CytoNiche Biotech Secures Tens of Millions in Series A+ Financing to Accelerate 3D Scalable 'Smart Manufacturing' Platform for Cell Therapies

VCBeat (WeChat: vcbeat) learned at the earliest opportunity that CytoNiche announced today the completion ofTens of millions of RMBA+Series Equity Financing Round: Led by 3E Bioventures, with Continued Additional Investment from an International Industrial Group as an Existing Investor. CytoNiche stated that the proceeds from this round will continue to be used for the large-scale production of various types of cell-based therapies.Upgrading the R&D platform for “intelligent manufacturing” process systems, developing full-chain new products for 3D cell microcarrier reagents, consumables, and process equipment, and expanding into international markets.

Beijing Huakan Biotechnology Co., Ltd. (CytoNiche) is an innovative company specializing in the development of scalable cell manufacturing processes and products, providing industrial-scale culture and preparation solutions based on 3D cell microcarrier technology for cell therapy developers. Founded in 2018 by a research team from Tsinghua University, the company’s core technologies stem from the commercialization of Tsinghua University’s scientific achievements. Its flagship product line, 3D FloTrix® cell microcarriers, represents the world’s first comprehensive solution for the industrial-scale expansion of stem cells, as well as a globally innovative, injectable excipient capable of delivering stem cells. The 3D FloTrix® products have passed quality and safety evaluations by the National Institutes for Food and Drug Control (NIFDC) and have been filed with the U.S. FDA as a Drug Master File (DMF No. 35481) for pharmaceutical excipients, making it the only microcarrier product listed in the FDA’s publicly available DMF database. Additionally, the product has obtained two pharmaceutical excipient registrations from China’s National Medical Products Administration (NMPA), with registration numbers F20200000496 and F20210000003.

CytoNiche 3D Microcarrier Products: Relevant Qualifications and Inspection Reports from Authoritative Institutions

CytoNiche’s “Gelatin Microcarriers for Cell Culture” are classified under Category IV of the FDA Drug Master File (DMF): Pharmaceutical Excipients. This filing indicates that the “Gelatin Microcarriers for Cell Culture”It can not only serve as a starting material for the production of cell-based drugs, but also be formulated with cell therapy products for regenerative medicine.CytoNiche’s “Gelatin Microcarriers for Cell Culture” streamline the product registration process for cell manufacturing and regenerative therapy companies. The FDA’s drug registration and licensing system requires that registration submissions include technical details on raw materials, excipients, and starting materials used in the production process. Therefore, cell manufacturing or regenerative therapy companies using products with Drug Master File (DMF) filings can directly reference the existing DMF documentation during drug applications, thereby avoiding cumbersome procedures and significantly reducing submission costs.

3D FloTrix® Cell Expansion Kit

The global stem cell market encompasses upstream stem cell storage, midstream research and development along with large-scale manufacturing, and downstream clinical applications. According to a report by Transparency Market Research, the global stem cell market size is projected to reach $270.5 billion by the end of 2025, with a compound annual growth rate (CAGR) of 13.8% anticipated over the past eight years. Currently, more than ten stem cell products have been approved for marketing internationally. To date, China has accepted 19 investigational new drug (IND) applications for stem cell therapies, and 14 stem cell drug candidates have received implicit approval to enter clinical trials, currently undergoing Phase I or Phase II studies. However, whether for stem cell products marketed abroad or those used in clinical trials or research within China, production processes largely rely on traditional two-dimensional (2D) manual culture. This 2D culture method suffers from inherent limitations, such as the inability to authentically simulate the three-dimensional (3D) growth environment of cells in vivo, as well as objective challenges including high labor costs, substantial space requirements, limited batch production capacity, and inconsistent quality between batches. Consequently, these methods fail to meet the demands for standardization, cell quality, and quantity required for clinical translation of stem cells, thereby severely constraining the development of the novel stem cell therapeutics industry.

Improving the quantity and quality of stem cells to meet the practical demands of clinical applications for stem cell-based therapeutic products represents a major challenge facing post-IND clinical translation. To address this, selecting an appropriate large-scale culture and manufacturing process for cell-based drugs is a critical solution, with the choice of microcarriers being a key variable in the expansion and cultivation of stem cells.

