Zhongbo Ruikang's Cell Preparation Tool Production Base Officially Opens, Paving the Way for Domestic Substitution in the Era of Cell and Gene Therapy
2021 was a year of significant progress in cell and gene therapy.
In the field of cell therapy, China’s National Medical Products Administration (NMPA) granted breakthrough approval to two domestically produced CAR-T cell therapy products in 2021: axicabtagene ciloleucel injection and relmacabtagene autoleucel injection. In the field of gene therapy, the first clinical trial results for in vivo CRISPR gene editing were announced in June 2021.
As the cell and gene therapy industry flourishes, upstream cell preparation tools are also garnering significant attention.
Timely supply of upstream cell preparation tools, rational selection of related tool modules, and seamless integration of the overall system are key to whether cell and gene therapy companies can ensure R&D efficiency, accelerate clinical progress, and control costs.
Previously, cell preparation tools were long monopolized by foreign companies, leading to persistent challenges for China’s cell and gene therapy enterprises, including prolonged supply lead times, high costs, and inadequate service capabilities.
Zhongbo Ruikang’s Cell Tool Manufacturing Base—The establishment of Zhongboruijia Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as “Zhongboruijia”) has provided a breakthrough in addressing the import monopoly on cell preparation tools.
November 18, 2021Opening Ceremony of Zhongbo Ruikang Cell Tool Production Building Held in ShanghaiDong Shupei, First-Level Researcher at the Biotechnology and Medicine Division of the Shanghai Municipal Science and Technology Commission; Zhang Xian, Director of the Fengxian District Economic Commission; Yang Lingyu, General Manager of Lingang Nanqiao Science and Technology City; Chen Shaoxiong, President of the Shanghai Biomedical Industry Association; Yuan Baozhu, Chief Scientist of the National Stem Cell Translation Resource Bank and former Director of the Center for Cell Resources at the National Institutes for Food and Drug Control; Kang Jiuhong, Dean of the School of Life Sciences at Tongji University; as well as multiple founders from 11 universities and hospitals and 60 enterprises, along with experts in research and development, production, quality control, and other related fields.Over 100 guests attended., with distinguished guests in attendance and experts gathered together,Jointly witnessing a significant step forward in the domestic cell preparation tools sector, achieving import substitution with Chinese-made alternatives.
Zhongboruikang is dedicated to developing comprehensive solutions for cell preparation tools for domestically produced cell and gene therapies. The company has launched a family of cell preparation products covering equipment, consumables, and reagents, thereby establishing an automated cell preparation process system. By enhancing the continuity, closed-system integrity, modularity, interoperability, and digitalization of its preparation tools, Zhongboruikang reduces customers’ R&D and production costs, minimizes inconsistencies and safety risks associated with multi-step manual operations, and meets the personalized needs of cell and gene therapies. Additionally, it provides customized tool manufacturing services, comprehensively boosting the competitiveness of China’s cell and gene therapy industry.
To prepare for the widespread commercial deployment of domestically produced cell preparation tools, Zhongbo Ruikang established a production center in Shanghai in April 2021, registered Zhongbo Ruijia, and began constructing a cell tool manufacturing facility.
According to reports, Zhongbo Ruijia’s production base is located in the Nanqiao Science and Technology City of Shanghai Lingang, with a total construction area of 7,600 square meters. It features a process R&D center, a cleanroom-grade equipment production center, GMP-grade consumables and liquid production workshops, a high-level quality control center, an experimental control and research center, and a high-level cold and ambient temperature storage center.Established production conditions and a product portfolio compliant with ISO and cGMP standards, as well as NMPA and CE regulatory requirements for product registration, thereby supporting cell and gene therapy companies in achieving dual cross-border drug filings. The facility has an annual production capacity of 3,000 cell preparation units, 200,000 sets of consumables, and 600,000 bottles of liquid products.
In addition, in November 2021, Zhongbo Ruikang (Chengdu) Biotechnology Co., Ltd., a wholly-owned subsidiary of Zhongbo Ruikang, was officially established as the company’s western regional headquarters.Since then, Zhongbo Ruikang has officially established an industrialized landscape featuring a “one body, two wings” structure encompassing R&D, production, and sales.
For Zhongbo Ruikang, the commissioning of the Zhongbo Ruijia production base will effectively ensure product stability, reliability, and cost-effectiveness. Meanwhile, production capacity will increase substantially, enhancing supply capability and shortening delivery lead times. This will enable the company to provide high-quality products and technical services to a broader customer base, accelerate commercialization, and further solidify its leading position in the cell preparation tools sector.
