RemeGen’s Telitacicept Gains China Approval for Myasthenia Gravis

This article first appeared on NeurologyLive^®.

China’s National Medical Products Administration (NMPA) recently approved telitacicept (RemeGen), an investigational agent, for the treatment of adult patients with anti–acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) to be used in combination with conventional therapies.

Telitacicept functions by attaching to and blocking the effects of 2 key signaling proteins: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). The therapeutic, which showed promise in a phase 3 study, is designed by combining the extracellular domain of the TACI receptor with the fragment crystallizable region of human immunoglobulin G. By simultaneously targeting BLyS and APRIL, it disrupts the production of pathogenic antibodies at their source, specifically attacking the growth and longevity of plasma cells and mature B cells.²

"We sincerely congratulate the approval of the therapeutic indication of telitacicept for MG! Telitacicept demonstrated rapid and significant clinical improvements in the phase 3 trial with good tolerability," said principal researcher, Yin Jian, MD, Beijing Hospital, in a statement.¹ "This is a major breakthrough and key progress for Chinese innovative drugs in the field of neuro-immune diseases.

"It provides a high profile basis for evidence-based clinical application of telitacicept in the treatment of MG, and has also opened up a new paradigm of precise treatment in this field. We believe that with the inclusion of this indication in the medical insurance, telitacicept will bring new and more effective treatment options to more patients."

Telitacicept, which showed promise in a phase 3 study, is designed by combining the extracellular domain of the TACI receptor with the fragment crystallizable region of human immunoglobulin G. Image Credit: Maggie L. Shaw/sora.chatgpt.com

The drug was approved based on phase 3 data that demonstrated a clinically significant efficacy and safety profile in patients with gMG. According to RemeGen, telitacicept demonstrated the highest Myasthenia Gravis-Activities of Daily Living (MG-ADL) response rate among all gMG treatments that have successfully completed phase 3 clinical trials.

The data, presented at the 2025 American Academy of Neurology Annual Meeting, showed that 98.1% of patients at 24 weeks in the telitacicept group demonstrated at least a 3-point improvement in MG-ADL score compared with 12.0% of those on placebo. In addition, MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were significantly improved relative to the placebo.

In the phase 3 study, MG-ADL scores decreased by 5.74 points in the telitacicept group vs 0.91 point in the placebo. Eighty-seven percent of telitacicept-treated patients showed at least a 5-point improvement in the QMG score, much higher than the 16.0% observed in the placebo group. QMG scores decreased by 8.66 points in the telitacicept group compared with 2.27 points in the placebo. Overall, telitacicept demonstrated a lower overall adverse event rate (45.6%) compared with placebo (59.6%), supporting a good safety profile.¹

MG affects approximately 220,000 patients in China and 80,000 in the US. There is no cure, but promising treatments like telitacicept have potential to improve symptoms and quality of life in patients with gMG. Telitacicept has also been approved in China for the treatment of systemic lupus erythematosus and rheumatoid arthritis.³

“RemeGen is advancing the global phase 3 clinical study of telitacicept for MG. We are looking forward to working closely with global experts and scholars to contribute to the continuous advancement of treating autoimmune diseases,” said Fang Jianmin, CEO of RemeGen, in a statement.¹

RemeGen's ongoing global phase 3 clinical study of telitacicept is currently accepting participants, offering a promising treatment option to address the unmet medical need in MG and demonstrating RemeGen’s commitment to advancing autoimmune disease therapeutics around the world.

References

1. RemeGen: Telitacicept for the treatment of generalized myasthenia gravis approved in China. News release. RemeGen; May 27, 2025. Accessed June 19, 2025. https://www.prnewswire.com/news-releases/remegen-telitacicept-for-the-treatment-of-generalized-myasthenia-gravis-approved-in-china-302465629.html
2. Dhillon S. Telitacicept: first approval. Drugs. 2021;81(14):1671-1675. doi:10.1007/s40265-021-01591-1
3. Kim T. Prevalence of myasthenia gravis in the US and worldwide. MGTeam. February 20, 2025. Accessed June 19, 2025. https://www.mgteam.com/resources/prevalence-of-myasthenia-gravis-in-the-us-and-worldwide