Beijing, Shanghai, Boston — May 22, 2025 — According to the official website of the National Medical Products Administration (NMPA), Jacobio Pharma (1167.HK) has received approval for its independently developed KRAS G12C inhibitor, glecirasib, to be launched on the market. The approved indication is for patients with non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy. This approval triggers a milestone payment from Jacobio’s partner Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH), and Jacobio will receive a milestone payment of RMB 50 million.
Dr. Yinxiang Wang, Chairman and CEO of Jacobio Pharma, stated: “The successful launch of glecirasib marks Jacobio’s transition from early-stage research to a new era of commercialization. This breakthrough is the result of our team’s decade-long dedication to tackling challenging drug targets. With the commercialization of glecirasib as a starting point, we will accelerate the translation of the innovation across our pipeline into clinical success.”
In patients with NSCLC treated with glecirasib monotherapy in the second-line or later settng, the objective response rate (ORR) was 49.6%, the disease control rate(DCR) was 86.3%, with a median progression-free survival (mPFS) of 8.2 months and a median overall survival (mOS) of 17.5 months. Safety data indicate that glecirasib has a favorable safety profile, particularly with favorable gastrointestinal tolerability among approved KRAS G12C inhibitors. Jacobio has out-licensed the rights to glecirasib in China (including Mainland China, Hong Kong, Macau, and Taiwan) to Allist Pharmaceuticals.
About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio Pharma. A number of 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 sitneprotafib in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in both the United States and Euorpe, and breakthrough therapy designation in China. Jacobio has out-licensed the rights to glecirasib in China (including Mainland China, Hong Kong, Macau, and Taiwan) to Shanghai Allist Pharmaceuticals Co., Ltd. (688578.SH).
About Jacobio Pharma
Jacobio Pharma (1167.HK) is committed to providing breakthrough treatments for patients. With an induced allosteric drug discovery platform, the company’s core projects focus on the KRAS pathway. The company envisions becoming a global leader in research and development, fostering strategic partnerships to drive innovation. Jacobio’s R&D centers are in Beijing, Shanghai (China), and Boston (USA). Clinical trials are conducted at over 180 sites in China, more than 30 sites in the USA, and over 10 sites across several European countries. For more information, please visit: http://www.jacobiopharma.com