瑞利珠单抗在华获批，用于成人全身型重症肌无力

Core Insights - The long-acting C5 complement inhibitor, Riluzole injection (brand name: Weili Rui), has been approved for use in combination with conventional therapies for adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) [1][2] - The approval is based on positive results from the CHAMPION-MG Phase III study, which demonstrated that Riluzole significantly improved the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to placebo at the primary efficacy endpoint [1] - Long-term follow-up from an open-label extension study indicated that the clinical benefits of Riluzole persisted for up to 60 weeks, with a 71.1% reduction in the annual exacerbation rate per 100 patients compared to placebo [1] Industry Context - Generalized myasthenia gravis is a rare, debilitating chronic autoimmune neuromuscular disease affecting approximately 113,000 diagnosed patients in China [2] - The treatment of gMG requires early initiation and long-term maintenance, with Riluzole showing rapid and sustained improvement as reported by both patient self-assessments and physician evaluations [2] - Riluzole has already received approvals in the United States, European Union, Japan, and other regions for treating adult patients with anti-AChR antibody-positive gMG, and has multiple indications approved globally [2]