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2026年3月9日，恒赛生物KSD-101注射液获中国国家药监局药品审评中心（CDE）临床试验默示许可（IND获批），适应症为“经标准治疗无效的EBV相关血液肿瘤”，标志着中国首个获得美国FDA IND批件、中国首个获得FDA快速通道资格（FTD）认定的原创树突细胞疫苗（DC疫苗）产品正式进入国内临床试验阶段。
KSD-101注射液是恒赛生物依托自主研发的“Eco-DC Vax”技术平台开发的全球首个靶向EBV广谱的DC疫苗。该产品通过采集患者自身的单核细胞，在体外诱导分化为树突细胞，并负载EBV相关的特异性复合抗原，制备成个体化的治疗性疫苗。通过皮下注射回输至患者体内后，可精准激活并训练患者自身的免疫系统，使其识别和杀伤表达EBV抗原的肿瘤细胞，并建立起持久的抗肿瘤免疫记忆。
前期临床研究显示，KSD-101注射液展现出良好的安全性与抗肿瘤活性，不良反应均为1-2级，无剂量限制性毒性，为后续临床试验的开展奠定了基础。未来，恒赛生物将严格按照临床试验要求，联合国内多家临床机构，有序推进临床试验工作，进一步验证产品在更大样本量患者中的安全性和有效性。
作为一家专注于DC疫苗研发与产业化的国家高新技术企业，恒赛生物自成立以来，持续深耕肿瘤免疫治疗领域。临港研发生产基地已具备规模化生产能力，能够为临床研究和未来商业化提供稳定支撑。同时，KSD-101注射液作为生物医学新技术转化应用项目已落地海南博鳌乐城先行区，将与国内临床推进形成协同，加快产品惠及患者的进程。
公司创始人兼CEO刘慧宁博士表示::此次KSD-101注射液国内IND获批，是公司中美双报战略的重要进展。未来，公司将继续秉持严谨的研发态度，稳步推进KSD-101注射液及后续管线的临床开发，同时持续完善技术平台与产业化布局，致力于为肿瘤患者提供安全、有效的免疫治疗方案，助力中国生物医药产业的高质量发展。
About Kousai
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.
公司依托自主构建的Eco-DC Vax平台，系统整合抗原预测、免疫学验证、工艺优化与质量控制四大模块，具备“一药多靶”和平台延展性。目前在上海自贸区临港新片区设有建筑面积 6300平、产能约5000人份/年的综合研发生产基地，配备行业顶尖设施，具备从科研到产业化的硬实力。
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