On January 2, 2025, the National Medical Products Administration (NMPA) of China granted approval for Amimestrocel Injection, the country's first stem cell drug, developed by CytoNiche's strategic partner, Platinum Life. This allogeneic umbilical cord mesenchymal stem cell (UCMSC) therapy is approved for treating steroid-refractory acute graft-versus-host disease (aGvHD) in patients aged 14 and older through intravenous infusion.

[A Transformative Milestone in the CGT Industry]

This landmark approval represents a pivotal moment for the global cell and gene therapy (CGT) industry. Notably, Amimestrocel Injection is the first commercially available stem cell product manufactured using the advanced 3D cell culture method—specifically CytoNiche’s Intelligent 3D FloTrix® Technology. This achievement sets the stage for future advancements in stem cell therapies and industrial-scale manufacturing.

[Cutting-Edge Manufacturing Excellence]

CytoNiche's intelligent 3D cellular mass manufacturing technology and GMP-compliant products—including 3D TableTrix® Microcarriers, 3D FloTrix® MSC Serum-Free Medium, and an array of advanced equipment—were instrumental in the development and production of Amimestrocel Injection. These innovations ensure a fully closed, scalable, and efficient manufacturing process that meets rigorous clinical safety standards while also reducing costs.

[China’s Rapid Ascent in CGT Innovation]

Since 2018, the NMPA has received 146 investigational new drug (IND) applications for stem cell therapies, with 109 approved for clinical trials. In 2024 alone, 32 new IND applications highlighted the growing momentum of China’s CGT sector. CytoNiche’s contributions to advancing intelligent, large-scale 3D cell manufacturing underscore China’s increasing influence in the global biopharmaceutical arena.

We are proud to celebrate this significant milestone and look forward to further breakthroughs in stem cell therapies. Together, let’s usher in a new era of CGT innovation and industrialization, bringing transformative therapies to more patients worldwide.

CytoNiche was established in 2018, led by Professor Yanan Du's research team from the School of Medicine at Tsinghua University, with Tsinghua University as a shareholder. The core technology originated from the transformation of scientific achievements at Tsinghua University and was recognized as a leading technology in "Science and Technology Innovation in China" by the China Association for Science and Technology. As a national-level high-tech enterprise, a national-level specialized and new technology "Little Giant" enterprise, a potential unicorn enterprise, it has also received key research and development special support from the Ministry of Science and Technology.

As an expert in high-quality three-dimensional cell manufacturing, CytoNiche provides a one-stop customized solution for cell scale-up based on 3D microcarriers. The company has built an original 3D cell smart manufacturing platform, achieving large-scale, automated, intelligent, and closed-cell drug and derivative production preparation. This helps global customers establish the most advanced cell drug production lines. After pioneering the production process pipeline for "billion-level" stem cells, the company is accelerating towards "hundred billion-level," dedicating efforts to empower the cell and gene therapy industry with 3D cell scale-up smart manufacturing technology to benefit more patients.