According to the CDE website, Dongyangguang Pharmaceutical's application for generic version of Xinuo amino acid tablets has been accepted as a Class 4 generic drug. So far this year, Dongyangguang Pharmaceutical has six products under review for approval.
Sinuosine tablets are used to treat focal seizures (partial seizures) in adults, especially for patients who do not respond to or cannot tolerate conventional antiepileptic drugs (ASM).
In recent years, the sales volume of antiepileptic drugs in China's three major terminals and six major markets (see the end of this article for the statistical scope) has exceeded 7 billion yuan, with a slight year-on-year decline in the first half of 2026. In terms of administration routes, the market share of oral medications continues to expand, accounting for more than 90% in the first half of 2026. Levetiracetam tablets, sodium valproate extended-release tablets (I), and lamotrigine tablets are the top three products.
According to data from Menet.com, only one company has an import license for Xinuo amino acid tablets, while seven other companies, including Qingfeng Pharmaceutical and Jiangsu Enhua Pharmaceutical, have submitted applications for production of generic Class 4 products.
This year, Dongyangguang Pharmaceutical has submitted six product applications for approval, covering multiple therapeutic subcategories including immunosuppressants, anti-inflammatory drugs, and antirheumatic drugs. Among them, Xinuominate tablets are aiming to become the first generic version and are expected to become the company's first antiepileptic chemical drug product; Vonoprazan fumarate sodium chloride injection is a chemically modified new drug; and Ailamode tablets are projected to be a blockbuster product with sales exceeding 1 billion yuan in six major markets across China's three major terminals by 2025.

Source: https://mp.weixin.qq.com/s?__biz=MjM5NzQ4MTg2MQ==&mid=2650455823&idx=2&sn=19b0e3b027b1c1283886e80301e7e668&chksm=bf55c995f99a5113a6835bde1ff074e2bc9f0f50f34e45fffb5560704dbdf184a54e61ce1884&scene=126&sessionid=0#rd