CytoNiche’s independently developed 3D FloTrix automated expansion process technology is specifically designed for large-scale production of cell-based therapeutics, providing a systematic and comprehensive solution. The 3D FloTrix cell expansion process leverages the core patented product, the 3D FloTrix Cell Expansion Kit (comprising 3D TableTrix cell microcarriers and 3D FloTrix Digest lysis buffer), along with CytoNiche’s proprietary 3D FloTrix bioreactor, to achieve large-scale expansion culture of adherent cells. Compared to traditional manual 2D cell culture, this approach saves approximately 90% in space, 90% in labor, 60% in reagents and consumables, and 60% in time costs, thereby enabling customized, scalable, and intelligent cell production.

CytoNiche 3D FloTrix® Series Products

CytoNiche currently operates a 1,000-square-meter R&D center and a 2,000-square-meter GMP manufacturing platform. Its proprietary technologies have secured over 50 patents and been featured in more than 30 international journal articles. The company’s core technology projects have received multiple national-level grants and support, including funding from the National Key R&D Program of China and the Zhongguancun Disruptive Technology R&D and Achievement Commercialization Project. CytoNiche has completed nearly RMB 100 million in financing, with investment from prominent domestic venture capital firms and international industrial groups. Furthermore, the company has entered into strategic cooperation agreements with multiple cell therapy IND holders and new drug application enterprises.Among them, several cell therapy developers have leveraged CytoNiche’s “intelligent manufacturing” process for scalable 3D cell production to conduct review and testing by the National Institutes for Food and Drug Control (NIFDC) and submit Investigational New Drug (IND) applications., jointly promoting the industrialization of novel cell therapy drugs.

Professor Ya-Nan Du, Co-founder & Chief Scientist of CytoNicheIt stated: “After more than two years of rapid growth, the CytoNiche team, emerging from Tsinghua University’s campus, has achieved a series of milestone accomplishments with strong support from all parties. It now possesses the qualifications and capabilities to serve and upgrade the domestic and international cell therapy and regenerative medicine industries. Moving forward, we will continue to forge ahead with determination and unceasing innovation, striving to contribute to the health of all humanity through original Chinese technologies.””

Dr. Liu Wei, Co-founder & CEO of CytoNicheHe stated, “Over the past two years since its establishment, through the concerted efforts of our team, we have rapidly completed the critical step of translating relevant technologies from Tsinghua University into market-oriented industrialization. We have received strong support from market capital and gained high recognition from experts and scholars across academia, industry, and research institutions. Recently, our core products have successively obtained qualification as pharmaceutical excipients from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA). As a result, we have become the only microcarrier product listed in the Drug Master File (DMF) database publicly disclosed on the FDA’s official website, and also the first cell-culture microcarrier product in China to receive pharmaceutical excipient qualification. The approval of these qualifications will accelerate the global promotion and application of our company’s large-scale manufacturing processes for cell-based therapies. In the next stage, the company will focus on developing new products across the entire value chain, promoting the global application of our core products and manufacturing processes, and advancing R&D of novel drugs based on cellular microtissues. Our goal is to develop original Chinese innovations with world-leading core technologies and products, thereby fostering the vigorous growth of the global cell therapy industry.””

Dr. Fang Yu, Partner at 3E Bioventures, as the lead investor in this roundstated: “We highly value CytoNiche’s application of its microcarrier technology products, designed and developed through years of accumulated expertise in micro- and nanofabrication, to the field of cell culture. By leveraging IT/BT cross-disciplinary innovation, the company has built a globally innovative 3D suspension stem cell culture technology platform. This platform not only ensures stability in cell culture but also significantly enhances production efficiency and reduces production costs, thereby addressing the bottleneck in large-scale stem cell manufacturing. This aligns with 3E Bioventures’ investment strategy across the cell culture, cell analysis, and cell therapy industry chain.””

3E Bioventures is a specialized fund dedicated to investing in globally leading life sciences and healthcare companies, with a focus on two key investment areas: innovative pharmaceuticals, and cross-disciplinary innovative medical devices and diagnostic technologies. The core founding team consists entirely of PhD holders in biomedical sciences from overseas institutions, boasting years of practical experience in the pharmaceutical and biotechnology industries, as well as over a decade of successful investment and entrepreneurial experience both domestically and internationally. The team combines professional expertise, industry experience, and a global perspective.

3E Bioventures is a dual-currency fund manager operating in both RMB and USD. It has cumulatively invested in and incubated more than 50 medical innovation enterprises domestically and internationally, with offices in Beijing, Shanghai, and Silicon Valley. Upholding the vision of “building great healthcare companies and establishing an internationally recognized professional investment brand,” 3E Bioventures empowers outstanding entrepreneurial teams and delivers superior performance returns to its investors.