{"id":2729,"date":"2025-12-26T17:12:04","date_gmt":"2025-12-26T09:12:04","guid":{"rendered":"https:\/\/www.kousai.vip\/?p=2729"},"modified":"2025-12-29T12:42:03","modified_gmt":"2025-12-29T04:42:03","slug":"%e6%81%92%e8%b5%9b%e7%94%9f%e7%89%a9ksd-101%e8%8e%b7%e7%be%8e%e5%9b%bdfda%e5%bf%ab%e9%80%9f%e9%80%9a%e9%81%93%e8%b5%84%e6%a0%bc%ef%bc%88ftd%ef%bc%89%e8%ae%a4%e5%ae%9a","status":"publish","type":"post","link":"https:\/\/www.kousai.vip\/en\/2025\/12\/%e6%81%92%e8%b5%9b%e7%94%9f%e7%89%a9ksd-101%e8%8e%b7%e7%be%8e%e5%9b%bdfda%e5%bf%ab%e9%80%9f%e9%80%9a%e9%81%93%e8%b5%84%e6%a0%bc%ef%bc%88ftd%ef%bc%89%e8%ae%a4%e5%ae%9a\/","title":{"rendered":"Kousai Bio KSD-101 Receives U.S. FDA Fast Track Designation (FTD)"},"content":{"rendered":"
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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-101<\/strong>The injection was officially approved by the U.S. Food and Drug Administration (<\/strong>FDA<\/strong>) granted fast-track status (<\/strong>Fast Track Designation, FTD<\/strong>) for the treatment of relapsed or refractory (<\/strong>R\/R<\/strong>)<\/strong>EBV <\/strong>Positive lymphoma<\/strong>KSD-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.<\/p>\n\n\n