Breakthrough Therapy Designation for Sanbexin Sublingual Tablets Granted by the U.S. Food and Drug Administration

NANJING, China, September 14, 2024 /PRNewswire/ — On September 2nd2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative stroke medicine, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). Sanbexin sublingual tablets are the world’s first innovative medicine to be designated by the FDA with Breakthrough Therapy for the treatment of stroke.

The Breakthrough Therapy designation is based on the provisions of the 《Food and Drug Administration Safety and Innovation Act》. It is intended to accelerate the development and regulatory review of drugs for treating serious diseases and addressing important unmet medical needs. The designation will be beneficial for the drugs to obtain the FDA’s guidance in clinical development, accelerate the clinical development process abroad, and is also expected to significantly shorten the time for marketing review through the priority review designation.