On May 27th, RemeGen Co., Ltd. (688331.SH / 09995.HK) announced that its independently-designed and -developed novel fusion protein targeting both BLyS and APRIL, telitacicept (synonym: RC18, brand name: 泰爱®), was approved for marketing by China’s National Medical Products Administration (NMPA), in combination with conventional therapeutic drugs for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis (gMG), which is the third indication for telitacicept approved for marketing following systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

As the first brand-name biological medication targeting BLyS/APRIL for gMG approved for marketing around the globe, the approval not only brought new therapy for patients but also filled the gap of domestically developed innovative medication for the treatment of gMG in China, with the potential to reshape the treatment landscape of gMG. Telitacicept was previously granted breakthrough therapy designation (BTD) and priority review by China’s NMPA and orphan drug designation and fast track designation by U.S. FDA.

Myasthenia gravis (MG) is an autoimmune disease caused by disorders of neuromuscular junction (NMJ), characterized by fluctuating muscle weakness, fatigue, long treatment cycles and high recurrence rate. About 80%-85% of MG patients are AChR antibody positive and over 85% of the patients will progress to gMG within 24 months of flare. According to the research report published by Frost & Sullivan, globally, 1.2 million people are suffering from MG, including 220,000 patients in China. At present, there is a great unmet medical demand.

Telitacicept is consisted of the extracellular domain of the transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) and the Fc region of human immunoglobulin G (IgG) and targets B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), acting on the source of pathogenic antibody ­— B cell and plasma cell.

Data of the Phase 3 study presented at the American Academy of Neurology (AAN) Annual Meeting 2025 on April 9 demonstrated significant clinical benefits and manageable safety profiles of telitacicept in treating gMG. According to the study, at Week 24, 98.1% of the participants in the telitacicept 240 mg group experienced a ≥ 3-point reduction in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, markedly higher than that of the placebo group (12%); the reduction from baseline in MG-ADL score was 5.74 points for the former and 0.91 point for the latter; 87% of the participants in the telitacicept 240 mg group experienced a ≥ 5-point reduction in Quantitative Myasthenia Gravis (QMG) score, markedly higher than that of the placebo group (16.0%); the reduction from baseline in QMG score was 8.66 points for the former and 2.27 point for the latter. The overall adverse event (AE) incidence of telitacicept was comparable to that of placebo, suggesting a manageable safety profile of telitacicept.

Telitacicept has the highest MG-ADL response rate among all drugs for gMG with Phase 3 studies reported to date. The recent BLA approval allows more patients with gMG in China to benefit from it and to see the possibility of achieving more ambitious treatment goals in the long-term management of gMG. RemeGen is advancing a global multicenter Phase 3 study on telitacicept in treating gMG, aiming to validate the efficacy and safety of telitacicept in a wider patient population, and to support oversea BLA submission.

“It’s exciting to see telitacicept approved for treating gMG in China. As demonstrated in the Phase 3 study, this agent enabled rapid and significant clinically meaningful improvement among the gMG patients and was well tolerated. The approval marks a great breakthrough and key progress in neuroimmunology, provides high-quality evidence for the clinical use of telitacicept for gMG, and reshapes the treatment landscape with a new targeted therapy option. RemeGen is seeking addition of telitacicept for treating gMG to the catalog of medicines covered by China’s national medical insurance system. I believe once it succeeds, an even larger population will benefit from this novel and effective treatment option.” noted Professor Jian Yin from Beijing Hospital, the principal investigator of the aforementioned study.

“It’s of great significance that telitacicept has been approved by NMPA for the treatment of gMG patients. Now, neurologists in China can provide a more targeted and effective treatment to their patients. I’m looking forward to seeing it listed in the coverage of China’s national medical insurance, to help relieve medical burdens of gMG patients and their households and improve the quality of their life. RemeGen is advancing a global multicenter Phase 3 study on telitacicept for this indication. We expect cooperation with experts and professionals worldwide to promote continuous improvement in the diagnosis and treatment of autoimmune disease.” said Dr. Jianmin Fang, CEO of RemeGen.