Simcere Secures NMPA Approval for Edaravone Sublingual Tablets Targeting Post-Stroke Cognitive Impairment

Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has received clinical trial approval from the National Medical Products Administration (NMPA) for its edaravone, borneol sublingual tablets, targeting post-stroke cognitive impairment (PSCI) in patients suffering from acute ischemic stroke (AIS).

The edaravone, borneol sublingual tablet is a solid oral formulation designed for rapid disintegration under the tongue, allowing for quick absorption via the sublingual venous plexus. This mechanism enables the active ingredients to enter the central nervous system, delivering anti-inflammatory and anti-oxidative effects while protecting the blood-brain barrier, thereby mitigating neuronal damage from stroke. Phase III clinical data indicated that the sublingual tablets significantly improved neurological recovery and independent living capabilities compared to a placebo, all while maintaining a favorable safety profile.

Approved for marketing in China in June 2023, the edaravone, borneol sublingual tablets are indicated for enhancing neurological symptoms, daily activity, and neurological function in patients with AIS, marking a significant advancement in the management of stroke-related complications.- Flcube.com

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