Hansoh Pharma's Inebilizumab Approved in China for Generalized Myasthenia Gravis

On March 27, the NMPA official website showed,Inebilizumab Injection Approved for New Indication in China, Used for TreatingAdult patients with generalized myasthenia gravis (gMG)。

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 regionsThe exclusive license for the development and commercialization of this product (Viela Bio was acquired by Horizon Therapeutics in 2021, which was then acquired by Amgen in 2023).

In March 2022, Inebilizumab was approved for the first time in China, indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies. In September 2025, Inebilizumab received approval for a new indication, applicable for adult patients with Immunoglobulin G4-related disease (IgG4-RD). This marks the drug's newly approvedThe Third Indication。

Screenshot source: Insight database

The approval and market launch of this new indication are based on the positive results of its global pivotal Phase III trial, MINT. MINT is a randomized, double-blind, multicenter, placebo-controlled, Phase III study (with an open-label phase) designed to evaluate the efficacy and safety of inebilizumab in adult patients with severe myasthenia gravis. The primary endpoint was at Week 26 for the overall study population.Myasthenia Gravis Daily Living Scale（MG-ADL）Change in Score Relative to Baseline。

Results at Week 26 showed that, compared with placebo, patients in the inebilizumab treatment groupGreater reduction in MG-ADL score(Least squares means were -4.2 and -2.2, difference -1.9, 95% CI: -2.9 to -1.0, P<0.001); in terms of Quantitative Myasthenia Gravis (QMG) score, the Inebilizumab groupThe decrease was also significantly greater than that of the placebo group.(The least squares means were -4.8 and -2.3, with a difference of -2.5, 95% CI: -3.8 to -1.2, P<0.001). This efficacy was particularly significant in the AChR+ population.

The trial also assessed the change in MG-ADL scores from baseline to Week 52 in AChR+ patients, with the inebilizumab group compared to the placebo group.Continuously Demonstrating Superior Efficacy(Corrected difference: -2.8, 95% CI: -3.9 to -1.7). In the inebilizumab group, AChR+ patients72.3%Achieving an improvement of ≥3 points in MG-ADL score, the placebo group was 45.2%.

At Week 52, the improvement in QMG scores from baseline in the inebilizumab group was also superior to that in the placebo group (adjusted difference -4.3, 95% CI: -5.9 to -2.8). Among AChR+ patients in the inebilizumab group,69.2%Achieving a QMG score improvement of ≥3 points, the placebo group was 41.8%.

In terms of safety, no new safety signals were identified during the study period. The adverse event (TEAE) profile was consistent with the known safety profile. The most common adverse events included infusion-related reactions, nasopharyngitis, and urinary tract infections.

In the field of myasthenia gravis, several products have been approved for marketing in China, includingTelitacip(Rongchang Bio)Zelucubrene Sodium(UCB),Rozelicixizumab(UCB),Efgartigimod(Argenx/Zai Lab),Relatlimab(AstraZeneca), etc.

Source: Dingxiangyuan Insight Database

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