The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical for its generic version of Amgen’s romiplostim, a treatment for chronic idiopathic thrombocytopenia (ITP) that has not responded well to other treatments such as corticosteroids and immunoglobulins. This marks the first approval of its kind in China for this class of drug.
Romiplostim, which works by stimulating the thrombopoietin (TPO) receptor (c-Mpl) to increase platelet production, was initially approved in the U.S. in August 2008 under the trade name Nplate, following its approval in Australia. Kyowa Kirin holds the development rights for the drug in Greater China, South Korea, Singapore, Malaysia, and other regions. The original drug was approved in China in January 2022 for idiopathic ITP, where it does not have patent protection. Qilu Pharmaceutical filed a Category 1 application for its generic version in March 2022. In the U.S., the patent for the original drug is not set to expire until December 2038, as recorded in the Orange Book.- Flcube.com
