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According to the information published on the official website of the State Food and Drug Administration, the application for listing of Telitacicept for injection, a class 1 new drug independently developed by Rongchang Biopharmaceuticals (Yantai), has been updated to "approval completed-pending certification", approval number It is: National Medicine Standard S20210008.
This means that this new drug has been officially approved in China, and the indication is systemic lupus erythematosus.
Taltazep is the first Chinese-made new drug for the treatment of systemic lupus erythematosus approved for marketing in China in decades.
In view of the fact that the US FDA and China's NMPA have only approved one SLE biologics-GSK's beliumab, the approval of Tatacept may have a huge impact on the SLE market.
Taltazep is a TACI-Fc fusion protein independently developed by Rongchang Biological.
It can simultaneously inhibit the two cytokines BLyS and APRIL, which are the key factors for the differentiation and maturation of B lymphocytes.
The overexpression of this factor is systemic.
Lupus erythematosus and other B lymphocyte-related autoimmune diseases are important causes.
Therefore, inhibiting BLyS/APRIL can more effectively reduce the body's immune response and achieve the goal of treating autoimmune diseases.
Systemic lupus erythematosus SLE is a complex systemic autoimmune disease that often causes damage to multiple organs and multiple systems, and is a major life-threatening disease.
According to the "Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus in China 2020", there are currently more than 1 million people suffering from SLE in mainland China, with a prevalence of about 70 per 100,000 people, ranking second in the world.
Despite the huge demand, the development of such new therapeutic drugs is very difficult.
Since hydroxychloroquine in 1955, only GSK's beliumab has been approved for marketing in the world, and most other products have ended in phase 3 clinical failure.The approved Tatacept was clinically approved by the National Food and Drug Administration in 2011, and was reported to be marketed in China in November 2019.
It was included in the priority review and approval due to its obvious therapeutic advantages in less than one month.
The key clinical research results of RC18 for the treatment of SLE released by Rongchang Biotechnology in July 2020 showed that the 48-week response rate of the high-dose tatacept group reached 79.
2%, and the response rate of the placebo control group was 32.
0%.
The anti-effect is more significant; its safety is also excellent, and it is well tolerated by patients.
According to estimates by professional investors, the potential market space for the mid-to-long term (2030) of Tetaxipu will reach 20 billion yuan.
According to CICC's calculations, Tetaxipu is expected to reach a peak sales of 9.
79 billion yuan in 2034.
At present, the registered clinical trial for the treatment of SLE with Taltazep was approved by the U.
S.
FDA in January 2020, was granted Fast Track status by the FDA in April, and was approved by the U.
S.
Phase II clinical trial (IND) in September.
It is reported that Rongchang Biology plans to launch a global phase 3 clinical trial of SLE in the first half of 2021, including the United States, Europe and other countries and regions.
This article synthesizes self-medicine gravity and relevant reports from the Beijing News.
After 30 years of selected onlookers, covering 2 million people, Harvard University found the most life-prolonging recipe: 160 grams of fruit and 240 grams of vegetables per day.
A new study found that men who are preparing to become pregnant also need to supplement with folic acid, and there are epigenetic changes in sperm.
Will it affect the health of future generations? Is it always a bad mood? Nature: It may be that your intestines have encountered "something".
Nature: Scientists have developed a new type of bacterial therapy to improve the condition of 2/3 of patients with eczema.
Are you still choosing your diet based on the carbon water content? NEJM reveals: This indicator is the top priority.
Medical immunotherapy| Biosimilars| Vaccines| Resistance| Drug targets| Healthy life| Pharmaceutical news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/ Translational medicine leukemia | Lung Cancer | Gastric Cancer | Colorectal Cancer | Liver Cancer | Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Genetic Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision Medicine Policy Anti-cancer Drugs | 4+7 Volume Procurement | Consumables | Record-filing System | Registrant System | Healthy China | New Edition Essential Medicine List | AI Medical Devices | Telemedicine | Same-share non-equity market/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R & D Investment | Acquisitions | Market & Consumption
This means that this new drug has been officially approved in China, and the indication is systemic lupus erythematosus.
