On October 12, Rongchang Biopharma (Yantai) Co., Ltd. announced that Taitasip (R&D code: RC18, product name: Taiai) has obtained the qualification certification of orphan drugs for the treatment of myasthenia gravis (MG) issued by the U.S. Food and Drug Administration (FDA). Prior to this, domestic phase II clinical study on tetacept for the treatment of systemic myasthenia gravis (gMG) has been completed and positive results have been obtained.
Orphan drug (Orphan drug), also known as rare disease drugs, refer to drugs used to prevent, treat and diagnose rare disease . The FDA-granted orphan drug qualification certification is applicable to drugs and biological agents with rare diseases with less than 200,000 people per year in the United States. The certified drugs can enjoy incentive policies such as fast track application for marketing, 7-year R&D exclusive period after marketing, and tax incentives in the United States.
According to reports, myasthenia gravis is a rare, chronic autoimmune disease that can cause impairment of neuromuscular junction transmission, which can affect eye movement, swallowing, speech, activity and respiratory function to varying degrees. About 85% of patients will experience symptoms other than the eye muscles, develop systemic myasthenia gravis, and even develop myasthenia gravis crisis. It has been included in the "First Rare Diseases Catalog" of my country.
At present, the main treatment methods of this disease include cholinesterase inhibitors, glucocorticoid and immunosuppressant . However, some patients still cannot fully and effectively control the disease due to drug efficacy, tolerance or contraindications, and there are a large number of unmet clinical needs.
Tetazep is an antibody fusion protein drug molecule invented and designed by Professor Fang Jianmin, CEO of Rongchang Biotechnology and Chief Science Officer. It can treat various autoimmune diseases mediated by B cells, including systemic lupus erythematosus and indications of myasthenia gravis. In March 2021, the first indication of titazep was approved by the China National Medical Products Administration (NMPA) in China for the treatment of systemic lupus erythematosus (SLE), becoming the world's first dual-target biological new drug in the field of treatment of this disease. In the first half of this year, Tatetacept completed a phase II clinical trial for the treatment of myasthenia gravis and obtained positive results.
As of now, in addition to the indications of systemic lupus erythematosus and myasthenia gravis, clinical research on multiple other indications of tetacept in the field of autoimmune diseases has also entered the phase II/III clinical research stage. Among them, the two indications of neuromyelitis optic lineage disease and rheumatoid arthritis have entered the phase III clinical stage. Multiple sclerosis indications are undergoing phase II clinical practice. Indications such as IgA nephropathy and Sjogren's syndrome have completed the phase II clinical trials in China, reaching the main endpoint.
Image source: Rongchang Bio
Source: Beijing Daily Client Reporter Yuan Lu
Process Editor: u028
Copyright Statement: The copyright of the text belongs to Beijing News Group and may not be reproduced or adapted without permission.
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