AstraZeneca's (AZN.US) new indication for its antibody drug has been accepted for review in China
AInvestFriday, Oct 11, 2024 3:40 am ET
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AZN --

On October 11, the National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) officially announced that the application for the approval of Ravulizumab, a long-acting C5 protein inhibitor developed by Alexion, a subsidiary of AstraZeneca (AZN.US), had been accepted. According to public information, Ravulizumab is the first application for the drug's approval in China. The drug was approved by the FDA in the United States in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Patients can effectively control hemolysis by receiving injections every 8 weeks. Since then, the drug has been approved by the FDA for the treatment of various autoimmune diseases, including atypical hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder (NMOSD).

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