诺华制药(NVS.US)全球首创自免新药在中国申报上市
NovartisNovartis(US:NVS) 智通财经网·2026-02-06 06:52

Core Viewpoint - Novartis has submitted a market application for Ianalumab in China, a fully human monoclonal antibody targeting BAFF-R, which has dual mechanisms of depleting B cells and inhibiting BAFF-R, aimed at treating various autoimmune diseases [1]. Group 1 - Ianalumab is the first anti-BAFF-R antibody to complete Phase III studies [1]. - The drug is indicated for conditions such as Sjögren's syndrome, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE) [1]. - The application was officially submitted on February 6, 2026, under the registration number JXSS2600007 [2]. Group 2 - The drug is classified as a therapeutic biological product and is imported [2]. - The application involves multiple entities, including Novartis Pharma Schweiz AG, Novartis Pharma Stein AG, and Beijing Novartis Pharma Co., Ltd [2].

诺华制药(NVS.US)全球首创自免新药在中国申报上市 - Reportify