CSPC Pharmaceutical Group (HKG:1093) subsidiary's investigational drug, SYS6010, has been granted breakthrough therapy designation by China's National Medical Products Administration (NMPA), according to a Hong Kong bourse filing on Thursday.
The designation is for SYS6010's use as a monotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations, after other treatment options have failed.
Lung cancer has a high incidence and mortality rate, with poor prognosis after standard treatments. The designation will enhance regulatory communication and speed up development, as current clinical data shows SYS6010 outperforms standard treatments, the company said.
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