BoShengJi Selected for 2023 National Center for Biopharmaceutical Innovation's Key 'Open Challenge' Project on Universal γδT Cell Therapy

Dec 16, 2023 11:54 CST Updated 11:54

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Developer of Tumor Cell Immunotherapy Technologies and Products

Recently, the 2023 National Biomedicine Innovation Center for Cell Therapy "Challenge Leader" Technical Project List was announced, and Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD was successfully listed."Development of Universal Cell Therapy for Malignant Tumors Based on γδT Cell R&D Platform"After going through rigorous procedures such as organizational application, expert review, interview defense, and deliberation by the competent authority, it was successfully selected as"Key Projects"。

National Biopharmaceutical Innovation Center

National Biopharmaceutical Innovation Center (referred to as: NBCIC) is the first national technological innovation center in the biopharmaceutical field in China, approved for construction by the Ministry of Science and Technology of China in March 2021. Cell therapy is one of the key technical focus areas of this center. In January 2023, the "Challenge-based" cell therapy technology project was officially launched, aiming to integrate the entire industrial and innovative chains of cell therapy to conduct forward-looking and innovative research in cell therapy technologies. This initiative seeks to achieve significant breakthroughs in technologies that are urgently needed across the cell therapy industry chain, restricted by patented technologies, and strongly oriented towards clinical applications, laying a solid foundation for meeting clinical needs with cell therapies.

Universal Cell Therapy

High production costs and long preparation times have posed significant challenges to the rapid development of cell therapies, prompting researchers to focus on universal, ready-to-use "off-the-shelf" cell therapies. As an important direction in the development of next-generation cell treatments, universal cell therapy has become an extremely popular field.

This award marks that Bo Sheng Ji's innovative leading position in the field of cell therapy has been recognized at the national level in China, and further confirms Bo Sheng Ji's strong R&D strength and technical accumulation in the biopharmaceutical field.

Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD began developing UCAR-γδT cell products as early as 2017. To date, it has developed three cell culture expansion platforms, and through extensive testing, confirmed that Type 1 γδT cells have significant advantages and potential in cancer treatment. However, the preparation process for Type 1 γδT cells presents considerable challenges. Researchers have spent a substantial amount of time and effort testing various processes and combinations, continuously optimizing and validating cell expansion methods. Currently, the Type 1 γδT cell culture platform can expand γδT cells nearly ten thousand times. The final product also exhibits very low αβT cell residue and demonstrates high cytotoxic activity in in vitro tumor cell killing assays. At present, our preparation process for Type 1 γδT cells has reachedInternational Advanced Level。

The first universal off-the-shelf cell drug incubated by this platform, UTAA09 Injection, uses type 1 γδT cells from healthy donors as the starting raw material. It is not affected by the patient's disease progression, can be prepared on a large scale in advance, and can be administered at any time without waiting. Under the powerful research and industrialization capabilities of Bo sheng ji medicine science and technology (suzhou) co., LTD, it has achievedThreefold Breakthrough in Preparation Cycle, Preparation Quality, and Preparation Cost, which can overcome the current pain point of low patient accessibility due to the exorbitant cost of CAR-T cells, and maximize patient accessibility.

UTAA09 Injection Has Submitted a Pre-IND Communication Application to the National Medical Products Administration (NMPA), with an Expected IND Approval in 2024. Additionally, Due to the Absence of Gene Editing and the Established Foundation of Process Development, Costs Have Been Significantly Reduced, Positioning It to BecomeThe First CAR-T Drug for Outpatient UseThe potential to improve patient accessibility to CAR-T cell products, fill the market gap for universal off-the-shelf CAR-T cell products, and has very broad application and industrialization prospects.

Bo sheng ji

Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD was registered on May 31, 2010, in Suzhou Industrial Park, Jiangsu Province. It is a national high-tech enterprise with a primary focus on the development, production, and clinical translation of tumor cell immunotherapy technologies and products such as CAR-T, CAR-γδT, and CAR-NK cell therapies. The company specializes in developing breakthrough First-in-class and Best-in-class CAR-T cell drugs with internationally leading standards.

A nearly 10,000-square-meter commercial production base meeting GMP standards has been completed. It is currently the largest fully automated CAR-T cell production base in the Asia-Pacific region. The facility includes world-class GMP plasmid and lentivirus production and purification workshops, P2 safety laboratories, quality control rooms, and R&D laboratories. It possesses a complete production chain system covering everything from plasmids and lentiviruses to CAR-T cell preparation. The company has a full industrial chain layout including original innovation, PBMC collection, quality control, commercial production, and cold chain transportation. It is the company with the most comprehensive fully automated and fully enclosed CAR-T cell production line built in China so far.