Interview | XinBio Co founder&CTO Chi Shen: Rooted in the upstream of the CGT industry chain, localization substitution To safeguard innovation and research and development

Date：2023-06-30 Views：

Cell and gene therapy (CGT), as a new generation of precision medicine, has shown great potential in many diseases such as tumors, rare diseases, and autoimmune diseases. Meanwhile, the CGT sector is gradually recovering after experiencing a capital winter, and the market is becoming more rational. But currently, CGT in China started relatively late and faces challenges such as homogeneous competition and incomplete development of the industrial chain. To jointly promote the development of CGT field, the "Wujiang Economic and Technological Development Zone Biomedical Industry Development Forum" hosted by Wujiang Economic and Technological Development Zone and Shanghai Jiao Tong University Health Yangtze River Delta Research Institute, and organized by XinBio, was successfully held on June 16th.

On this occasion, the "Peak Interview" program under eMedClub has specially invited Dr. Chi Shen, co-founder and CTO of XinBio, as well as Dr. Zong Hongliang, CMC Vice President of Neukio Biotherapeutics, and Dr. Tang Wenjie, a researcher at Shanghai Oriental Hospital Translational Medicine Center, to discuss CGT and share their insights on the development of this field from different perspectives.

Chi Shen, co-founder and CTO of XinBio, holds a PhD in genetics from the Technical University of Munich and a postdoctoral fellow in tumor immunology at the Shanghai Academy of Life Sciences. Previously responsible for technical application support, application technology development, and core customer management at Miltenyi Biotec. Later, responsible for antibody drugs and cell gene therapy CDMO business at Thermo Fisher, accumulating profound industry experience.

Digging into pain points, keeping the original intention unchanged

During his studies, Dr. Chi Shen had already formed an inseparable bond with the CGT field. Both during his doctoral studies and postdoctoral experience, he engaged in scientific research related to gene and cell therapy. In his subsequent vocational training and work experience, Dr. Chi Shen had contact with more people dedicated to the CGT field. His profound accumulation and confidence in the industry prompted Dr. Chi Shen to firmly choose the CGT industry.

"I entered the CGT industry relatively early. Cell therapy technology gradually transitioned to commercialization from 2014 to 2017, and then in 2021, China opened the first year of commercialization of cell therapy. I saw a constantly improving industry chain from early research and development to later process transformation and clinical production. In the process of development, whether early difficulties or bottlenecks encountered in the later stage, we can truly feel them from our friends and customers around us. "Dr. Chi Shen said," I think we can help customers solve their problems to a certain extent through education or work experience and accumulation. At this point, I hit it off with other startup partners of XinBio. On the one hand, there is a sense of achievement.  On the other hand, by identifying customer pain points and addressing industry pain points, we can promote industry development to a certain extent, which is also the original intention of our establishment of XinBio."

Automation replaces manual labor, domestication replaces imports

Dr. Chi Shen believes that as a rapidly developing sunrise industry, the pain points of CGT's demand are constantly being exposed. In terms of process, enterprises need to accumulate basic technology, practice, and market feedback in the exploration of process paths, in order to achieve better results. Meanwhile, Dr. Chi Shen gave an example of CAR-T therapy that was approved for market in the early stages, which mostly used CD3 or unsorted PBMCs for subsequent product preparation. However, it was later discovered that unsorted cell therapy products were not conducive to controlling process stability and increased the risk of complications in the later stages. Therefore, it chooses to continuously improve the stability and safety of the product through the optimization of the process route.

From the early laboratory stage to the clinical stage and then to the commercialization stage, there is actually a higher demand for the process. In this case, relying solely on manual operation and step-by-step production will still pose challenges to the stability of subsequent production, and cannot effectively guarantee the quality of products. Currently, European and American countries and enterprises at the forefront of CGT have a higher recognition of automation and integration, and are also developing in this direction. We can learn from some foreign experiences and lessons, so as to avoid detours, "said Dr. Chi Shen.

At present, automation and integration has become a consensus in the entire CGT industry, and it is also an inevitable trend for the continuous improvement of product quality and output demand. But as for the domestic CGT industry, it has another "characteristic", that is, the industrial chain is not perfect, and innovative pharmaceutical companies heavily rely on imported equipment and consumables. However, with the development of domestic CGT, the call for domestic substitution is becoming increasingly louder.

Researcher Tang Wenjie said: "At the earliest, our related equipment was German equipment, but the imported equipment was expensive, and it was relatively troublesome in terms of maintenance and technical support. The exchange process took a long time. Especially after COVID-19, we would prefer to have domestic related equipment and reagents to reduce our research costs and improve efficiency."

"Domestic substitution is a major trend. From a non political perspective, imported equipment and reagents will be affected by logistics, price increases, and other factors, resulting in high research and development costs and long production cycles. For us, the greater risk lies in political factors, especially in the high-tech industry, where we need to prepare in advance. To prepare for this, people in hardware equipment manufacturing, reagents, drug research and development, and even more people in this industry need to work together. "Dr. Zong Hongliang said," I think the gap between us and foreign countries is about 5 years, but this is not absolute. At this stage, domestic substitution still relies more on imitating foreign ideas. The real difficulty lies in how we can develop our own original designs, equipment, materials, etc. based on years of industry experience to achieve true independent innovation, and there is still a long way to go in this regard."

