#China #Yantai #RemeGen #Myasthenia Gravis #Telitacicept

RemeGen's Telitacicept Approved for Myasthenia Gravis Treatment in China

On May 27, 2025, RemeGen Co., Ltd. announced the official approval of Telitacicept by the National Medical Products Administration (NMPA) in China. This groundbreaking drug is aimed at adult patients suffering from anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG), and will be used in combination with conventional therapies.

Telitacicept stands out as the world’s first innovative biologic therapy designed to target both B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). With this approval, RemeGen not only introduces a new treatment option but also fills a significant void in the availability of innovative therapies for this autoimmune disease in China. The treatment landscape for myasthenia gravis is poised for change as this approval follows Telitacicept's previous classifications as a breakthrough therapy and orphan drug designation by the FDA.

Myasthenia gravis is characterized by muscle weakness and fatigue, resulting from a disruption in neuromuscular junction transmission. Within two years of onset, over 85% of patients can progress to generalized myasthenia gravis. Internationally, around 1.2 million people live with this condition, including approximately 220,000 in China alone, highlighting a substantial need for effective treatments.

The composition of Telitacicept comprises the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor combined with the Fc domain of human immunoglobulin G (IgG). This dual-action mechanism targets and inhibits the root cause of pathogenic antibody production—B cells and plasma cells.

Recent phase III clinical trial data, which were presented at the American Academy of Neurology’s annual conference on April 9, 2025, indicated that Telitacicept has a favorable safety and efficacy profile. After 24 weeks of treatment, a remarkable 98.1% of patients receiving Telitacicept showed a significant improvement of at least three points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, compared to only 12% in the placebo group. Furthermore, the quantitative improvement in the Quantitative Myasthenia Gravis (QMG) score recorded a reduction of 8.66 points in the Telitacicept group, contrasting sharply with a mere 2.27-point reduction for the placebo cohort.

Notably, Telitacicept exhibited the highest response rate in MG-ADL among gMG drugs that have completed phase III trials, marking a significant milestone. With this new approval, RemeGen anticipates an enhancement in the quality of life for many patients in China, paving the way for more ambitious treatment goals and better long-term disease management.

Professor Yin Jian from Beijing Hospital commented on the approval, expressing optimism for the new treatment pathway that Telitacicept represents. He emphasized the rapid and significant improvements seen during the phase III trials, coupled with good tolerability, as a pivotal development for Chinese innovative drugs in neuro-immune diseases. His hope is that inclusion in medical insurance will broaden access to this therapy for many patients.

Dr. Fang Jianmin, the CEO of RemeGen, highlighted the significance of this approval, viewing it as a new tool for clinicians to treat patients more precisely and effectively. RemeGen is also progressing with the global phase III clinical trial of Telitacicept for larger patient populations, aiming to further validate its efficacy.

In addition to its new myasthenia gravis indication, Telitacicept is already approved in China for other serious conditions, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This showcases the drug’s potential in addressing critical health challenges.

As advancements in immunotherapy continue, Telitacicept’s approval marks a hopeful horizon for those living with generalized myasthenia gravis, promising tailored and effective treatment options that could significantly enhance their quality of life.