The reporter learned today from the State Drug Administration that a new target innovative drug developed and simultaneously declared around the world was the first to be approved for sale in China today, achieving an original target innovative drug developed by multiple centers around the world, and a historic breakthrough that was first introduced in China. Liu Zongying, Vice Director of the Pharmaceutical Pharmacy Department of the National Drug Administration: The State Drug Administration recently approved the launch of a “selective orexin type 2 receptor agonist”. This innovative drug with a new target and mechanism is used to treat type 1 narcolepsy in adolescents and adults aged 16 and above. Xu Xiaoqiang, Director of the Chemical Drugs Department of the Drug Registration Department of the State Drug Administration: This innovative drug has simultaneously submitted drug marketing registration applications to China, the United States, Japan and other countries. China was the first in the world to approve its listing, marking China's historic breakthrough in the field of “new global” drug research and development, from target originality to simultaneous promotion of international multi-center clinical trials, to registration and listing. According to information, this innovative drug is a rare disease treatment, and it has submitted marketing applications simultaneously in many countries and regions around the world. In China, it was certified as a breakthrough treatment variety and included in the priority review and approval process, and obtained the “double acceleration channel”; obtained breakthrough therapeutic drug certification in the US and included in the fast track; obtained pioneer and orphan drug qualification certification in Japan and included in the rapid review and approval; and obtained orphan drug qualification in the European Union.

The reporter learned today from the State Drug Administration that a new target innovative drug developed and simultaneously declared around the world was the first to be approved for sale in China today, achieving an original target innovative drug developed by multiple centers around the world, and a historic breakthrough that was first introduced in China. Liu Zongying, Vice Director of the Pharmaceutical Pharmacy Department of the National Drug Administration: The State Drug Administration recently approved the launch of a “selective orexin type 2 receptor agonist”. This innovative drug with a new target and mechanism is used to treat type 1 narcolepsy in adolescents and adults aged 16 and above. Xu Xiaoqiang, Director of the Chemical Drugs Department of the Drug Registration Department of the State Drug Administration: This innovative drug has simultaneously submitted drug marketing registration applications to China, the United States, Japan and other countries. China was the first in the world to approve its listing, marking China's historic breakthrough in the field of “new global” drug research and development, from target originality to simultaneous promotion of international multi-center clinical trials, to registration and listing. According to information, this innovative drug is a rare disease treatment, and it has submitted marketing applications simultaneously in many countries and regions around the world. In China, it was certified as a breakthrough treatment variety and included in the priority review and approval process, and obtained the “double acceleration channel”; obtained breakthrough therapeutic drug certification in the US and included in the fast track; obtained pioneer and orphan drug qualification certification in Japan and included in the rapid review and approval; and obtained orphan drug qualification in the European Union.