Viva Biotech Completes Nearly RMB 300 Million Series B Funding Round to Accelerate Industrialization of 3D Cell "Smart Manufacturing"

Beijing Huaxan Biotechnology (hereinafter "Huaxan Bio"), a company focused on innovative 3D cell technology, recently announced the completion of a nearly RMB 300 million Series B funding round. The round was co-led by Gaorong Ventures, CICC Capital's CICC Qide Fund, and CICC Qiyuan National Emerging Industry Venture Capital Guidance Fund, with follow-on investments from both new and existing shareholders including China Sinovac and China National Biotec Group.

The proceeds will be used for R&D upgrades, expanding production capacity for core products, diversifying the product portfolio and intelligent total solutions, and expanding international business and CDMO services.

Developing the First Pharmaceutical Excipient-Grade Microcarrier for Cell Drug Development

Huaxan Bio was founded in 2018 by the research team of Professor Yanan Du from Tsinghua University School of Medicine. The company focuses on building an original 3D cell "intelligent manufacturing" platform, providing total solutions for scalable, customized cell expansion processes based on 3D microcarriers to address pain points in the global cell industry.

As biopharmaceuticals enter the CGT (cell and gene therapy) era, cell drugs represent the third revolution in pharmaceuticals, following small-molecule drugs and protein/nucleic acid drugs. Meanwhile, the industry faces entirely new requirements for large-scale cell manufacturing processes.

Huaxan Bio's core product, 3D TableTrix® Microcarrier Tablets, is an independently innovated, first-of-its-kind pharmaceutical excipient-grade microcarrier for cell drug development. As a porous microsphere, its chemical and physical properties are precisely controllable, enabling customized design of the cellular microenvironment based on cell type; through specific lysis technology, it achieves 100% cell harvest; it meets GMP requirements, holds inspection reports from authoritative agencies including the National Institutes for Food and Drug Control, and has obtained US FDA DMF and China NMPA pharmaceutical excipient qualifications (DMF#: 35481; CDE approval registration numbers: F20210000003, F20210000496).

Building on 3D microcarrier cell culture technology, Huaxan Bio has further developed the 3D FloTrix® large-scale fully automated cell preparation process system. This encompasses automated equipment including cell culture bioreactors, cell washing and harvesting systems, and extracellular vesicle enrichment systems, as well as reagent consumables including stem cell culture media and extracellular vesicle preparations. It completes the entire workflow from cell inoculation, expansion, scale-up, gentle harvesting, washing and concentration to formulation filling, meeting the requirements for fully enclosed, scalable, and intelligent production of cell drugs, cell derivatives, viruses, and proteins. Compared to traditional manual 2D cell culture, Huaxan Bio's 3D cell scale-up "intelligent manufacturing" system can help customers save approximately 90% of production space, 90% of labor, 60% of reagent consumables, and 60% of time costs.

Widely Applied in Gene and Cell Therapy, Vaccines, and Other Fields

Huaxan Bio's products and services can be widely applied in upstream process development for gene and cell therapy, extracellular vesicles, vaccines, and protein products. They also have broad application prospects in regenerative medicine, organoids, and food technology (cell-cultured meat, etc.).

Among these, in more mature industry chains such as vaccines, antibody drugs, and virus production, Huaxan Bio's core products are becoming key raw materials that break international monopolies and enable industrial optimization and upgrading, with both cell culture yields and virus production significantly outperforming traditional imported products.

In emerging blue-ocean markets such as gene and cell therapy and regenerative medicine, Huaxan Bio's microcarrier is the world's first commercial product with pharmaceutical excipient qualifications that meets clinical application requirements in the cell therapy field, with its total solution maintaining a globally leading position.

To date, Huaxan Bio has served over a hundred industry-leading customers in stem cells, vaccines, gene therapy, and immunotherapy, and has reached strategic cooperation agreements with multiple medical institutions and research universities. In early 2022, the company's GMP production platform was expanded to 4,000 square meters, with a new 1,200L microcarrier production line; the R&D and translation platform was expanded to 5,000 square meters, including a CDMO platform of over 1,000 square meters.

Building the "3D Cell Intelligent Manufacturing Factory," Advancing the Cell Industry Toward Industry 4.0

Yanan Du, Chief Scientist of Huaxan Bio and professor at Tsinghua University, stated, "The global cell industry is at a pivotal moment. We thank our new and existing shareholders for helping Huaxan Bio accelerate toward our vision of building a modern '3D cell intelligent manufacturing factory.' We will live up to the opportunities of our era and the strong support from all parties."

Liu Wei, Co-founder and CEO of Huaxan Bio, said, "At this critical juncture where Huaxan Bio's core technologies are achieving market commercialization, we thank our new and existing shareholders for their support and recognition. We see that the global cell industry's industrialization today is facing challenges in cell preparation scalability, cost, and uniformity. Huaxan Bio looks forward to seizing industry opportunities, continuously developing globally leading original Chinese products, solving practical industry problems, striving to become a core enterprise in the supply chain for cell drug industry and derivative biological products production, and actively promoting intelligent manufacturing upgrades in the cell industry."

Regarding future development goals, Liu Wei noted, "After achieving scalable, customized cell culture, the next goal is true automation, intelligence, and even unmanned operation in the production preparation process. In the future, we hope to combine advanced AI, big data, and industrial automation technologies with industry partners to jointly advance the cell industry into the Industry 4.0 era."

Yang Kun, Partner at Gaorong Ventures, stated, "Developing the cell industry is no longer a multiple-choice question today, but a must-answer question. As a leader in upstream cell industry manufacturing, Huaxan Bio, based on its core technology moat, full-process solution capabilities, and deep understanding of market demand, is bringing entirely new high-quality solutions to innovative vaccines, novel cell and gene therapies, and also pushing 3D cell culture science continuously forward. We look forward to Huaxan Bio's products and technologies being applied in more life science fields and more markets globally, providing the industry with premium cellular 'soil.'"