Hengsai Bio DC Vaccine for Kidney Cancer Program Officially Launched

On March 3, 2025, Hengsai Bio's self-developed KSD-201 DC vaccine for the treatment of advanced renal cell carcinoma was formally launched at Tongji Hospital of Huazhong University of Science and Technology Tongji Medical College ("Wuhan Tongji Hospital").Relying on Hengsai Bio's world-leading Eco-DC Vax technology platform and in collaboration with a team of urology experts from Wuhan Tongji Hospital, the project aims to provide a novel immunotherapy solution for patients with relapsed and refractory kidney cancer. This is another solid tumor pipeline of Hengsai Biotech that has entered clinical research after EBV-related nasopharyngeal carcinoma.

The scene of the launch event

The Department of Urology of Wuhan Tongji Hospital, as one of the "Top 10 Urological Tumors in China", has a leading position in the field of minimally invasive surgery and individualized comprehensive treatment of renal cancer by its multidisciplinary team (MDT). Renal cell carcinoma (RCC) is a malignant tumor originating from the epithelium of renal tubules, accounting for about 85% of renal malignancies. clear cell renal cell carcinoma (ccRCC) is the most common pathological subtype of RCC. ccRCC has the poorest prognosis of all the pathologic types of RCC, with the highest recurrence and metastatic potential, and it is insensitive to both radiotherapy and chemotherapy. Advanced ccRCC is an incurable disease, prone to metastasis, recurrence, and refractory to eradication, with marked individualized differences in efficacy and survival benefit of targeted therapies, severe adverse effects, and easy drug resistance. Therefore, ccRCC has always been a difficult problem for many patients, bringing a heavy burden to patients and their families.

At the launching meeting, a team of urology experts headed by the principal investigator Prof. Wang Shaogang and the clinical team of Hengsai Biologicals discussed the focuses and difficulties of the IIT study of DC vaccine treatment for ccRCC disease, and both sides clarified the project objectives and division of labor between the two sides, showing high expectations and firm confidence in the future development of the project, which laid a solid foundation for the efficient promotion of the subsequent project.

Dr. Huining Liu, Founder and CEO of Hengsai Biologics, said, "The unique advantage of DC Vaccine lies in inducing long-term immune memory and exerting lasting anti-tumor effects through precise and specific immune responses. This collaboration with Wuhan Tongji Hospital will accelerate the translation of the technology from the laboratory to the clinic, and we look forward to DC Vaccine providing more kidney cancer patients with a safe, convenient and long-lasting effective treatment option."

KSD-201It is an autologous dendritic cell vaccine of human mononuclear origin loaded with a broad spectrum of clear cell renal cell carcinoma-associated antigen. It is a tumor therapeutic vaccine prepared by inducing monocytes to transform into dendritic cells through cytokines, loading dendritic cells with broad-spectrum clear cell renal cell carcinoma-associated antigen and inducing them to become mature dendritic cells. It can activate the patient's immune function in the body after subcutaneous injection, so as to achieve the effect of treating advanced clear cell renal cell carcinoma.

Founded in 2018, Kousai Bio is a scientific and technological innovative enterprise and national high-tech enterprise dedicated to the research, development and industrialization of dendritic cell vaccines (DC vaccines). The company has successfully constructed the Eco-DCVax platform, aiming to break down the technical barriers to industrialization and develop global First-in-Class high-quality DC vaccine products with independent property rights that are safe, efficient and convenient to administer. The developed product, therapeutic dendritic cell vaccine, provides a new approach and strategy for the treatment of relapsed and refractory tumors, chronic viral infections, autoimmune diseases and other diseases that are in urgent need of effective clinical treatment.

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Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay were put into use in 2021, and Zhongshan R&D center is under construction. The company's first pipeline KSD-101 has successfully completed the dual reporting in China and the United States, and is about to formally enter the registered clinical stage. The Company has now established stable partnerships with a number of domestic and international research institutions and tertiary hospitals to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and efficacy of the DC vaccine. Period completion and efficient operation!"