Inebilizumab by Hansoh Pharma Becomes First Approved Therapy for IgG4-Related Disease in China
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Source: NMPA Official Website
Inebilizumab is a depleting antibody targeting CD19 B cells, designed to modulate the immune system by depleting peripheral B cells.In 2019, Hansoh Pharma entered into a licensing agreement with Viela Bio to obtain exclusive rights for the development and commercialization of the product in mainland China, Hong Kong, and Macao.Viela Bio was acquired by Horizon Therapeutics in 2021, which was then acquired by Amgen in 2023.In March 2022, Shinevue® was approved for the first time by the NMPA for marketing in China., used for treatmentAdult patients with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD)。
ThisApprovedTreatment of Immunoglobulin G4-Related Disease (IgG4-RD)YesThe Second Indication of the Drug in China。
This approval is mainly based on the positive results of the global pivotal Phase III clinical trial MITIGATE (NCT04540497).The study was conducted at 80 clinical trial research centers across 22 countries, including China, and is the first randomized, double-blind, placebo-controlled study in IgG4-RD.
The study results showed that patients receiving inebilizumab treatment had a significant 87% reduction in the risk of IgG4-RD recurrence within 52 weeks (hazard ratio 0.13, P<0.001).The annualized recurrence rate decreased from 0.71 to 0.10 (P<0.001).。Moreover, 57.4% of patients achieved complete remission without recurrence or the need for treatment at week 52, and 58.8% achieved complete remission without recurrence or the need for corticosteroids (P<0.001).
Notably, 89.7% (61 out of 68) of patients receiving inebilizumab did not require glucocorticoids to control the disease during the placebo-controlled period, compared to 37.3% (25 out of 67) in the placebo group. After week 8, the total glucocorticoid usage in the inebilizumab-treated group was ten times less than that in the placebo group.
The safety results during the placebo-controlled period were consistent with the known safety profile of inebilizumab. The most common treatment-related adverse events included COVID-19, lymphopenia, urinary tract infection, and headache.
These dataPublished in The New England Journal of Medicine, and presented at the American College of Rheumatology Annual Meeting in November 2024.The study confirmed the safety and efficacy of inebilizumab in treating IgG4-RD through CD19 B-cell depletion, validating its unique mechanism of action.
Currently, globally onlyApproval of 2 CD19 Monoclonal Antibodies, Inebilizumab isThe First Product Approved for IgG4-RD(Tafasitamab is only approved for use in diffuse large B-cell lymphoma and follicular lymphoma).
This approval marks a further expansion of Xinyue® in the Chinese market, providing a new treatment option for IgG4-RD patients and demonstrating Hansoh Pharma's continued efforts in innovative drug development and clinical application.
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