Simcere’s Stroke Drug Wins FDA Breakthrough Designation

Simcere Pharmaceutical Group Limited (HK:2096) has released an update.

Simcere Pharmaceutical Group Limited has announced that their Sanbexin sublingual tablets received the U.S. FDA’s Breakthrough Therapy designation for acute ischemic stroke treatment. This designation is expected to expedite the development and review process, significantly reducing the time for marketing approval. The drug, which is currently under review in China and has completed Phase I trials in the U.S., promises to improve stroke treatment with its quick-absorption formula.

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