Cytoniche's 3D Microcarrier Tablet Secures World’s First FDA/DMF Type IV Excipient Qualification

On April 15, 2021, according to the public disclosure on the official website of the U.S. FDA (https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs),CytoNiche（CYTONICHE）The World's FirstFor the Production and Preparation of Cell-Based Therapeutics and Regenerative Medicine Applications“Gelatin Microcarriers for Cell Culture”(GELATIN MICROSPHERE TABLET FOR CELLS, STERILE, EXCIPIENT) CompletedDMF Filing for Pharmaceutical Excipients (DMF: 35481), and it is also the only microcarrier product listed in the DMF filings published on the official website of the U.S. FDA.

List No.: DMF35481

Name: Gelatin Microcarrier Tablets for Cells (Sterile, Excipient)

DMF Type: Type IV (Pharmaceutical Excipients)

CytoNiche’s “Gelatin Microcarriers for Cell Culture” is classified under Category IV of the Drug Master File (DMF): Pharmaceutical Excipients. This filing indicates that the “Gelatin Microcarriers for Cell Culture”It can serve not only as a starting material for the manufacturing of cell-based therapies, 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, starting materials, and other components used in the manufacturing process. Therefore, cell manufacturing or regenerative therapy companies that utilize products with Drug Master File (DMF) filings can directly reference these existing DMF records during their drug applications, thereby avoiding cumbersome procedures and significantly reducing submission costs.

3D FloTrix® Cell Expansion Kit

Previously, CytoNiche had two products filed with the Center for Drug Evaluation (CDE) of the National Medical Products Administration as pharmaceutical excipients (with CDE approval registration numbers F20210000003 and F20210000496). The recent approval of CytoNiche’s Drug Master File (DMF) registration number by the U.S. Food and Drug Administration (FDA) demonstrates CytoNiche’s capability to enter the international market and further solidifies its leading global position in microcarrier products.

CytoNiche Qualifications and Quality Inspection Reports from Authoritative Institutions Obtained for 3D Microcarrier Products

To date, 13 stem cell drug products from 11 companies in China have been approved for implicit entry into clinical trials. Improving the quantity and quality of stem cells to meet the practical demands of clinical applications for stem cell therapeutic products represents a significant challenge facing stem cell clinical translation post-IND. In this regard, selecting an appropriate large-scale culture and manufacturing process for stem cells is a critical solution to address this challenge, with the choice of microcarriers being a key variable in the stem cell expansion process.

CytoNiche 3D FloTrix® Series Products

Beijing Huakan Biotechnology Co., Ltd. (CytoNiche) was co-founded by the research team led by Professor Du Yanan from the School of Medicine at Tsinghua University, with equity participation and joint development support from Tsinghua University. Its core technologies stem from the commercialization of scientific achievements at Tsinghua University. Among these, the globally original 3D FloTrix® product series and process system provide a comprehensive solution for the large-scale manufacturing of cell-based therapeutics, while also serving as an innovative injectable pharmaceutical product specifically designed for stem cells worldwide. The company has developed two excipient products intended for use in the production and formulation of cell-based therapeutics (with CDE registration numbers F20210000003 and F20210000496, respectively), and has obtained U.S. FDA Drug Master File (DMF) qualification for these excipients (DMF No.: 35481).

The company currently operates a 1,000-square-meter R&D center and a 2,000-square-meter GMP-compliant production 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 are widely applied in practice. To date, the company has completed nearly RMB 100 million in financing, with investments from prominent domestic venture capital firms and international industrial conglomerates.