Beijing, Shanghai, Boston, May 6, 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 submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the treatment of patients harboring advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation in a second line setting.

The NDA submission is 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. The results of the pivotal phase II study will be presented at the 2024 April ASCO Plenary Series and the education session of ASCO Annual Meeting in June. 

Prof. Yuankai Shi, chief physician of Cancer hospital Chinese Academy of Medical Sciences, said: “KRAS is one of the earliest oncogenes discovered. It has not been developed into a drug for more than 40 years. Currently, no drugs have been approved in China. The trend in the treatment of lung cancer is to reduce the use of chemotherapy. Currently, when lung cancer patients who harboring KRAS G12C mutation fail first-line treatment, chemotherapy shut as docetaxel is the main second-line treatment in China. Existing clinical data shows that glecirasib is more effective and safer than chemotherapy. We look forward to glecirasib being approved as soon as possible, and bring more treatment options to patients.”

Dr. Yinxiang Wang, Chairman and CEO of Jacobio, said: “Since its establishment in 2015, Jacobio has been committed to develop the undruggable targets. Glecirasib's NDA  submission is a milestone for the company and also marks that Jacobio will enter the commercialization stage. NDA submission is just the beginning. We will continue to explore the potential of glecirasib as a single agent and combination therapy in the fields of lung cancer, pancreatic cancer, colorectal cancer and multi-tumors basket to solve the actual clinical needs of more patients.

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 a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and 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