瑞利珠单抗最早于2018年获得美国FDA批准上市，用于治疗阵发性睡眠性血红蛋白尿症(PNH)，患者只需要每8周接受一次注射就可以有效控制溶血的发生。此后，该药相继获FDA批准治疗多种自身免疫性疾病，包括非典型溶血性尿毒症综合征、重症肌无力、视神经脊髓炎谱系疾病(NMOSD)等。The application for the new AstraZeneca (AZN.US) antibody drug for marketing in China was accepted.
The Zhitong Finance App learned that on October 11, the official website of the China Drug Administration Drug Evaluation Center (CDE) just announced that AstraZeneca (AZN.US) and its Alexion company, which focuses on rare diseases, have been accepted. According to public information, ravulizumab (ravulizumab) is a long-acting complement C5 protein inhibitor developed by Alexion. According to the CDE website, it can be seen that in China, the first marketing application for raylizumab was accepted in December 2023, and this is the second marketing application for this product in China.
Screenshot source: CDE official website
Ralizumab was first approved and marketed by the US FDA in 2018 to treat paroxysmal nocturnal hemoglobinuria (PNH). Patients only need to receive an injection every 8 weeks to effectively control the occurrence of hemolysis. Since then, the drug has successively been approved by the FDA to treat various autoimmune diseases, including atypical hemolytic-uremic syndrome, myasthenia gravis, and optic neuromyelitis spectrum disease (NMOSD).
