December 17, 2025 – AmoyDx, a leading company in tumor companion diagnostics, announced that the companion diagnostic for MET exon 14 skipping mutations for Tabrecta® (Capmatinib Hydrochloride Tablets) has received approval from the National Medical Products Administration (NMPA) in China. The approval was based on the independently developed AmoyDx® Lung Cancer PCR Panel (PCR-11) and supported by the global pivotal clinical study of capmatinib, providing a new precision treatment option for non-small cell lung cancer (NSCLC) patients harboring MET exon 14 skipping mutations in China.
In June 2024, NMPA approved capmatinib for the treatment of adult patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations who have not received prior systemic therapy. Novartis licensed Tabrecta® (capmatinib) from Incyte and holds exclusive worldwide development and commercialization rights.
On May 20, 2024, AmoyDx® Lung Cancer PCR Panel was approved in Japan as the companion diagnostic for capmatinib. The approval in China further demonstrates the steady advancement of Chinese companies in the internationalization of companion diagnostics.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
In June 2024, NMPA approved capmatinib for the treatment of adult patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations who have not received prior systemic therapy. Novartis licensed Tabrecta® (capmatinib) from Incyte and holds exclusive worldwide development and commercialization rights.
On May 20, 2024, AmoyDx® Lung Cancer PCR Panel was approved in Japan as the companion diagnostic for capmatinib. The approval in China further demonstrates the steady advancement of Chinese companies in the internationalization of companion diagnostics.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
AmoyDx® Pan Lung Cancer PCR Panel submission for regulatory approval in Japan for the additional indication of Amivantamab in combination with chemotherapy
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