Hansoh Pharma's XinYue Expands Indication to Generalized Myasthenia Gravis, Offering New Treatment Option for Adult Patients

Recently, the National Medical Products Administration approved a new indication for a rare disease drug. Hansoh Pharma's innovative drug Inebilizumab Injection (brand name: Xunyue) has been approved for an additional indication: in combination with conventional treatments, for the treatment of adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. This is the third rare disease indication approved for Xunyue in China, following previous approvals covering neuromyelitis optica spectrum disorder (NMOSD) and Immunoglobulin G4-related disease (IgG4-RD), two major rare disease areas.

Generalized Myasthenia Gravis is a rare chronic autoimmune neuromuscular disease, caused by dysfunction in neuromuscular junction transmission. Its core characteristics include fluctuating skeletal muscle weakness and easy fatigability, potentially affecting the ocular muscles, pharyngeal muscles, and respiratory muscles. Severe cases may lead to life-threatening respiratory failure.

Xinyue is a B-cell depleting agent targeting CD19. This approval is based on the positive results of the global pivotal Phase III MINT study: Inebilizumab demonstrated clinically meaningful and statistically significant efficacy in both AChR+ and MuSK+ myasthenia gravis patients. The related research findings were successively published in The New England Journal of Medicine and selected for the latest breakthrough oral presentation at the 2025 American Academy of Neurology (AAN) Annual Meeting.