Company Overview

Introduction

The Cell & Gene Therapy Innovation Center (CGTIC) is a research and development platform dedicated to cell and gene therapy, established by the Beijing Tsinghua Industrial R&D Institute with the support of Beijing Municipal Science and Technology Commission and Changping District. It collaborates with top domestic and international biopharmaceutical research institutions and emerging enterprises. Beijing LotusLake BioMedical Technology Co., Ltd. serves as the main operator of CGTIC, undertaking the operational management of the center. CGTIC is located in the Life Science Park of Changping District, Beijing, covering an area of about 15,000 square meters. It includes 10 complete GMP production lines that comply with standards from China, the United States, and Europe. CGTIC is capable of highly flexible co-line production for a variety of drugs, including mRNA, cell therapy, and gene therapy, with its batch production capacity ranking among the top in the nation. Additionally, CGTIC relies on the innovation system of the Beijing Tsinghua Industrial R&D Institute and works in conjunction with supply chain partners to achieve a new industrialized definition and design. On this foundation, CGTIC has constructed a new "short process" development paradigm for the cell and gene therapy industry, characterized by "fast R&D, fast production, fast clinical".

Under the "short process" development paradigm, CGTIC has achieved remarkable results in its three years since establishment, supporting 6 innovative drug pipelines to successfully obtain 11 IND clinical trials, and realizing "four global firsts and two Chinese firsts". This includes the world's first synthetic biology oncolytic adenovirus gene therapy drug receiving IND permissions in both China and the U.S., the world's first STAR-T cell therapy drug receiving IND permissions in both China and the U.S., the world's first epilepsy AAV gene therapy drug entering clinical trials, the world's first classical swine fever mRNA vaccine completing animal testing, China's first COVID-19 mRNA vaccine approved for IND in the U.S. (the first mRNA vaccine project to complete an IND application with the U.S. FDA in China), and China's first gene-editing ophthalmic AAV gene therapy drug receiving IND permissions in both China and the U.S. Clinically, CGTIC has closely collaborated with research-oriented clinical hospitals, promoting multiple clinical studies initiated from the clinical side. It has enrolled and treated hundreds of subjects, accumulating valuable real-world clinical data. Moreover, since its production started in September 2022, CGTIC has signed contracts exceeding 280 million yuan, greatly promoting the development of the cell and gene therapy field in Beijing and the surrounding areas in terms of scientific research, clinical studies, and industry.

The high precision and personalized nature of cell and gene therapy determine the necessity of its close integration with the clinical end. However, there is a significant issue of disconnection between research and development and clinical practice within the industry. In the practice of the "short process" model, CGTIC has gradually clarified that the current drug development has entered a new era driven by clinical needs, and the trend of research and development that meets clinical demands has become a must. Guided by clinical feedback, based on its own standard GMP production capabilities, and linking top scientific research resources, CGTIC proposes a new paradigm of bio-pharmaceutical engineering oriented by clinical practice, accelerating the development of functional and effective drugs, continuously deepening and improving the construction of the "short process" model, with the aim of achieving substantial breakthroughs in "real clinical, real research and development, real drugs". CGTIC will continue to commit to breaking down the barriers between basic research and clinical application, using its own engineering capabilities as the axis, to promote rapid two-way response from the laboratory to the bedside, and comprehensively promote global innovation in China's cell and gene therapy field.

Background / Collaboration

Beijing Tsinghua Industrial R&D Institute, established in 1998, is a public institution jointly established by the People's Government of Beijing and Tsinghua University. It undertakes the mission of transforming and industrializing the scientific and technological achievements of Tsinghua University in Beijing , promoting the landing of Tsinghua University's scientific and technological achievements in the capital. It has built multiple globally influential technology innovation centers and transfer and transformation bases, and has constructed an internationalized technology transfer and innovation ecosystem.

CGTIC relies on Tsinghua Industrial R&D Institute, using the first-class academic strength, talent, and technical advantages of Tsinghua University and related colleges and top research institutions as the foundation for development. It aims to build a complete industrial development chain in the field of cell and gene therapy. It carries out in-depth exchanges and cooperation with leading life science companies in the industry, utilizing multidisciplinary and industry-leading technical resources to achieve platform development and fundamental breakthroughs in underlying technologies in this field. Tsinghua Industrial R&D Institute plays a crucial role in the coordination of funds, engineering, technical resources, and the development strategy planning of CGTIC. As the initiator of our innovation platform, Tsinghua Industrial R&D Institute continuously introduces advanced international projects in cell and gene therapy, incubating high-tech enterprises with strong competitiveness. At the same time, it attracts global professionals and cutting-edge technology to gather here, providing comprehensive production and technical services for technology companies in the field of cell and gene therapy.