---
title: "‘Historic breakthrough’: China approves novel drug ahead of US, Japan and Europe"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/293418276.md"
description: "China's NMPA has approved Takeda's novel narcolepsy drug TAK-861, marking the first time a globally trialed medicine was authorized in China ahead of the US, Japan, and Europe. Regulators hailed this as a 'historic breakthrough' in biopharmaceutical innovation, reflecting China's strategic push to elevate biotech as a pillar industry and accelerate access to cutting-edge therapies for its patients."
datetime: "2026-07-22T04:04:28.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/293418276.md)
  - [en](https://longbridge.com/en/news/293418276.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/293418276.md)
---

# ‘Historic breakthrough’: China approves novel drug ahead of US, Japan and Europe

China’s drug regulator has for the first time approved a novel, globally trialled medicine ahead of authorities in the United States, Japan and Europe, marking a “historic breakthrough” as the country doubles down on biopharmaceuticals as one of its growth engines. The drug was filed for market approval in multiple countries, and “China was the first in the world to approve it”, Xu Xiaoqiang, head of chemical drugs registration at the National Medical Products Administration (NMPA), told state broadcaster CCTV on Tuesday. “It marks a historic breakthrough for China” in globally developed, first-in-class drug innovation, Xu said, noting that Chinese patients had been included from the outset in international clinical trials, enabling approval ahead of anywhere else. The NMPA gave the green light for commercial sales of a rare-disease therapy for narcolepsy type 1 in people aged 16 and older, state media reported. The drug was not named, but reports said it had won fast-track designations in the US and orphan-drug designation in Japan and the European Union. Orphan-drug status means a therapy for a rare disease gets government incentives like tax breaks and exclusive rights to make development viable. Narcolepsy type 1 is a lifelong brain condition that makes people intensely sleepy during the day and causes them to fall asleep without warning. For many sufferers, it also causes them to suddenly lose control of their muscles when they feel strong emotions, like laughing, being surprised, or getting angry. The NMPA website showed that Takeda’s TAK-861, developed by the Japanese drug maker, had its marketing application accepted for review in China in January and was proposed for priority review the same month. The therapy completed two global phase 3 trials, according to Takeda’s website. China’s acceleration of novel drug reviews comes as biotech was elevated to “pillar industry” status in this year’s government work report, delivered in March. The shift follows a record wave of cross-border licensing deals between Chinese biotech firms and global pharmaceutical giants. The country approved 38 innovative drugs in the first half, with home-grown therapies accounting for most of them. China was long seen as a follower in cutting-edge drugs, with foreign therapies typically launching first in the US, Japan or Europe, forcing Chinese patients to wait for years before the drugs arrived, according to a 2022 study published in the medical journal Therapeutic Innovation & Regulatory Science.

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