China Medical System Holdings Limited announced that, on Dec, 11 2025, the National Medical Products Administration in China accepted the New Drug Application for Y-3 for Injection (proposed generic name: Loberamisal for Injection), a Class 1 innovative brain cytoprotectant intended for the treatment of acute ischemic stroke.

The submission is supported by a Phase III trial led by Beijing Tiantan Hospital, Capital Medical University, which enrolled nearly 1,000 patients across about 40 sites in China within 48 hours of stroke onset. The study met its primary efficacy endpoint and showed an overall favorable safety profile; detailed results will be presented at international conferences and published in academic journals.

Y-3 for Injection targets multiple pathological processes of the ischemic cascade by uncoupling PSD95-nNOS, inhibiting MPO activity, and enhancing α2-GABAA receptor activity. The product is also being investigated for its potential to prevent post-stroke depression and anxiety, complications that affect roughly 30 % and 25 % of stroke patients, respectively.

Stroke remains a major health burden in China, with around 3.94 million new cases each year; ischemic stroke accounts for approximately 72 % of these cases. The company highlighted the significant market opportunity for therapies that can improve neurological outcomes and overall prognosis.

Under an Aug, 24 2023 collaboration agreement, China Medical System holds exclusive promotion rights for Y-3 for Injection in mainland China, Hong Kong and Macau. The company stated that, if approved, the drug will complement its existing central nervous system portfolio and is expected to contribute positively to future financial results.

Shareholders and investors were advised to exercise caution when dealing in the company’s securities.