DRUG REGISTRATION APPROVAL OF THE SECOND INDICATION OF XINYUE (INEBILIZUMAB INJECTION) WAS GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
On September 1, 2025, Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) announces that the innovative drug XINYUE (昕越®) (Inebilizumab Injection) (the “Product”) has been granted drug registration approval by the National Medical Products Administration (the “NMPA”) of China, approving the addition of an indication: for immunoglobulin G4-related disease (IgG4-RD) in adult patients. This is the second indication of XINYUE which has been approved in China, this indication was included in the Priority Review and Approval Procedure by the NMPA on February 8, 2025.
IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. Hansoh Pharma’s collaborator Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) had approved inebilizumab the treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD) on April 3, 2025.
This approval of inebilizumab by the NMPA for the treatment of IgG4-RD is supported by data from the MITIGATE trial, the first randomized, double-blind, placebo-controlled trial conducted in IgG4-RD. This trial demonstrated the potential of inebilizumab to decrease disease activity by reducing flares in patients, while maintaining its established safety profile. Compared to the placebo group, inebilizumab reduced the risk of disease flare by 87%. Additionally, all key secondary endpoints were also met, which were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission.
ABOUT THE PRODUCT
Inebilizumab is a targeted CD19 B-cell depleting antibody. On May 24, 2019, the Group entered into a license agreement with Viela Bio (Viela Bio was acquired by Horizon Therapeutics in 2021, which was acquired by Amgen in 2023), and has been granted an exclusive license to develop and commercialize the Product in Chinese Mainland, Hong Kong and Macau. On March 14, 2022, the Product was approved to be launched in China by the NMPA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. In January 2023, the Product was included in the National Reimbursement Drug List for the first time, and this inclusion was successfully renewed in November 2024. On May 29, 2025, the third biologics license application (BLA) of the Product was accepted by the NMPA for the treatment of generalized myasthenia gravis (gMG) in adult patients.
ABOUT IGG4-RD
Immunoglobulin G4-related disease (IgG4-RD) is a chronic, systemic, immune-mediated, fibroinflammatory disease which can affect numerous and generally multiple organs of the body. It is a progressive disease that can affect a variety of organ systems and often affects multiple organs over time. It is characterized by periods of remission and unpredictable disease flares. IgG4-RD can cause permanent organ damage with or without the presence of symptoms. Awareness of how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD. B cells are central to the pathogenesis of IgG4-RD. In IgG4-RD, CD19-expressing (CD19+) B cells are thought to drive inflammatory and fibrotic processes and interact with other immune cells that contribute to disease activity.
The prevalence is estimated at 20,000 people in the United States (5 in 100,000 worldwide), although the number of IgG4-RD patients is difficult to determine based on limited epidemiology data. The typical age of onset of IgG4-RD is between 50 and 70 years old and, unlike many other immune-mediated diseases, IgG4-RD is more likely to occur in men than women.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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Forward-Looking Statements
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