Shanghai BioEngine Sci-Tech Co., Ltd helped Wuhan Huada Genoin Biotechnology Co., Ltd. receive clinical trial approval for new tumor antigen drug

On September 30, 2019, the clinical trial application (IND application) for innovative biological products for therapeutic use, Neo-T Autoimmune T Cell Injection (Neo-T Injection), submitted by Wuhan Huada Genoin Biotechnology Co., Ltd. (Huada Genoin) and Shenzhen Jinuoyin Biotechnology Co., Ltd. successfully obtained the acceptance notice from the State Drug Administration (acceptance number: CXSL1900109). On January 8, 2020, the official website of CDE showed that the acceptance was approved for clinical.

State Drug Administration Acceptance Notice (Image source: CDE official website)

Neo-T injection is the first domestic immunotherapy product based on tumor nascent antigens approved by the State Drug Administration to enter clinical trials, and the first product independently developed by Huada Genoin to declare to the State Drug Administration. Tumor neoantigen-based drugs represent a new direction in tumor treatment, and the approval of clinical trial marks the first time personalized precision therapy enters the clinical stage in China.

As an important partner of Huada Genoin, BioEngine has been highly recognized by the client for its solid technical strength and professional and high-quality service level. HIPP-T009 immune effector cell serum-free medium for this project is a serum-free medium with independent intellectual property developed by Bechtel Biologicals, which adopts high-quality standard raw materials with clear composition and does not contain antibiotics. It is suitable for in vitro serum-free culture and expansion of PBMC, T cells, and NK cells.

As a supplier of domestic high-quality culture media, technology provider, and problem solver in the field of cell culture, BioEngine will continue to provide high-quality professional services to create better value and benefits for customers.

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(Article information source: CDE official website, Huada Genoin WeChat public account)