China’s National Medical Products Administration (NMPA) granted drug registration approval on March 25, 2026, for Xinyue (inebilizumab injection) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The inebilizumab approval, secured by Hansoh Pharmaceutical Group, marks the third indication for the product in China, following earlier approvals for neuromyelitis optica spectrum disorder (NMOSD) in 2022 and immunoglobulin G4-related disease (IgG4-RD) in 2025.
Inebilizumab is a humanized anti-CD19 monoclonal antibody originally discovered at MedImmune, AstraZeneca’s biologics unit, and subsequently developed through Viela Bio. Hansoh licensed exclusive China rights in May 2019; those rights now sit opposite Amgen, which acquired the global asset through successive purchases of Viela Bio (2021) and Horizon Therapeutics (2023). The drug is marketed by Amgen under the brand name Uplizna.
The NMPA drug registration approval specifies that inebilizumab injection in China is to be used in combination with conventional therapeutic drugs. The approved population encompasses adult gMG patients positive for either AChR or MuSK antibodies, a label that distinguishes it from several other targeted biologics approved elsewhere that are restricted to AChR-positive patients only.
The approval of inebilizumab for myasthenia gravis in China adds to a competitive landscape that has expanded considerably since 2021. In the US, the US FDA has approved multiple targeted biologics for gMG across three distinct mechanisms: FcRn inhibitors including efgartigimod (Vyvgart, argenx, 2021), rozanolixizumab (Rystiggo, UCB, 2023), and nipocalimab (Imaavy, Johnson & Johnson, 2025); complement C5 inhibitors including ravulizumab (Ultomiris, Alexion/AstraZeneca, 2022) and zilucoplan (Zilbrysq, UCB, 2023); and the earlier complement inhibitor eculizumab (Soliris, 2017). In China specifically, RemeGen’s telitacicept, a dual BLyS/APRIL inhibitor, received NMPA approval for AChR-positive gMG in May 2025.
Inebilizumab is the only approved anti-CD19 agent for gMG in any jurisdiction, and its mechanism differs from anti-CD20 agents such as rituximab — used off-label in MuSK-positive disease — by targeting a broader range of B-lineage cells, including plasmablasts and some plasma cells involved in pathogenic antibody production. The inclusion of both AChR-positive and MuSK-positive patients in the label is notable, as MuSK-positive gMG represents a subgroup that responds poorly to conventional immunosuppression and has been excluded from the approved populations of most complement and FcRn inhibitors.
For Hansoh, the approval extends a deliberate strategy of expanding inebilizumab across autoantibody-mediated diseases in the Chinese market. Xinyue was first included in China’s National Reimbursement Drug List for NMOSD in January 2023, with that listing renewed in November 2024, a factor that could facilitate future reimbursement discussions for the gMG indication. Generalized myasthenia gravis affects an estimated 15–25 per 100,000 people globally, with a substantial and growing patient population in China. Conventional treatment relies on corticosteroids and immunosuppressants such as azathioprine and mycophenolate, therapies associated with cumulative toxicity and incomplete disease control in a substantial minority of patients. The pipeline continues to evolve, with assets including batoclimab (Immunovant/Harbour BioMed), pozelimab plus cemdisiran (Regeneron/Alnylam), and CAR-T approaches such as Descartes-08 (Cartesian Therapeutics) in various stages of clinical development.