By Fineline Cube 
US biotech giant Amgen (NASDAQ: AMGN) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for Uplizna (inebilizumab-cdon), a CD19 monoclonal antibody (mAb). This approval makes Uplizna the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD).
Drug Profile and Mechanism
Uplizna is a CD19-targeted monoclonal antibody designed to address the underlying pathology of IgG4-RD, a rare and chronic autoimmune disorder. By binding to CD19, Uplizna depletes B cells, which play a key role in the disease process.
Global Licensing and Commercialization
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) entered into a licensing agreement with Viela Bio Inc., which was acquired by Horizon Therapeutics plc in 2021 and subsequently by Amgen in 2023. Under the agreement, Hansoh secured development and commercialization rights for Uplizna in Greater China.
Previous Approvals and Reimbursement
Uplizna has previously been approved in the US, Japan, and the European Union (EU) in 2020, 2021, and 2022, respectively. In China, the drug was approved in March 2022 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) and was included in the National Reimbursement Drug List (NRDL) in November 2023.-Fineline Info & Tech