The National Medical Products Administration of China (NMPA) has granted priority review designation to the NDA for IBI 351 to treat advanced non-small cell lung cancer harboring KRAS G12C mutation
Innovent Biologics, Inc. announces that the New Drug Application (NDA) for IBI 351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted Priority Review designation for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who 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.
The NDA acceptance and Priority Review designation are based on the results from a single-arm registrational Phase II clinical study (NCT05005234) intended to evaluate the efficacy and safety of IBI 351 monotherapy in advanced NSCLC patients harbouring KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The results will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia Congress 2023.
Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, stated: “KRAS mutation as the ‘undruggable’ target for decades has become one of the most popular direction for clinical development recently. Although FDA has approved KRAS G12C targeted drugs overseas, there’s no drug approved in China. IBI 351, as a novel, irreversible covalent inhibitor of KRAS G12C mutation, demonstrated favorable safety and promising efficacy in KRAS G12C mutated advanced NSCLC as monotherapy. We look forward to the NDA approval of this novel drug to benefit more NSCLC patients with KRAS G12C mutation soon."
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