Jacobio Pharma (1167.HK), a China-based clinical-stage pharmaceutical company, announced on Tuesday that it has received approval from the Center for Drug Evaluation (CDE) of China for the Phase II pivotal study of its KRAS G12C inhibitor JAB-21822.

The study is intended for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation as a second line or beyond therapy. The Phase II pivotal clinical trial, a multi-centre, single-arm, open-label study approved in China, is intended to assess the efficacy and safety of the product as a single agent intended to treat NSCLC patients with a KRAS G12C mutation.

The company intends to apply for the new drug marketing application (NDA) for the product after the successful completion of this pivotal study.