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On November 8th, according to the official website of CDE, Biotec Bio-Tocilizumab Injection (BAT1806) was declared for marketing.
The indications applied for include rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA) And Cytokine Release Syndrome (CRS)
.
This is the first domestic tocilizumab biosimilar to be declared for marketing
.
BAT1806 is a tocilizumab injection developed by Biotech in accordance with the relevant guidelines of China's NMPA, US FDA, and EU EMA biosimilars.
It is a recombinant humanized monoclonal antibody targeting IL-6R.
It can be combined with soluble and Membrane-bound IL-6 receptors (sIL-6R and mIL-6R) specifically bind to and inhibit signal transduction mediated by sIL-6R and mIL-6R
.
Biotech BAT-1806 was first applied for clinical application in July 2016, and the clinical trial was launched for the first time in May 2018.
Its international multi-center phase III clinical trial was launched in 2019, targeting rheumatoid arthritis (RA) and enrolling 253 domestic patients And 621 international patients
.
The results of the study showed that the study reached the primary clinical endpoint, indicating that the drug is equivalent to the reference drug in patients with moderate to severe rheumatoid arthritis whose condition has not been effectively controlled after receiving methotrexate treatment
.
In April of this year, Biotech signed an agreement with Biogen, stipulating that Biotech will license the exclusive product rights and interests of BAT1806 injection in global markets other than China to Biogen for a fee
.
Biotech will retain the relevant rights of this product in China
.
As tocilizumab injection's original molecular protection patent has expired, domestic and foreign pharmaceutical companies have devoted themselves to the research and development of their biosimilar drugs
.
At present, the domestic research and development of tocilizumab drug companies have similar biological Hisun Pharmaceutical, Livzon Pharmaceutical, Bio Integration of biological and so on
.
Among them, Biotec’s tocilizumab biosimilar has the fastest development progress and has already been declared for marketing.
It is expected to become the first domestic tocilizumab approved by the National Medical Products Administration for marketing
.
End reference materials: [1]https:// Featured onlookers to watch major advances in cancer vaccines! "Nature" Sub-Journal: Scientists have invented the technology of making cancer vaccines through low-temperature silicification of tumor cells.
Although hot coffee lasts for life, you will get sick if you drink too much! Coffee metabolites and kidney disease-related hot articles reverse the epidemic and kill Merck? ! Pfizer's oral anti-coronavirus drug reduces hospitalization or mortality by 89%, and it can be taken at home for the first time in the world! my country has achieved large-scale carbon monoxide synthesis and protein synthesis.
Science Sub-Journal: Providing "wake-up services" for the immune system may effectively eliminate tumors in the body! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company 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 | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic medicine catalog | AI medical devices | Telemedicine | Same stock market with different rights / capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
The indications applied for include rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA) And Cytokine Release Syndrome (CRS)
.
This is the first domestic tocilizumab biosimilar to be declared for marketing
.
BAT1806 is a tocilizumab injection developed by Biotech in accordance with the relevant guidelines of China's NMPA, US FDA, and EU EMA biosimilars.
It is a recombinant humanized monoclonal antibody targeting IL-6R.
It can be combined with soluble and Membrane-bound IL-6 receptors (sIL-6R and mIL-6R) specifically bind to and inhibit signal transduction mediated by sIL-6R and mIL-6R
.
Biotech BAT-1806 was first applied for clinical application in July 2016, and the clinical trial was launched for the first time in May 2018.
Its international multi-center phase III clinical trial was launched in 2019, targeting rheumatoid arthritis (RA) and enrolling 253 domestic patients And 621 international patients
.
The results of the study showed that the study reached the primary clinical endpoint, indicating that the drug is equivalent to the reference drug in patients with moderate to severe rheumatoid arthritis whose condition has not been effectively controlled after receiving methotrexate treatment
.
In April of this year, Biotech signed an agreement with Biogen, stipulating that Biotech will license the exclusive product rights and interests of BAT1806 injection in global markets other than China to Biogen for a fee
.
Biotech will retain the relevant rights of this product in China
.
As tocilizumab injection's original molecular protection patent has expired, domestic and foreign pharmaceutical companies have devoted themselves to the research and development of their biosimilar drugs
.
At present, the domestic research and development of tocilizumab drug companies have similar biological Hisun Pharmaceutical, Livzon Pharmaceutical, Bio Integration of biological and so on
.
Among them, Biotec’s tocilizumab biosimilar has the fastest development progress and has already been declared for marketing.
It is expected to become the first domestic tocilizumab approved by the National Medical Products Administration for marketing
.
End reference materials: [1]https:// Featured onlookers to watch major advances in cancer vaccines! "Nature" Sub-Journal: Scientists have invented the technology of making cancer vaccines through low-temperature silicification of tumor cells.
Although hot coffee lasts for life, you will get sick if you drink too much! Coffee metabolites and kidney disease-related hot articles reverse the epidemic and kill Merck? ! Pfizer's oral anti-coronavirus drug reduces hospitalization or mortality by 89%, and it can be taken at home for the first time in the world! my country has achieved large-scale carbon monoxide synthesis and protein synthesis.
Science Sub-Journal: Providing "wake-up services" for the immune system may effectively eliminate tumors in the body! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company 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 | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic medicine catalog | AI medical devices | Telemedicine | Same stock market with different rights / capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
