YinaBio Files IPO Prospectus: A Leading CDMO in Continuous Perfusion with Antibody Titers Exceeding 5g/L
It has been exactly two years since Hangzhou Just Biotherapeutics and Mabwell merged to establish Transcenta Holding. Hangzhou Just Biotherapeutics specializes in process development and accelerated manufacturing of biopharmaceuticals, while Mabwell focuses on early-stage R&D and pipeline building for biopharmaceuticals. The two companies leveraged their complementary strengths to form Transcenta Holding through this strategic merger.
However, the merger with Mabwell has not affected the growth of Hangzhou Just Biotherapeutics’ independent CDMO business. Dr. Yang Xiaoming, General Manager of Hangzhou Just Biotherapeutics, further emphasized that the company remains focused on the R&D of antibody and recombinant protein-based biologics, providing pharmaceutical companies with comprehensive CDMO services—including cell line development, process development, analytical and formulation development, quality standards, stability studies, preclinical and clinical sample production, and commercial manufacturing—while safeguarding each client’s intellectual property rights.
Dr. Yang Xiaoming, General Manager of Just Biotherapeutics
Just Biotherapeutics was established in 2016. Its initial strategic choice to focus on drug manufacturing process development via a License-in model, rather than pursuing novel drug R&D, may be attributed to the professional backgrounds of its core founding team. Dr. Yang Xiaoming, who holds a Ph.D. from Rutgers University, has held key positions at several renowned biopharmaceutical companies and institutions in the United States, including Merck & Co., Johns Hopkins School of Medicine, Allergan Biologics, and Amgen. He also founded and managed Dongzhuming Bioengineering Company. Throughout his career, he has led or participated in the clinical-stage development and commercialization of more than ten large-molecule drug products, accumulating nearly 30 years of industry experience in manufacturing, process development, and startup management.
Dr. Ye Feng and Dr. Huang Guangcheng, the other two core leaders of Just Biotherapeutics, are both experts in the fields of biopharmaceutical manufacturing and quality. Dr. Ye previously worked at international pharmaceutical companies such as Schering-Plough, GlaxoSmithKline, and Amgen, supporting drug development and manufacturing, and has 20 years of experience in drug product management, quality systems, and supply chain. Prior to joining Just Biotherapeutics, Dr. Huang spent more than twenty years at Genzyme and Sanofi, accumulating extensive experience in product process development, technology transfer, GMP manufacturing, and regulatory support.
To date, approximately one hundred large-molecule drugs have been launched globally, all demonstrating absolute competitive advantages in efficacy. However, their penetration in developing countries remains low, as few patients can afford the prohibitive costs of these medications.
“The original mission behind the establishment of Just Biotherapeutics was to make biologic drugs affordable for patients worldwide,” remarked Yang Xiaoming. “We have observed that while certain high-end biologics have been available in Europe and the United States for several years, they remain unaffordable for most people in China and developing countries. The underlying reason is the excessively high cost of drug production. Therefore, we are eager to leverage our technological advantages to manufacture biologic drugs that are accessible even to populations in low-income nations.”
How to Reduce Drug Production Costs? Yang Xiaoming Mentioned Two Key Factors:Continuous, Automated。
“In the past, drug prices could be set very high, so pharmaceutical companies did not place as much emphasis on the efficiency of production and development processes. However, over the past decade, cost and efficiency have become major challenges in the commercialization of new drugs, prompting the industry to seek new technological platforms for process development. Biopharmaceutical manufacturing has also begun to move toward automation and continuous processing,” said Yang Xiaoming.
Just Biotherapeutics was founded to meet the pharmaceutical industry’s need for continuous and automated new drug development. Yang Xiaoming revealed to VCBeat that, as the company has achieved mastery in process development over the past few years,It is now possible to produce 5 grams of antibody per liter of raw material per day, achieving a yield 10–20 times that of traditional processes and reducing production costs to one-fifth of the original level., reaching the international advanced level of CDMO process development.
As China intensifies its efforts in innovative drug R&D, the pharmaceutical market requiring CDMO services is poised to expand accordingly. Since completing its first GMP manufacturing batch in July 2018, the company has achieved several key milestones. In October of the same year, it commenced delivery of its first batch of clinical samples. Subsequently, it successfully completed an international intellectual property protection audit, filed Investigational New Drug (IND) applications in both China and the United States for projects under its development, and achieved successful GMP manufacturing using continuous flow technology.
Innovative drug R&D is gaining momentum both domestically and internationally, with increasing attention being paid to Chemistry, Manufacturing, and Controls (CMC) studies for innovative drugs. CMC information in an Investigational New Drug (IND) application generally includes details on the drug substance, formulation composition, manufacturing processes, stability and production control, placebo information, outer labeling of the drug product, and environmental assessment data. The purpose is to fully demonstrate that the manufacturer can consistently produce and provide test samples with stable and uniform quality.
Just Biotherapeutics is committed to providing high-quality, reliable, and efficient services to every client and for each CMC project. The company’s CDMO services comprehensively cover the entire lifecycle of new drug development, from cell line construction to commercial clinical manufacturing, including developability assessment, antibody sample preparation, process development, pilot-scale production, GMP manufacturing, late-stage development, innovative technologies, quality control, analytical testing, regulatory support, and project management.
Just Biotherapeutics'Drugability Assessment PlatformWe offer a range of services, including protein structure characterization, stability prediction, and forced degradation studies, tailored to clients with needs in drug discovery and early-stage biologic development. The company’s early-stage antibody sample preparation can be rapidly completed using high-yield stable cell pools, enabling the production of gram-level antibody proteins from transfection in approximately six weeks.
Just Biotherapeutics'Pilot Plant WorkshopWe can provide large-scale production of protein materials (up to 1,000 grams) for additional formulation studies, viral clearance studies, toxicology studies, and more. The pilot plant is capable of performing fed-batch or perfusion culture processes.
In addition, Hangzhou Just Biotherapeutics has introduced a Bosch fully automated filling production line, providing GMP-compliant sterile filling services with a capacity of 100,000 units per batch.
Cell Line Development Process
AtCell Bank EstablishmentIn this regard, Hangzhou Just Biotherapeutics, LTD. can provide customized services according to customer needs, efficiently establishing Master Cell Banks (MCB) and Working Cell Banks (WCB). The company is capable of establishing two batches of cell banks per month, with each batch comprising more than 200 cryovials. It possesses cell culture and bulk drug substance production lines with scales ranging from 50L to 2000L, and has established a comprehensive GMP quality system.
To date, Hangzhou Just Biotherapeutics has successfully delivered over 30 GMP batches of products and completed more than 20 projects, many of which have been utilized in clinical trials in both China and the United States. Leveraging the company’s science-based and robust development platform, perfusion process development can be conducted rapidly and efficiently, minimizing the need for scale-up from pilot toxicology study batches to GMP manufacturing. This approach ensures consistent product quality and facilitates rapid entry into clinical and commercial production.
As a CDMO, it is not enough to have strong business capabilities. Dr. Yang Xiaoming also mentioned that the company needs a stable and complete core team, a quality system that aligns with long-term development in both China and the United States, technical expertise that surpasses competitors while achieving greater efficiency. Additionally, significant investment is required to expand the company’s scale, enabling continuous expansion of production lines and other capabilities in response to customer demands.
Guided by this theory, Hangzhou Just Biotherapeutics has gradually gained market recognition, with its operational volume surpassing the 100 million mark in 2020. The company plans to further expand production capacity in 2021 by establishing a R&D base twice the size of its existing facility, positioning itself as a high-quality, high-efficiency branded CDMO.