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

2024年3月30日，恒赛生物宣布首发管线KSD-101获得美国食品药品监督管理局（FDA）授予新药临床试验（IND）许可，成为我国首款获得美国FDA IND批件的原创树突细胞疫苗(DC疫苗)产品。

恒赛生物创始人兼CEO刘慧宁博士表示：“很高兴与大家分享这一喜讯， KSD-101的安全性和有效性在临床IIT研究中已得到初步验证，现在即将正式进入注册临床阶段，这是公司研发进展的重要里程碑。本次获批临床是境外药物监管机构对我们DC疫苗的全方位高度认可，彰显了公司在免疫治疗领域的创新能力和国际竞争力。目前我们正在积极推动KSD-101在国内的注册申报并筹备生产基地的建设。”

关于KSD-101

KSD-101是负载EB病毒相关类肿瘤复合抗原的人单核细胞来源自体树突细胞疫苗。通过细胞因子诱导单核细胞转化为树突细胞，用类肿瘤复合抗原负载树突细胞并诱导其成为成熟的树突细胞，制备成树突细胞疫苗，是一种肿瘤治疗性疫苗。通过皮下注射后能在人体内激活EBV特异CTL，从而实现对肿瘤细胞的有效识别及杀伤，具有良好的有效性及安全性。
关于恒赛生物

Founded in 2018, Hengsai 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.
Hengsai Bio's R&D center and pilot plant in Shanghai Lingang Blue Bay officially came into operation in 2021, and a large-scale R&D/production base is under construction. The company has now established stable cooperative relationships with a number of domestic and foreign research institutions and tertiary hospitals, and is in the process of dual-reporting between China and the U.S. to carry out clinical research and technical cooperation in order to comprehensively verify the clinical safety and effectiveness of the DC vaccine.