On July xx(date) 2025, Suzhou, China, Evopoint Biosciences, a platform-based innovative pharmaceutical company committed to addressing major unmet clinical needs worldwide through a disease-oriented and innovation-driven approach, announced today that the first patient has successfully been dosed in a Phase III clinical trial of XNW28012 for the treatment of advanced metastatic pancreatic cancer.
XNW28012 is a next-generation antibody-drug conjugate (ADC) targeting Tissue Factor (TF), independently developed by Evopoint. Classified as a Category 1 therapeutic biologic, the drug received Clinical Trial Approval (CTA) from China’s National Medical Products Administration (NMPA) in July 2023, Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) in August 2023, and Breakthrough Therapy Designation (BTD) from the NMPA’s Center for Drug Evaluation (CDE) in May 2025.
Pancreatic cancer is often diagnosed at an advanced stage and is called “king of cancer” due to its extremely high treatment difficulty. It is the sixth leading cause of cancer-related deaths worldwide. Despite the significant progress in the treatment of many types of cancers in recent years, clinical advancements in pancreatic cancer remain limited. The 5-year survival rate for patients with metastatic pancreatic cancer is only about 3%. Current first-line therapies provide a median overall survival (OS) of just 7 to 11 months, and the availability of actionable targets in late-stage disease remains low, leaving a substantial unmet clinical need. Treatment options for second-line and later stages are also extremely limited. In the Phase I/II clinical trial, XNW28012 demonstrated promising efficacy in patients who had failed standard treatments, indicating encouraging potential for clinical benefit. In addition, XNW28012 does not require screening for TF-positive patients, allowing for broader coverage of patient population.
Relevant study results are planned to be presented at future academic conferences or published in peer-reviewed journals.
About Tissue Factor
Tissue Factor (TF), also known as coagulation factor III or tissue thromboplastin, is a transmembrane glycoprotein expressed on the surface of certain cells. It is primarily located in the cells of outer layer of blood vessel walls and in surrounding fibroblasts, with minimal expression in the medial or intimal layers of blood vessels. During oncogenesis, tumor cells release TF-positive microparticles into the circulation and TF plays a critical role in tumor growth, invasion, and metastasis. It has been found that TF is overexpressed in more than 70% of cancer cells in certain types of cancer including pancreatic, ovarian, and cervical cancer, while it is minimally expressed in normal vascular endothelial cells. This differential expression pattern makes TF an attractive and selective target for ADC-based
