China approves AstraZeneca's Orpathys for gastric cancer

AstraZeneca's selective MET inhibitor Orpathys has won conditional approval in China for a new indication in MET-amplified gastric cancer, marking the first targeted therapy approved in the country for the biomarker-defined subgroup and underscoring China's growing role in precision oncology drug development.

China's National Medical Products Administration approved the drug for adults with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma harboring MET gene amplification after failure of at least two prior systemic therapies, AstraZeneca said on Thursday.

The approval expands Orpathys beyond lung cancer into gastric cancer, broadening the commercial potential of a drug jointly developed by AstraZeneca and Shanghai-based biopharmaceutical company Hutchmed, with AstraZeneca responsible for commercialization.

The decision is significant because it introduces the first precision medicine specifically targeting MET amplification in gastric cancer in China, a disease that remains one of the country's leading causes of cancer deaths. Around 4 to 6 percent of gastric cancer patients carry MET amplification, translating into an estimated 18,000 new eligible patients annually in China, according to the company.

The approval also highlights China's increasing shift toward biomarker-driven cancer treatment, where molecular testing identifies patients most likely to benefit from targeted therapies. While precision oncology has become standard practice in lung cancer, targeted options for gastrointestinal cancers remain comparatively limited, making the approval a notable expansion of the precision medicine model.

Orpathys was China's first approved selective MET inhibitor. It is already approved for patients with MET exon 14 skipping mutation non-small cell lung cancer and, in combination with osimertinib, for EGFR-mutated non-squamous non-small cell lung cancer with MET amplification after progression on EGFR tyrosine kinase inhibitor therapy.

For AstraZeneca, the latest approval strengthens its oncology franchise in China, one of its largest global markets, while giving Hutchmed a third approved indication for its homegrown oncology asset, reinforcing the commercialization potential of Chinese-developed targeted cancer medicines.