Chinese inhibitor drug candidate becomes first to enter phase-3 clinical study

Chinese biotech company Jacobio Pharma announced on Monday that it had received approval from Chinese regulatory authorities for the registration phase-3 clinical trial of a combination therapy using its SHP2 inhibitor drug candidate JAB-3312.

SHP2 inhibitors are expected worldwide to have a substantial clinical effect in cancer and immunity disease treatment, and the approval made JAB-3312 the first SHP2 inhibitor to enter the phase-3 clinical study globally.

The approved clinical study in China is designed to evaluate the efficacy and safety of JAB-3312 in combination with the company's other investigational drug candidate KRAS G12C inhibitor glecirasib, for treating first-line non-small cell lung cancer patients with KRAS G12C mutations.

The control arm is the current standard treatment for first-line non-small cell lung cancer, which is the combination therapy of PD-1 antibody and chemotherapy.