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HD004CAR-T Cells, Independently Developed and Produced by HuaDao CAR-Tcell with Full Intellectual Property Rights and Proprietary Industrial Technology, Were Officially Accepted by the CDE on August 8, 2024. To date, HD004CAR-T Cells are not only the fourth CAR-T cell drug submitted by HuaDao CAR-Tcell but also its first cell drug targeting solid tumor treatment. Additionally, it is the world’s first cell drug product for treating malignant ascites in advanced solid tumors with positive CLDN18.2 expression.
HuaDao CAR-Tcell was established in 2017, with an 8,000-square-meter cell drug research and development base and a 4,000-square-meter medical device R&D base. As a high-tech emerging biopharmaceutical company specializing in cellular immunotherapy (entered the cultivation database for high-tech enterprises in 2019 and received high-tech enterprise certification in 2020), its R&D team has extensive experience in the fields of cellular immunotherapy, software development, and intelligent equipment.HuaDao CAR-Tcell, with the mission of "making cell drugs affordable for ordinary Chinese people," adheres to a dual innovation path across the entire industry chain, focusing on "cell drug research and development + key equipment and technological breakthroughs for industrialization" through self-owned intellectual property rights. It has now become a national high-tech enterprise in China’s cellular immunotherapy field, possessing self-owned intellectual property rights for key equipment, reagents, and consumables across the entire industry chain. It is also a provider of comprehensive CAR-T cell therapy solutions encompassing the entire industry chain, from plasmid virus to cell culture harvest, along with supporting warehousing and cold chain systems.As of 2022, the company has completed four rounds of financing (A, B, C, D), developed multiple cell immunotherapy drugs, and initiated several registered clinical trials. It has obtained 18 licensed patents, independently applied for more than 40 patents (25 of which have been authorized), and secured 8 software copyrights. In 2023, the company officially launched the construction of five major production bases across China (Songjiang Base in Shanghai, East China; Bishan Base in Chongqing, Southwest China; Xianyang Base in Shaanxi, Northwest China; Changchun Base in Jilin, Northeast China; Zhengzhou Base in Henan, Central China). The company is making solid progress not only in making treatments "affordable for ordinary people" but also ensuring they are "accessible to ordinary people." HuaDao CAR-Tcell is committed to becoming a platform-based pharmaceutical enterprise in China that holds pricing power in the CAR-T cell drug market and possesses continuous independent innovation R&D capabilities and production conversion capacity across the entire "cell drug" industry chain.Source of the article: HuaDao CAR-Tcell
