On April 8, it was learned from the Shanghai Municipal Science and Technology Commission that the world’s first allogeneic cell therapy drug for refractory epilepsy derived from induced pluripotent stem cells (iPSCs), independently developed by Shanghai YueSai Biotechnology Co., Ltd. (referred to as “YueSai Bio”), has successively received clinical trial approvals from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration’s Center for Drug Evaluation (CDE). This makes it the only innovative product in the field of iPSC cell therapy for epilepsy to achieve “dual approval in China and the U.S.”
Epilepsy is one of the most common neurological disorders. Unlike traditional drugs, this cell therapy works by locally transplanting inhibitory neurons into the lesion site to achieve functional remodeling of the brain region.
Founded in 2021, YueSai Bio is an innovative enterprise in the field of cell therapy. In the area of neural differentiation, its scientific research team already possessed an internationally leading research foundation. After the establishment of YueSai Bio, benefiting from Shanghai’s talent aggregation effect, the company quickly assembled an interdisciplinary team composed of neuroscientists, stem cell biologists, and drug development experts, and established a high-standard cell drug R&D and industrialization system.
Whether in terms of scientific research platform construction, talent aggregation effects, or industrial chain collaboration, Shanghai holds significant advantages.
Biomedicine is one of Shanghai’s three leading industries. Data shows that in 2025, the scale of Shanghai’s biomedicine industry exceeded one trillion yuan for the first time, with the output value of biomedicine manufacturing nearing 210 billion yuan.
Shanghai Municipal Science and Technology Commission
The Shanghai Municipal Science and Technology Commission is a government agency responsible for planning, managing, and promoting scientific and technological development within Shanghai. It was established as part of China’s modernization efforts, playing a key role in implementing national tech policies and fostering the city’s transformation into a global innovation hub. Its history is intertwined with Shanghai’s economic reforms and its rise as a leading center for research and high-tech industry.
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and the nation’s food supply. It was formally established with its modern name in 1930, but its origins trace back to the 1906 Pure Food and Drugs Act, a landmark law enacted in response to public outrage over unsanitary conditions in the food and patent medicine industries.
China National Medical Products Administration’s Center for Drug Evaluation (CDE)
The China National Medical Products Administration’s Center for Drug Evaluation (CDE) is the primary regulatory body responsible for the technical review and evaluation of new drug applications in China. Established to ensure the safety, efficacy, and quality of pharmaceuticals, it plays a critical role in the country’s drug approval process. Its history is tied to the evolution of China’s regulatory system, with its functions and authority being significantly strengthened in recent decades to align with international standards.
Shanghai YueSai Biotechnology Co., Ltd.
Shanghai YueSai Biotechnology Co., Ltd. is a modern Chinese biotechnology company, not a historical or cultural site. It was founded in the early 21st century and focuses on research, development, and application in fields like biomedicine and cosmetics. As a commercial enterprise, its primary significance lies in its contributions to the biotech industry rather than a historical legacy.
YueSai Bio
“YueSai Bio” is not a place or cultural site, but a Chinese cosmetics and skincare brand founded in 1992 by Yue-Sai Kan, a pioneering television host and entrepreneur. It is historically significant as one of the first major beauty brands in China to blend modern cosmetics with traditional Chinese herbal ingredients, helping to shape modern beauty standards in the Chinese market.
