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(Yicai) Jan. 3 -- Chinese regulators have conditionally approved the county's first stem cell therapy, a major biomedical milestone and one that offers new hope for patients with acute graft-versus-host disease resistant to steroid treatment.
The National Medical Products Administration announced yesterday that it has given the conditional nod to Animimatuo, a stem cell therapy developed by Platinsine Biotechnology Beijing for the treatment of steroid-refractory-aGVHD that mainly affects the digestive tract of patients aged 14 and over. It did not disclose the cost of the treatment.
GVHD is a serious complication that can occur after allogeneic hematopoietic stem cell transplantation that is characterized by tissue inflammation and fibrosis primarily affecting the skin, gastrointestinal tract, liver, lungs, and mucosal surfaces, the NMPA said. The Animimatuo injection is a human umbilical cord-derived mesenchymal stem cell preparation, providing a new treatment option.
Stem cell therapy works by transplanting healthy stem cells into patients to repair or regenerate damaged tissues and organs, with the potential for diverse medical applications.
China had approved 106 of 148 investigational new drug applications for stem cell therapies as of October, according to data from the Prospective Industry Research Institute. Mesenchymal stem cells, used in Animimatuo, account for nearly 74 percent of approved INDs, making them the primary cell type in stem cell drug development.
MSCs have properties that promote angiogenesis, osteogenesis, immune regulation, and anti-inflammation, according to research by Huafu Securities. They are easily obtainable, highly scalable, safe for use, and can be developed rapidly on a large scale.
The world's first MSC drug for treating chronic motor paralysis received conditional authorization in Japan in August. Ryoncil, developed by Australia's Mesoblast for treating SR-aGVHD, won approval in the United States last month.
Editor: Martin Kadiev