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Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) was Approved by NMPA on the Chinese Market

Release time:2020-07-30

On July 30, 2020, the categoryinnovative drug Sanbexin® (edaravone and dexborneol concentrated solution for injection) developed by Simcere was approved to be sold in the market by the National Medical Products Administration (NMPA), with the approval reference number “National Medicine Zhunzi H20200007”. This has brought a new option for ischemic stroke treatment in China.

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Sanbexin® has received 8 patents in multiple countries and regions (including China mainland, the United States, Japan, Australia, Canada, Europe, Hong Kong, etc.). It has won 2 National Major Scientific and Technological Special Project for “Significant New Drugs Development” from the Ministry of Science and Technology. 

Stroke is the leading cause of death in China.The incidence in China ranks first in the world. Nearly 4.6 million Chinese patients are diagnosed with stroke each year, and the number is still increasing at a rate of 8.7% annually. Over 70% of stroke cases fall into ischemic stroke category[1]. The socio-economic burden of stroke is 100 billion yuan/year[2]. The direct treatment cost for this disease is about 50 billion yuan, not including the indirect economic loss caused by death or disability.

Currently, the most effective treatment for acute ischemic stroke is intravenous thrombolytic therapy and endovascular therapy within the time window. However, in the CHINA QUEST study, it shows that the average time from onset of stroke to treatment in China is 20.1 hours, significantly longer than the Western countries. Less than 3% of stroke patients received thrombolytic therapy in China, displaying huge unmet clinical needs.

Dexborneol (a bicyclic monoterpene compound) is a new type of anti-inflammation agent with the activity of inhibiting the expression of inflammatory cytokines TNF-α, IL-1β and inflammatory proteins COX-2 and iNOS in cerebral ischemia-reperfusion models. It activates GABAa receptors, thus blocking the vicious circle of inflammations and oxidative stress, reduces cell apoptosis and cell necrosis and cerebral edema, thereby protecting against ischemia-reperfusion injury. 

Edaravone is a free radical scavenger and antioxidant. The compound has been marketed in Japan since 2001 as a stroke treatment that effectively improves the prognosis of patients. In 2003, Simcere was the second in the world and first in China to launch Bicun® (Edaravone injection), which soon became the best-selling edaravone in China. Presently, edaravone has been included in multiple guidelines and clinical pathways in China and overseas. Based on its exact free radical scavenging and oxidative stress inhibiting mechanism, there is also rapid development to apply edaravone as an orphan drug to treat Amyotrophic lateral sclerosis (ALS).

Sanbexin® (Edaravone and Dexborneol injection concentrated solution) combines edaravone and dexborneol with a ratio of 4:1. With its dual action mechanism, edaravone and dexborneol concentrated solution for injection scavenges free radicals, inhibits inflammatory response and improves the permeability in blood-brain barrier, thereby minimizing brain injury or impairment caused by acute ischemic stroke.

A phase III, randomized, double-blind, comparative trial of approximately 1,200 acute ischemic stroke patients has shown that, compared to edaravone monotherapy, edaravone and dexborneol concentrated solution for injection has significantly higher efficacy while keeping similar safety profile,. The launch of Sanbexin® has great significance to stroke treatment in China.

Reference:
1.Wu B, Liu M, et al. The Lancet Neurology 2019;18:394-405.
2.W, Jiang B, Sun H, et al. Circulation 2017;135:759-771.