The iPSC epilepsy cell drug developed by the Shanghai team has become the first in the world to receive dual approvals from China and the United States.

Shanghai Yuesai Biotechnology Co., Ltd.'s iPSC-derived allogeneic cell drug recently received clinical trial approval from the U.S. FDA and the China National Medical Products Administration (CDE) Drug Review Center, becoming the world’s first iPSC-derived allogeneic epilepsy cell therapy product to enter clinical stages and achieve dual approvals in China and the U.S. The drug works by transplanting inhibitory neurons to suppress overactive neural activity and supplement missing functional neurons, with the goal of achieving a one-time treatment with long-term efficacy. The research team spent years developing the new “SISBAR” technology, which increases the proportion of target functional cells in the drug to over 50%, significantly improving the drug’s efficacy and safety. (The Paper)