Our country's first autologous stem cell therapy drug has been approved and launched on the market, with YIDU TECH(02158) helping to drive its success.

date
06/01/2025
avatar
GMT Eight
On January 2, 2025, China's first stem cell therapy drug "Emimaituosi Injection" developed by YIDU TECH (02158) for participation in Phase II and Phase III clinical development was approved for market. The market launch of this drug has promoted clinical exploration of stem cell therapy in multiple indications, marking an important milestone in the field of stem cell therapy in China. Graft versus host disease (GVHD) is one of the most common and severe complications after allo-HSCT treatment. Approximately 60%-70% of aGVHD patients have gastrointestinal involvement, which is more difficult to treat. Currently, there is no evidence to suggest that any one drug has a significant advantage over other drugs in treating steroid-resistant aGVHD with gastrointestinal involvement. Mesenchymal stem cells (MSCs) as a novel cell therapy drug provide a safe and long-lasting treatment for steroid-resistant aGVHD, which was previously lacking in second-line therapy. Emimaituosi Injection was independently developed by Pusis Epuris Biotech (Beijing) Co., Ltd. and is indicated for the treatment of acute graft-versus-host disease (aGVHD) in patients aged 14 and older, with predominant gastrointestinal involvement and ineffective steroid treatment. On June 12, 2024, Emimaituosi was granted priority review and approval by the CDE. Its approval for market launch is a major milestone in domestic similar therapies. As a close partner of Pusis Epuris, YIDU TECH played a key role in the project, providing SMO services in Phase II and Phase III clinical research. The project team fully supported the national agency's verification, laying a solid foundation for the successful approval of "Emimaituosi Injection." It is worth mentioning that while YIDU TECH has made significant breakthroughs in supporting the biotechnology field, its performance has also been remarkable. The financial report for the first half of 2025 shows that YIDU TECH's existing business management Caliber adjusted EBITDA has turned from a loss to a profit, with a continuous profit of over 27 million yuan. The mid-term profit level is basically the same as the full year of 2024, reaching the best level in history at the same period.

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