Hengsai Biotechnology
中美双批！恒赛生物KSD-101注射液临床开发进程再提速
412026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...
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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...
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 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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China's First! Hengsai Bio's Original DC Vaccine KSD-101 Receives FDA IND Approval
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Hengsai Bio USA - San Diego The 65th Annual Meeting of the American Society of Hematology (ASH) was grandly held in San Diego, USA on December 9-12, 2023. As the largest, most numerous and most influential annual meeting in the field of international hematology, this year's ASH Congress gathered 35,000 specialists and scholars from 109 countries and regions around the world to present their latest achievements, exchange ...
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