Edaravone of Mitsubishi Tanabe was approved for marketing in China on July 31, 2019, with the acceptance No.: JXHS1900047 and indication of amyotrophic lateral sclerosis (ALS). The drug was included in the list of 2nd batch of clinically imperative overseas new drugs and was directly filed the marketing application to the NMPA on Apr. 12, 2019

List of 2nd Batch of Clinically Imperative Overseas New Drugs
27 | Radicava (Edaravone) | Mitsubishi Tanabe Pharma Corporation | Japan | June 1, 2015 | Central nervous system | Free radical | Amyotrophic lateral sclerosis | Rare disease drug |
Edaravone is an older drug in my impression. According to my query of the keyword "edaravone" among Chinese-produced pharmaceutical products on the NMPA website, there are 35 records, meaning that there are about 35 specifications of edaravone marketed in China, wherein, edaravone (trade name: Bicun) of Simcere Pharmaceutical has been approved for marketing in China early in 2003.
Can edaravone marketed early in China be used for ALS?
How edaravone of Mitsubishi Tanabe is different?
This article will answer the above questions.
I. Why edaravone of Mitsubishi Tanabe is so excellent?
As mentioned above, there have been dozens of enterprises marketing edaravone in China according to the query on the NMPA website, however, all their indication is ischemic stroke. The marketing application filed by Simcere Pharmaceutical for edaravone dexborneol on Nov. 1, 2018 is still indicated for ischemic stroke, which is only a new compound preparation constituted by edaravone/(+)-2-decanol (4:1), with the safety and effectiveness improved.
Q1: Can Chinese-produced edaravone be used for ALS?
The answer is clear: no!
Edaravone of dozens of Chinese enterprises and hospital supply companies has been approved for stroke, and edaravone compound preparation applied for marketing by Simcere Pharmaceutical is also for stroke, supported by safety and effectiveness data; however, Chinese-produced edaravone has not been verified safety and effectiveness in ALS patients, therefore, the Chinese-produced varieties are different from edaravone of Mitsubishi Tanabe and they must not replace edaravone of Mitsubishi Tanabe to be used for ALS.
Q2: How is Chinese-produced edaravone different from edaravone of Mitsubishi Tanabe?
With the same name "edaravone" but different indications, there must be something different with edaravone of Mitsubishi Tanabe, otherwise, China would not have included it in the list of clinically imperative overseas new drugs to specially accelerate its marketing in China.

Chemical Structure of Edaravone
Difference 1: Specification










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