Good news for the industry! According to Shenzhen Satellite TV Shenzhen News: In order to implement the requirements of the “Comprehensive Reform Pilot Implementation Plan for Building Shenzhen into a Pioneer Demonstration Zone of Socialism with Chinese Characteristics (2020-2025)”, Shenzhen will deeply implement the biomedicine development strategy and strengthen the management of cell and gene therapy, Shenzhen will take the lead in the country in legislating cell and gene therapy management!
The following is the full text of the news report
Reprinted from “Shenzhen Satellite TV Shenzhen News”
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Shenzhen, speed up legislation in emerging fields
According to the official website of the Municipal People’s Congress Standing Committee, in order to implement the requirements of the “Comprehensive Reform Pilot Implementation Plan for Building a Pilot Demonstration Zone of Socialism with Chinese Characteristics in Shenzhen (2020-2025)”, in-depth implementation of the biomedicine development strategy, and strengthen cell and gene therapy management, the Municipal People’s Congress Standing Committee recently held a working meeting on the drafting of the “Shenzhen Special Economic Zone Cell and Gene Industry Promotion Regulations” (tentative name) to listen to the opinions of relevant departments and experts.
At the meeting, relevant responsible comrades from the Municipal Development and Reform Commission, Municipal Science and Technology Innovation Commission, Municipal Industry and Information Technology Bureau, Municipal Health Commission, and Municipal Market Supervision Bureau, as well as clinical experts from Shenzhen University General Hospital and Sami International Medical Center, and technical experts from Inno Translational Medicine Research Institute and Shenzhen Cell Therapy Technology Association, respectively put forward opinions and suggestions on the legislative work.
The meeting emphasized that the comprehensive reform pilot implementation plan gives Shenzhen the right to pioneer in emerging fields such as artificial intelligence, driverless driving, big data, biomedicine, medical health, information services, and personal bankruptcy, and supports Shenzhen to fully utilize the legislative power of special economic zones to explore. Shenzhen should take this opportunity to accelerate legislation in emerging fields.
The meeting pointed out that it is necessary to optimize the special class. In addition to the existing experts, it is also necessary to widely absorb top experts in biomedicine from across the country and even the world to form a special legislative class to provide professional guidance for legislation; it is necessary to speed up the progress of legislative work, actively carry out data collection and research work, and formulate a basic framework of regulations on the basis of understanding the current situation of the industry, and continuously revise and improve it.
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Cell and Gene Therapy
The American “Science” magazine once ranked stem cell research among the top ten scientific achievements in the world. The COVID-19 epidemic has also prompted society to pay more attention to cell and gene therapy.
The world-renowned German Bayer Group officially announced on December 3 this year that it will establish a cell and gene therapy platform to accelerate prescription drug innovation. The new platform will drive groundbreaking scientific and technological innovation with the cell and gene therapy platform (C>) to provide patients with breakthrough innovative treatment options.
Rao Zihe, a member of the National Committee of the Chinese People’s Political Consultative Conference and an academician of the Chinese Academy of Sciences, said that with the continuous strengthening of my country’s scientific research investment and technological strength,The number of clinical research on cell and gene therapy in China is increasing year by year. The number of new clinical studies every year is second only to the United States. It has become one of the most active regions in the world for clinical research on cell therapy.
Rao Zihe said that the occurrence of domestic cell therapy and gene editing incidents in recent years shows that the clinical benefits and industrial development of cell and gene therapy in my country are still significantly different from the international advanced level. It is also necessary to continue to standardize clinical scientific research guidance and supervision in the field of cell and gene therapy.
According to statistics, so far, the European Union and the U.S. Food and Drug Administration (FDA) have approved 6 cell and gene therapy products, and the FDA predicts that 40 gene therapies will be approved by 2022. AndThere is still no safe and effective cell and gene therapy product approved for marketing in my country.
As a member of the National Committee of the Chinese People’s Political Consultative Conference, Rao Zihe put forward his own suggestions in the People’s Political Consultative Conference newspaper:
Introduce and train national professionals in the field of cell and gene therapy supervision, and give them professional decision-making rights;
Increase support for clinical research and industrial transformation funding of cell and gene therapy products;
Standardize clinical products in the field of cell and gene therapy and enhance the industry’s confidence and determination in the transformation and application of cell therapy;
Establish an incentive mechanism to encourage regulatory authorities to approve nuclear gene therapy and a limited liability system for regulatory personnel under legal protection to encourage innovation and industrialization from an institutional perspective;
Promote earlier interactive communication with R&D companies, guide and standardize the product development process, guide companies to better and faster meet product clinical transformation requirements, and shorten the R&D process.
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Is Shenzhen suitable to take the lead in legislation?
Following the IT industry, biotechnology and biomedicine are considered to be the industries with the greatest development potential and space. The biopharmaceutical industry is also one of the seven strategic emerging industries in Shenzhen, with important strategic significance and broad development prospects.
