Catug Bio's Dr. Lin Jin: Building a Technology-Driven CRDMO with Reverse-Output Capability

This year, capacity expansion is no longer the main theme in the CDMO sector. The essential challenge for every company is to stand out in a market characterized by ample capacity and fierce competition.

The market demands large, comprehensive, one-stop CXOs that offer “everything under one roof” to lay the foundation for new infrastructure, while also requiring specialized, niche-focused players that are “small but refined” to provide clients with distinct competitive advantages. This dual approach will help pharmaceutical companies in innovative sectors become top-tier global players and develop best-in-class products.“Small but specialized” also occupies a niche in the industry due to its unique scarcity.

Catug is precisely such a “small yet specialized” CRDMO enterprise,Leveraging its core technical service platforms in high-quality, large-scale plasmid process development and manufacturing, end-to-end mRNA synthesis and delivery process development and manufacturing, as well as nucleic acid analytical methods and quality research, the company provides one-stop, full-chain CRDMO services for gene and cell therapy drugs and nucleic acid therapeutics, covering every stage from product development, quality research, and clinical application to industrialization.

Currently, Catug has established R&D centers and industrialization bases in Suzhou and Wuhan, respectively. Its GMP facility covers an area of over 10,000 square meters, while the R&D center laboratories exceed 2,000 square meters. From building technical platforms and deploying production capacity to establishing operational systems, Catug’s founding team has demonstrated exceptional execution and decision-making capabilities.

Recently,VCBeat’s New Medicine interviewed Dr. Jin Lin, Co-founder of Catug, General Manager of the RNA Division, and Chief Technology Officer, discussing the story behind Catug’s establishment, the differentiation in its strategic layout, and its future strategic planning.

Whether it was the solid foundation of academic research in academia or the accumulation of cutting-edge technical experience in industry, Dr. Jin Lin feels fortunate and grateful for every stage of her journey. In reality, however, behind each successful choice lay her undeniable strength, accumulated expertise, insight, and judgment.

During her undergraduate studies in the Department of Chemical Engineering at Tsinghua University, Jin Lin majored in Chemical Engineering and Industrial Biological Engineering. This interdisciplinary field sparked her strong interest in biological engineering and medical engineering, inspiring her to pursue more in-depth research in these areas. After graduating from Tsinghua, Jin Lin chose to further her education in the United States, where she began her doctoral academic research under the supervision of Nobel laureate Professor Jack Szostak at Harvard Medical School and Boston University. Throughout her scientific career, Jin Lin has gained a profound understanding of RNA. Influenced by Jack, she also maintains a humble and cautious attitude toward all aspects of her work and life.

Given her engineering background and preference for applied technologies, Jin Lin chose not to pursue further academic studies after graduation. Instead, she entered the industry by joining a top-tier international mRNA biotech company to explore the vast application scenarios of innovative technologies. “Although the company I worked for at that time did not yet have a mature product pipeline, it was already a rapidly growing star enterprise, and its mRNA technology platform held immense promise.” Jin Lin collaborated with her team on the development of mRNA and lipid nanoparticle (LNP) delivery vectors, as well as various novel analytical methods, to ensure a smooth transition to the next stage of Chemistry, Manufacturing, and Controls (CMC) development following proof-of-concept for the product pipeline. Her responsibilities included technology transfer, preparation of regulatory submission documents, and the proposal and establishment of quality standards.

 Dr. Jin Lin, Co-founder of Catug, General Manager of the RNA Business Unit, and Chief Technology Officer. Source: Catug

Following the outbreak of the COVID-19 pandemic, Dr. Jin Lin’s company leveraged its previously established technology platform to rapidly complete the R&D of its COVID-19 vaccine and advance it into Chemistry, Manufacturing, and Controls (CMC) development. To swiftly achieve commercial-scale manufacturing capacity and global supply of mRNA vaccines, the company entered into a collaboration agreement with a leading global Contract Development and Manufacturing Organization (CDMO). As a global Subject Matter Expert (SME) in analytical testing, Dr. Jin Lin was deeply involved in the entire process of technology transfer to the CDMO, with primary responsibility for quality control.

During this period, Jin Lin deepened her understanding of the industrialization process for mRNA vaccines and identified a novel business model within it: “Although leading CDMOs with a century-long history boast well-established systems, their response speed and comprehension of emerging technologies have, to some extent, constrained the rapid production of products.At that time, plasmids produced in the United States had to be shipped to Europe for mRNA production and LNP encapsulation, before being transported to another facility for fill-finish operations. At the time, no single CDMO was capable of executing the entire end-to-end manufacturing process at one site.”

“In fact, your raw materials, bulk drug substances, and finished formulations all require testing and release throughout the entire operational process. Moreover, as this involves various regions across Europe and the United States, the time, labor, and transportation costs incurred during this end-to-end supply chain circulation are extremely high. This is also a major reason why the initial production cost of mRNA COVID-19 vaccines was so high,” introduced Jin Lin.

These pain points inspired Jin Lin to conceive the idea of starting a business, aiming to establish a one-stop, full-chain CRDMO to address the challenges of multi-regional, cross-border manufacturing of mRNA vaccines and therapeutics.In her view, the success of mRNA-based COVID-19 vaccines would also signify the maturation of mRNA technology, which holds immense potential and is poised for explosive growth in the future.

