We are thrilled to share an extraordinary achievement in our journey at CytoNiche! Today marks a historic milestone as our esteemed partner, Platinum Life, has achieved a remarkable feat in the biotechnology realm.

According to recent disclosures from the China National Medical Products Administration (NMPA), Platinum Life has secured formal acceptance for the New Drug Application (NDA) of "Amimestrocel Injection" — the first stem cell drug in China's history to enter the priority review phase. This groundbreaking therapy targets steroid-refractory acute graft-versus-host disease (aGVHD), demonstrating exceptional safety and efficacy during Phase III clinical trials.

At the heart of this transformative success lies CytoNiche's cutting-edge technology and comprehensive product suite. Leveraging our globally leading three-dimensional cell culture capabilities, CytoNiche played a pivotal role in advancing the cell production process from 2D to 3D, crucially supporting all phases of clinical research. Our state-of-the-art products, including the 3D TableTrix^® Microcarrier and 3D FloTrix^® systems, enabled Platinum Life to achieve unprecedented levels of efficiency and scalability in stem cell production, culminating in the successful acceptance of this landmark NDA.

Platinum Life, renowned for its dedication to standardizing and industrializing cell therapy technologies since 2010, stands as a beacon of innovation in the industry. Through rigorous research, engineering platform construction, and global collaborations, they have solidified their position as pioneers in stem cell drug development and production.

CytoNiche, founded in 2018 and recognized as a national high-tech enterprise, is committed to revolutionizing cell manufacturing through our proprietary 3D cell intelligent manufacturing platform. By spearheading the "Billion-scale" stem cell preparation process, we are driving towards the "Trillion-scale," empowering the cell and gene therapy industry with scalable, automated, and intelligent solutions.

We extend our heartfelt congratulations to Platinum Life on this momentous achievement and express gratitude to our dedicated team whose relentless pursuit of excellence continues to redefine possibilities in biotechnology.

Join us as we celebrate this incredible milestone and look forward to shaping a healthier future together!

#Biotechnology #Innovation #Healthcare #StemCellTherapy #NewDrugApplication #PriorityReview #TransformingHealthcare #CytoNiche #PlatinumLife

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.