Dual-Targeted Antibody Fusion Protein Drug Tetacept

7Month12On the same day, Rongchang Biopharmaceutical (Yantai) Co., Ltd. announced its independent research and development of new biological drugs in the press conference hall of the Great Hall of the People.RC18(General name Tetasep, trade name Tetasep) Treatment of systemic lupus erythematosus (SLE) the keyII/IIIThe results of the phase-in clinical study showed that the high-dose group of taitacept was treated.48of the weekSRI(systemic lupus erythematosus response index) was significantly higher than the placebo control group (79.2% vs 32.0%), and the safety performance is excellent and well tolerated by patients.

systemic lupus erythematosus

Systemic lupus erythematosus (SLE) is a complex systemic autoimmune disease, which often leads to multi-organ and multi-system damage. It is a major life-threatening disease.15-45For women of childbearing age, the male-to-female ratio is approximately1:9. Epidemiological survey in China shows that the prevalence of systemic lupus erythematosus is70/10There are about 10,000 patients in China.100Ten thousand people, about patients worldwide500Ten thousand people. At present, there is a lack of effective treatment in clinical treatment in China. regular treatment is mainly glucocorticoids (prednisone, hydrocortisone, betamethasone), immunosuppressants (cyclophosphamide), antimalarial drugs (hydroxychloroquine) and biological agents. These drugs are often accompanied by large toxic and side effects, especially the long-term use of glucocorticoids commonly used in clinical practice is very harmful to human body.

Systemic lupus erythematosus has a huge clinical demand for new therapeutic drugs, but it is extremely difficult to develop new drugs.IIIThe project basically ended in failure. From1955years of hydroxychloroquine since the U.FDAin the past60Only one new drug for the treatment of systemic lupus erythematosus has been approved for many years, namely2011The drug, which was approved for sale in 2010, is also recently approved in China, but it is difficult to meet clinical needs in terms of price and therapeutic effect (long-term medication, no cure).

Tetasap Details

Although the pathogenesis of systemic lupus erythematosus is not fully clear, but the mainstream view that this is aBAutoimmune diseases caused by excessive cell proliferation are stimulated by the interaction of genetic factors, environmental factors, estrogen levels and other factors,BExcessive proliferation of cells produces a large number of autoantibodies, which combine with the corresponding autoantigens in the body to form corresponding immune complexes, which deposit in the skin, joints, small blood vessels, glomeruli and other parts, and then cause acute and chronic inflammation and tissue necrosis with the participation of complement. Or antibodies directly interact with tissue cell antigens, causing cell destruction, resulting in multi-system damage to the body.

A number of studies at home and abroad have shown that the formation of systemic lupus erythematosus and the human bodyBLySandAPRILThe abnormal increase in factors is directly related,BLySandAPRILYesBLymphocyte differentiation and maturation of the key factors, the overexpression of the factor is systemic lupus erythematosus and otherBLymphocyte-related autoimmune diseases are important causes of inhibitionBLyS/APRILIt can more effectively reduce the body's immune response and achieve the purpose of treating autoimmune diseases.

The new biological class I drug, Tetasip, independently developed by Rongchang Bio, has the research code nameRC18orRCT-18The World Health Organization (WHO2) Common NameTelitacicept,The general name of the State Pharmacopoeia Committee is Taitaxip, and the commodity name is Taiai, which is combined at the same time.BLySandAPRILThe dual-targeted antibody fusion protein drug can efficiently blockBLySandAPRILinteraction with its receptor, thereby effectively blockingBThe differentiation and maturation of lymphocytes inhibits excessive immune response, and is used to treat a variety of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. Tetasepp in2011The first clinical trial approval was obtained from the State Food and Drug Administration in,2012Completed phase I clinical trials in Peking Union Medical College Hospital in,2013Year7In January, it was approved by the State Food and Drug Administration for Phase II and III clinical trials. In addition to systemic lupus erythematosus, there are currently6Indications are being or will soon be carried out II./Phase III clinical trials.

The invention patents of Tetacip have been authorized by China, the United States, Europe, Russia, South Korea, Japan and many other countries, as shown in the table below.

Xip taiitvsBelimumab

The target targeted by belimumab isBLyS, Chinese nameBlymphocyte stimulating factor, so it is not difficult to understand the mechanism of action of belimumab. Soluble by specific binding of serumBLyS, belimumab can blockBLySwithBreceptor binding on the cell, inhibitingBcell proliferation andBdifferentiation of cells into plasma cells, thereby reducingBcells produce autoantibodies to achieve therapeuticSLEThe purpose.

2011Year12Monthly published inArthritis RheumJournal of a global, randomized, placebo-controlledIIIPhase Clinical Research (NCT00410384) into the group819Patients, belymumab52WeekSRIsignificantly better than the placebo group (43.2% vs 33.5%）。

2018Year3Monthly published inAnn Rheum DisJournal of a randomized, placebo-controlled study of China, South Korea, and JapanIIIPeriod Study (NCT01345253) into the group677Patients, belymumab52WeekSRIsignificantly better than the placebo group (53.8% vs 40.1%）。

If we compare the clinical data released by Rongchang Biology, we can find that taitcept is compared with placebo (79.2% vs 32.0%) YesSRIThe degree of improvement is significantly better60For years the onlySLENew drug belimumab. This clinical result is not only a milestone in the field of systemic lupus erythematosus, but also another sign of the improvement of China's innovative drug development strength.

Summary

Professor Zhang Fengchun, head of clinical trials of Tetasep and director of rheumatology department of Peking Union Medical College Hospital, is full of hope for Tetasep. He pointed out: "Tetasep is a new drug originally created in the world. This study has reached the main clinical endpoint, and the main clinical indicators have been greatly improved compared with the existing drugs. YesSLEA major breakthrough in the treatment, Tetasep is targeted.BLySandAPRILThe dual-targeted biological new drug is of great significance ".

Professor Fang Jianmin, founder and CEO of Rongchang Biology and inventor of Tetasep, said: "the results of this clinical trial are exciting and an important milestone for Tetasep to move towards the registration and declaration of new drugs. We hope to bring new hope to patients with systemic lupus erythematosus through the research and development of innovative drugs".

References:http://www.remegen.cn/news/140707.htm
http://www.sohu.com/a/326415427_100023701