Shouyao Holdings: RET inhibitor Sotorasib tablets (SY-5007) new drug application has been accepted
Shouyao Holdings announced that its self-developed RET inhibitor Sotorasib tablets (SY-5007) have been accepted for new drug application by the National Medical Products Administration. This drug is suitable for patients with locally advanced or metastatic non-small cell lung cancer with RET gene fusion positivity, showing significant efficacy and good safety, and is expected to provide new treatment options for patients
According to the Zhitong Finance APP, Shouyao Holdings (688197.SH) announced that it recently received the "Acceptance Notice" issued by the National Medical Products Administration. The company's fully independently developed Sotorasib tablets (SY-5007, proposed trade name: Shouyi Ze®) has had its new drug application (NDA) accepted for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are positive for RET gene fusion.
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, while also exhibiting good safety and tolerability. This fully validates its clinical potential as a highly selective RET inhibitor and is expected to provide new treatment options for patients with RET fusion-driven non-small cell lung cancer in China
