China’s First National Major Science and Technology Infrastructure for Biotherapy Translational Medicine Officially Opened in West China Hospital of Sichuan University!
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The infrastructure will significantly enhance the independent innovation capability of China's translational medicine research and shorten the time from basic research to clinical application of biotherapeutic results by 30-50%.
On July 18, the West China Hospital Translational Medicine Complex— the core base for clinical research of the National Major Science and Technology Infrastructure for Translational Medicine (Sichuan) was officially opened. The complex is equipped with nearly 200 research beds, which will be used for clinical translational research and dedicated to promoting the application of innovative therapies, drugs, technologies and diagnostic reagents in clinical practice; it also houses supporting platforms for precision medicine testing, precision imaging evaluation, cell therapy product development and preparation to provide support for precision decision-making and personalized treatment in clinical translation. The opening of the Translational Medicine Complex also marks the new stage of opening and operation of the infrastructure.
As one of the 16 major science and technology infrastructures laid out during the 12th Five-Year Plan period, the national major science and technology infrastructure of translational medicine, relying on Shanghai Jiao Tong University (Ruijin Hospital), Peking Union Medical College Hospital, Chinese PLA General Hospital, Air Force Medical University of PLA and Sichuan University (West China Hospital), will construct five national-level science and technology infrastructures for translational medicine with different focuses and research directions. The National Major Science and Technology Infrastructure for Translational Medicine (Sichuan) is the first national major science and technology infrastructure for biotherapy translational medicine in China, and the second major science and technology infrastructure for translational medicine in China after Shanghai.
The infrastructure, with its preparatory work formally started in April 2013, was commenced in August 2018 and officially opened in July 2021. It focuses on four translational research platforms: screening of biologics, preparation of biologics, clinical translational validation and supporting technology platform, aiming to build an interrelated and highly integrated biotherapy translational medicine research system.
Li Weimin, President of West China Hospital of Sichuan University, said that after the operation of the Translational Medicine Complex of the hospital, it will significantly enhance the independent innovation capability of China's translational medicine research and shorten the time from basic research to clinical application by 30-50%; in the next 5-10 years, it will support the transformation of 50-100 independently innovated and developed biotherapeutic products candidates; it will remarkably enhance the competition and influence of China's biotherapy in the international arena, promote the leapfrog development of China's biotherapeutic industry for major diseases, and make important contributions to the protection of people's health and the training of high-level national biomedical talents.
At the launch ceremony, West China Hospital of Sichuan University released two major translational achievements. Academician Wei Yuquan’s team’s Phase III clinical trial of COVID-19 vaccine, Professor Liu Jin’s team’s fospropofol disodium injection (approved as a type 1.1 new anesthetic drug), and the skeletal muscular relaxant R&D (started with 500 million yuan contract funding) were awarded the “Innovative Translation Prize” by West China Hospital, Sichuan University in 2021.
Later, the scientists inaugurated the West China Hospital Translational Medicine Complex—the core base for clinical research of the National Major Science and Technology Infrastructure for Translational Medicine (Sichuan).
The West China Translational Medicine Forum held at the same time invited many famous experts such as Academician Chen Saijuan, Academician Fang Jiancheng, Academician Chen Zhinan, Academician Han Demin, Academician Cheng Jing, Academician Fu Xiaobing and Academician Liu Depei, to discuss in depth on medical application, biotherapy, translational medicine and other topics, and to contribute to the leapfrog development of China's biotherapeutic industry for major diseases.
The first national-level major science and technology infrastructure for biotherapy translational medicine
The National Major Science and Technology Infrastructure for Translational Medicine (Sichuan) takes advantage of the multidisciplinary crossing and integration of Sichuan University and West China Hospital, focusing on four key scientific and engineering issues: system integration, multidisciplinary integration, large-scale preparation, and high-throughput research and development, covering all key aspects from basic research on biotherapy to translational application research on clinical therapy, and forming a complete biotherapeutic translational “technology chain” from basic research to clinical research that combines upstream and downstream sectors.
The infrastructure is the largest, most comprehensive and integrated, most advanced and highly open and shared biotherapy translational medicine research center in China, with three major tools to lead the biotherapy translation nationwide.
Precision imaging and evaluation service chain covering the whole process of “basic discovery - clinical research - result transformation - industrial development”
As an important part of the chain, the Precision Imaging Center is one of the few clinical imaging research centers in the world that integrates first-class devices such as 7T MRI scanner, MEG machine, PET-MRI scanner, etc.; the center has the R&D capability to lead the international advanced technology. The center focuses on several research directions such as basic and clinical research of mental imaging, translational research of molecular imaging, physical research and development of magnetic resonance, clinical development and translation of targeted drugs in nuclear medicine, etc. It is the only innovative group in the field of imaging supported by National Natural Science Foundation of China, and has won the first second prize of National Natural Science Award in imaging and other awards. The team integrates advantageous scientific research and clinical resources through the joint medical-industrial innovation system, innovates independently and promotes the application of results.
In this chain, the Precision Medicine Center is the core component of the clinical testing module of national major science and technology infrastructure for translational medicine, and is also one of the important strategic development directions of West China Hospital. The center has built three top platforms at home and abroad of high-throughput sequencing, single-cell sequencing and bioinformatic analysis, and boasts the most complete and advanced Illumina, Ion Torrent, BGI and Oxford Nanopore series of second- and third-generation sequencing systems, 10X Genomics single-cell library preparation system and high-performance servers in the world. It mainly offers scientific research and clinical testing services for whole genome sequencing, whole exome sequencing and gene panel sequencing, has undertaken the task of whole genome sequencing for a cohort study of 100,000 natural population at West China Hospital, with a single test throughput of up to 140 samples and data analysis of 15 minutes per sample, making its sequencing and analysis capacity the highest among medical institutions nationwide. So far, the center has more than 1 million samples available for sequencing research.