Shenzhen’s biopharmaceutical industry started early. In 2005, it was recognized as one of the first batch of national biopharmaceutical industry bases by the National Development and Reform Commission. In 2018, the added value of Shenzhen’s biopharmaceutical industry grew by 22.3%, ranking first among the seven strategic emerging industries.
In 2019, Shenzhen established more than 300 innovative carriers in the field of biomedicine, High-end biomedical engineering, gene sequencing and biological information analysis and other technologies are at the forefront of the world. The biopharmaceutical industry achieved an added value of 33.781 billion yuan throughout the year, an increase of 13.3%. Amid the COVID-19 epidemic, this industry, which the industry calls “a sunrise industry that will never decline,” has achieved growth despite the trend.
As early as the beginning of this year, the Shenzhen Municipal Government introduced policies to promote the clustered development of the biopharmaceutical industry“1+3” policy document, which clearly proposes to focus on the common needs and weak links of the development of Shenzhen’s biomedical industry, create a professional service platform covering the entire chain of the biomedical industry, and provide strong support for the development of Shenzhen’s biomedical industry and enterprise clusters.
On April 29, the Municipal People’s Congress Standing Committee passed “Decision on Accelerating the High-Quality Development of the Biopharmaceutical Industry”, the “Decision” proposes to strengthen the guarantee of industrial development factors, requiring strengthening guarantee from talents, funds, land and other aspects to promote industrial development.
The country’s first free trade zone legislation, the “Shenzhen Special Economic Zone Qianhai Shekou Pilot Free Trade Zone Regulations”, which came into effect on October 1, has given new impetus to the development of Shenzhen’s cell and gene therapy industry. The regulations clearly stipulate: Medical institutions and scientific research institutions in the free trade area can carry out research and transformation applications of new technologies such as stem cells, immune cells, gene therapy, monoclonal antibodies, and tissue engineering based on their own technical capabilities and in accordance with relevant regulations.
At the 2020 Shenzhen BT (Biotechnology) Industry Leaders Summit held on November 18, Academician Zhong Nanshan also specially praised Shenzhen’s epidemic prevention work and the development of Shenzhen’s biomedical industry.
Zhong Nanshan said that Shenzhen is currently vigorously developing the biomedical industry and has formed a number of high-quality characteristic industrial clusters such as Pingshan National Bio-Industry Base, which has laid a good foundation for accelerating the creation of the core engine of the biomedical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.
The comprehensive reform pilot implementation plan gives Shenzhen the right to pioneer in emerging fields such as artificial intelligence, driverless driving, big data, biomedicine, medical health, information services, and personal bankruptcy. Shenzhen has chosen to take the lead in legislating cell and gene therapy management to further promote the healthy and sustainable development of this industry. It is the right time and the right thing to do.
Shen Weixing, dean of Tsinghua University School of Law and vice president of the Chinese Health Law Society, previously said in an interview with a reporter from Shenzhen Satellite TV that we should not only pay attention to the development of biomedical technology, but also put safety awareness first. Therefore, Shenzhen has great potential for future technology while ensuring safety.
He said,The rule of law itself cannot produce technology, nor can it cure diseases, but it can ensure that people’s basic rights are fully protected and make medical and health technology innovations, including medical and health technology innovation, stable and long-term.
Reference information: “Commissioner Rao Zihe: Promoting the Industrialization of Cell and Gene Therapy” (published in the “People’s Political Consultative Conference”)
Source: Shenzhen Satellite TV Shenzhen News
—— Further reading——
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Currently, Beike Biotechnology has cooperated with 5 hospitals to apply for and pass the registration of stem cell clinical research institutions by the National Health Commission, including the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Peking University Shenzhen Hospital, Shenzhen People’s Hospital, the Second Affiliated Hospital of Kunming Medical College, and Hubei Shiyan Taihe Hospital.
has accumulated rich clinical experience and clinical research results in the treatment of refractory diseases with mesenchymal stem cells. “A Randomized, Parallel, Controlled Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes under Different Transplantation Routes” The project has passed the national stem cell clinical research filing and was Recruitment for clinical research will begin in June 2020; submitted in cooperation with Hubei Shiyan Taihe Hospital“Clinical Study on the Safety and Effectiveness of Human Umbilical Cord-Derived Mesenchymal Stem Cells Combined with Modern Rehabilitation in the Treatment of Cerebral Palsy in Children” was registered as a stem cell clinical research project of the National Health Commission, and was also published in Clinical study recruitment will begin in June 2020.
In addition, Beike Biotech has also been insisting on R&D innovation in the field of cells, actively participating in clinical research of mesenchymal stem cells in refractory diseases, and has collaborated with clinical institutions to publish more than 100 domestic and foreign papers. Beike’s biological research results“Key technological innovation and clinical application of allogeneic mesenchymal stem cells in the treatment of refractory lupus erythematosus”obtained2019 National Technology Invention Award!