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

Stock News
2025/10/22

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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