As the CEO and co-founder of the company, Meng Ruifeng graduated from Wenzhou Medical University with a major in Pathogenic Biology, specializing in Immunology. After graduation, he successively founded and served as a co-founder in multiple biopharmaceutical and cell therapy service-oriented companies. Later, he worked at Jiangsu Hillgene Co., Ltd., responsible for CRO&CDMO business in the CGT field, and participated in and facilitated strategic cooperation with multiple well-known pharmaceutical companies.

The business world is like a battlefield. After years of trial and error, Meng Ruifeng and his team deeply understand that cell therapy is revolutionary as a cancer treatment, future sub-health management, and the demand for medical aesthetics. Therefore, they firmly chose the cell therapy industry. Meng Ruifeng has also rooted himself in the supply chain of closed automated cell preparation equipment with his keen business intuition.

In the production of cell therapy drugs, closed automated preparation helps minimize human errors and deviations, making the manufacturing process more controllable and accelerating the commercialization of cell therapy. That's why foreign countries have taken the lead in launching fully enclosed integrated machine equipment that can be used for cell preparation. The domestic market of such products is largely monopolized by imported products.

Meng Ruifeng, General Manager of XinBio, explained to us: "As users of imported equipment, we often face problems such as long delivery times, high prices, and poor flexibility during use. These problems will inevitably become more prominent with the rapid development of the domestic cell therapy industry. Therefore, we have the idea of localizing such products, hoping to solve the above difficulties from the source. So in 2018, we initiated a project and collaborated with overseas returnees from multiple universities to design and develop an integrated cell preparation system."

In just a few years, the R&D team of XinBio has continued to expand, and the product has undergone several iterations. Finally, the fully automated cell preparation system SophCyte^® Kunlun with independent intellectual property rights has been developed and was launched for sale at the end of 2022.

SophCyte^® Kunlun is the first to realize the full process of domestic cell preparation equipment. It can complete one-stop operations from initial sample centrifugation and cleaning, target cell isolation, activation, transduction, amplification, to final product collection in a fully enclosed pipeline system, and can cooperate with quality control and management throughout the entire process. In addition, SophCyte^® Kunlun can also meet customized service needs, achieving different production technology paths while ensuring process stability, which is more conducive to capacity expansion and cost control.

Meng Ruifeng stated that SophCyte^® Kunlun is a bottom level technological innovation product developed by XinBio after extensive rigorous and detailed market research and firsthand experience of customer needs. The purpose is to meet customer needs and effectively solve practical problems.

General Manager Meng Ruifeng explained to us based on actual production that CAR-T cell therapy products often require the collection of patients' own T cells as raw materials, which are then transformed and expanded in vitro before being reinfused back into the body. However, due to factors such as the frequency of radiotherapy and chemotherapy, patient age, etc., there are differences in the amount of T cells collected from patients, and sometimes the available amount for some patients cannot meet the implementation needs of CAR-T therapy. SophCyte^® Kunlun can handle these application scenarios with greater ease.

"The minimum sample size of SophCyte^® Kunlun can meet a wider range of requirements for cell loading. For example, in clinical applications, the required blood collection volume for CAR-T therapy in children may sometimes not reach the minimum sample volume of imported machines. In this situation, the sample size of SophCyte^® Kunlun can meet the requirement of loading fewer cells."

"In addition, the current representative cell therapies in China are mostly CAR-T cell therapies used for tumor treatment. In addition to T cells, cell therapy also involves cells such as TILs, NK cells, and mesenchymal stem cells (MSCs) in the field of regenerative medicine. For diversified customer needs, XinBio has also reflected them in its products(Prodigy already has relevant programs for NK/TEL/MSC/DC, etc.). At the initial stage of design, the R&D team of XinBio had already considered this issue and therefore built a preparation program for multiple immune cells into the basic version of SophCyte^® Kunlun."

02 The iteration of production tools is a prerequisite for technological innovation

When it comes to the key issues of industry development and enterprise development, Meng Ruifeng also believes that in the development of the cell therapy industry, "self" to "universal" and "in vitro modification" to "in vivo modification" are the two major directions of development. Among them, the preparation of universal cell therapy is more suitable for large-scale fully automated production compared to autologous therapy. Its characteristic of single batch mass production can further diminish the production cost, thereby reducing the final pricing of the product after it is launched. XinBio since then has determined the future iteration direction of the product.

"At present, there are roughly two directions for our product upgrade. One is to increase the cell flux of the product. According to SophCyte^® Kunlun's current cell culture volume, taking T cell products as an example, the final yield is about 5x10⁹ T cells, which can meet the transfusion needs of autologous cell therapy patients without pressure. However, for universal products, we are striving to expand the culture volume to 5-10 liters or even larger. Currently, we have also collaborated with leading enterprises for joint research and development."

"Secondly, due to the widespread application of stem cells nowadays, research directions related to CAR-T and CAR-NK developed based on stem cells are also very hot. Based on this, we will develop a platform suitable for stem cell culture. In addition, XinBio is currently establishing cooperation with universities and enterprises in the fields of microcarriers and membrane loading technology to jointly develop."

It is reported that currently, in addition to the SophCyte^® Kunlun fully automated cell manufacturing system, XinBio has launched multiple reagents and consumables products for cell separation, cell amplification, and cell storage, which have received good customer feedback.

Multiple technology platforms are currently being built to further increase XinBio's product coverage of the cell therapy process.

