Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted for review its market approval filing for the injectable Arcalyst (rionacept). The drug is indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged 12 and above, as well as for reducing the risk of recurrence.
Arcalyst, which can block interleukin (IL)-1α and IL-1β signal transduction, originated with Regeneron Pharmaceuticals (NASDAQ: REGN), Inc. Initially approved in the US in 2008, the drug gained an additional marketing nod for IL-1 receptor antagonist deficiency (DIRA) in 2020. Kiniksa Pharmaceuticals licensed Arcalyst from Regeneron in 2017 and subsequently earned breakthrough therapy designation (BTD) in the US for RP in 2019, Orphan Drug Designation (ODD) status in the US for pericarditis (including RP) in 2020, and ODD status for idiopathic pericarditis in Europe in the same year. The drug’s US marketing approval in March 2021 for RP established it as the first and currently only therapy suitable for populations aged 12 and above.
In February 2022, Huadong Medicine entered into a deal valued at USD 662 million with Kiniksa, securing development, regulatory filing, and commercialization rights for Arcalyst and the antibody drug mavrilimumab in China, South Korea, Australia, and a total of 24 countries across the Asia-Pacific region (excluding Japan). A market filing for the drug was accepted for review in China in November 2023 for the indication of cryopyrin-associated periodic syndromes (CAPS).- Flcube.com
