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Title: CytoNiche Expands U.S. FDA Regulatory Filings for 3D RecomTrix Recombinant Collagen Microcarriers

Singapore, Singapore, 28th Aug 2026 — CytoNiche Biotech, a pioneer in advanced 3D cell manufacturing technologies, announced a pivotal regulatory milestone in its global expansion strategy. The company’s proprietary 3D RecomTrix recombinant collagen microcarriers (CW01) have formally completed multiple Drug Master File (DMF) and Master File (MF) submissions with the U.S. Food and Drug Administration (FDA). This international achievement follows the successful registration of CW01 as an excipient with the eCentre for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA).The U.S. regulatory portfolio for 3D RecomTrix CW01 encompasses Type II DMF (Filing No. DMF043937) and Type IV DMF (Filing No. DMF043963) with the FDA Centre for Drug Evaluation and Research (CDER), alongside a Type II Master File (Filing No. MF32742) with the FDA Centre for Biologics Evaluation and Research (CBER). In addition, CW01 holds NMPA CDE Excipient Registration No. F20250000786. By securing comprehensive regulatory backing across both CDER and CBER divisions, CytoNiche reinforces its position as a trusted global supply chain partner, giving biopharma developers the confidence to advance innovative cell therapies toward global commercialisation.Supporting Regulatory Readiness for Cell and Gene Therapy ManufacturingAs the global cell and gene therapy (CGT) sector matures from clinical development to commercial-scale manufacturing, international regulatory bodies—led by the U.S. FDA—are enforcing rigorous Chemistry, Manufacturing, and Controls (CMC) standards. Ensuring complete raw material traceability, non-animal-derived purity, and stringent risk mitigation against adventitious agents is now paramount for therapeutic developers.By establishing comprehensive regulato...

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