Shouyao Holdings Co., Ltd. (688197.SH): NDA for RET Inhibitor SY-5007 Accepted

Stock News
Oct 22, 2025

Shouyao Holdings Co., Ltd. (688197.SH) has announced that it recently received an Acceptance Notification from the National Medical Products Administration. The application for its independently developed RET inhibitor, SY-5007 (trade name: Shouyize®), for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion, has been accepted as a New Drug Application (NDA). SY-5007 has demonstrated significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive non-small cell lung cancer, and it shows good safety and tolerability. This strongly validates its clinical potential as a highly selective RET inhibitor, providing a new therapeutic option for patients with RET fusion-driven non-small cell lung cancer in China.

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