PuGongYing Bio·News | Top Headlines in Biopharma (Feb 20–26, 2025)

February 24, 2025Day,Shize BioPharma (Suzhou) Co., Ltd. announced that the Investigational New Drug (IND) application for its self-developed world's first universal iPSC-derived subtype neural progenitor cell injection product, intended for treating Amyotrophic Lateral Sclerosis (ALS), one of the "four major incurable diseases in the world," has been fully approved by the U.S. Food and Drug Administration (FDA) to proceed with registration clinical trials. The IND application for Shize BioPharma's universal iPSC-derived subtype neural progenitor cell injection ("XS-228 Injection") for the treatment of ALS has also been formally accepted by China's National Medical Products Administration (NMPA).

This new cell therapy drug independently developed by Shize Bio,China’s first iPSC-derived cell therapy to receive U.S. FDA approval and be granted Global Orphan Drug Designation, the world’s first and only iPSC-derived cell therapy with orphan drug designation for the treatment of ALS, as well as the world’s first and only regenerative neural cell therapy formally approved to conduct registrational clinical trials in the U.S. for the treatment of ALS., marking the global leading and exclusive position of Shize Bio in the field of ALS cell therapy.