Group 1 - The National Medical Products Administration (NMPA) has approved a new indication for Hansoh Pharmaceutical's (03692.HK) Inalizumab injection for the treatment of Immunoglobulin G4-related disease (IgG4-RD), which was previously prioritized for review by the Center for Drug Evaluation (CDE) [1] - Inalizumab is a targeted CD19B cell-depleting antibody, and it was first approved by the NMPA in March 2022, making this the second indication for the drug [1] - The approval is based on positive results from the global pivotal Phase III trial MITIGATE, which was conducted in 22 countries, including China, and is the first randomized, double-blind, placebo-controlled study in IgG4-related disease [1] Group 2 - In the 52-week placebo-controlled period, the risk of relapse for IgG4-RD patients treated with Inalizumab was significantly reduced by 87% compared to the placebo group [2] - Among 68 patients treated with Inalizumab, only 7 experienced a relapse, while 40 out of 67 patients in the placebo group relapsed [2] - 57.4% of patients treated with Inalizumab achieved complete remission without relapse or treatment by week 52, compared to 22.4% in the placebo group [2] Group 3 - Inalizumab is currently the only approved CD19 monoclonal antibody for IgG4-RD globally, highlighting its unique position in the market [3]