Jingfang Pharmaceutical-B (02595): Research data on KRAS G12D inhibitor GFH375 in the treatment of advanced pancreatic ductal adenocarcinoma was presented in the oral report and breakthrough research summary at the 2025 ESMO Annual Meeting

Zhitong Financial App News, Jingfang Pharmaceutical-B (02595) issued an announcement. Data on patients with KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) with GFH375 appeared on October 19, local time in Germany, in the breakthrough research summary (LBA) and oral report at the 2025 European Society of Medical Oncology (ESMO) Annual Meeting. The oral report was completed by Professor Zhou Aiping of the Cancer Hospital of the Chinese Academy of Medical Sciences. The title of the report was “Efficacy and Safety of GFH375 in the Treatment of Advanced KRAS G12D Mutant PDAC Patients” (Abstract No.: LBA84). The report focuses on the study data of PDAC patients in the 600 mg QD (RP2D) dose group of this trial, showing that GFH375 has outstanding efficacy and controllable safety in treating PDAC patients.

As of the data cutoff date, 59 advanced and late-line patients (nearly 70% were third-line and above) received the first dose of GFH375 at least 4 months from the data cutoff date and were assessed after receiving at least one treatment: the objective response rate was 40.7%, the disease control rate was 96.7%, the median progression-free survival was 5.52 months, and the 4-month overall survival rate was 92.2%.

The G12D mutation subtype accounts for the highest proportion of KRAS mutations (accounting for nearly 30%), and according to Frost & Sullivan's predictions, the KRAS G12D mutation will affect nearly 1.38 million new cancer cases worldwide in 2025. At the same time, scientific literature shows that nearly 40% of pancreatic cancer patients have KRAS G12D mutations, which means there are a large number of people whose critical needs have not been addressed.

GFH375 monotherapy was approved by the State Drug Administration for phase I/II trials in June 2024. GFH375/VS-7375 has obtained FDA fast-track qualification this year and can be used to treat patients with locally advanced and metastatic KRAS G12D mutation in the first-line and post-line treatment of locally advanced and metastatic KRAS G12D mutant PDAC; previously, early data on GFH375 monotherapy for solid tumors was disclosed in the form of LBA and oral reports at this year's ASCO, WCLC and other authoritative international academic conferences.

Dr. Wang Yu, Chief Medical Officer of Jingfang, said, “Since clinical approval last year, the GFH375 study has shown rapid clinical progress and excellent efficacy. There are huge unmet clinical needs in patients with KRAS G12D mutations, and we look forward to making further breakthroughs in clinical development of GFH375 through key research planning for backline treatment and combination treatment studies for frontline treatment.”

GFH375 is an oral high-activity, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor. It binds KRAS G12D protein in a non-covalent form to inhibit its binding to downstream effector proteins, thereby disrupting the continuous activation of KRAS G12D in cells, and ultimately efficiently inhibits tumor cell proliferation. Preclinical studies have shown that the inhibitory effect of GFH375 alone on tumor growth increases with increasing dosage and cycle, and has shown a low risk of off-target in kinase selectivity and safety target tests.

Jinfang and Verastem have reached an authorization and early cooperative development agreement for three products related to RAS/MAPK driven cancer developed by Jinfang. The partnership gave Verastem the exclusive option to obtain individual licenses for these three products after successfully reaching pre-set milestones in phase I clinical trials. In December 2023, Verastem selected GFH375/VS-7375 (an oral KRAS G12D (ON/OFF) inhibitor) as the lead project for its collaboration. The license obtained for GFH375 was the first license obtained in this collaboration. These licenses will grant Verastem the right to develop and commercialize outside of Greater China, and Jinfang reserves such rights within China.