Kousai Bio KSD-101 Receives U.S. FDA Fast Track Designation (FTD)

On December 25, 2025, Kousai Bio, an innovative Chinese biopharmaceutical company, announced a significant piece of good news - its original independently developed dendritic cell vaccine (DC vaccine)KSD-101The injection was officially approved by the U.S. Food and Drug Administration (FDA) granted fast-track status (Fast Track Designation, FTD) for the treatment of relapsed or refractory (R/R)EBV Positive lymphomaKSD-101 has become the first DC vaccine product in China to be recognized by the FTD, signifying that the therapy has been highly recognized by international regulatory agencies for addressing unmet clinical needs and will accelerate its clinical development and marketing review process in the U.S., bringing new therapeutic hope to patients with relapsed or refractory EBV-positive lymphoma disease around the world.

The FTD designation is intended to accelerate the development and review of drugs for serious diseases with unmet medical needs, and to facilitate the early delivery of benefits to patients through a series of facilitation measures, such as more frequent regulatory communication and rolling reviews.KSD-101 was granted the FTD based on its innovation as the world's first broad-spectrum DC vaccine targeting EBV, as well as the significant therapeutic potential it has demonstrated in early-stage clinical studies. KSD-101 was awarded the FTD based on its innovation as the world's first broad-spectrum DC vaccine targeting EBV and its significant therapeutic potential in early clinical studies.

EBV is a common virus with a global prevalence of infection exceeding 95%, and has been clearly recognized by the World Health Organization as the first significant virus associated with human tumors. Its infection can cause a variety of serious diseases such as EBV-associated lymphoproliferative disease (EBV-LPD), nasopharyngeal carcinoma and gastric cancer. Currently, there is still a lack of effective therapeutic options for patients with EBV-associated lymphoproliferative diseases, and there is a significant unmet medical need.KSD-101, as China's first original DC vaccine licensed by the FDA for clinical trials of new drugs (IND), uses patients' own monocytes to induce the differentiation of mature dendritic cells and loads with the EBV-associated tumor complex antigen, which can accurately deliver EBV-associated tumorigen to the patient. It can accurately deliver various viral antigenic epitopes such as EBV latency and lysis proteins LMP2A, EBNA3A/3B, EBNA4, BMLF1, etc., and efficiently activate CD4⁺ helper T-cells and CD8⁺ cytotoxic T-cells, thus building up a comprehensive and powerful antiviral and antitumor immune response.

KSD-101drug aloneIn the phase I clinical study for the treatment of relapsed and refractory EBV-associated hematological tumors, the objective remission rate (ORR) was as high as 91.67%, with a complete remission rate (CR) of 83.33% and a disease control rate (DCR) of 100%, while demonstrating a durable response and a favorable safety profile. This breakthrough data provides solid support for the clinical value of KSD-101.

KSD-101 is the first autologous DC vaccine developed by Kousai Biotechnology on the basis of its self-developed "Eco-DC Vax" technology platform, and it is the first original DC vaccine product in China that has been approved by FDA IND. Its mechanism of action is to prepare an individualized therapeutic vaccine by collecting the patient's own mononuclear cells, inducing them to differentiate into dendritic cells in vitro, and loading them with EBV-related specific complex antigens. After the vaccine is infused back into the patient's body, it can accurately activate and train the patient's own immune system to recognize and kill EBV-antigen-expressing tumor cells, and establish a long-lasting anti-tumor immune memory.

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 treatments.

Dr. Huining Liu, Founder and CEO of the company, said, "The FDA Fast Track accreditation of KSD-101 is an important affirmation of our R&D strength and product value. Kousai Bio will take this opportunity to fully utilize the regulatory convenience brought by Fast Track to accelerate the global clinical development process of KSD-101 and provide more effective treatment options for domestic and foreign patients with EBV-related diseases at an early date."

As a leader in the field of DC vaccine R&D in China, Kousai Biological has realized the dual reporting of KSD-101 in China and the United States, and its domestic IND application has been formally accepted by China's State Food and Drug Administration (SFDA). The FDA fast-track accreditation will not only accelerate the overseas clinical advancement and listing process of KSD-101, but also further enhance the influence of domestic original biologics in the global tumor immunity field, and inject new momentum into the international development of China's biopharmaceutical industry. KSD-101 is an original DC vaccine product. Its mechanism of action is to prepare an individualized therapeutic vaccine by collecting patients' own mononuclear cells, inducing them to differentiate into dendritic cells in vitro, and loading them with EBV-related specific complex antigens. After the vaccine is infused back into the patient's body, it can accurately activate and train the patient's own immune system to recognize and kill EBV-antigen-expressing tumor cells, and establish a long-lasting anti-tumor immune memory.

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