“The biggest challenge facing the cell and gene therapy industry is the high cost of upstream equipment, reagents, and consumables, which keeps prices for mid- and downstream products prohibitively high—exemplified by the CAR-T therapy that recently went viral for its price tag of RMB 1.2 million per dose.”If prices are not reduced, cell and gene therapies will remain accessible only to a select few.“We look forward to seeing Zhongbo Ruikang achieve more breakthroughs in this critical, bottleneck sector and make greater contributions to promoting the widespread adoption of cell and gene therapies nationwide,” said Chen Shaoxiong, President of the Shanghai Biopharmaceutical Industry Association.
Professor Xia Jianchuan from the Biotherapy Center of Sun Yat-sen University Cancer Center stated, “Cell and gene therapies have already assumed a significant role in clinical oncology. We believe that Zhongbo Ruikang’s domestically produced cell preparation tools will provide a substantial boost to the rapid development of China’s cell and gene therapy industry.”
Professor Wang Xiaoning, Secretary-General of the Joint Committee of Life Science Societies under the China Association for Science and Technology (CAST) and Chairman of the China GCP Alliance, stated, “Over 90% of upstream equipment and consumables in frontier areas of life sciences rely on imports. Zhongbo Ruikang has taken a long-term view and seized the critical leverage point in this field. Its equipment and consumables match international leading products in performance while being more affordable, which will significantly boost China’s cell and gene therapy industry.”
Dr. Sun Yan, Vice President of Shanghai Cell Therapy Group Co., Ltd., stated, “Zhongbo Ruikang has turned the dream of localizing cell preparation tools into reality. By persisting in this field for many years, Zhongbo Ruikang has built a cell tool platform that effectively addresses key industry pain points.”
Dr. Qi Feifei, Co-founder and CTO of Beijing ImmuneOnco Biopharmaceutical Technology Co., Ltd., stated, “Zhongbo Ruikang has achieved full localization of cell preparation equipment, reagents, and consumables. We hope that Zhongbo Ruikang will further ensure the regulatory compliance of production materials to meet GMP standards in the future.”
Professor Yuan Baozhu, Chief Scientist of the National Stem Cell Translational Resource Bank and former Director of the Center for Cell Resources at the National Institutes for Food and Drug Control, stated, “China’s cell and gene therapy industry has long lacked relevant quality standards,”The emergence of domestically produced cell preparation tools is an important prerequisite for China to establish quality standards,“Zhongbo Ruikang is poised to lead China in accelerating the development of relevant quality standards.”
Dong Shupei, a First-Level Researcher at the Biotechnology and Medicine Division of the Shanghai Municipal Science and Technology Commission, stated, “Previously, all bioreactors we used were imported, and we were unable to domestically produce even a single solenoid valve. Today, domestic equipment and materials have undergone significant transformations. We hope that Chinese scientists will actively embrace domestically produced products, giving homegrown instruments and consumables the opportunity to mature. We also encourage relevant manufacturers to adhere to international development standards and strive for excellence. I am confident that we can develop world-class cell preparation tools. I look forward to seeing an increasing number of domestically made equipment in research institutes and manufacturing facilities in the future.”
Previously, Zhongbo Ruikang had already attracted attention from numerous industry players, hospitals, and investors by virtue of its family-oriented product portfolio and differentiated service capabilities in the cell preparation tools sector. In September 2021, Zhongbo Ruikang completed a tens-of-millions-yuan angel financing round invested by Sinovation Ventures.
With the completion of Zhongbo Ruijia’s production base, Zhongbo Ruikang has attracted increased attention. At the opening ceremony, multiple cell and gene therapy companies extended olive branches to Zhongbo Ruikang.Zhongboruikang has entered into strategic cooperation agreements with Shanghai Duoning Biotechnology Co., Ltd., Imbrie (Hangzhou) Biopharmaceutical Co., Ltd., Chongqing Precision Biotechnology Co., Ltd., and Beijing Qinghui Liannuo Biotechnology Co., Ltd.
