China's First! Hengsai Bio's Original DC Vaccine KSD-101 Receives FDA IND Approval

Apr 01, 2024 07:20 CST Updated 07:20

Kousai

Developer of Dendritic Cell Tumor Therapeutic Vaccines

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On March 30, 2024, Hengsai Biotech announced that its lead pipeline KSD-101 received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), becoming the first original dendritic cell vaccine (DC vaccine) product produced in China to obtain FDA IND clearance.

Dr. Hui Ning Liu, founder and CEO of Hengsai Biotech, stated: "We are delighted to share this exciting news with everyone. The safety and efficacy of KSD-101 have been preliminarily validated in the clinical IIT study, and it is now about to officially enter the registration clinical stage, marking an important milestone in the company’s R&D progress. This clinical approval represents comprehensive and high recognition from overseas drug regulatory authorities for our DC vaccine, demonstrating the company's innovation capability and international competitiveness in the field of immunotherapy. Currently, we are actively promoting the registration and submission of KSD-101 in China while preparing for the construction of a production base."

About KSD-101

KSD-101 is an autologous dendritic cell vaccine derived from human monocytes loaded with EBV-associated tumor-like composite antigens. Monocytes are induced to transform into dendritic cells through cytokines, and the dendritic cells are loaded with tumor-like composite antigens and induced to mature, forming a dendritic cell vaccine, which is a therapeutic cancer vaccine. After subcutaneous injection, it can activate EBV-specific CTL in the human body, thereby achieving effective recognition and killing of tumor cells, demonstrating good efficacy and safety.

About Hengsai Biotech

Hengsai Biotech, established in 2018, is an innovative technology enterprise dedicated to the research and development as well as industrialization of dendritic cell vaccines (DC vaccines) and is a national high-tech enterprise. The company has successfully built the Eco-DCVax platform, aiming to break through industrialization technological barriers and develop high-quality DC vaccine products with independent intellectual property rights that are global First-in-Class, safe, efficient, and convenient for administration. The developed product – therapeutic dendritic cell vaccines – provides new treatment pathways and strategies for diseases in urgent clinical need of effective treatments, such as recurrent and refractory tumors, chronic viral infections, and autoimmune diseases.

Hengsai Biotech's R&D center and pilot workshop located in Lanwan, Lingang, Shanghai, were officially put into use in 2021. A large-scale R&D/production base is currently under construction. The company has now established stable cooperative relationships with multiple scientific research institutions and Class III hospitals both domestically and internationally. It is in the process of dual IND submissions in China and the United States, conducting clinical research and technical cooperation to comprehensively verify the clinical safety and efficacy of DC vaccines.

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Disclaimer: This article aims to convey industry development information and explore the frontier progress of biomedicine. The content of the article represents the author's viewpoint, and does not represent the position of EMedClub, nor does it constitute any value judgment, investment advice, or medical guidance. If necessary, please consult a professional for investment or visit a正规 hospital for medical advice.

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