RemeGen Announces the Acceptance of the Marketing Application of Telitaccept for the Treatment of Myasthenia Gravis in China

Rhea-AI Summary

RemeGen announced that its drug Taicercept® for treating generalized myasthenia gravis (gMG) has been accepted for marketing application by China's Center for Drug Evaluation (CDE) and included in priority review. The drug targets a rare chronic autoimmune disease affecting an estimated 217,000 patients in China, with global cases expected to reach 1.5 million by 2025. Telitacept, a dual target antibody fusion protein, completed Phase III clinical trials in China in August 2024, showing continuous and effective improvement in gMG patients. The drug has received orphan drug and fast track status from the FDA and breakthrough therapy status from China's NMPA.

Positive

• Marketing application accepted with priority review status in China
• Large market potential with 217,000 patients in China and 1.5 million globally by 2025
• Successful completion of Phase III clinical trials showing effective improvement
• Received multiple regulatory designations (orphan drug, fast track, breakthrough therapy)
• Global expansion with US Phase III trial initiation

Negative

• None.

YANTAI, China, Oct. 29, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced that the marketing application of Taicercept ® for the treatment of generalized myasthenia gravis (gMG) has been officially accepted by the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration and has been included in the priority review and approval process.

Myasthenia gravis (MG) is a rare chronic autoimmune disease that has been included in the First List of Rare Diseases in China. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.5 million in 2025, and the number of patients in China is about 217,000. The disease involves immunoglobulin G (IgG) antibodies that disrupt synaptic transmission between nerves and muscles, leading to muscle weakness and, in severe cases, life threatening risks. More than 85% of patients develop generalized myasthenia gravis within 24 months of disease onset, characterized by extreme fatigue and significant difficulty with facial expression, speech, swallowing, and mobility.

Currently, there is no satisfactory treatment for myasthenia gravis, and effective, safe and precise targeted biological agents have become a hot spot in the research and development of myasthenia gravis drugs. In recent years, B-cell targeted therapies have shown a good therapeutic prospect in myasthenia gravis treatment. Studies have found that compared with traditional immunotherapy, B-cell targeted therapies can significantly reduce the recurrence rate of myasthenia gravis, and the withdrawal rate is low. Teritacept is a dual target antibody fusion protein, which can target BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and resulting in therapeutic effect.

In August 2024, the company announced the completion of the domestic phase Ⅲ clinical trial of telitacept in the treatment of generalized myasthenia gravis. The results of the clinical study showed that telitacept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Internationally, the global multicenter phase Ⅲ clinical trial of gMG has achieved the first patient enrollment in the United States in August 2024. Telitacicept has been granted orphan drug and fast track status by the Food and Drug Administration (FDA) of the United States, and breakthrough therapy status by National Medical Products Administration (NMPA) of China.

About Telitacicept (RC18) 

Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatment of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted complete marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023 and rheumatoid arthritis (RA) in July 2024.

About RemeGen Co. Ltd.

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases.

For more details, please visit: www.remegen.com

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SOURCE RemeGen Co., Ltd

FAQ

What is the status of Telitacept's marketing application for myasthenia gravis in China?

The marketing application has been accepted by China's Center for Drug Evaluation (CDE) and included in the priority review process.

How many myasthenia gravis patients are expected globally by 2025?

According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.5 million by 2025.

What regulatory designations has Telitacept received for myasthenia gravis treatment?

Telitacept has received orphan drug and fast track status from the FDA, and breakthrough therapy status from China's NMPA.

When did RemeGen complete Phase III clinical trials for Telitacept in China?

RemeGen completed the Phase III clinical trials for Telitacept in China in August 2024.