October 21, 2025，Fudan University Shanghai Cancer Center held a kick-off meeting for the project "KSD-301 in combination with AG regimen (gemcitabine and albumin-bound paclitaxel) for the treatment of locally advanced unresectable pancreatic cancer". President Xianjun Yu (This project is led by Professor Yu Xianjun, the president of Fudan University Shanghai Cancer Center and the director of Shanghai and Fudan University Pancreatic Cancer Institute). KSD-301, which was a tumor therapeutic vaccine independently developed by KOUSAI Bio Co., Ltd It aims to evaluate the safety, tolerability, immune response and preliminary clinical efficacy of the KSD-301 combined with AG regimen in patients with unresectable locally advanced pancreatic cancer who have not received systemic treatment.
Pancreatic cancer is known as the "King of cancers" due to its high malignancy, difficulty in early diagnosis and limited treatment options. According to the latest data released by the National Cancer Center, there were 118,700 new cases of pancreatic cancer in China in 2022, ranking 10th and accounting for 23.22% of the total global pancreatic cancer cases. The death toll was 106,300, ranking 6th, accounting for 22.74% of the total global deaths from pancreatic cancer. Pancreatic cancer is highly malignant and progresses rapidly. However, it has an insidious onset, with an early diagnosis rate of less than 5%. About 60% of patients have already metastasized at their first visit, and the 5-year survival rate is only 7.2% to 9%. Radical resection of pancreatic cancer is a possible cure for pancreatic ductal adenocarcinoma (PDAC), but only up to 20% of patients are considered eligible for surgical resection at diagnosis, and nearly 80% of patients will experience recurrence after surgery. Therefore, there is an urgent need to explore new adjuvant
The main difficulty in treating pancreatic cancer lies in the fact that the tumor microenvironment has significant immunosuppressive characteristics, which makes it difficult for the body's immune system to effectively recognize and eliminate tumor cells. DC vaccines can precisely target and clear tumors by activating specific anti-tumor immune responses, breaking the immunosuppressive microenvironment, and inducing long-lasting immune memory, providing a brand-new approach for the treatment of pancreatic cancer. Preclinical studies have demonstrated that KSD-301 can effectively stimulate lymphocyte responses in patients, participate in both active and passive immune reactions, reshape the immune system, and enhance the immune system's ability to recognize and clear pancreatic tumors.
The kick-off meeting was presided over by President Xianjun Yu .The expert team from the Pancreatic Surgery Department of Fudan University Shanghai Cancer Center and the clinical team of Hengsai Biology participated together. Professor Xu Jin, the director of the Pancreatic Surgery Department, delivered the concluding speech.President Xianjun Yu highly praised the scientific design and clinical prospects of the KSD-301 DC vaccine, expressed his full support for the project's implementation, and looked forward to both sides working together to promote innovative breakthroughs in pancreatic cancer immunotherapy.Professor Xu Jin highly affirmed the scientific value and clinical significance of the KSD-301 project, expressing that the team is confident in completing the clinical research of the project with high quality and bringing new hope to pancreatic cancer patients.
Founder of Hengsai Bio Dr. Huining Liu, on behalf of the company, expressed sincere gratitude to President Yu Xianjun's research team and the experts present, thanking everyone for their trust and support in Hengsai Biotech. Dr. Liu Huining stated that Hengsai Biotech is dedicated to the fundamental research and process exploration of dendritic cells. It has successfully overcome numerous technical challenges and achieved a series of milestone scientific and technological achievements, laying a solid foundation for the clinical application of dendritic cells. Pancreatic cancer, recognized as one of the most difficult problems in the medical field, brings great pain and distress to patients. Hengsai Biology adheres to the simple concept of "enabling cancer patients to be cured painlessly", and is engaged in research related to pancreatic cancer treatment. It hopes to bring hope to patients and contribute to medical progress through its own technological advantages and strength. During the project's advancement, Hengsai Biotech will maintain close communication and collaboration with the research team, leverage their respective professional strengths, and with a rigorous scientific research attitude, efficient execution capabilities, and high-quality research standards, fully promote the smooth progress of the project and ensure the high-quality completion of the research work.
After the meeting,President Xianjun Yu and the research team immediately threw themselves into the intense patient screening work, racing against time to secure a glimmer of hope for the patients.
KOUSAI Bio Co., Ltd
