Hansoh Pharmaceutical's Inebilizumab Receives FDA Approval as First Treatment for IgG4-Related Disease

IgG4-related disease is a chronic, disabling immune-mediated inflammatory condition that can affect multiple organs and lead to fibrosis and permanent organ damage. Previously, the FDA granted inebilizumab breakthrough therapy designation for the treatment of IgG4-related disease, recognizing the significant unmet clinical needs in this serious disease area and the drug's potential to benefit patients.

The FDA approval of Inebilizumab for the treatment of IgG4-related disease is based on the positive results from its global pivotal Phase III trial, MITIGATE. This trial is the first randomized, double-blind, placebo-controlled study conducted in IgG4-related disease, demonstrating that Inebilizumab can reduce disease activity by decreasing the number of patient flare-ups. Compared to the placebo group, Inebilizumab reduced the risk of disease flares by 87%, offering the potential for complete remission without the use of steroids or occurrence of flare-ups.

The second indication for which Inebilizumab has been approved by the FDA is IgG4-related disease, with the first being the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies.

In addition, Amgen has been granted orphan drug designation by the FDA for Inebilizumab for the treatment of generalized myasthenia gravis (gMG). Currently, Amgen is conducting the registration application for gMG, with submission expected to be completed in the first half of 2025.

● May 24, 2019Hansoh PharmaEntered into a licensing agreement with Viela Bio to obtain the exclusive rights for the development and commercialization of Inebilizumab in mainland China, Hong Kong, and Macao (Viela Bio was acquired by Horizon Therapeutics in 2021, which was subsequently acquired by Amgen in 2023). In March 2022, the product received approval from the National Medical Products Administration (NMPA) for marketing in China under the Chinese trade name Sinreve®.

● March 4, 2025Hansoh PharmaHansoh Pharma announces that the Biologics License Application (BLA) for Xinyue® for the treatment of IgG4-related disease has been accepted by the NMPA, and this indication was included in the priority review and approval process by the NMPA on February 8, 2025.