A new drug targeting narcolepsy, developed and submitted for approval globally, has received its first approval for marketing in China, the National Medical Products Administration (NMPA) said on Tuesday.
The drug was submitted for marketing approval in multiple countries and regions around the world. It was designated as a breakthrough therapy in China and entered the priority review and approval process.
"This innovative drug was submitted for marketing authorization applications simultaneously in the United States, Japan, and other countries. China is the first country globally to approve its marketing. This indicates that in the field of the development of globally new drugs, China has achieved a historic breakthrough in global first-to-report and first-to-market status, from original target discovery to simultaneous international multi-center clinical trials and registration," said Xu Xiaoqiang, director of the chemical drugs division of the drug registration department of National Medical Products Administration.
Experts say that China has a large number of cases involving a wide range of diseases, which can provide representative clinical data for drug development for various diseases worldwide, including rare diseases.
"I think the reason why the world is paying attention to China is not only because we have a huge market, but more importantly because our clinical research capabilities have been enhanced. Secondly, our management mechanism has been greatly improved. This time we achieved a global first in the marketing of the new drug," said Han Fang, director of the department of sleep medicine at Peking University People's Hospital.
"Taking narcolepsy as an example, China has established a clinical cohort for narcolepsy, accumulating valuable clinical experience in sleep monitoring, management of the disease in adults and children, long-term follow-up, and participation in international multi-center clinical studies. Now, China is not only a global pharmaceutical market, but also a source, validation, and translation hub for innovative drugs globally," said Zhan Shuqin, a professor at the sleep disease center of the Xuanwu Hospital Capital Medical University.
China achieves global-first marketing of innovative drug targeting narcolepsy
