Rongchang bio's first original innovative drug tai ai ® approved to open the systemic lupus erythematosus "double target ...

20210312，（），^®（：）（NMPA），“、（SLE）”。

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SLE“”，^®BLySAPRIL，B，，。

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Professor Zhao Yan of the Rheumatology Branch of the Chinese Medical Association and Professor of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital said: “SLE patients in China are mostly young women.

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Systemic lupus erythematosus treatment encounters difficulties

Systemic lupus erythematosus treatment encounters difficulties

The patients are mostly young women

The patients are mostly young women

Systemic lupus erythematosus is a systemic autoimmune disease that cannot be cured.

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In recent years, with the advancement of diagnosis and treatment, the 5-year survival rate of SLE patients has exceeded 90%, but how to improve the prognosis of patients in the long term, prevent and reduce recurrence, delay disease progression, and improve the quality of life of patients is still the treatment of SLE treatment in my country Focus.

According to the "Guidelines for Diagnosis and Treatment of Systemic Lupus Erythematosus in China in 2020," SLE treatment drugs in my country mainly include glucocorticoids, immunosuppressants, and antimalarials.

SLE treatment is still facing the status quo of poor disease control and drug side effects

One is that about 60% of patients have continuous disease activity or repeated recurrences;

Second, the use of long-term, high-dose glucocorticoids and immunosuppressive agents causes irreversible damage to the patient's organs, and even induces serious adverse reactions such as infection and bone marrow suppression.

With the deepening of the study of SLE, clinical findings in patients with refractory or relapsed, the use of biological agents can significantly alleviate the condition, disease activity and reduce the recurrence rate ¹ .

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Thai Love ^® "double target" mechanism

Tai ^Ai® "Dual Targets" Mechanism of ^Action®

Bringing milestone progress to SLE treatment

Bringing milestone progress to SLE treatment

The causes of SLE are complex, mainly related to the abnormality of B lymphocytes in the human body and the production of a large number of pathogenic autoantibodies.

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Studies have found that BLyS and APRIL are key factors for abnormal B cell maturation and differentiation, and the levels of BLyS and APRIL in patients with SLE determine the severity of the ^disease6,7,8 .

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As the world's only two targets approved therapeutic biological agents in SLE, Thai love ^® can inhibit BLyS and APRIL two cytokines simultaneously, and using fusion protein technology breakthrough, so that the drug and the two cytokines stronger affinity , To achieve more effective inhibition, so as to achieve a "two-pronged" treatment effect, which not only increases the effectiveness but also enhances the safety of the drug.

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Clinical Study IIb of an included 249 cases of SLE patients display ⁹ , on receiving the Thai love ^® 160.

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As the person in charge of this clinical study, within the first Beijing Union Medical College Hospital, Professor Zhang Fengchun science department, he said: "Love Thai ^® is a Chinese biopharmaceutical companies have a Class 1 drug innovation completely independent intellectual property rights, not only encouraging in efficacy As a result, its safety performance is also excellent.

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Actively pioneer and innovate

Actively pioneer and innovate

Rongchang Biological Leads China's Innovative Drugs to the World

Rongchang Biological Leads China's Innovative Drugs to the World

Thai Love ^® a new target, a new structure, the features of the new mechanism, making the Chinese invention patents, the United States, Europe, Russia, South Korea, Japan and other authorization, the R & D project also won the national "Eleventh Five-Year", "Twelfth During the 5th and 13th Five-Year Plan period, "Major new drug creation" special science and technology projects are supported.

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National Research Center, Professor of Dermatology and autoimmune diseases in clinical medicine chairman, Beijing Union Medical College Hospital Division of Rheumatology Director Zeng Feng said: "Thai love ^® is approved as a result of epoch-making significance of major new drugs created major projects of national science and technology, it opens.

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Dr.

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In addition to targeting local patients, the commercialization process of Taltazep overseas is also accelerating.

Rongchang Bio is currently rapidly advancing the clinical trials of Tai ^Ai® in other diseases, including rheumatoid arthritis, neuromyelitis optica spectrum disorder, IgA nephropathy, myasthenia gravis, Sjogren’s syndrome and multiple sclerosis.

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references

references

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A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study[C]//ARTHRITIS & RHEUMATOLOGY.
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