...Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC....

...- Pathologically diagnosed, previously treated, advanced tumor with KRAS p.G12C mutation...

...1.Volunteer to participate in the research and sign the informed consent form; 2.≥18 years old and ≤75 years old when signing the informed consent form; 3.Expected survival time ≥3 months; 4.According to the 9th edition of the International Association for Lung Cancer Research and the Joint Commission for the Classification of Cancer in the United States, lung cancer TNM stage, locally advanced (phase III B/III C), metastatic or recurrent (phase IV) non-scale NSCLC subjects who cannot be surgically removed and cannot be subjected to radical synchronous radiotherapy confirmed by histology or cytology; 5.There is a clear test report proving that there is a mutation of KRAS G12C. ...

Innovent Biologics...announces that the New Drug Application (NDA) for IBI351 (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 2 clinical study (NCT05005234) intended to evaluate the efficacy and safety of IBI351 monotherapy in advanced NSCLC patients harbouring KRAS G12C mutation who failed or were intolerant to the standard treatment in China.

Innovent Biologics...announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy....The NMPA BTD for IBI351 was based on the results from a phase I/II trial (CDE Registration No. CTR20211933).

Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in previously-treated advanced NSCLC, CRC and pancreatic cancer harboring KRASG12C mutation.