The board of directors of JACOBIO PHARMACEUTICALS Group CO., Ltd. announced that, the Company received approval of registrational phase III clinical trial of the combination therapy between its independently developed novel KRAS G12C inhibitor Glecirasib (JAB-21822) and epidermal growth factor receptor (anti-EGFR antibody) inhibitor ERBITUX® (cetuximab) in patients with KRAS G12C-mutated colorectal cancer. This approved registrational phase III trial in China aims to evaluate the efficacy and safety of Glecirasib in combo with cetuximab versus positive control treatment in colorectal cancer patients with unresectable or metastatic KRAS G12C mutations. In October 2022, Jacobio entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor Lecirasib and Merck's epidermal growth factor receptor ("anti-EGFR antibody") inhibitor ERBITUX® ("cetuximab).

Merck will provide cetuximab for combimation trials in China and Europe under the collaboration agreement. In June 2023, Jacobio announced clinical results of Glecirasib In combination therapy with cetuximab to treat KRAS G12C mutant advanced colorectal cancer at the Second JCA - AACR Precision Cancer Medicine International Conference. In a trial of Glecirasib with cetuximab, the overall response rate (ORR) is 62.8% (27/43), the disease control rate (DCR) is 93% (40/43).

The majority of treatment related adverse events (TRAEs) in monotherapies and combinations are grades 1-2. Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Glecirasib (J AB-21822) is a KRAS G12C inhibitor independently developed by Jacobio. A number of Phase I/II clinical trials of Glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation".

These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer, and a registrational pivotal clinical trial of single drug treatment for pancreatic cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China. ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor.

As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. To date, ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of RAS Wild-type metastatic coloreCTal cancer and for the treatment the treatment of squamous cell carcinoma of the head and neck (SCCHCHC).