Jacobio Pharma (1167.HK), a clinical-stage oncology company, announced on Sunday that it has received approval for its registrational phase III clinical trial of the combination therapy of its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312.

JAB-3312 is the first SHP2 inhibitor, entered into phase III study globally in combination with KRAS G12C inhibitor.

This approved study, a randomised active controlled phase III trial design conducted in China, is to assess the efficacy and safety of JAB-3312 along with glecirasib for first-line non-small cell lung cancer (NSLC) subjects with KRAS G12C mutations. The control arm is the current standard treatment for first-line NSLC, which is the combination therapy of PD-1 antibody and chemotherapy.

The firm commenced clinical trials of SHP2 inhibitors in 2018. The company's JAB-3312 and glecirasib are both oral formulations, and the combination therapy is also the first approved Phase III registration clinical trial for dual oral inhibitors in the first-line treatment of NSLC globally.