The Precision Imaging Center and the Precision Medicine Center have built a precision imaging and evaluation service chain for the realization of “basic discovery - clinical research - result transformation - industrial development”.
National Drug Clinical Trial Institution (clinical trial center)—“one-stop” fully-equipped innovation-based clinical trial research platform
As a “one-stop” fully-equipped innovation-based clinical trial research platform with fully integrated functions and all-round shared services, the National Drug Clinical Trial Institution boasts 21 full-time research physicians who have rich clinical and research experience, 187 dedicated research beds and 4 standard ICU resuscitation wards.
The platform integrates clinical research wards, follow-up centers, collective management of subjects' research data, clinical tests, endoscopy, imaging, pathology and other functions. Thanks to the intelligent clinical trial system computing, free examination and testing, green reservation channel, fast admission process, and professional researcher project, the main implementation aspects of clinical trials can be completed in the translational medicine building in a "one-stop" manner, which accelerates the implementation of clinical trial projects. In addition to serving the supporting entities, the platform is also open to universities & colleges, research institutes, enterprises, hospitals and other institutions in the society.
Meanwhile, the platform has five leading innovative clinical studies in China. First, it has integrated a research platform for personalized biologics including systematic cell products for cell preparation, release testing, clinical evaluation and detection, which can carry out a series of research on CRISPR (clustered regularly interspaced short palindromic repeats) editing technology for biologics, CAR-T (chimeric antigen receptor T-cell immunotherapy) and individualized vaccines. Secondly, it has a hyperinsulinemic-euglycemic clamp technique laboratory in accordance with international standards and a research team. The laboratory is the research platform with the largest number of completed cases and the best quality of clamp test in China. Thirdly, it has built 4 negative pressure drug delivery chambers dedicated to PK research of inhalation products. The quantity and quality of PK (pharmacokinetics) and PKPD (pharmacokinetics/pharmacodynamics) studies on inhalation products completed in the past three years are among the top in China. Fourthly, it has built a model-guided drug development platform and completed the first approved case of pediatric indication based on virtual population study for pharmaceutical companies in China. Fifth, it is the first and exclusive medical institution in China to build a mass spectrometry imaging research platform, which has introduced mass spectrometry imaging technology into clinical translational research.
Large-scale Preparation Center for Biologics—“clinical-grade cell preparation factory”
The center covers an area of 2,900 square meters, with 10 cell preparation workshops, 7 quality testing platforms and 5 R&D laboratories. It is equipped with the most advanced fully-automatic, enclosed cell preparation production lines, and the core area environment of cell preparation reaches B+A level. Besides, the center spent 160 million yuan to have procured an array of advanced cell production, storage and testing devices in accordance with the newest industry standards at home and aboard and development trends including advanced cell treatment workstations, enclosed C+ isolators, large-scale cell extraction and purification systems, liquid nitrogen-free freezing systems and flow cell sorters. With these domestic leading devices, the center has become a cell research and application base integrated with industry, academia and research. It is a modernized, standardized and large-scale "clinical-grade cell preparation factory", which mainly focuses on the clinical translation research of cell therapy, and realizes the preparation, quality control and R&D of various immune cells including CAR-T, NK (natural killer cells) and umbilical cord blood and mesenchymal stem cells.
At present, the center is planned to build four modules, namely, immune cell preparation, stem cell preparation, cell quality testing and R&D. Through these modules, the center can realize the preparation, preservation and quality control of normal and genetically modified immune cells, umbilical cord blood stem cells, adipose and umbilical cord mesenchymal stem cells. In the future, the center will take advantage of cell and genetic engineering technology to provide “on-demand” research-grade, clinical-grade and traceable cell products for the development of biotherapy and project translation in China.
Big news! Two major translational achievements released
At the launch ceremony, West China Hospital of Sichuan University released two major translational achievements.
The first one is the Phase III clinical trial of COVID-19 vaccine led by Academician Wei Yuquan’s team. The recombinant protein COVID-19 vaccine developed by Academician Wei Yuquan’s team is based on precise design of structural biology, targeting the binding site of novel coronavirus and human cells, and using insect cells to introduce the gene of novel coronavirus virus into insect cells by mass propagation in culture solution to produce high quality recombinant vaccine protein. Currently, the phase III clinical trials of the vaccine are working with international partners in Japan, Nepal, Kenya, Indonesia, Bahrain, Belarus, Uzbekistan, Mexico and other countries.
The second one is the skeletal muscular relaxant R&D (started with 500 million yuan contract funding) and fospropofol disodium injection (approved as a type 1.1 new anesthetic drug) led by Professor Liu Jin’s team. On May 23, West China Hospital of Sichuan University and Yichang Humanwell Pharmaceutical Co., Ltd. signed two technology contracts for joint development of new skeletal muscle relaxants for a total of 500 million yuan, including a joint development agreement of 400 million yuan+ 5% commission on annual sales revenue and a patent license agreement of 100 million yuan (China-wide). On May 24, the fospropofol disodium injection was successfully obtained the Drug Registration Certificate of type I new drug, which is the first new drug certificate with independent intellectual property rights obtained by West China Hospital of Sichuan University, and a landmark moment for the transformation of new drug development achievements of West China Hospital of Sichuan University.