Taltazep is the first Chinese-made new drug for the treatment of systemic lupus erythematosus approved for marketing in China in decades.
In view of the fact that the US FDA and China's NMPA have only approved one SLE biologics-GSK's beliumab, the approval of Tatacept may have a huge impact on the SLE market.
Taltazep is a TACI-Fc fusion protein independently developed by Rongchang Biological.
It can simultaneously inhibit the two cytokines BLyS and APRIL, which are the key factors for the differentiation and maturation of B lymphocytes.
The overexpression of this factor is systemic.
Lupus erythematosus and other B lymphocyte-related autoimmune diseases are important causes.
Therefore, inhibiting BLyS/APRIL can more effectively reduce the body's immune response and achieve the goal of treating autoimmune diseases.
Systemic lupus erythematosus SLE is a complex systemic autoimmune disease that often causes damage to multiple organs and multiple systems, and is a major life-threatening disease.
According to the "Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus in China 2020", there are currently more than 1 million people suffering from SLE in mainland China, with a prevalence of about 70 per 100,000 people, ranking second in the world.
Despite the huge demand, the development of such new therapeutic drugs is very difficult.
Since hydroxychloroquine in 1955, only GSK's beliumab has been approved for marketing in the world, and most other products have ended in phase 3 clinical failure.The approved Tatacept was clinically approved by the National Food and Drug Administration in 2011, and was reported to be marketed in China in November 2019.
It was included in the priority review and approval due to its obvious therapeutic advantages in less than one month.
The key clinical research results of RC18 for the treatment of SLE released by Rongchang Biotechnology in July 2020 showed that the 48-week response rate of the high-dose tatacept group reached 79.
2%, and the response rate of the placebo control group was 32.
0%.
The anti-effect is more significant; its safety is also excellent, and it is well tolerated by patients.
According to estimates by professional investors, the potential market space for the mid-to-long term (2030) of Tetaxipu will reach 20 billion yuan.
According to CICC's calculations, Tetaxipu is expected to reach a peak sales of 9.
79 billion yuan in 2034.
At present, the registered clinical trial for the treatment of SLE with Taltazep was approved by the U.
S.
FDA in January 2020, was granted Fast Track status by the FDA in April, and was approved by the U.
S.
Phase II clinical trial (IND) in September.
It is reported that Rongchang Biology plans to launch a global phase 3 clinical trial of SLE in the first half of 2021, including the United States, Europe and other countries and regions.
This article synthesizes self-medicine gravity and relevant reports from the Beijing News.
After 30 years of selected onlookers, covering 2 million people, Harvard University found the most life-prolonging recipe: 160 grams of fruit and 240 grams of vegetables per day.
A new study found that men who are preparing to become pregnant also need to supplement with folic acid, and there are epigenetic changes in sperm.
Will it affect the health of future generations? Is it always a bad mood? Nature: It may be that your intestines have encountered "something".
Nature: Scientists have developed a new type of bacterial therapy to improve the condition of 2/3 of patients with eczema.
Are you still choosing your diet based on the carbon water content? NEJM reveals: This indicator is the top priority.
Medical immunotherapy| Biosimilars| Vaccines| Resistance| Drug targets| Healthy life| Pharmaceutical news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/ Translational medicine leukemia | Lung Cancer | Gastric Cancer | Colorectal Cancer | Liver Cancer | Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Genetic Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision Medicine Policy Anti-cancer Drugs | 4+7 Volume Procurement | Consumables | Record-filing System | Registrant System | Healthy China | New Edition Essential Medicine List | AI Medical Devices | Telemedicine | Same-share non-equity market/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext Board | R & D Investment | Acquisitions | Market & Consumption
