China Medical System’s Class 1 Stroke Drug Y-3 Wins NDA Acceptance in China, Targeting Treatment and Post‑Stroke Depression
Link: https://links.sgx.com/1.0.0/corporate-announcements/9TWX6LHIHG8WFB9C/60232186b2546c2346351bfd63600aa65564a36c6ebec04d952ce204fe04e5df
Summary:
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China’s drug regulator has accepted the New Drug Application for Class 1 innovative brain cytoprotectant Y-3 for Injection (Loberamisal) for the treatment of acute ischemic stroke.
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Y-3 targets multiple stroke pathways via PSD-95–nNOS uncoupling, MPO inhibition and α2-GABAA receptor modulation, aiming to improve neurological outcomes and reduce post-stroke depression and anxiety.
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A Phase III trial in China enrolled about 1,000 patients within 48 hours of stroke onset across roughly 40 centers and met its primary endpoint with notable clinical benefit and a favorable safety profile.
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With around 2.8 million new ischemic strokes annually in China and high rates of post-stroke mood disorders, the company sees substantial market potential and expects Y-3 to enhance its CNS portfolio and future financial results.
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The group holds exclusive promotion rights for Y-3 in mainland China, Hong Kong and Macau under a permanent collaboration agreement with NeuroDawn Pharmaceutical.