All-oral first-line regimen targets NSCLC patients with PD-L1 expression below 50%

Beijing, China, May 8, 2026 — Jacobio Pharma (1167.HK) today announced that the KRAS G12C inhibitor combined with a SHP2 inhibitor, licensed to Shanghai Allist Pharmaceuticals Co., Ltd. (“Allist”) for development and commercialization, has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).

The designation is granted for the first-line treatment of patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) whose PD-L1 expression is below 50%. The program is among the first frontline KRAS G12C dual-target combination approaches in China focused on the PD-L1 low-expression population.

The investigational therapy utilizes an all-oral combination approach, with the potential to enhance anti-tumor activity and delay resistance development. Compared with current chemotherapy plus immunotherapy regimens, the therapy may offer improved convenience and long-term treatment adherence.

Clinical data for the combination were previously published in The Lancet Respiratory Medicine. In the Phase I/IIa study, frontline KRAS G12C-mutant NSCLC patients achieved an objective response rate (ORR) of 71% and a median progression-free survival (mPFS) of 12.2 months, demonstrating a highly competitive efficacy profile.

Jacobio stated that the Breakthrough Therapy Designation reflects regulatory recognition of the clinical value and innovation potential of the combination therapy. The company will continue supporting Allist in advancing pivotal clinical development to bring this novel treatment option to patients as early as possible.
 

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