After careful consideration, Jin Lin ultimately decided to return to China to start a business, joining Catug as a co-founder. Together with Dr. Wang Xiao and Dr. Ren Keyun, she aims to provide one-stop CRDMO services to biopharmaceutical companies focused on areas such as mRNA.

Compared to traditional CDMO services,Catug aims to provide customers with greater professional value-added services.In Jin Lin’s view, as a platform company for adopting new technologies, Catug can provide valuable support to pharmaceutical clients by helping them accelerate product development and enhance CMC quality, delivering immense benefits to these companies.

And Catug has truly achieved this. “We have not only integrated the entire industry chain—from plasmids to RNA, LNPs, and filling—delivering genuine end-to-end services, but we have also enabled production and regulatory filing for both early-stage R&D and clinical batches. In short, we grow alongside our clients.”

Positioning itself as a specialized and agile CRDMO, Catug demonstrates strong professional focus. Its experienced team continuously drives technological innovation, iteration, and deep expertise, enabling Catug to update and refine its platform technologies in the emerging field of large nucleic acids (such as circular RNA and self-amplifying RNA). This allows the company to provide cutting-edge technical services at an early stage, when clients may struggle to find suitable partners. Furthermore, Catug’s technological innovations help clients achieve further cost reduction and efficiency gains. “We actively research alternatives using domestically produced materials and equipment, engaging in related studies at an early stage. This enables us to offer clients services across different price ranges in later stages.”

Since its establishment,Catug has established a robust, end-to-end technical platform, encompassing mature plasmid development process platforms, RNA development process platforms, multi-pathway delivery encapsulation process platforms, and comprehensive analytical testing and quality research platforms.

On the RNA development and manufacturing platform, differences in application directions lead to variations in the overall production process, including the control of certain impurities. Among these, double-stranded RNA (dsRNA) impurities are difficult to remove; if common methods are employed, they may compromise the integrity of the mRNA. AndCatug has developed a method to effectively remove double-stranded RNA impurities generated during mRNA production, which not only simplifies the purification process but also enhances mRNA integrity.“A foreign biotech company we recently communicated with has also invited us to write an article for its special issue on the removal of double-stranded RNA impurities. Catug has currently filed related patents as well,” introduced Jin Lin.

In addition to its proprietary double-stranded RNA (dsRNA) impurity removal method,Catug has also differentiated itself in maintaining RNA integrity and in LNP delivery vectors.In maintaining RNA integrity, Catug has adopted an upstream approach to exert control at the source, achieving significant results; the ultra-long self-replicating RNA produced by the company has reached a high level of purity within the industry. In terms of LNP delivery systems, Catug Biotechnology offers both the commonly used microfluidic technology platform available on the market and its proprietary, patented Max Mix™ technology platform, effectively addressing the bottlenecks associated with process scale-up.

Catug’s innovations in these technology platforms will deliver tailored solutions for client projects at various stages and with diverse needs, providing customized services throughout the entire lifecycle of innovative drug development.

“Since its establishment, Catug has received extensive market feedback, with many regarding us as a down-to-earth yet decisive and efficient enterprise,” said Jin Lin.

Indeed, the word “fast” is vividly embodied in Catug.

First, team building progressed rapidly. Mr. Duan Chengcai, Vice President of Quality at Catug; Dr. Park Hee-jun, Vice President of RNA Technology; and Dr. Zhang Weicheng, Executive Director of mRNA Analytical Development, were all impressed by Catug’s vision and the sincere attitude of its founding team, prompting them to join quickly. Currently, Catug has rapidly grown from a handful of employees with just a few desks and chairs into a company with over 260 staff members.

Secondly, facility construction is rapid. Catug already operates two R&D centers and industrialization bases in Suzhou and Wuhan, with GMP-compliant manufacturing facilities covering over 10,000 square meters. It has established four plasmid production lines, two RNA drug production lines, and three LNP production lines that meet the GMP requirements of the NMPA, FDA, and EMA, along with two vial aseptic filling lines and one pre-filled syringe filling line. The company is also equipped with quality control laboratories and R&D facilities. These capabilities have laid a solid foundation for Catug’s rapid contract signings.

“As a CRDMO serving small and medium-sized innovative enterprises, our team is relatively young, and we did not have extensive prior experience working as a service provider, so it was inevitable that skepticism would arise in the market,” said Jin Lin. “However, by letting our real-world data and team capabilities speak for themselves, we have earned the trust and strong reputation of many clients.”

Nowadays, Catug has partnered with over 60 clients, achieving a reorder rate of more than 50%.The company has maintained long-term customer stickiness, validating Catug’s “reverse output” capability.In the future, Catug will continue to drive technological innovation, helping customers accelerate the entire product production cycle.

Catug’s Billboard at the Highway Exit, Source: Catug

Not long ago, at the junction of the Shanghai-Changzhou Expressway and the Suzhou Chefang Expressway exit, Catug erected its own billboard, hoping that its brand would be seen and trusted by more industry professionals. They will continue to race forward and grow on the highway they have built for themselves.