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The rare disease new drug "Vitolasheng Injection" is declared for listing, and it is planned to be reviewed first

 Last Update: 2021-08-29
 Source: Internet
 Author: User

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On August 9th, the CDE official website announced the latest announcement that it was planned to include Vitorasin injection into the priority review and approval.

Source: CDE official website

Duchenne muscular dystrophy (Duchenne muscular dystrophy, DMD) is the most common X-linked recessive hereditary muscular degeneration disease, the incidence in male newborns is about 1/3500.

Vitorasheng injection is an antisense oligonucleotide drug jointly developed by Tigermed and Japan New Drug Co.

In a phase II clinical trial (NCT02740972), 16 subjects were randomized to receive this product or placebo for 4 weeks, and then received 2 different doses (40 mg/kg, 80 mg/kg) of Vitor Open treatment for 20 weeks

On March 25, 2020, Vittorase was approved for listing in Japan; on August 12, 2020, it was approved for listing in the United States.

In May 2021, Vitorasen injection was applied for clinical application in China for the first time, and it was approved for clinical use on July 13

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