Officially included in the breakthrough therapy variety! Remegen Taitacept was again recognized for myasthenia gravis

On November 17, Rongchang Biopharmaceutical (Yantai) Co.
, Ltd.
(688331.
SH/09995.
HK) announced that tataceptept for injection (R&D code: RC18; Trade name: Taiai ^®) was officially included in the breakthrough therapy variety by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration for the treatment of generalized myasthenia
gravis.

Breakthrough therapy drugs refer to innovative drugs or improved drugs
that are used to prevent and treat diseases that are seriously life-threatening or seriously affect the quality of life, and there are no effective prevention and treatment methods, or have more significant or important treatment methods than existing treatments.
For innovative drugs that include breakthrough therapy drugs, the Drug Review Center of the State Food and Drug Administration will prioritize the allocation of resources for communication, and the time to market of new drugs will be greatly shortened
.

The breakthrough treatment of tatacept by CDE is based on a domestic phase II.
clinical study
for the treatment of generalized myasthenia gravis.
The study led by Professor Xu Xianhao of Beijing Hospital showed that tatacept could significantly improve the condition of patients with generalized myasthenia gravis, demonstrating good efficacy and safety
.

This is the second blockbuster recognition
recently received by Tatacept in the field of myasthenia gravis.
In October 2022, Remegen announced that Tatacept Myasthenia gravis has been granted orphan drug designation by the US Food and Drug Administration (FDA
).
It is reported that the identified drugs can enjoy incentive policies
such as fast track for marketing application, a 7-year market exclusivity period after listing, and tax incentives in the United States.

About Tatacept

Tatanercept is an antibody fusion protein drug molecule invented and designed by Professor Fang Jianmin, CEO and Chief Scientific Officer of Remegen Biologics, which inhibits the overexpression of two cytokines, BLyS and APRIL, and prevents the abnormal differentiation and maturation of B cells, thereby treating B-cell-mediated systemic lupus erythematosus and other autoimmune diseases
.
Due to the first treatment mechanism and new molecular design, the world's leading data have been obtained in the phase III clinical trial of systemic lupus erythematosus, with an effective rate of 82.
6%, which is more than 30 percentage points
higher than the existing international biological drugs.
In March 2021, the indication of systemic lupus erythematosus (SLE) of tatacept was conditionally approved by the National Medical Products Administration (NMPA) of China, becoming the world's first dual-target biological new drug
in the field of treatment of this disease.
Phase III clinical studies of the drug for the treatment of rheumatoid arthritis, IgA nephritis, Sjogren's syndrome, neuromyelitis optica, myasthenia gravis, multiple sclerosis and other indications are advancing
.

About myasthenia gravis

Myasthenia gravis (MG) is a rare, chronic autoimmune disease, caused by autoantibodies against acetylcholine receptors, muscle-specific kinases or other acetylcholine receptor-related proteins on the postsynaptic membrane, resulting in impaired neuromuscular junction transmission, which can affect eye movement, swallowing, speech, activity and respiratory function to varying degrees, about 85% of patients will have symptoms other than the eye muscle, develop into generalized myasthenia gravis (gMG), and even myasthenic crisis, has been included in China's " The first list of rare diseases"
.
At present, the main treatment methods of the disease include cholinesterase inhibitors, glucocorticoids and immunosuppressants, but there are still some patients who cannot fully and effectively control the disease due to drug efficacy, tolerability or contraindications, and there are a large number of unmet clinical needs
.