RemeGen Stock Up On Positive Phase 3 Trial Results Of Telitacicept In Myasthenia Gravis Patients

(RTTNews) - Shares of RemeGen Co., Ltd. gained around 10 percent in the Hong Kong trading on Wednesday after the Chinese biotechnology company revealed positive results from the Phase 3 clinical trial to assess the efficacy and safety of Telitacicept, also known as RC18, in patients with Generalized Myasthenia Gravis or gMG.

On the Hong Kong Stock Exchange, the stock traded up 9.6 percent to close at HK$25.950.

With the highest Myasthenia Gravis Activities of Daily Living or MG-ADL response rate among all drugs for gMG with phase 3 studies reported to date, Telitacicept will provide an important new treatment option for gMG, the company noted.

Myasthenia Gravis is an autoimmune disease that disrupts neuromuscular junction transmission, leading to fatigue, fluctuating symptoms, long treatment durations, and a high recurrence rate. Over 85 percent of the patients move on to Generalized Myasthenia Gravis, within 24 months of the onset of the disease.

Telitacicept, developed by RemeGen, is a fusion protein, which independently targets both BlyS and APRIL.

The Phase 3 clinical trial was done in China and led by Professor Jian Yin of Beijing Hospital.

A total of 114 gMG patients were enrolled in the study, with 57 patients each in the Telitacicept 240 mg group and the placebo group. The company said that the trial included a 24-week double-blind treatment phase followed by an open-label treatment phase. The positive results are from the double-blind treatment phase.

According to RemeGen, the results revealed that among patients in the Telitacicept 240 mg group, majority showed reduction in the MG-ADL score and Quantitative Myasthenia Gravis or QMG score at Week 24.

Commenting on the trial results, Principal Investigator Yin Jian said, "Telitacicept demonstrated rapid and significant clinical improvement in the phase 3 trial, and was well tolerated. Its dual-targeting mechanism not only inhibits abnormal B cells and plasma cells thoroughly and reduces the level of pathogenic antibodies, but also effectively slows down disease progression in the long term, and reduces steroid dosage as symptoms improve, providing a more precise, efficient, persistent, and safer option for gMG treatment."

The trial results were presented during the Late-Breaking Science Session at the 2025 American Academy of Neurology Annual Meeting held in San Diego, California.