On May 30, 2025, Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) announces that Third Biologics License Application of XINYUE (Inebilizumab Injection) has been accepted by the National Medical Products Administration (the “NMPA”), which is for the treatment of generalized myasthenia gravis (gMG) in adult patients.

The biologics license application of new indication of XINYUE(昕越^®) is based on the positive results of the globally pivotal Phase III MINT trial. The data demonstrated durable and sustained efficacy of Inebilizumab in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year, following an initial loading dose. Findings have been presented as a late-breaking oral presentation during the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025, in San Diego.

The MINT trial（NCT04524273） is a a randomized-control trial, evaluated Inebilizumab in muscle-specific kinase autoantibody-positive (MuSK+) and AChR+ gMG patients, with the MuSK+ group followed for 26 weeks and the AChR+ group followed for 52 weeks. The trial demonstrated continued improvement in efficacy of Inebilizumab compared to placebo (adjusted difference, −2.8, 95% CI, −3.9 to −1.7) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ subpopulation through week 52. Among the AChR+ patients in the Inebilizumab group, 72.3% had a ≥3 point improvement in the MG-ADL score, compared to 45.2% in placebo.

Change from baseline in the Quantitative Myasthenia Gravis (QMG) score was also greater for patients in the Inebilizumab group as compared to placebo at Week 52 (adjusted difference, −4.3, 95% CI, −5.9 to −2.8). Among the AChR+ patients in the Inebilizumab group, 69.2% improved by ≥3 points in the QMG score, compared to 41.8% in the placebo group.¹

MINT was the first and only Phase 3 trial for a biologic to incorporate a corticosteroid taper into its protocol. Patients who entered the study taking corticosteroids were tapered down starting at Week 4 to prednisone 5 mg per day by Week 24.

No new safety signals were identified. The overall TEAE profile during the study period is consistent with the known safety profile for the approved indication (NMOSD). The most common adverse events included infusion-related reactions, nasopharyngitis and urinary tract infections.

In March 2022, the first indication of XINYUE was approved to be launched in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. XINYUE was included in the National Reimbursement Drug List for the first time in January 2023, and it was successfully renewed in November 2024.

On March 4, 2025, the second BLA of XINYUE was accepted by NMPA for the treatment of immunoglobulin G4-related disease (IgG4-RD). On February 8, 2025, this indication has been included in the Priority Review and Approval Procedure by NMPA.

About Generalized Myasthenia Gravis (gMG)

Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision^2-4. Approximately 85% of patients with myasthenia gravis have the generalized form, or gMG^5,6 . Approximately 85% of patients with myasthenia gravis have detectable antibodies against AChR, and approximately 7% have detectable antibodies against MuSK⁹. Global prevalence is estimated at 2-36 cases per 100,000.10 The disease is more frequently seen in young women (age 20-30) and men aged 50 years and older⁶,10.B cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by pathogenic CD19+ plasmablasts and plasma cells that target critical proteins in the neuromuscular junction^2-4.

ABOUT THE PRODUCT

Inebilizumab is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells).. 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 Macao. On March 14, 2022, the Product was approved to be launched in China by 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 March 4, 2025, the second BLA of the Product was accepted by NMPA for the treatment of immunoglobulin G4-related disease (IgG4-RD).

References

1.Nowak R, Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy Data in AChR+ Generalized MG Subpopulation Through Week-52 [Late-breaking oral presentation]. To be presented at American Academy of Neurology Annual Meeting (5-9 April 2025).

2.Yi, J. S., Guptill, J. T., Stathopoulos, P., Nowak, R. J., & O'Connor, K. C. (2018). B cells in the pathophysiology of myasthenia gravis. Muscle Nerve, 57(2):172-184.

3.Willcox H. N., Newsom-Davis, J., & Calder, L. R. (1984). Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clinical and Experimental Immunology., 58:97-106.

4.Stathopoulos P., Kumar, A., Nowak, R. J., & O'Connor, K. C. (2017). Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight, 2(17):e94263.

5.Lazaridis K., & Tzartos, S. J. (2020). Autoantibody Specificities in Myasthenia Gravis; Implications for Improved Diagnostics and Therapeutics. Frontiers in Immunology, 11:212.

6.Dresser L., Wlodarski, R., Rezania, K., & Soliven, B. (2021). Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. J Clin Med, 10(11):2235.

7.Ye et al. Frontiers in Neurology. (2024);15:1339167.

8.Rodrigues E., Umeh, E., Aishwarya, Navaratnarajah, N., Cole, A., & Moy, K. (2024). Incidence and prevalence of myasthenia gravis in the United States: A claims-based analysis. Muscle Nerve, 69(2):166-171.

9.Hehir, M. K., & Silvestri, N. J. (2018). Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurologic Clinics, 36:253-60.

10.Bubuioc, A. M., Kudebayeva, A., Turuspekova, S., Lisnic, V., & Leone, M. A. (2021). The epidemiology of myasthenia gravis. Journal of Medicine and Life, 14(1):7-16.