Hansoh Pharma's Innovative Drug Inebilizumab Gains New Approval for IgG4-Related Disease as Innovative Products Account for 83% of Revenue

　　【Pharmaceutical Network Product InformationAt the start of September, the field of innovative drugs in China welcomed good news. The website of the National Medical Products Administration (NMPA) showed that the new indication for Inebilizumab Injection, developed by Hansoh Pharma's Changzhou Hengbang, was approved for marketing. It is used to treat adult patients with Immunoglobulin G4-Related Disease (IgG4-RD). This news has brought new hope to patients suffering from IgG4-RD.
 

IgG4-RD is a chronic, systemic, immune-mediated fibroinflammatory disease that can affect multiple organ systems, such as the pancreas, salivary glands, lacrimal glands, retroperitoneal tissues, etc. Its clinical manifestations are complex and diverse, often leading to organ enlargement and dysfunction, significantly impacting patients' quality of life. Due to the rarity and complexity of the disease, treatment options for IgG4-RD have been relatively limited, with patients often facing long-term suffering and a high risk of recurrence.
 

Inebilizumab, as a B-cell depleting antibody targeting CD19, has brought new ideas and methods for the treatment of IgG4-RD. Its mechanism of action mainly involves binding to the CD19 antigen on the surface of B cells, triggering a series of immune responses that ultimately lead to B-cell depletion, thereby reducing the production of inflammatory mediators and inhibiting disease progression. This targeted treatment approach, compared with traditional immunosuppressive therapy, offers higher specificity and effectiveness while minimizing damage to normal cells and reducing the risk of adverse reactions.
 

The approval of Inebilizumab for IgG4-RD is mainly based on the positive results of the global pivotal Phase III trial MITIGATE. The study data showed that during the 52-week placebo-controlled period, compared with placebo, the risk of IgG4-RD relapse in subjects treated with Inebilizumab was significantly reduced by 87%, which was clinically and statistically significant. Among the 68 subjects treated with Inebilizumab, 7 experienced relapses, while among the 67 subjects treated with placebo, 40 experienced relapses. In addition, 57.4% (39/68) of subjects treated with Inebilizumab achieved complete remission without relapse and without the need for treatment at week 52, compared to 22.4% (15/67) in the placebo group (P <0.001); 58.8% (40/68) of subjects treated with Inebilizumab achieved complete remission without relapse and without the need for corticosteroids at week 52, compared to 22.4% (15/67) in the placebo group (P <0.001).
 

Reviewing the Development History of Inebilizumab: A Journey Full of Challenges and Breakthroughs
 

For the vast number of IgG4-RD patients, the approval of Inebilizumab is undoubtedly a timely rain. It provides patients with a new and effective treatment option, which is expected to significantly improve patient prognosis and enhance quality of life. At the same time, this will also promote further development in the field of IgG4-RD treatment, providing valuable experience and reference for more related research.
 

According to reports, in recent years, Hansoh Pharma has continued to increase its R&D investment, and innovative drugs have gradually entered the harvest period. Under the positive impact of innovative drug revenue, Hansoh Pharma submitted a report card showing double-digit growth in both revenue and net profit for the first half of the year.
 

In the first half of 2025, the company achieved revenue of approximately RMB 7.434 billion, representing a year-on-year increase of about 14.3%. Of this, revenue from innovative drugs and collaboration products amounted to approximately RMB 6.145 billion, marking a year-on-year growth of about 22.1%, accounting for approximately 82.7% of total revenue. Additionally, the company's profit in the first half of the year was approximately RMB 3.135 billion, reflecting a year-on-year increase of about 15%.
 

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