Beijing, Shanghai, Boston, October 21, 2024 - Jacobio Pharma (1167.HK), a clinical stage biotech company, today announced that it’s in-house developed KRAS G12C inhibitor glecirasib has been granted orphan drug designation (ODD) by the European Medicines Agency (EMA).

Pancreatic cancer is a highly malignant tumor. Currently, patients lack effective standard treatments, and the five-year overall survival rate of advanced pancreatic cancer is only 3.1%. Previously, Glecirasib for pancreatic cancer was granted orphan drug designation from FDA in the United States and breakthrough therapy designation from CDE in China. The pivotal trial (NCT06008288) in the advanced KRAS G12C mutated PDAC and other solid tumors is ongoing in the 30 sites of China.

Previously, Jacobio has announced data of glecirasib in patients with pancreatic cancer in the oral abstract session at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (2024 ASCO GI). For second-line and above KRAS G12C mutated pancreatic cancer patients, the cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 10.7 months. 

About Glecirasib 
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. 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 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 
Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.