Cell and gene therapy technology is undoubtedly one of the most popular biotechnology fields at present, and is also regarded as the next generation of innovative therapies for disease treatment. In this field, the development at home and abroad is particularly rapid and favored by capital.
In China, pain points and difficulties such as homogeneous competition, backward clinical design, and insufficient preparation capabilities lie in the way of the industrialization of cell and gene therapy. How to grasp the pulse of the times, seize innovation opportunities, and promote industry transition is related to whether domestic biotechnology companies can win in this international competition and whether the unfinished needs of human beings in pursuit of life and health can be met.
On the afternoon of May 22, the East Taihu Cell and Gene Therapy Industrialization Development Summit and Spectrum Biopharmaceuticals Establishment Celebration, co-hosted by Tongxieyi and Spectrum Biopharmaceuticals, was held as scheduled in Wuzhong District, Suzhou. Nearly 100 industry leaders and guests gathered, and Suzhou government leaders came to provide guidance and discuss key issues in the innovative development of cell and gene therapy drugs.
In addition, industry community ceremonies such as the strategic signing of the cell and gene therapy CXO industrialization platform, the establishment of the second board of directors of the Tongxieyi Cell Gene Therapy Club, and the closed-door meeting of the Tongxieyi Cell Gene Therapy Club directors were also held successively, jointly writing a new chapter for the industry.
As a new entity and brand that operates independently after the CDMO business of Pregenics was split, Spectrum Biopharma will build a global solution for the industrialization of cell and gene therapy drugs based on Pregenics' pharmaceutical development, production, non-clinical and clinical evaluation and conversion capabilities. The establishment of the Spectrum Biopharma project will promote the innovation, agglomeration and characteristic development of Wuzhong's biopharmaceutical industry.
During the COVID-19 pandemic, cell and gene therapy products have shown very high social and economic value and development prospects. Although my country lags behind the international advanced level in this regard, thanks to the strong support of governments at all levels and the efforts of frontline scientists and entrepreneurs, the industrialization of cell and gene therapy is accelerating, jointly writing a new chapter for China.
Many innovative companies have emerged in the field of cell and gene therapy in my country. With strong government support, basic research, clinical and industrial sectors have formed a complete industrial chain. As a leader in innovation, Spectrum Biopharma has opened up the entire chain from early research and development, clinical trials to CDMO industrialization, laying a good foundation for the research and development of cell and gene therapy products.
The development of China's cell and gene industry has kept pace with the international pace, making steady progress. In the future, it is necessary to actively promote, innovate and improve the industrial structure. We believe that the establishment of Spectrum Bio will bring positive significance to this process, and together with other companies, promote the vigorous development of the industry, so that Chinese patients can use the most effective and safe cell and gene therapy drugs as soon as possible.
Cell and gene drugs are very complex in form, and there are still some blind spots in the existing service model, which also determines the need to actively develop advanced formats in the fields of CDMO, clinical CRO, and non-clinical CRO services. The series of platforms of Spectrum Biotech is indeed a brand-new attempt. I hope that colleagues in the industry will actively explore the direction of industry development and better solve the problems of the cell and gene therapy drug industry.
Spectrum Biotech is based in China and looks to the world. The "new" of Spectrum Biotech is globalized. We believe that reliable and stable production processes are replicable and scalable. We and domestic and foreign partners have continuously deepened our attention and understanding of process stability through active exchanges and practices. Spectrum Biotech is willing to work with friends in the industry and investment community to jointly explore and optimize the division of labor to promote the healthy development of cell and gene therapy in China.
By 2030, Suzhou will gather 10,000 high-quality biopharmaceutical companies and realize a biopharmaceutical output value of over 1 trillion yuan. The development direction of Wuzhong's biopharmaceutical industry will include the research and development of high-end biological new drugs, mainly small molecule drugs, peptide drugs, new antibody drugs, cell and gene drugs, in addition to in vitro diagnostics, high-end imaging equipment, medical devices and other aspects. Our pharmaceutical and medical device CRO and CDMO public service platforms will continue to exert their strength to create a higher-standard industrial cluster and contribute to China's pharmaceutical industry.
Technical requirements for cell therapy registration clinical research
The technical requirements for cell therapy product development cover a wide range and develop rapidly. The evaluation gold standards include safety, effectiveness, quality control, and clinical accessibility (reliability).
Cell therapy product supervision and preclinical research and development strategy
After joining ICH, my country's regulatory policies have gradually been aligned with international standards and continuously optimized. In terms of application strategy, whether to directly apply for IND or to file an application for a set of tests at the same time, this needs to be implemented in combination with the characteristics of each company.
Clinical value-oriented cell therapy drug development
Currently, important research and development directions facing cell therapy are: first, how to improve the effectiveness of CAR-T therapy; second, how to screen the precise population for CAR-T therapy; third, what to do with cases that fail CAR-T treatment; fourth, how to select rational reagents in clinical trials; and fifth, what to do with unexpected problems and difficulties in the clinical treatment process.
Key issues in the innovative development of cell therapy drugs: bottlenecks and breakthroughs
[Host]
Cheng Zengjiang: Initiator of Tongxieyi Forum
[Guest]
Wang Liqun: Vice President and CTO of Fosun Pharma
Zhou Guoying: Chairman of Yinuo Micromedicine
Zhang Yu: CSO of Zhongyuan Xiehe
Yao Yi: CMO of Pregene Bio
Zhang Jinhua: Chairman of Xunlu Medical
Yuan Jijun: CEO of GeneCare Gene
Wei Dong: CEO of BoyaGene
The closed-door meeting of the club's board of directors was chaired by Secretary-General Zhang Yu, who elected the president-elect, vice president and executive director, clarified the club's work arrangements for the next stage, and actively absorbed more knowledgeable people in the field of cell and gene therapy to work together to promote policy reform and industrial development.
