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ByDrug’s Acigene® receives companion diagnostic label for carmatinib again – ByDrug

2024年6月， NMPA批准盐酸卡马替尼片适用于治疗用于未经系统治疗的携带间质上皮转化因子（MET）外显子14跳跃突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。

Medical Information July 12, 2026

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In June 2024, the NMPA approved carmatinib hydrochloride tablets for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal epithelial transforming factor (MET) exon 14 skipping mutations who have not received systemic therapy. AmoyDx’s companion diagnostic reagent, AiHuiJie® (Lung Cancer PCR-11 Gene), covers 11 essential and extended genes for NSCLC, enabling co-detection of DNA and RNA. Among these, EGFR, ALK, ROS1, MET, and KRAS genes have been approved for companion diagnostic use in China, guiding the clinical application of eight targeted therapies domestically.

Currently, AmoyDx® has been approved for marketing in China, Japan, and Europe, with seven genes receiving companion diagnostic approval. These companion diagnostics guide the clinical application of up to 22 targeted therapies, benefiting numerous non-small cell lung cancer patients worldwide. AmoyDx adheres to regulations and will continue to expand its innovative products in the companion diagnostics field, collaborating with domestic and international partners to promote more and better treatment options in clinical practice, benefiting more cancer patients.

On December 11, 2025, AmoyDx, a leading company in oncology companion diagnostics, announced that its companion diagnostic reagent for MET exon 14 skipping mutations developed for Toruida® (camatinib hydrochloride tablets) has been approved by the National Medical Products Administration (NMPA). This approval is based on AmoyDx’s independently developed AiHuiJie® (lung cancer PCR-11 gene) and Novartis’s carmatinib pivotal clinical trials, providing a new precision treatment option for patients with MET exon 14 skipping mutation-positive non-small cell lung cancer.

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