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On January 9, Luoxin Pharmaceutical announced that its subsidiary Shandong Luoxin had recently received the "Approval Notice for Supplementary Drug Application" for Edaravone Injection approved and issued by the State Food and Drug Administration
.
After review, the drug passed the consistency evaluation of generic drugs.
Edaravone injection is a brain protective agent (free radical scavenger), used to improve neurological symptoms, activities of daily living and functional impairment caused by acute cerebral infarction, and inhibit amyotrophic lateral sclerosis (ALS) caused by Progression of dysfunction.
Edaravone injection was first developed by Japan Tanabe Mitsubishi Pharmaceutical Co., Ltd., with the trade name of RADICUT® and the specification of 20ml: 30mg.
It was launched in Japan on June 1, 2001, and the original formulation has not yet been launched in China.
The Edaravone injection developed by Shandong Luoxin was approved for the first time in June 2018, with the approval number: Guoyao Zhunzi H20183191.
According to IQVIA data, the global market size of edaravone injection in 2020 is 300 million US dollars (calculated at ex-factory price); according to IQVIA and Minet data, the domestic market size of edaravone injection in 2020 is 1.07 billion yuan (calculated in Tender price calculation).
