. For more information, please visit www.astrazeneca.com.
About AstraZeneca China
China is AstraZeneca's second largest market in the world and a strategic hub for its global innovation. The company has two global strategic R&D centers in China and has led more than 20 global clinical trials so far. It has four production and supply bases and provides high-quality innovative drugs to more than 70 markets around the world. It has set up a China headquarters in Shanghai and regional headquarters in five places to carry out commercial operations. Since 2023, the company has reached 17 cooperation projects with 15 Chinese innovative pharmaceutical companies. Since entering China in 1993, AstraZeneca has brought more than 40 innovative drugs to Chinese patients, covering oncology, cardiovascular, renal and metabolic, respiratory and immune, infectious diseases, digestion, rare diseases and other fields. In 2025 alone, the company's innovative drugs will benefit 68 million Chinese patients.
Content source: press release (approval number: CN-187267)
Statement: The uses of many drugs involved in this study have not yet been approved for indications in China, and AstraZeneca does not recommend the use of any unapproved drugs.
References
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.
5. Peng Z, Liu T, Wang H. et al. Savolitinib in MET-amplified gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Nat Med. Published online June 1, 2026. doi:10.1038/s41591-026-04459-7
6. Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).
7. World Health Organization. World Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. Accessed May 2026