Press Releases

On March 27, 2026, Hansoh Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Hansoh Pharma,” stock code: 03692.HK) announced that its innovative drug XINYUE (Inebilizumab Injection) has been approved by the National Medical Products Administration (NMPA) for marketing, which marks the drug’s third approved indication: in combination with conventional therapies, this product is indicated for the treatment of adult patients with anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive generalized myasthenia gravis (gMG).

Generalized myasthenia gravis (gMG) is a rare chronic autoimmune neuromuscular disease caused by impaired transmission at the neuromuscular junction. It is characterized by fluctuating skeletal muscle weakness and fatigability, and may affect the eyes, swallowing muscles, and respiratory muscles. In severe cases, patients may develop respiratory muscle weakness, which can be life-threatening due to respiratory failure.

XINYUE is a CD19-targeting B-cell depleting agent. In a global pivotal Phase III clinical trial (‌MINT study‌), it demonstrated positive results in the treatment of gMG: Inebilizumab showed clinically meaningful and statistically significant efficacy in patients with AChR or MuSK antibody-positive gMG. The relevant studies have been published in The New England Journal of Medicine and presented as a Late-Breaking Oral Presentation at the American Academy of Neurology (AAN) 2025 Annual Meeting.

Previously, XINYUE has been approved for the treatment of two rare diseases: neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease (IgG4-RD). The current approval for gMG marks the third rare disease indication approved for XINYUE in China.

● March 2022 – First Approved Indication

For the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive NMOSD. It was first included in the National Reimbursement Drug List (NRDL) in January 2023 and successfully renewed in November 2024.

● September 2025 – Second Approved Indication

For the treatment of adult patients with IgG4-RD.

Hansoh Pharma remains committed to rare disease patient populations, respecting the power of life and responding to patients’ aspirations for a better life. The company continues to improve the accessibility and affordability of innovative therapies, enabling more patients to benefit from globally advanced treatment options and embrace a fulfilling life.

About XINYUE

Inebilizumab Injection (Chinese brand name: XINYUE) is a CD19-targeting B-cell depletion antibody. In May 2019, Hansoh Pharma entered into a licensing agreement with Viela Bio, obtaining exclusive rights to develop and commercialize the product in mainland China, Hong Kong, and Macau. (Viela Bio was acquired by Horizon Therapeutics in 2021, which was subsequently acquired by Amgen in 2023.) Inebilizumab received marketing approvals from the U.S. Food and Drug Administration (FDA), Japan Ministry of Health, Labour and Welfare (MHLW), and the European Medicines Agency (EMA) in 2020, 2021, and 2022, respectively. In March 2022, XINYUE was approved by NMPA for marketing in China for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). In January 2023, XINYUE was included for the first time in the NRDL for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance, and its inclusion was successfully renewed in November 2024. In August 2025, XINYUE’s second indication has been approved in China for the treatment of adult patients with immunoglobulin G4-related disease (IgG4-RD). In March 2026, XINYUE’s third indication has been approved in China for use in combination with conventional therapies in the treatment of adult patients with anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive generalized myasthenia gravis (gMG).

About the MINT Study

The Phase III MINT study (NCT04524273) of Inebilizumab in the treatment of generalized myasthenia gravis (gMG) demonstrated^[1] that Inebilizumab significantly improved patients’ activities of daily living and muscle strength, with a favorable safety profile. The study enrolled 238 anti-AChR or anti-MuSK antibody-positive gMG patients and randomly assigned them to receive intravenous Inebilizumab or placebo. The primary endpoint was the change in MG-ADL score at Week 26, and the key secondary endpoint was the change in QMG score. Results showed that, at Week 26, reductions in both MG-ADL and QMG scores were significantly greater in the Inebilizumab group than in the placebo group. In addition, with continued treatment through Week 52, symptom improvement in AChR antibody-positive patients was further enhanced (as measured by MG-ADL scores, with the between-group difference versus placebo increasing from 1.8 points at Week 26 to 2.8 points at Week 52). Overall, Inebilizumab represents a new effective treatment option for patients with gMG.

About gMG

Myasthenia gravis (MG) is an acquired autoimmune disease characterized by impaired neuromuscular junction transmission, with typical clinical features including fluctuating muscle weakness and easy fatigability. The global prevalence of this disease is approximately 12.4 per 100,000 people. In China, the incidence of MG is approximately 0.68 per 100,000 people, with a slightly higher rate in females than in males. Approximately 85% of patients have generalized myasthenia gravis (gMG), in which multiple muscle groups may be affected, significantly impairing quality of life^[2-3].

The disease is primarily driven by autoantibodies such as AChR and MuSK, which target and damage key proteins at the neuromuscular junction. CD19+ B cells (particularly plasmablasts and a subset of plasma cells) are the upstream producers of these pathogenic antibodies. B cells play a central role in the pathogenesis of gMG^[4-6].

References

[1] Nowak R, Benatar M, Ciafaloni E, et al. A phase 3 trial of inebilizumab in generalized myasthenia gravis. N Engl J Med. 2025;392(23):2309-2320.

[2] 中华医学会神经病学分会神经免疫学组.中国重症肌无力诊断和治疗指南(2025版)[J].中华神经科杂志, 2025, 58(07):721-741.DOI:10.3760/cma.j.cn113694-20250120-00041.

[3] Lazaridis K, Tzartos SJ. Autoantibody specificities in myasthenia gravis: implications for improved diagnostics and therapeutics. Front Immunol. 2020;11:212.

[4] Yi JS, Guptill JT, Stathopoulos P, Nowak RJ, O'Connor KC. B cells in the pathophysiology of myasthenia gravis. Muscle Nerve. 2018;57(2):172-184.

[5] Willcox HN, Newsom-Davis J, Calder LR. Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clin Exp Immunol. 1984;58:97-106.

[6] Stathopoulos P, Kumar A, Nowak RJ, O'Connor KC. Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight. 2017;2(17):e94263.