The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that the Company's in-house KRAS G12C inhibitor JAB-21822 (Glecirasib) was granted breakthrough therapy designation for KRAS G12C-mutated pancreatic cancer patients who have progressed on frontline standard care treatment by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation was granted based on the solid clinical efficacy and safety data of JAB-21822. It will expedite the clinical development of JAB-21822 and accelerate its early access to the patients.

JAB-21822's pivotal study for pancreatic cancer has been approved by CDE, which became the first global pancreatic cancer registrational clinical study for KRAS G12C. The approved pivotal clinical trial will evaluate the efficacy and safety of single agent Glecirasib in KRAS G12C- mutated locally advanced or metastatic pancreatic cancer patients who have advanced on frontline standard care treatment. This is a multi-center, single-arm, open-label study.

pancreatic cancer is a highly malignancy and there is a limited effective treatment currently. The five-year overall survival rate is only 5%. The breakthrough therapy designation will help accelerate the clinical study.

pancreatic cancer is JAB-21822's second indication that was granted breakthrough therapy designation by CDE in China. In December 2022, JAB-21822 was granted breakthrough therapy designation for the second line setting and beyond of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation by CDE. About CDE's Breakthrough Therapy Designation.

CDE's breakthrough therapy designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.

JAB-21822 is an oral, small molecule KRAS G12C inhibitor independently developed by the Company. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors harbouring KRAS G12C mutation, including a pivotal clinical trial to treat non-small cell lung cancer in China, a monotherapy study for STK11 co-mutated NSCLC in the front-line setting; combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and Cetuximab.