In addition to tracking industrial development, the market environment is also a strategic observation perspective for the upstream supply side of the pharmaceutical market. From the beginning of 2022 to the present, news related to the "capital winter" has been frequent, reflecting the infiltration and spread of panic in the frontline financing environment from offline to online.

"The 'capital winter' does exist, and from a series of black swan events derived from the epidemic to changes in geopolitical conditions, it can be seen that there is a certain degree of uncertainty in future development. However, we always adhere to a simple viewpoint that as ordinary people, the treatment of diseases is an eternal need. Especially in cancer treatment, the currently commercialized antibody PD-1/PD-L1 only meets a small part of the demand, and the remaining large proportion of patients still need other treatment options."

"According to the published clinical data on cell therapy in cancer treatment, the objective response rate (ORR) of many cell drugs exceeds 80% or even 95%, Carvykti of Legend even can reach 100%. If the product can truly solve patients' problems, then it will naturally generate strong demand. Therefore, we conclude that cell therapy, as a revolutionary therapeutic approach, is bound to have a long-term growth trend in its industrial development." Meng Ruifeng said.

03 Our journey is the constellations and beyond

From project proposal in 2018 to tproduct release in 2022, looking back on the progress of the entire project, Meng Ruifeng is filled with emotion.

"We have been promoting the all-in-one machine project since 2018. In 2019, Shanghai JiaoTong University established the Healthy Yangtze River Delta Research Institute, and the establishment process of the institute also received support from four vice national leaders. The all-in-one machine project became one of the industrial incubation projects of the institute that year."

"So, we joined forces with the Health Yangtze River Delta Research Institute and Shanghai JiaoTong University to start the project promotion. At first, research and development were carried out in the laboratory of Jiaotong University. After making certain progress, in 2020, XinBio cooperated with Shanghai Tongren Hospital and received support from the Changning District Health Commission and Science and Technology Commission as a major project, which was also the top one major project of that year."

"Later we considered the need for large-scale production of equipment that requires a larger site for testing. After inspecting numerous industrial parks across the country, we believed that Wujiang District in Jiangsu Province is a relatively suitable location. In February 2021, our project was introduced into Wujiang District as a key double recruitment and double introduction project, and has successively won awards for the "Chongben Leading Talents" and "Wujiang Leading Talents" projects. We have established factories and offices that meet the qualifications for Class I medical device production, with a total area of nearly 1200 square meters. Currently under construction, there are nearly 3000 square meters of GMP and cleanroom facilities that meet the requirements of Class II and III medical enterprises. The company has also been awarded titles such as "Jiangsu Province Private Technology Enterprise" and "Wujiang District Unicorn Cultivation Enterprise". Recently, we have also received the highest amount of research and development subsidies issued by the local science and technology bureau."

At the end of the interview, General Manager Meng Ruifeng stated, "At the production level, more than 95% of key equipment and raw materials in China come from imports, and prices continue to increase almost every year. In such a market environment, it is almost impossible for companies to reduce costs in production. The ultimate goal of XinBio is to fundamentally help companies reduce production costs. We are confident that we can help pharmaceutical companies reduce more than 50% of their original costs. By reducing the cost of equipment and raw materials through localization, we can comprehensively lower the cost of the entire cell therapy industry, benefit more cell therapy companies, then benefit more patients, and possibly lower the price of cell therapy drugs to less than 500000 yuan, if cell drugs are included in medical insurance negotiations, order volume will further expand, and the cost will be diminished. It will forme a virtuous cycle. So we firmly believe that the future development of the cell therapy industry is very positive and optimistic."

除了SophCyte^TM Kunlun，欣协生物还计划推出哪些产品和业务呢？

“除了SophCyte^TM Kunlun这个高难度的系统集成设备，我们后续会将其中的几个系统进行模块化拆分以满足不同客户的需求。比如离线培养模块、分选模块，灌装模块等。然后是相应配套的管路，来适配一系列的设备。第三类是配套的试剂，比如用于细胞分选的磁珠抗体或是用于FACS或western blot的一些试剂等。

除了全封闭自动化细胞制备一体机以外，我们比较擅长的是抗体靶点的开发。针对有需求的客户，我们提供抗体的靶点开发服务。目前我们建立了三个抗体开发库，包括人源、兔源和鼠源，并建立了噬菌体展示技术和酵母菌展示技术的抗体筛选平台，未来还会引入纳米抗体开发平台技术。”

细胞疗法的产品工艺流程包括细胞分离、细胞改造、细胞扩增、细胞质检、细胞储存等环节。除了全自动细胞制备一体机SophCyte^TM Kunlun，欣协生物其他的产品可应用于哪些环节？

欣协生物始终秉承“为CGT客户提供高品质全流程解决方案”的理念，持续推出满足客户需求的自主创新产品。目前除了SophCyte^TM Kunlun全自动细胞制备系统，我们已有多款应用在细胞分离、细胞扩增和细胞储存环节的试剂和耗材类产品已经推向市场，并取得了良好的客户反馈。同时我们也希望通过正在搭建的多种技术平台，进一步增加欣协生物在细胞治疗工艺流程中的产品覆盖度。

欣协从创办到现在，您认为有挑战的时期是什么阶段？

“19年到20年是我们对于机器进行前期迭代的研发关键时期，不管是物料供应，还是实验测试都十分重要。那时正值疫情上升期，供应链和人员调配面临着极大挑战。但是终，我们全公司所有员工克服种种困难，保质保量地达成了我们的目标。这也是至今为止都让我们感到骄傲的一点。”