Yongtai Biology: "One Unit of Cellular Immunotherapy"
Yongtai Biopharmaceutical Co., Ltd. (stock code: 06978.HK, referred to as "Yongtai Biology") was established in 2006, has always been committed to the research and development and commercialization of tumor curative immune cell drugs, in 2020 to become China's first listed on the Hong Kong Stock Exchange immune cell drug companies.
The company has nearly 80 core technology patents in key steps such as cell preparation. Now it has established a pipeline of 10 + genes and cell products for different cancer species, covering gene modification/non-gene modification, multi-target/single target, with target indications covering solid tumors, blood tumors, virus infection and other related diseases. Research and development progress is at the international advanced level. The company has undertaken a number of scientific research projects, such as the National 863 Project, the National Nature Fund, the Ministry of Industry and Information Technology High-quality Development Project, the Beijing Science and Technology Innovation Fund, and the National Ministry of Science and Technology Major New Drug Creation.
As of June 2024, a total of five immune cell therapy products have entered clinical trials. Core Product EAL®It is an immune cell therapy product approved to enter the Phase II clinical trial of solid tumor treatment in China, and will be included in the list of CDE breakthrough treatment varieties in September 2023, which is expected to fill the gap of immune cell therapy in the field of solid tumors in China. At the same time, with aT19, RC19D2, CAR-T-19 injection and other three approved gene-modified cell drugs into clinical trials, and the perfect combination of two gene-modified product TCR-T-CMV and TCR-T-EBV for infection after hematopoietic stem cell transplantation, a rich research and development layout of immune cell therapy product pipelines in the field of hematological tumors has been formed.
At present, Yongtai Biology has established a complete full-cycle research and development management system and production and quality control system for cell drugs, and has built a GMP-compliant autoimmune cell drug digital factory with a total area of nearly 30000 square meters in Beijing. Digital systems such as SCADA, BMS, EMS, LIMS and MES have been set up to intelligently manage the whole process of production and quality control, and many sets of intelligent equipment and systems such as package robot workstation and cell culture intelligent detection system have been independently developed. It solves the key technical problems of large-scale production and quality inspection of immune cell drugs, and realizes the standardization and large-scale production of immune cell drugs.
Through the establishment and continuous improvement of the above system, Yongtai Biology has constructed a standard path of accurate and efficient connection of immune cell drugs from target and structure discovery, pre-clinical research, registration and declaration to GMP production and commercialization, and will gradually promote the solution of industry-university-research transformation difficulties, high import dependence, low degree of automation, insufficient standardization, small industrial scale and high production cost in CGT field, accelerate the improvement of the level of development of the industry. As the pioneer of immune cell drugs in China, we will continue to uphold the corporate mission of "let life continue in our hands", and promote the standardization and large-scale process of R & D and production of immune cell drugs in China based on the rich product R & D pipeline layout, so as to contribute to the promotion of precision medicine and healthy China, and the improvement of people's health.
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