Subsequently, leveraging its in-depth collaboration with Zhongbo Ruikang, cell and gene therapy enterprises such as Shanghai Duoning Biotechnology Co., Ltd., ImbriCell (Hangzhou) Biopharmaceutical Co., Ltd., Chongqing Precision Biotechnology Co., Ltd., and Beijing Qinghui Liannuo Biotechnology Co., Ltd. have gained access to options with superior cost-effectiveness and enhanced service capabilities beyond imported products. This development effectively reduces the costs of cell and gene therapies, ensures R&D efficiency, and facilitates the rapid large-scale promotion and application of these therapeutic modalities.
Multiple guests expressed high recognition of Zhongbo Ruikang’s domestically produced cell preparation tools and technical service capabilities.
Dr. Ma Weiwei, CEO of Beijing Qinghui Liannuo Biotechnology Co., Ltd., stated, “We have collaborated with Zhongbo Ruikang for many years and received strong support from them in the early stages of our establishment. I was deeply impressed by Zhongbo Ruikang’s exceptional team execution capabilities. The cell and gene therapy industry is developing rapidly, yet the long-standing issue of import monopoly on upstream domestic cell preparation tools has remained unresolved. Zhongbo Ruikang identified this pain point and providedStable, Reliable, Automated, Fully Enclosed, Customizablesolutions. In the future, Qinghui Liannuo will continue to collaborate with Zhongbo Ruikang to develop high-quality cell therapy products.”
Professor Liu Baochi, Chief Physician of the Department of Surgery at Shanghai Public Health Clinical Center, stated: “Previously, we used imported brands, with equipment costs exceeding RMB 800,000 and consumable costs of over RMB 5,000 per procedure. We have been eagerly awaiting the emergence of domestically produced instruments and consumables.”Compared with imported products, Zhongboruikang’s products are more aesthetically pleasing, feature more sensors, deliver superior separation performance, and are more affordable, ensuring substantial market potential in the future.”
In addition, Zhongbo Ruikang has also signed a strategic cooperation agreement with Lingang Nanqiao Science and Technology City. Going forward, Zhongbo Ruikang will join forces with Lingang Nanqiao Science and Technology City to jointly build“Shanghai Cell and Gene Therapy Industrial Base”, accelerate the clustering of the biopharmaceutical industry in the park, and create a new highland for the biopharmaceutical industry in Fengxian District.
Yang Lingyu, General Manager of Lingang Nanqiao Science and Technology City, stated: “Lingang Nanqiao Science and Technology City will provide Zhongbo Ruikang with comprehensive, high-quality services and work hand in hand with the company to build more advanced technology platforms, supplying domestically produced cell preparation tools to cell and gene therapy enterprises in China and around the world.”
The cell and gene therapy industry has emerged as a global sunrise industry. According to Frost & Sullivan’s research report, the global cell and gene therapy sector has experienced rapid growth since 2016. From 2016 to 2020, the global market size for cell and gene therapies increased from $50 million to $2.08 billion, representing a compound annual growth rate (CAGR) of 153%. The overall global market for cell and gene therapies is projected to reach $30.54 billion by 2025, with a CAGR of 71% from 2020 to 2025.
It is foreseeable that,More cell therapy products will accelerate their market entry in the future, and China will be the most promising market in the global cell and gene therapy sector.In this case,The importance and strategic significance of domestically produced cell preparation tools in the upstream sector will become increasingly prominent.
Dr. Zou Qiang, CEO of Chengdu U-Sino Biotechnology Co., Ltd., stated, “Domestically produced cell preparation tools must first comply with the requirements of national regulatory authorities, ensuring that”Compliant, Traceable, and Verifiable. In the future, as the industry matures, the demand for cell preparation tools will continue to grow, making it imperative to achieveHigh-Throughput, Scalable, thereby achievingAutomation and Intelligence, ultimately achieving the productSpecialization, presenting a vibrant landscape where diverse techniques and products flourish.”
Dr. Zhou Zhengjun, Vice General Manager of Chongqing Precision Biotechnology Co., Ltd., stated, “The industrial chain for China’s cell and gene therapy sector is currently being refined. Upstream cell preparation tools constitute a critical link in this chain; only when all supporting components, such as cell preparation tools, achieve global leadership can a complete innovation ecosystem be established.”
As a key player in the domestic cell preparation tools sector, Zhongbo Ruikang has demonstrated impressive growth momentum—from R&D and the establishment of production facilities with high-standard quality management to signing contracts with clients across China.Amid the rapid development of the cell and gene therapy industry, Zhongbo Ruikang will intensify its market expansion efforts and launch more self-developed products to better serve cell and gene therapy companies in China and even globally.