AstraZeneca Submits New Indication Application in China for Ravulizumab, a Long-Acting C5 Inhibitor Administered Once Every 8 Weeks

Oct 11, 2024 14:55 CST Updated 14:55

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

Today (October 11), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has just announced that AstraZenecaAndUnder its umbrella, focusing on the rare disease field,Submitted by AlexionRelatlimabMarketing application accepted for review。Public information shows,Relatlimab（ravulizumab）YesDeveloped by AlexionALong-acting complement C5 proteinInhibitor.As can be queried through the CDE official website,In China,The first marketing application for Relatlimab has been submitted in China.Accepted in December 2023, this is the second marketing application for the product in China.

Screenshot source:CDE Official Website

Complement protein C5 is at the terminal end of the complement cascade, and targeting this protein can modulate complement signals activated by all three different pathways.In a variety of complement-mediated immune diseases, inhibiting the activity of C5 can suppress autoimmune attacks, thereby alleviating disease symptoms.。

RelatlimabYesA Long-Acting C5 Monoclonal Antibody, which can provide instant, full, and sustained complement inhibition.Unique design makesThe ProductHasA longer half-life than the first-generation C5 complement inhibitorsAdult patients only need to receive an intravenous injection once every 8 weeks after the initial dose.

RelatlimabFirst obtained FDA approval in the United States in 2018Approved for Marketing, used forTreatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), patients only need to receive an injection every 8 weeks.Can effectively control the occurrence of hemolysis. Subsequently, the drug was successively approvedFDA Approves Treatment for Multiple Autoimmune Diseases, IncludingAtypical Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorders（NMOSD）etc.

According to the information from the Drug Clinical Trial Registration and Information Disclosure Platform, AstraZeneca has conducted multiple trials in China.RelatlimabInternational Multicenter (including China) Phase 3 Clinical Trial, targeting indications includingParoxysmal Nocturnal Hemoglobinuria (PNH),IgA Nephropathy、Treatment of Thrombotic Microangiopathy (TMA) Following Hematopoietic Stem Cell Transplantation (HSCT) in Adults and Adolescents、Prevention of Severe Renal Adverse Events in Chronic Kidney Disease Patients During Extracorporeal Cardiopulmonary Circulationetc.

This timeRelatlimab Files for New Indication in China, Marking a New Development in the Product's Research and Development in the Country.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Oct 11，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). Retrieved March 25, 2024 fromhttps://www.astrazeneca.com/media-centre/press-releases/2024/ultomiris-approved-in-the-us-for-nmosd.html

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