Results of China Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis Selected for Oral Presentation at 2025 AANEM Annual Meeting

Rhea-AI Summary

RemeGen (REGMY) announced that its 48-week open-label extension data from the China Phase III clinical study of telitacicept for generalized myasthenia gravis (gMG) has been selected for oral presentation at the 2025 AANEM Annual Meeting on October 29, 2025.

The previously presented 24-week data showed exceptional results with 98.1% of patients achieving ≥3 points improvement in MG-ADL score and 87% achieving ≥5 points improvement in QMG score, demonstrating the highest MG-ADL response rate among Phase III gMG treatments. In June 2025, RemeGen out-licensed telitacicept to Vor Bio (VOR), which is now conducting global Phase III trials across multiple regions.

Positive

• Achieved highest MG-ADL response rate (98.1%) among Phase III gMG treatments
• Successfully out-licensed to Vor Bio for global development
• Global Phase III trial expansion across multiple regions
• Strong efficacy data with 87% of patients showing significant QMG score improvement

Negative

• None.

Insights

Biotechnology Medical Researcher

RemeGen's telitacicept shows exceptional 98.1% response rate in Phase III gMG trial, positioning it as potential best-in-class therapy.

The announcement regarding RemeGen's telitacicept (RC18) represents a significant milestone in the treatment landscape for generalized myasthenia gravis (gMG). The 48-week open-label extension data being selected for oral presentation at the prestigious AANEM Annual Meeting highlights the scientific community's recognition of this therapy's potential importance.

The previously released 24-week data reveals remarkably high response rates that stand out in the competitive landscape: 98.1% of patients achieved a clinically meaningful improvement of ≥3 points in MG-ADL scores, while 87% reached the important threshold of ≥5 points improvement in QMG scores. These metrics are crucial for assessing real-world functional benefits for patients with this debilitating neuromuscular condition.

What makes telitacicept particularly noteworthy is its dual-targeting mechanism against BLyS and APRIL, addressing the autoimmune pathology of myasthenia gravis at multiple levels. The company's claim that telitacicept has demonstrated the highest MG-ADL response rate among drugs completing Phase III trials in gMG suggests a potential competitive advantage in efficacy.

The out-licensing agreement with Vor Bio (Nasdaq: VOR) in June 2025 provides validation from an external biopharmaceutical company and enables acceleration of the global Phase III program across multiple regions. This expanded development pathway increases the likelihood of eventual regulatory submissions in major markets beyond China, significantly expanding the potential market for this therapy if approved.

YANTAI, China, Sept. 17, 2025 /PRNewswire/ -- RemeGen (688331.SH/09995.HK) announced that the 48-week open-label extension (OLE) data from China Phase III clinical study of telitacicept (RC18, brand name: 泰爱®, a BLyS/APRIL dual-target fusion protein innovative drug independently developed by RemeGen) for the treatment of generalized myasthenia gravis (gMG) was selected as an oral presentation at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. The meeting will be held from October 29 to November 1, 2025, local time, at the Hilton San Francisco Union Square in California, USA.

Oral Presentation Details

Presentation Title: Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis: Results from a Phase 3 Study
Session: MGFA. This session, invited by the Myasthenia Gravis Foundation of America (MGFA) Medical and Scientific Advisory Committee (MSAC), features clinical and scientific experts sharing current and future peer-reviewed research findings on myasthenia gravis (MG).
Presentation Time: October 29, 2025, at 10:50 AM Pacific Standard Time (October 30, 1:50 AM Beijing Time).

Previously, at the 2025 American Academy of Neurology (AAN) Annual Meeting held in March this year, RemeGen presented the 24-week data from the Phase III study of telitacicept for myasthenia gravis. The results showed that 98.1% of patients achieved an improvement of ≥3 points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, and 87% of patients achieved an improvement of ≥5 points in the Quantitative Myasthenia Gravis (QMG) score. Among drugs that have completed Phase III clinical studies for generalized myasthenia gravis, telitacicept has demonstrated highest MG-ADL response rate. The complete 48-week data to be presented at the AANEM Annual Meeting should further highlight telitacicept's potential to become a best-in-class therapy in the field of myasthenia gravis.

In June 2025, RemeGen out-licensed telitacicept to Vor Bio (Nasdaq: VOR) and Vor Bio is actively advancing the global multicenter Phase III clinical trial of telitacicept for generalized myasthenia gravis (gMG), with patient recruitment progressing smoothly in the United States, Europe, South America, and the Asia-Pacific region.

About Telitacicept

Telitacicept is the world's first and first-in-class injectable recombinant B-lymphocyte stimulator (BLyS)/A proliferation-inducing ligand (APRIL) dual-target fusion protein developed by RemeGen. It simultaneously inhibits the binding of BLyS and APRIL cytokines to their receptors on B cells, preventing abnormal differentiation and maturation of B cells, thereby treating autoimmune diseases. Telitacicept has been approved in China for the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG).

About Vor Bio

Vor Bio is a clinical-stage biotechnology company committed to the treatment of autoimmune diseases. The company focuses on rapidly advancing the Phase III clinical development and commercialization of the novel dual-target fusion protein telitacicept to meet the needs of patients with autoimmune diseases worldwide. For more information, please visit www.vorbio.com.

About Generalized Myasthenia Gravis (gMG)

gMG is a rare, chronic autoimmune disorder that disrupts communication between nerves and muscles, leading to muscle weakness that can affect mobility, vision, swallowing, and breathing. The disease is antibody-mediated, primarily by autoantibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), which interfere with neuromuscular transmission. Despite various treatment options, many patients continue to suffer from refractory symptoms or significant side effects. There is a significant unmet clinical need for new therapies that offer long-lasting efficacy, safety, and convenience. Currently, there are approximately 90,000 gMG patients in the US, 140,000 in Europe, and 29,000 in Japan.

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SOURCE RemeGen Co., Ltd

FAQ

What are the Phase III clinical trial results for RemeGen's telitacicept in gMG patients?

The 24-week data showed 98.1% of patients achieved ≥3 points improvement in MG-ADL score and 87% achieved ≥5 points improvement in QMG score, demonstrating the highest MG-ADL response rate among Phase III gMG treatments.

When will RemeGen present the 48-week telitacicept data at AANEM 2025?

RemeGen will present the 48-week data on October 29, 2025, at 10:50 AM Pacific Standard Time at the Hilton San Francisco Union Square.

Who is developing telitacicept globally for gMG treatment?

Vor Bio (VOR) obtained the license from RemeGen in June 2025 and is conducting global Phase III trials across the United States, Europe, South America, and Asia-Pacific.

What makes RemeGen's telitacicept unique in the gMG treatment landscape?

Telitacicept has demonstrated the highest MG-ADL response rate among all drugs that have completed Phase III clinical studies for generalized myasthenia gravis.

What is telitacicept's mechanism of action for treating gMG?

Telitacicept (RC18) is a BLyS/APRIL dual-target fusion protein innovative drug developed by RemeGen for treating generalized myasthenia gravis.