An industry boost! According to Shenzhen TV's Shenzhen News: in order to implement the requirements of the Implementation Plan for the Comprehensive Reform Pilot of Building Shenzhen as a Pilot Demonstration Zone of Socialism with Chinese Characteristics (2020–2025), deepen the biopharmaceutical development strategy, and strengthen the management of cell and gene therapy, Shenzhen is set to take the national lead in legislating on the management of cell and gene therapy!
Below is the full news report
Reprinted from "Shenzhen TV's Shenzhen News"
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01
Shenzhen accelerates legislation in emerging fields
According to information disclosed on the official website of the Standing Committee of the Municipal People's Congress, in order to implement the requirements of the Implementation Plan for the Comprehensive Reform Pilot of Building Shenzhen as a Pilot Demonstration Zone of Socialism with Chinese Characteristics (2020–2025), deepen the biopharmaceutical development strategy, and strengthen the management of cell and gene therapy, the Standing Committee of the Municipal People's Congress recently held a drafting meeting for the Shenzhen Special Economic Zone Regulations on Promoting the Cell and Gene Industry (provisional title) and heard the opinions of relevant departments and experts.
At the meeting, principal officials in charge from the Municipal Development and Reform Commission, the Municipal Science and Technology Innovation Committee, the Municipal Bureau of Industry and Information Technology, the Municipal Health Commission, and the Municipal Market Supervision Bureau, as well as clinical experts from Shenzhen University General Hospital and the Sami International Medical Center, and technology experts from Yinuo Translational Medicine Research Institute and the Shenzhen Cell Therapy Technology Association, respectively offered opinions and suggestions on the legislative work.
The meeting stressed that the Comprehensive Reform Pilot Implementation Plan grants Shenzhen pilot rights to take the lead in emerging fields such as artificial intelligence, autonomous driving, big data, biopharmaceuticals, healthcare, information services, and personal bankruptcy, and supports Shenzhen in fully utilizing its special economic zone legislative power for exploration. Shenzhen should seize this opportunity and accelerate legislation in emerging fields.
The meeting noted the need to optimize the working group: in addition to existing experts, top experts from across China and even worldwide in biopharmaceuticals should be broadly recruited to form a legislative working group that provides expert guidance for the legislation. The meeting also called for accelerating progress on the legislation, actively conducting data collection and field research, drafting the basic framework of the regulations on the basis of a clear understanding of the industry's status, and continuously revising and improving the draft.
02
Cell and gene therapy
The journal Science once ranked stem cell research at the top of the world's ten greatest scientific achievements. The COVID-19 pandemic has also brought greater public attention to cell and gene therapy.
The world-renowned German group Bayer officially announced on December 3 of this year the establishment of a cell and gene therapy platform to accelerate prescription drug innovation. The new Cell & Gene Therapy (C>) platform will drive groundbreaking technological innovation to provide patients with breakthrough innovative treatments.
Member of the National Committee of the CPPCC and Academician of the Chinese Academy of Sciences Rao Zihe stated that as China's R&D investment and technological strength continue to grow, clinical research on cell and gene therapy in China is increasing year by year. The number of new clinical studies added each year is second only to the United States, making China one of the most active regions in the world for cell therapy clinical research.
Rao Zihe said that recent incidents in domestic cell therapy and gene editing show that there is still a clear gap between China's clinical benefits and industrial development in cell and gene therapy and the international advanced level, and that clinical research guidance and regulation in the cell and gene therapy field need to be continually standardized.
According to statistics, to date, the European Union and the U.S. Food and Drug Administration (FDA) have approved a total of 6 cell and gene therapy products. The FDA expects that by 2022, 40 gene therapies will have been approved. However, in China, no safe and effective cell and gene therapy product has yet been approved for marketing.
As a member of the National Committee of the CPPCC, Rao Zihe put forward his suggestions in the People's Political Consultative Daily:
Recruit and cultivate professional national talents in the field of cell and gene therapy regulation and grant them professional decision-making authority;
Increase financial support for clinical research and industrial translation of cell and gene therapy products;
Standardize clinical products in the field of cell and gene therapy and strengthen the industry's confidence and resolve in the translational application of cell therapy;
Establish a set of incentive mechanisms encouraging regulators to approve cell and gene therapies, along with a system of limited liability under legal protection for regulators, so as to institutionally encourage innovation and industrialization;
Promote earlier interaction and communication with R&D enterprises, guide and standardize the product development process, help enterprises better and more quickly meet the requirements for clinical translation of products, and shorten R&D timelines.
03
Is Shenzhen the right place to legislate first?
After the IT industry, biotechnology and biopharmaceuticals are regarded as industries with the greatest development potential and room to grow. The biopharmaceutical industry is also one of Shenzhen's seven strategic emerging industries, with major strategic significance and broad development prospects.
Shenzhen's biopharmaceutical industry got an early start, and as early as 2005 it was designated by the National Development and Reform Commission as one of the first batch of national biopharmaceutical industry bases. In 2018, the value-added growth rate of Shenzhen's biopharmaceutical industry reached 22.3%, ranking first among the seven strategic emerging industries.
