1月2日，我国首款干细胞药物艾米迈托赛注射液（商品名：睿铂生®）通过国家药品监督管理局（NMPA）优先审评审批程序附条件批准上市，用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病（aGVHD）。

在美国这一里程碑式批准后不久，国内干细胞疗法的进展同样传来振奋人心的消息。2025年1月2日，NMPA官网传来喜讯，铂生卓越生物科技（北京）有限公司的干细胞疗法“艾米迈托赛”成功获批上市，专为治疗14岁以上、消化道受累为主且激素治疗无效的急性移植物抗 ...

FDA新闻稿指出，Ryoncil是首款获得FDA批准上市的MSC疗法。 SR-aGVHD是一种严重且危及生命的疾病，通常发生于同种异体造血干细胞移植（allo-HSCT ...

这款名为“艾米迈托赛注射液”（人脐带间充质干细胞）产品的适应症同样为激素失败的急性移植物抗宿主病（aGVHD），对标刚刚获FDA批准的MSC细胞 ...

Transformative Scientific Breakthrough Pioneered by Spencer Trask & Co. Venture Osiris Therapeutics NEW YORK, Jan. 16, 2025 ...

Mesoblast has gained US Food and Drug Administration (FDA) approval for its mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), to treat steroid-refractory acute graft versus host ...

RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and ...

FDA approves Mesoblast's Ryoncil, the first U.S. MSC therapy, for children with steroid-refractory acute graft-versus-host disease. In a Phase 3 trial, 70% of SR-aGvHD patients responded to ...

Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil ...