CytoNiche Biotech Files IPO Prospectus: Pioneering 3D Cell Scalable 'Smart' Manufacturing Platform

Beijing Huakan Biotechnology Co., Ltd. was founded under the leadership of Professor Du Yanan’s research team from the School of Medicine at Tsinghua University, with Tsinghua University participating as an equity partner in its establishment. The company’s core technologies are derived from the commercialization of scientific and technological achievements at Tsinghua University. Huakan Biotechnology is dedicated to building an original 3D cell manufacturing platform, providing comprehensive solutions for scalable, customized cell expansion processes based on 3D microcarriers.

CytoNest's Core Product: 3D TableTrix^®Microcarriers are an independently developed, first-in-class pharmaceutical excipient-grade microcarriers designed for cell-based drug development. As porous microspheres, their chemical and physical properties are precisely controllable, enabling customized design of the cellular microenvironment tailored to specific cell types. Utilizing specific cleavage technology, they achieve 100% cell harvest. Compliant with GMP requirements, these microcarriers have been tested and certified by authoritative institutions such as the National Institutes for Food and Drug Control (NIFDC). They have obtained both U.S. FDA Drug Master File (DMF) status (DMF#: 35481) and approval from China’s National Medical Products Administration (NMPA) as pharmaceutical excipients (CDE Registration Numbers: F20210000003, F20200000496).

Based on 3D microcarrier cell culture technology, CytoNest has further developed 3D FloTrix^®Large-Scale Fully Automated Cell Manufacturing Process System. This system encompasses automated equipment such as cell culture bioreactors, cell washing and harvesting units, and extracellular vesicle (exosome) collection systems, along with reagents and consumables including stem cell culture media and exosome formulations. It enables a complete closed-loop workflow from cell seeding, expansion, stepwise scale-up, gentle harvesting, washing and concentration, to final formulation and filling, meeting the requirements for large-scale, intelligent, and closed-system production of cell-based therapies, cell-derived products, viruses, and proteins. Compared with traditional manual 2D cell culture, Huakan Biosciences’ 3D Cell Large-Scale Intelligent Manufacturing System helps customers reduce production space by approximately 90%, labor costs by 90%, reagent and consumable usage by 60%, and time costs by 60%.

Huakan Biotech’s products and services are widely applicable to upstream process development for the production of gene and cell therapies, extracellular vesicles, vaccines, and protein-based products. They also hold broad application prospects in the fields of regenerative medicine, organoids, and food technology (such as cultured meat).

In mature segments of the industrial chain, such as vaccines, antibody drugs, and viral production, CellCay Bio’s core products are becoming key raw materials and excipients that break international monopolies and enable industrial optimization and import substitution. Both cell culture capacity and viral yield significantly outperform traditional imported products.

In emerging blue-ocean markets such as gene and cell therapy and regenerative medicine, Huakan Bio’s microcarriers are the world’s first commercialized product with pharmaceutical excipient qualifications that meet the clinical application requirements of the cell therapy field, and its overall solution is globally leading.

To date, Cellverse Biosciences has established a research and translation platform spanning over 5,000 square meters, including a CDMO service platform of more than 1,000 square meters focused on 3D cell intelligent manufacturing and micro-tissue regenerative medicine therapeutic products. The company also operates a 4,000-square-meter GMP production facility and has newly built a 1,200L microcarrier production line. Cellverse Biosciences has served over one hundred leading industry clients in the fields of stem cells, vaccines, gene therapy, and immunotherapy, and has entered into strategic cooperation agreements with numerous medical institutions and research universities.