In 2019, Shenzhen had set up more than 300 innovation carriers in the biopharmaceutical field. Technologies such as high-end biomedical engineering, gene sequencing, and bioinformatics analysis ranked among the world's leading edge. The biopharmaceutical industry achieved a value-added of 33.781 billion yuan for the year, an increase of 13.3%. Even amid the COVID-19 pandemic, this industry — described as the "ever-rising sun industry" — has continued to grow against the trend.
As early as the beginning of this year, the Shenzhen Municipal Government issued the "1+3" policy documents to promote the clustered development of the biopharmaceutical industry, clearly proposing to focus on the common needs and weak links of Shenzhen's biopharmaceutical industry, and to build professional service platforms covering the entire biopharmaceutical industry chain, providing strong support for the clustered development of Shenzhen's biopharmaceutical industry and enterprises.
On April 29, the Standing Committee of the Municipal People's Congress passed the Decision on Accelerating the High-Quality Development of the Biopharmaceutical Industry. The Decision calls for strengthening the safeguarding of factors for industry development, with enhanced support across talent, capital, land, and other dimensions, in order to drive industry development.
The Regulations on the Qianhai-Shekou Free Trade Zone of the Shenzhen Special Economic Zone — the country's first piece of free-trade-zone legislation, which took effect on October 1 — provides further momentum for Shenzhen's cell and gene therapy industry. The regulations clearly state that medical institutions and scientific research institutions in the free trade zone may, in accordance with their own technical capabilities and relevant regulations, conduct research and translational application of new technologies including stem cells, immune cells, gene therapy, monoclonal antibody drugs, and tissue engineering.
At the 2020 Shenzhen BT (Biotechnology) Industry Leaders Summit held on November 18, Academician Zhong Nanshan also made a special point of praising Shenzhen's epidemic control work and the development of its biopharmaceutical industry.
Zhong Nanshan said that Shenzhen is currently making vigorous efforts to develop the biopharmaceutical industry and has formed a number of high-quality, characteristic industrial clusters such as the Pingshan National Biopharmaceutical Industry Base, laying a solid foundation for accelerating the building of the core engine of the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.
The Comprehensive Reform Pilot Implementation Plan grants Shenzhen pilot rights to take the lead in emerging fields such as artificial intelligence, autonomous driving, big data, biopharmaceuticals, healthcare, information services, and personal bankruptcy. Shenzhen's choice at this time to take the lead in legislating on the management of cell and gene therapy, so as to further promote the healthy and sustained development of this industry, comes at just the right moment and is a duty it should not shirk.
Shen Weixing, Dean of Tsinghua University School of Law and Vice President of the China Health Law Society, said in an earlier interview with Shenzhen TV that we must value the development of biotechnology, but should give an even higher priority to safety. With safety ensured, Shenzhen has great potential in future technology.
He said, "The rule of law itself does not produce technology and cannot cure disease, but it can ensure that fundamental human rights are fully safeguarded, allowing endeavors including innovation in medical and health technologies to advance steadily and over the long term."
References: "Member Rao Zihe: Promoting the Industrialization of Cell and Gene Therapy" (published in the People's Political Consultative Daily)
Source: Shenzhen TV's Shenzhen News
—— Further reading ——
As a member of Shenzhen's pharmaceutical industry, Beike Biotech has been deeply engaged in the cell industry for 15 years. It has a top-tier, mature stem cell R&D team and cutting-edge cell storage and preparation technologies, and has innovatively pioneered the industry development model of "Comprehensive Cell Bank + Regional Cell Manufacturing Center + Cell Quality Testing Platform", providing a complete technology platform and infrastructure for the clinical translation of cell therapy technologies.
To date, Beike Biotech has, in cooperation with five hospitals, applied for and obtained filing as stem cell clinical research institutions with the National Health Commission. The hospitals are: the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Peking University Shenzhen Hospital, Shenzhen People's Hospital, the Second Affiliated Hospital of Kunming Medical University, and Taihe Hospital in Shiyan, Hubei.
Beike Biotech has accumulated extensive clinical experience and clinical research achievements in mesenchymal stem cell therapy for refractory diseases. The project "Randomized, Parallel, Controlled Clinical Study of Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells via Different Transplantation Routes for the Treatment of Type 2 Diabetes", jointly submitted with Peking University Shenzhen Hospital, has been filed nationally as a stem cell clinical research project, and began clinical research recruitment in June 2020. The project "Clinical Study on the Safety and Efficacy of Human Umbilical Cord-Derived Mesenchymal Stem Cells Combined with Modern Rehabilitation in the Treatment of Pediatric Cerebral Palsy", jointly submitted with Taihe Hospital in Shiyan, Hubei, has also been filed with the National Health Commission as a stem cell clinical research project, and similarly began clinical research recruitment in June 2020.
In addition, Beike Biotech has consistently pursued R&D innovation in the cell field and has actively participated in clinical research on mesenchymal stem cells for refractory diseases. Together with clinical institutions, it has co-published more than 100 papers domestically and internationally. Beike Biotech's research achievement "Key Technology Innovation and Clinical Application of Allogeneic Mesenchymal Stem Cells in the Treatment of Refractory Lupus Erythematosus" received the 2019 National Technology Invention Award!
