Recently, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration officially approved the KSD-101 injection, developed by Kousai, to enter clinical trials. This marks not only the first original dendritic cell vaccine (DC vaccine) in China to receive FDA IND approval but also the first of its kind in China to be granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration. This milestone signifies a new era in personalized immunotherapy for EBV-associated hematologic tumors.
KSD-101 is the first autologous DC vaccine developed by Kousai Biotechnology based on its self-developed “Eco-DC Vax” technology platform, and it is the first original DC vaccine product in China to receive FDA IND approval. Its mechanism of action involves preparing 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 precisely activate and train the patient’s immune system to recognize and kill tumor cells expressing EBV antigens, while establishing long-lasting anti-tumor immune memory.
### Impressive Clinical Data: Preliminary Evidence of Safety and Efficacy
The potential of KSD-101 has been preliminarily validated in earlier clinical studies. In a Phase I clinical study of KSD-101 as a monotherapy for relapsed and refractory EBV-associated hematologic tumors, the objective response rate (ORR) reached as high as 91.67%, with a complete remission rate (CR) of 83.33% and a disease control rate (DCR) of 100%. The treatment also demonstrated durable responses and a favorable safety profile. This groundbreaking data provides strong support for the clinical value of KSD-101.
### Why Choose China for Cutting-Edge Treatments?
China is advancing rapidly in the clinical research and application of cutting-edge fields such as cell therapy and immunotherapy. The International Department of Beijing South Region Oncology Hospital is dedicated to connecting global patients with the latest medical technologies and clinical trial opportunities. The rapid progress of KSD-101 in China means that international patients may have earlier access to this revolutionary therapy.
### Contact Us for More Information or to Assess Eligibility
If you or a loved one is affected by EBV-associated hematologic tumors (such as lymphoma refractory to standard treatment or CAEBV) and are interested in the breakthrough therapy KSD-101, we sincerely invite you to reach out to the International Department of Beijing South Region Oncology Hospital. Our international medical team will provide professional consultations, medical record evaluations, and assist in determining eligibility for participation in upcoming clinical trials.
Please contact us immediately through the following channels:
Phone: 400-880-3716
WeChat: 17801183037
Email: 100085_010@163.com | myimmnet@163.com (backup)
We understand that every treatment opportunity is a matter of life and hope. The International Department of Beijing South Region Oncology Hospital is committed to bridging the gap between patients and cutting-edge medical technology with professional expertise and compassionate care. Let us look forward to and work together to overcome the disease.
**Beijing South Region Oncology Hospital International Department**
Phone: 400-880-3716
WeChat: 17801183037
Email: 100085_010@163.com / myimmnet@163.com
Post time: Mar-17-2026