Hengsai Bio Launches RMB 700 Million Cell Therapy Manufacturing Facility with IND-Approved DC Vaccine Candidate KSD-101

Recently, the opening ceremony of Hengsai Biotech's Lingang R&D and production base was grandly held in the Life Blue Bay Intelligent Manufacturing Park in the new Lingang area.

The large-scale production base for this cellular drug, with a total investment of approximately 700 million yuan, covers an area of over 6,300 square meters. Equipped with internationally advanced professional facilities, it has the capacity to produce dendritic cell (DC) vaccines for 5,000 patients annually, with an expected annual output value of about 1.5 billion yuan. The official launch of this base marks the company's successful establishment of a complete chain from basic research to large-scale industrialization. This not only represents a significant leap in its own development but will also effectively fill the gap in China’s DC vaccine industrialization field, opening up new treatment hopes for patients suffering from relapsed and refractory tumors, chronic viral infections, and autoimmune diseases.

Since its establishment in November 2018, Hengsai Biotech has been committed to the research and industrialization of dendritic cell (DC) vaccines. Relying on its self-developed Eco-DC Vax technology platform, the company has achieved a series of breakthroughs in the safety, therapeutic efficacy, and scalable manufacturing processes of tumor vaccines. The company’s first investigational cell drug, KSD-101, is not only the world's first broad-spectrum DC vaccine targeting the Epstein-Barr virus (EBV), but also China’s first original DC vaccine to receive FDA IND approval.

At the 2025 European Hematology Association (EHA) Congress not long ago, Hengsai BiotechDemonstrates Positive Clinical Outcomes of the Cellular Drug in Various EBV-Associated Lymphoproliferative Disorders (EBV-LPDs). Ongoing Phase I clinical trial results show that KSD-101 exhibits favorable safety and efficacy in multiple refractory diseases, including angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, and chronic active EBV infection. Treatment-related adverse effects are mostly mild, with no ≥Grade 3 severe toxicity, demonstrating good tolerability. The recommended Phase II clinical dose has been determined as 5×10⁶ DCs/dose. At a median follow-up of 42.7 weeks, most patients achieved and maintained complete response (CR), with preliminary efficacy data being highly encouraging. Leveraging its technological advantages such as multi-antigen presentation, overcoming HLA restrictions, and synergistic activation of CD4⁺ and CD8⁺ T cells, KSD-101 not only brings new hope to EBV-associated tumor treatment but also lays a solid foundation for future expansion into virus-associated cancers such as HPV, HBV, and KSHV, highlighting China's innovative strength in the field of cancer immunotherapy.

Hengsai Biotech stated that the company will always adhere to the clinical demand-oriented approach, with technological innovation as the core engine, continuously deepen the research and development of DC vaccine products, and is committed to creating an innovative treatment solution that combines safety, efficacy, and accessibility, leading the new era development wave in the cell therapy field.

E.N.D

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