Innovent Biologics : China Grants Priority Review Designation To NDA For IBI351

(RTTNews) - Innovent Biologics Inc. said that the New Drug Application or NDA for IBI351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation or CDE of the National Medical Products Administration or NMPA of China and granted Priority Review designation, for the treatment of patients with advanced non-small cell lung cancer or NSCLC harboring KRAS G12C mutationwho have received at least one systemic therapy.

It is China's first NDA for a KRAS G12C inhibitor and is anticipated to benefit more lung cancer patients harbouring KRAS G12C mutation after approval.

Innovent said it is also exploring the potential of IBI351 in combination therapy for previously-untreated advanced NSCLC patients with KRAS G12C mutation. Two Phase 1b studies of IBI351, in combination with cetuximab (ERBITUX, EGFR inhibitor) and sintilimab (TYVYT, PD-1 inhibitor) respectively, are currently ongoing.

Besides, IBI351 monotherapy also demonstrated excellent efficacy and safety in previously-treated advanced colorectal carcinoma (CRC) patients with KRAS G12C mutation.

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