Science and Products
Cellular Drug Clinical Trial Organization and Management Platform
Based on the characteristics of clinical trial design for cell and gene therapy, the company has summarized years of clinical practice experience in cell therapy products and developed a framework covering five major modules: project management, clinical operations, medical monitoring, data management, and statistical analysis.SOP ,It can guide the project team to effectively and规范ly execute clinical trial projects for cell products, providing full-process supervision and guidance for subjects from blood sample collection, cell preparation, to cell reinfusion processes, thereby improving the qualification of cell product preparation and the规范性 of cell reinfusion from the source.。
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.