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Hansoh Pharma's CD19 Monoclonal Antibody Inebilizumab Gains First Global Approval for IgG4-Related Disease

Sep 01, 2025 16:36 CST Updated 16:36
Hansoh Pharma

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On September 1, the NMPA official website showed,Inebilizumab Injection Approved for New Indication in ChinaTreatment of Immunoglobulin G4-Related Disease（IgG4-RD）. PreviouslyThis indication has been included in the priority review by the CDE.

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Screenshot source: NMPA official website

Inebilizumab is a targeted CD19 B-cell depleting antibody. On May 24, 2019,Hansoh Pharma Enters into Licensing Agreement with Viela Bio, obtained inMainland China, Hong Kong, and Macao regionsExclusive License for the Development and Commercialization of the Product(Viela Bio was acquired by Horizon Therapeutics in 2021, which was then acquired by Amgen in 2023.)。

In 2020, Inebilizumab was approved in the United States.FDA AboveCity approval,Used forAnti-Aquaporin 4（AQP4）Antibody-Positive Neuromyelitis Optica Spectrum Disorders（NMOSD）Treatment of Adult PatientsIn April 2025, the drug received FDA approval for a new indication, used forTreatmentAdult IgG4-RD. In China,Inebilizumab was first approved by the NMPA for marketing in March 2022, and this is the second approved indication for the drug.

This approval is mainly based onGlobal Pivotal Phase III Trial MITIGATEThe positive results. MITIGATE was conducted at 80 clinical trial research centers across 22 countries, including China.

This is the first randomized, double-blind, placebo-controlled study conducted in IgG4-related disease, confirming the safety and efficacy of Inebilizumab in treating IgG4-RD through CD19+B cell depletion. Specific results showed:

  • During the 52-week placebo-controlled period, compared with placebo, subjects receiving inebilizumab treatmentThe risk of IgG4-RD recurrence was significantly reduced by 87%., with clinical significance and statistical significance(Hazard ratio 0.13, P<0.001); Among the 68 subjects treated with inebilizumab, 7 experienced relapses, while among the 67 subjects treated with placebo, 40 experienced relapses.
  • During the placebo-controlled period, the annualized relapse rate was reduced in patients receiving treatment as determined by the adjudication committee;Subjects receiving inebilizumab treatment were 0.10, while the figure for subjects receiving placebo was 0.71.（P<0.001）。
  • 57.4%（39/68）Subjects treated with Inebilizumab achieved complete remission without relapse or need for further treatment at Week 52, compared to 22.4% in the placebo group.（15/67）(P<0.001)。
  • 58.8%（40/68）Subjects treated with Inebilizumab achieved complete remission without relapse and without the need for corticosteroids at Week 52, compared to 22.4% in the placebo group.（15/67）(P<0.001)。

  • Validation of Inebilizumab's Unique Mechanism of Action: Rapid and Sustained Depletion of Peripheral B Cells to Reduce Levels of Disease Biomarkers.

It is worth noting that,89.7%（61/68）Subjects receiving inebilizumab during the placebo-controlled periodNo need to use glucocorticoids to control the disease., while the proportion in the placebo group was 37.3%.（25/67）By Week 8, the total glucocorticoid dosage in the inebilizumab-treated group was reduced 10-fold compared to the placebo group.
Insight database shows that currently, only two CD19 monoclonal antibodies have been approved globally, and Inebilizumab is one of them.The FirstProducts Approved for IgG4-RD（Tislelizumab is only approved for use inDiffuse Large B-Cell Lymphoma and Follicular Lymphoma）。
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Screenshot source: Insight database

Insight Database Compiled the 2025 Global New Drug Approval and Market Launch List，Scan the QR code below and reply with the keywordNew Drug ApprovedCan be obtained for free（Updated once a month, currently updated to July)。

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Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment options. If necessary, please consult and contact正规医疗机构.


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