Jingfang Pharmaceutical-B (02595): GFH375/VS-7375 has made positive progress in many domestic and overseas clinical studies, showing excellent efficacy in various RAS mutant solid tumors

Zhitong Finance App News, Jingfang Pharmaceutical-B (02595) issued an announcement. GFH375/VS-7375 (oral KRAS G12D inhibitor) has made positive progress in several domestic and overseas clinical studies and released the latest data on related studies. Currently, GFH375 has obtained three breakthrough therapy certifications (BTD) for treating KRAS G12D mutant pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC) in China, and has entered two registered phase III studies for single-drug treatment of pancreatic cancer and NSCLC. At the end of this year, Jingfang's overseas partner Verastem Oncology (Verastem) is expected to launch a registered phase III study of VS-7375 multiple combination programs (combined with anti-EGFR therapy or chemotherapy) for first-line PDAC treatment, with progression-free survival (PFS) and objective response rate (ORR) as the two main endpoints and overall survival (OS) as the secondary end point. A consensus has now been reached with the US Food and Drug Administration (FDA) on the research plan.

Dr. Wang Yu, Chief Medical Officer of Jingfang, said, “We are pleased to see the initial efficacy of GFH375 combined with cetuximab in treating colorectal cancer in domestic studies, as well as the efficacy data shown by GFH375/VS-7375 in multiple overseas trials. GFH375 is the world's first oral KRAS G12D inhibitor to enter NSCLC and pancreatic cancer phase III studies; the product is also expected to enter the world's first first-line phase III study of KRAS G12D inhibitors combined with anti-EGFR therapy by the end of this year as a first-line chemotherapy treatment plan by the end of this year. We look forward to more innovative single-agent, combination therapies from GFH375/VS-7375 to bring hope to patients around the world.”