Applied Cell Bioscience Files IPO Prospectus: A Leading Chinese Supplier of Clinical-Grade Cell Culture Products Serving Over 200 Cell Therapy Companies
Dr. Yu Guangju, a participant in the Fosun Star Future Entrepreneurship Camp and founder of Applied Cell (Ezesis Bio), has focused his academic and professional journey on stem cell research since his graduate studies at Fudan University. His subsequent establishment of Applied Cell has remained centered on the production and supply of cell culture products. In Dr. Yu’s own words, “My work in the cell field has been ‘consistent and continuous.’ From my early research in cell biology to founding a company for the industrial-scale production of cell-based products, there has been no significant shift in direction.”
It is precisely this dedication to translating scientific research into industrial applications that has equipped Applied Cell with extensive experience and expertise in the field of cell product manufacturing. Applied Cell, officially known as Shanghai Applied Cell Biotechnology Co., Ltd., was established in 2018. Its founding team previously founded iMedCell and completed its angel financing round. Due to business development needs, the team reorganized and established Applied Cell.
Dr. Guangju Yu, Founder of Ezeth Bio
As evidenced by the two English names assigned to the company by Dr. Yu Guangju’s team, its strategic positioning has consistently centered on cells. AizeSi Biotech is a supplier dedicated to the research, development, and manufacturing of clinical-grade cell culture products. Its current product portfolio encompasses key areas in stem cell and immune cell therapies, including expansion, cryopreservation, and isolation.
According to information disclosed on the official website of Ezeth Bio, the company currently supplies approximately 40 cell-related products. Ezeth Bio implements rigorous screening of raw materials and strict production controls for all its products to ensure standardization and consistency. All products have obtained ISO 9001:2015 Quality Management System certification. Multiple products have secured Class I medical device certification, filed with China’s Center for Drug Evaluation (CDE), and listed with the U.S. FDA Drug Master File (DMF). Additionally, one product is currently undergoing application for U.S. FDA 510(k) clearance.
Dr. Yu Guangju stated, “In the early stages of the entire biopharmaceutical industry, imported brands dominated the market. This was particularly true in the cell therapy sector, where I operate, with imported brands accounting for over 90% of the market share. At Aizesi Biologics, our mission is to enter the cell therapy market and drive import substitution by establishing a leading domestic brand for Chinese cell-based products.”
Faced with the advantages of imported products, how can Ezes Bio enter the market and achieve import substitution? Dr. Yu Guangju addressed this question, stating, “For domestic brands, ‘cost advantage’ is an inevitable consideration.” Dr. Yu revealed that cell-based products developed and manufactured by Ezes Bio can reduce costs by approximately 40%–60%.
"As a raw material supplier, the second step for Ezis Bio is to assist cell therapy companies with compliance and support their regulatory filings. 'Because our entire production process strictly adheres to compliance standards, whereas for imported brands, joint filings face certain difficulties due to the absence of domestic manufacturing facilities and subsequent audit requirements,' explained Dr. Yu Guangju. This is one of the advantages of Applied Cell’s domestic brand."
On the other hand, Ezeth Bio is more focused on technological research. Dr. Yu Guangju, the company’s founder, began his research on the regulation of cell signaling pathways as early as 2010. By 2013, he had already accumulated substantial data to master strategies for cellular regulation. Dr. Yu stated candidly that the Ezeth Bio team can achieve any desired cellular state or direct the differentiation of cells according to user requirements.
Built on a foundation of robust core capabilities, Ezeth Bio is able to provide customers with more customized products. Dr. Yu Guangju also mentioned a Japanese cell therapy company with which he collaborates. This company was engaged in the research, development, and regulatory filing of a certain class of cell-based drugs; however, in terms of clinical translation, no CRO had previously been able to meet their specific needs. It was not until they connected with Ezeth Bio that this gap was filled. Following discussions, Ezeth Bio doubled the yield of the company’s target product (effectively reducing costs by half) and can support both parties in submitting drug applications in Japan.
In addition to providing cell separation, culture, and cryopreservation products at the cell therapy grade, Eze Bioscience also offers CRO services for production technology development and CDMO services for cell therapies to cell therapy companies. It is committed to empowering downstream cell therapy enterprises with end-to-end support, ranging from clinical trials and compliance audits to production optimization.
Ezeth Bio's End-to-End Services
“Helping clients customize cell culture and optimize cell culture processes is the core business of Ezesis Bio,” listed Dr. Yu Guangju. “We can apply our self-developed culture systems to induce or maintain cells in a specific state, thereby achieving optimal therapeutic effects for different indications. The optimization of early-stage cell culture processes is critical to subsequent clinical applications and overall production of corporate cellular drugs.”
The challenges involved extend beyond the fact that industrial-grade cell culture products face higher barriers than low-threshold research-grade ones; another significant technical hurdle is the need for cell-specific optimization. “When we help clients optimize their cell culture processes, we not only ensure increased yield but also achieve targeted improvements in cellular functionality,” cited Dr. Yu Guangju. “Taking stem cell therapeutics as an example, we must regulate the secretory functions of cells to ensure they exert their therapeutic effects against diseases. In some cases, we even need to facilitate cellular function from the perspective of cell differentiation.”
In addition to cost and technological advantages, Ezesis Bio has another noteworthy strength: regulatory compliance. Cell therapies must inevitably proceed through the drug application process, which requires traceability and control of all raw materials used in the drug product. For most R&D companies, developing a standalone production system entails prohibitively high costs. From a cost-control perspective, partnering with Ezesis Bio enables companies to circumvent these compliance challenges by directly leveraging Ezesis Bio’s culture systems for manufacturing.
It is reported that Ezeth Biotech has partnered with over 200 downstream cell therapy companies, six of which are jointly filing Investigational New Drug (IND) applications for Class I novel cell therapies with Ezeth Biotech. The company’s cell culture product portfolio spans general cell preparations, stem cells, immune cells, fibroblasts, and various cell lines. After purchasing these products, clients can independently complete more than half of the operational procedures, ensuring ease of use and regulatory compliance.
In August 2020, Eze Bioscience’s newest production base is scheduled to be completed, positioning the company to potentially become the first supplier in China to produce cell therapy raw materials in compliance with active pharmaceutical ingredient (API) standards. It is reported that Eze Bioscience is currently undergoing a new round of financing, with participation from industry-focused funds, and positive developments are expected in the near future.
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