To achieve true independent innovation

Fully automated cell manufacturing system assists in product research and development

On the road to achieving true independent innovation, it will also provide more opportunities and better development prospects for upstream suppliers. Dr. Chi Shen believes that the entire process of domestic substitution can be summarized as "from scratch, from weakness to strength". "Foreign companies have a relatively long development time and high overall recognition. From the perspective of customers, when choosing foreign and domestic brands, they often have strict requirements for domestic brands, including stability, after-sales service, reputation, and other aspects. As a supplier of domestic equipment, our products also face such challenges. Therefore, we need to improve the quality of our products as its the core value. Currently, domestic substitution is gradually emerging from scratch, from weak to strong, and more domestic companies are joining the industry chain. I hope this is a healthy competition, through which we can ensure quality while reducing the price of cell drugs, ultimately benefiting patients."said Dr. Chi Shen.

▲SophCyte^®  Kunlun automated cell manufacturing system

(Source: XinBio)

XinBio adheres to the mission of "using technology to safeguard life and health", and focuses on the integration of research, production, and sales, as well as localization in the CGT field for industrial layout. It has independently developed  SophCyte^®  Kunlun，the first fully automated cell manufacturing system in China. The equipment relies on the principle of cell magnetic sorting, integrating functions such as cleaning, centrifugation, sorting, and cultivation. With fully enclosed pipelines, it can achieve high integration, scale, automation, and domestic substitution in the cell preparation process, ensuring the repeatability of GMP grade cell preparation and effectively reducing the research and production costs of enterprises. At the same time, its intelligent integrated platform system can achieve functions such as remote control, real-time monitoring, and audit tracking, effectively avoiding errors and pollution risks that may occur during manual operation. It can develop customized programs according to different process requirements and provide one-stop services for cell preparation for various experiments.

Previously, XinBio and Neukio Biotherapeutics signed a strategic cooperation agreement. In an interview, Dr. Zong Hongliang stated, "Although XinBio is a relatively new company, they have been deeply involved in the research and development of all-in-one machines for many years. Currently, they are relatively ahead of their peers in China. Neukio Biotherapeutics mainly develops CAR-NK cell therapy derived from iPSC, which is a relatively new field worldwide. The intermediate manufacturing process is a huge challenge. There is no mature process mode and equipment yet, and we need to explore highly customized processes. The automated cell manufacturing system can meet our early research and development needs for iPSC CAR-NK. Although the all-in-one machine is mainly aimed at autologous cell therapy, the universal use of intermediate modules and technologies may be realized in the future. If it can be appropriately modified to meet some special needs during cell differentiation, our process can be fully automated at an earlier stage, bringing more stable quality to the product."

Three major features enhance the first mover advantage

Iterative innovation is the key to achieving stability and long-term success

Meanwhile, Dr. Chi Shen also introduced us the three major characteristic advantages of XinBio. Firstly, at the equipment level, as the first and only enterprise in China to launch fully automated cell manufacturing system,  XinBio's team has accumulated advanced experience, created platform technology, and established a research and development system; At present, XinBio has a complete and industry-leading team in mechanical, electronic, software, materials, and biotechnology, and has established a comprehensive modular technology development platform and a stable process validation platform; This is the advantage and confidence of XinBio in continuously developing new intelligent devices, optimizing preparation processes, and supplying supporting pipeline consumables that far exceed industry standards.

▲ Work scenarios of team members

(Source: XinBio)

Secondly, compared to similar enterprises, XinBio has its own antibody development platform to meet the needs of different types of customers for various products such as cell sorting, analysis, and detection, in order to enhance customer stickiness. At present, XinBio has established three antibody development libraries, including human, rabbit, and mouse sources, and has established antibody screening platforms of phage display technology and yeast display technology. In the future, it will also introduce nanobody development platform technology. The third major feature lies in the core operation team of XinBio, which has rich industry experience and mature business operation thinking, ensuring that the enterprise operates with a relatively mature mindset in the process of development to face industry cycles and market challenges.

Dr. Chi Shen said, "When facing challenges, we mainly start from two aspects: speed and stability. Speed means learning quickly, conducting precise and in-depth analysis, and making predictions based on grasping industry development trends to achieve better advance layout. Stability means ensuring stable and reliable product quality, and steady development. At present, we focus on product research and development, while also continuously enhancing our self generating ability. Currently, we hope to enhance our existing first mover advantage through the unique advantages of XinBio, so that the enterprise can go further."

In addition, when it comes to strategic planning, Dr. Chi Shen introduced, "The focus of future efforts lies in product iteration and innovation. Iteration includes level iteration, from early R&D level to GMP level that can meet industrial production. It can both start from the early stage and meet the commercial needs of customers in the later stage. In terms of product innovation, with the development of the industry, there will be a continuous stream of new pipelines and product types, and R&D enterprises will face new problems that need to be solved. We will seek cooperation with enterprises with innovative pipelines to use our product advantages to solve problems. Whether it is for different types of samples or universal cell therapies, improving automation is what we have been doing."

Together for the future

The development of the CGT industry is very important for the country, society, and the public, and requires a group of ambitious individuals dedicated to promoting the industry to work together and innovate comprehensively from top to bottom. As an upstream supply chain enterprise, XinBio is rooted in the production equipment and consumables field which is relatively weak. It has achieved preliminary results in solving the pain points of CGT development and realizing full automation and localization substitution, providing support for the research and development of innovative drug pipelines. It is believed that in the future, China's CGT industry chain will be more perfect, forming a virtuous cycle and making China's voice heard worldwide.

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