Huadong Medicine (000963.SZ) published an announcement on November 27, the company's wholly-owned subsidiary Hangzhou Sino-American Huadong Pharmaceutical...
According to the Zhizhong Finance APP, Huadong Medicine (000963.SZ) announced that on November 27, its wholly-owned subsidiary Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd. ("Sino-American Huadong") received the "Pharmaceutical Registration Certificate" approved and issued by the National Medical Products Administration (NMPA). The marketing application for Rilonacept for Injection, registered by Sino-American Huadong, was approved for the treatment of Cold-Inducible Autoinflammatory Syndrome (CAPS) in adults and adolescents aged 12 and older, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
It is reported that Rilonacept for Injection is a recombinant dimeric fusion protein that can block the signal transduction of interleukin-1α (IL-1α) and interleukin-1β (IL-1β). This product was first developed by Regeneron Pharmaceuticals, Inc., and was approved by the U.S. Food and Drug Administration (FDA) in 2008, under the trade name ARCALYST, for the treatment of Cold-Inducible Autoinflammatory Syndrome (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). In 2020, the FDA approved its use for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
