Cspc Innovation's Subsidiary Drug SYS6010 Granted Breakthrough Therapy Designation

Stock News09-01

Cspc Innovation Pharmaceutical Co.,Ltd. (300765.SZ) has announced that its majority-owned subsidiary, CSPC Group MegaStone Biopharmaceutical Co., Ltd., has received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration for its drug candidate, SYS6010.

The designated indication for SYS6010 is for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have failed prior treatment with immunotherapy and platinum-based chemotherapy.

According to the company announcement, SYS6010 had previously been granted two other Breakthrough Therapy Designations by the CDE, excluding this latest one. Those earlier designations cover two distinct indications: first, as a monotherapy for patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have failed prior EGFR-TKI and platinum-based chemotherapy; and second, for patients with unresectable locally advanced or metastatic esophageal squamous cell carcinoma who have failed first-line treatment with platinum-based chemotherapy and immune checkpoint inhibitors (ICIs).

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