Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for Arcalyst (rilonacept) for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs). The drug is specifically filed for approval in treating familial cold autoimmune syndrome (FCAS) and Muckle-Wells syndrome (MWS).
Rilonacept’s Background and Mechanism
Rilonacept is a recombinant dimer fusion protein that blocks interleukin-1 α (IL-1 α) and interleukin-1 β (IL-1 β) signal transduction. Originally developed by Regeneron Pharmaceuticals Inc., it was approved for marketing in the United States in 2008. The molecule gained additional approval to treat IL-1 receptor antagonist deficiency (DIRA) in the U.S. in 2020.
Global Partnerships and Designations
Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) obtained a license to the drug in 2017, and it was awarded breakthrough therapy designation (BTD) for use in recurrent pericarditis (RP) in the U.S. in 2019. Orphan drug designations (ODDs) were granted in the U.S. and Europe in 2020 for the treatment of pericarditis and idiopathic pericarditis, respectively. The molecule was approved in the U.S. in March 2021 for the treatment of RP.
Huadong Medicine’s Licensing Deal and Rights
Huadong Medicine struck a significant USD 662 million licensing deal with Kiniksa in 2022, securing exclusive development, regulatory filing, and commercialization rights to rilonacept along with mavrilimumab, both therapies for autoimmune diseases, in China, South Korea, and other regions.
Rilonacept’s Status in China
Rilonacept was included in China’s first batch of clinically urgently needed drugs already approved overseas in 2018 and was awarded priority review status in 2023. Recurrent pericarditis (RP), meanwhile, is on the recently released second list of rare diseases in China, highlighting the importance of rilonacept’s potential approval and availability in the country.- Flcube.com
