Hengsai Biotechnology
恒赛生物KSD-101注射液获美国FDA再生医学先进疗法（RMAT）认定
1132026年3月24日，中国创新生物制药企业恒赛生物宣布一项重磅喜讯——其自主研发的原创树突状细胞疫苗（DC疫苗）KSD-101注射液正式获得美国食品药品监督管理局（FDA）授予的再生医学先进疗法（Regenerative Medicine Advanced Therapy, RMAT）认定，用于治疗复发或难治...
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2026年3月24日，中国创新生物制药企业恒赛生物宣布一项重磅喜讯——其自主研发的原创树突状细胞疫苗（DC疫苗）KSD-101注射液正式获得美国食品药品监督管理局（FDA）授予的再生医学先进疗法（Regenerative Medicine Advanced Therapy, RMAT）认定，用于治疗复发或难治...
View details 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...
View details On December 30, 2025, Hengsai Bio's premiere pipeline KSD-101 dendritic cell (DC) vaccine for the treatment of EBV-related hematological tumors, a project of translational application of new biomedical technologies, was officially landed in the Hainan Hospital of Ruijin Hospital, Affiliated to the Medical College of Shanghai Jiao Tong University. The project has been declared and selected, evaluated by experts, verified at the production site and approved by the Health Commission of Hainan Province, the Administration of Lecheng Advance Zone and the Drug Administration jointly. ...
View details Recently, Hengsai Biologics completed the first round of strategic financing, exclusively invested by Tianshili Capital. This round of funding will be mainly used to promote the R&D and clinical trials of the core pipeline as well as the company's internationalization strategy layout. Both parties have carried out extensive and in-depth communication and planning on domestic and international project cooperation. In the future, they will give full play to their respective business advantages, with equity investment as the core link, through business synergy,...
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1. PURPOSE This document describes KOUSAI´s position, and reflects our Corporate Policy on how patients in medical need may be able to access our new medicines before they are fully approved for use on prescription. 2. This document describes KOUSAI´s position and reflects our Corporate Policy on how patients in medical need may be able to access our new medicines before they are fully approved for use on prescription. 2. SCOPE We cover ...
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On December 25, 2025, Hengsai Bio, an innovative Chinese biopharmaceutical company, announced a significant news - its original dendritic cell vaccine (DC vaccine), KSD-101 injection, independently developed by Hengsai Bio, has been formally granted Fast Track Designation, FTD, by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) EBV-positive gonorrhea. Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) EBV-positive lymphoma...
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On October 21st, 2025, the Cancer Hospital of Fudan University held a kick-off meeting for the project "KSD-301 in combination with AG regimen (Gemcitabine, Albumin Paclitaxel) for the treatment of locally advanced unresectable pancreatic cancer". The project is led by Prof. Xianjun Yu, President of the Affiliated Cancer Hospital of Fudan University and Director of the Institute of Pancreatic Tumor Research of Shanghai and Fudan University, as the principal investigator, and the investigational drug KSD-301 is Hengsai's...
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On the morning of August 30, 2025, the Policy Promotion Meeting for New Biomedical Technologies in LeCheng Advanced Zone and the First Batch of Enterprises Concentrated Signing Conference were held in Boao LeCheng Never Ending International Innovative Pharmaceuticals and Devices Exhibition. Hainan Provincial People's Government, Hainan Provincial Department of Industry and Information Technology, Hainan Provincial Healthcare Commission, Hainan Provincial Medical Insurance Bureau, Hainan Provincial Drug Administration, Hainan International Economic and Development Bureau, Lecheng Advanced Zone Administration, Qionghai Municipal People's Government, Lecheng...
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On August 15, 2025, the opening ceremony of the R&D and production base of Hengsai Biologicals in Lingang was held grandly in the 10th phase of Life Blue Bay Intelligence Park in Lingang New Area. With the theme of "Hengchuang Frontier, Sai Leads Health", the ceremony invited the Lingang Administrative Committee, industry experts, shareholders' representatives, partners, leaders of the park and all the staff of Hengsai Biologicals to witness this important moment together. Har...
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Hengsai BioItaly - Milan The 30th Annual Meeting of the European Hematology Association (EHA 2025) was successfully concluded from June 12 to 15 in Milan, Italy. As a global top event in the field of hematology, EHA gathered the world's top experts, scholars and industrial pioneers to discuss the latest breakthroughs and future direction of blood disease diagnosis and treatment. In this international academic feast, Hengsai Biotechnology, as one of the...
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