The meeting elected the executive director, president, vice president and president-elect.
Spectrum Bio is positioned as a cell and gene therapy drug CDMO enterprise with industrialized core technologies. The company's shareholders include the National Small and Medium Enterprise Development Fund, the Chinese Academy of Sciences-controlled Guoke Jiahe Fund, Haier Medical, Huabang Health, Hunan Health Pension Fund, etc. The company's headquarters is located in Wuzhong District, Suzhou City, on the beautiful shore of Taihu Lake, with a registered capital of 100 million yuan. The company has Suzhou headquarters (7000m2 GMP plant) and Zhengzhou base (7000m2 GMP plant under construction), and has initially formed a nationwide production base network layout.
Spectrum Bio focuses on the field of cell and gene therapy drugs, and has built a nucleic acid product process development platform, a suspended serum-free virus culture platform and a fully enclosed cell process development platform, creating a highway from drug discovery to product delivery. The platform has supported multiple partners to successfully incubate a number of CAR-T, TCR-T, stem cells, mRNA and other drugs, and is committed to allowing more projects to reach the next milestone earlier and faster, bringing more cell and gene therapy drugs to the market, benefiting more patients, and writing a new chapter in cell and gene therapy in China.
Guangdong Lion Pharmaceuticals Research Institute Co., Ltd. ("Lion Pharmaceuticals") is a non-clinical drug evaluation and research institution with 9 full GLP certifications from NMPA and full international AAALAC certification. Both GLP and non-GLP tests that have been applied for have been approved by FDA and support the listing of pharmaceutical products or clinical approval. Lion Pharmaceuticals focuses on providing professional technical services to support biopharmaceutical research and development, such as drugability evaluation, pharmacology and efficacy, drug safety evaluation, preclinical pharmacokinetic and toxicological studies, new drug registration and application, animal medical testing and inspection, and experimental animal and animal disease model research. Lion Pharmaceuticals has 15,000 square meters of advanced experimental facilities and complete instruments and equipment and a systematic management system. It has gathered a core expert team including academicians of the two academies, national specially appointed experts, and tenured professors from international universities. The research team has rich research experience in in-depth drug mechanism research, drugability evaluation research, drug safety evaluation, new drug pharmacology and efficacy, and pharmacokinetics. It can provide customers with NMPA and FDA bilateral application services. Currently, the single and double application projects that have submitted registration applications have successfully passed the review and received praise from customers. As a leading GLP institution in South China, Lion Pharmaceuticals owns Guangdong Provincial Key Laboratory for Non-clinical Drug Evaluation and Research, Guangdong Provincial New R&D Institution, Ophthalmology National Key Laboratory Ophthalmology Drug Non-clinical Evaluation Research Center, National Engineering Technology Research Center for Modernization of Traditional Chinese Medicine Chinese Medicine Non-clinical Evaluation Branch Center, Guangdong Provincial Innovative Drug Evaluation and Research Engineering Technology Research Center, Guangdong Provincial Cell and Gene Therapy Innovative Drug Engineering Technology Research Center, Guangdong Provincial Ophthalmology Drug Creation and Evaluation Engineering Technology Research Center, Guangdong Provincial Innovative Chiral Drug R&D Academician Workstation, Guangdong-Hong Kong-Macao Greater Bay Area Cell and Gene Therapy Drug R&D and Evaluation One-Stop Public Service Platform and many other national and provincial and ministerial platforms and high-end cooperative innovation platforms for industry-university-research cooperation; it has especially created non-pharmacological, toxicological and pharmacokinetics research technology platforms for new vaccines, infectious drugs, cell and gene therapy drugs, pediatric drugs, and ophthalmic drugs. The team has more than 4,000 non-clinical drug evaluation research experiences. In recent years, it has provided technical research and development services to more than 200 domestic and foreign pharmaceutical research and development institutions. It is the strongest professional team in South China that can systematically carry out non-clinical evaluation research of biological drugs and domestic advanced ophthalmic drugs, pediatric drugs, cell and gene therapy drugs. It can provide one-stop professional technical services and research and development consulting for non-clinical evaluation research of the entire drug research and development process for domestic and foreign pharmaceutical research and development institutions.
Beijing Xinling (stock code: 600222) was established in 2005. It is a high-tech enterprise that provides pharmaceutical preclinical research, clinical CRO and CDMO services to the world. It has been rated as "China's Top 10 Pharmaceutical R&D Companies (ranked first in 2019)" for many consecutive years. The company is headquartered in Beijing Zhongguancun High-tech Park. At the same time, it has established six R&D platforms that meet international standards (FDA, EMA and NMPA GMP standards) in Zhengzhou Linkong Biotechnology Park, including new drug screening and testing platform, drug evaluation platform (animal house, GLP, AAALAC, CNAS certification), large molecule pilot and large-scale production service platform, small molecule CMC preparation research and production platform, cell technology service platform and clinical CRO platform, forming a "new leading CXO" full industry chain service system. Combining imitation and innovation, dual-engine drive, it can provide customers with diversified services throughout the life cycle of pharmaceutical R&D
Miltenyi Biotech was founded in Cologne, Germany in 1989. It has now developed into a multinational biotechnology company with nearly 3,000 employees and branches in 28 countries. Miltenyi Biotech is committed to the research and development, manufacturing and sales of products related to basic biomedical research and clinical applications. It has more than 18,000 products and services, especially in the fields of cell biology, immunology, regenerative medicine and cell therapy. It enjoys a high reputation.
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