KOUSAI Bio Co., Ltd
恒赛生物 KSD-101 注射液注册临床试验首例患者给药
322026年7月28日，专注肿瘤DC疫苗开发的创新型细胞治疗企业恒赛生物宣布，自主研发的全球首个靶向EB 病毒（EBV）的DC疫苗KSD-101 注射液，已成功完成注册临床试验首例患者首次给药。 该试验为国家药品监督管理局（NMPA）批准开展的I期临床试验，由上海交通大学...
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2026年7月28日，专注肿瘤DC疫苗开发的创新型细胞治疗企业恒赛生物宣布，自主研发的全球首个靶向EB 病毒（EBV）的DC疫苗KSD-101 注射液，已成功完成注册临床试验首例患者首次给药。 该试验为国家药品监督管理局（NMPA）批准开展的I期临床试验，由上海交通大学...
View details 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 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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