Beijing, Shanghai, Boston, May 21 2024—Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, today announced that the New Drug Application (NDA) for KRAS G12C inhibitor glecirasib (JAB-21822) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and granted Priority Review designation, for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) harbouring KRAS G12C mutation.

The NDA acceptance and Priority Review designation are based on the results from a Phase II pivotal clinical trial (NCT05276726) intended to evaluate the efficacy and safety of glecirasib as a single agent for the treatment of NSCLC patients with KRAS G12C mutation. According to the regulations of the NMPA, the review time for NDA included in the Priority Review designation is within 130 working days, which will further accelerate the approval of glecirasib and meet unmet clinical needs.
 
Clinical results of the registrational phase II trial of glecirasib announced in 2024 April ASCO Plenary Series showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively.

In December 2022, based on the solid clinical efficacy and safety data, glecirasib was granted breakthrough therapy designations for the second line and above treatment of advanced or metastatic NSCLC patients with KRAS G12C mutation by the CDE of the NMPA.

In addition, multiple studies of glecirasib as a single agent and in combination are being conducted globally, including in combination with the SHP2 inhibitor JAB-3312 for the treatment of non-small cell lung cancer, in combination with cetuximab for the treatment of colorectal cancer, and as a single agent for the treatment of pancreatic cancer, etc.

About Glecirasib
Glecirasib is a KRAS G12C inhibitor 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 combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About Jacobio