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Yesterday, Zai Lab announced that the State Food and Drug Administration has approved the new drug listing application of Nurex® (Omacycline tosylate)
.
Nuzero is a new type of antibiotic, available in oral and intravenous infusion formulations, approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
.
New Relac is approved as a Class 1 new drug by the National Food and Drug Administration, and it is produced in China
.
CABP is the most common type of pneumonia acquired outside the hospital, one of the most common infectious diseases, and an important cause of death and morbidity worldwide
.
ABSSSI is a bacterial infection of the skin and related tissues (such as loose connective tissue and mucous membranes)
.
ABSSSI is common and has a variety of disease manifestations, with varying degrees of severity
.
In 2015, in China alone, the estimated incidence of ABSSSI and CABP were 2.
8 million and 16.
50 million, respectively
.
Linezolid and moxifloxacin are the current standard treatments for ABSSSI and CABP, respectively
.
There are still a large number of unmet needs for broad-spectrum antimicrobials that are safe and treat multi-drug resistant bacterial infections
.
And Zai Lab's Nuzai® (Omacycline tosylate) is a new type of tetracycline antibacterial drug with two dosage forms of oral and intravenous infusion once a day, specially designed to overcome tetracycline resistance Sex and improve broad-spectrum antibacterial activity, such as Gram-positive, Gram-negative, atypical and many other pathogenic infections
.
Nurelox was launched in the United States in February 2019 as a once-daily oral and intravenous infusion of antibacterial drugs for the treatment of adult CABP and ABSSSI
.
The FDA approved a pure oral dosing regimen for the treatment of CABP in adults by the FDA in June 2021
.
Currently, New Zarax is the fourth product approved by Zai Lab in the past 24 months, and it is also the first product approved for marketing in the non-oncology field by Zai Lab
.
Dr.
Ren Hairui, Chief Medical Officer of Zai Lab Autoimmune and Anti-infection, said: “Nutrara provides doctors with intravenous infusion in the hospital and conversion to oral dosage form after discharge from the hospital.
This is a flexible way of administration.
It will help reduce the potential risk of hospitalization and reduce related hospitalization costs
.
"End reference materials: [1] http:// Selected in the past The approval is Tojoo Pharmaceuticals' first antibody drug hot article "The Lancet" sub-issue: HPV vaccine is no longer exclusive to women! Men's vaccination can also prevent cancer! Hot article's top ten breakthroughs in the world in 2021 How will the technology "flow code" mRNA evolve? Rewen, the first domestic RNAi therapy company, Shengnuo Pharmaceutical has passed the hearing and has completed 7 rounds of nearly US$270 million in financing.
Rewen TIL therapy: anti-solid tumor "dark horse" to conquer a variety of cancers "Accelerated" Medical Immunotherapy| Biosimilars| Vaccines| Drug Resistance| Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Stomach 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 Anticancer Drugs | 4+7 Volume Procurement | Consumables | Filing System | Registrant System | Healthy China | New Edition of Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same-share 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 |
.
Nuzero is a new type of antibiotic, available in oral and intravenous infusion formulations, approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
.
New Relac is approved as a Class 1 new drug by the National Food and Drug Administration, and it is produced in China
.
CABP is the most common type of pneumonia acquired outside the hospital, one of the most common infectious diseases, and an important cause of death and morbidity worldwide
.
ABSSSI is a bacterial infection of the skin and related tissues (such as loose connective tissue and mucous membranes)
.
ABSSSI is common and has a variety of disease manifestations, with varying degrees of severity
.
In 2015, in China alone, the estimated incidence of ABSSSI and CABP were 2.
8 million and 16.
50 million, respectively
.
Linezolid and moxifloxacin are the current standard treatments for ABSSSI and CABP, respectively
.
There are still a large number of unmet needs for broad-spectrum antimicrobials that are safe and treat multi-drug resistant bacterial infections
.
And Zai Lab's Nuzai® (Omacycline tosylate) is a new type of tetracycline antibacterial drug with two dosage forms of oral and intravenous infusion once a day, specially designed to overcome tetracycline resistance Sex and improve broad-spectrum antibacterial activity, such as Gram-positive, Gram-negative, atypical and many other pathogenic infections
.
Nurelox was launched in the United States in February 2019 as a once-daily oral and intravenous infusion of antibacterial drugs for the treatment of adult CABP and ABSSSI
.
The FDA approved a pure oral dosing regimen for the treatment of CABP in adults by the FDA in June 2021
.
Currently, New Zarax is the fourth product approved by Zai Lab in the past 24 months, and it is also the first product approved for marketing in the non-oncology field by Zai Lab
.
Dr.
Ren Hairui, Chief Medical Officer of Zai Lab Autoimmune and Anti-infection, said: “Nutrara provides doctors with intravenous infusion in the hospital and conversion to oral dosage form after discharge from the hospital.
This is a flexible way of administration.
It will help reduce the potential risk of hospitalization and reduce related hospitalization costs
.
"End reference materials: [1] http:// Selected in the past The approval is Tojoo Pharmaceuticals' first antibody drug hot article "The Lancet" sub-issue: HPV vaccine is no longer exclusive to women! Men's vaccination can also prevent cancer! Hot article's top ten breakthroughs in the world in 2021 How will the technology "flow code" mRNA evolve? Rewen, the first domestic RNAi therapy company, Shengnuo Pharmaceutical has passed the hearing and has completed 7 rounds of nearly US$270 million in financing.
Rewen TIL therapy: anti-solid tumor "dark horse" to conquer a variety of cancers "Accelerated" Medical Immunotherapy| Biosimilars| Vaccines| Drug Resistance| Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Basic Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Stomach 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 Anticancer Drugs | 4+7 Volume Procurement | Consumables | Filing System | Registrant System | Healthy China | New Edition of Essential Medicine Catalog | AI Medical Devices | Telemedicine | Same-share 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 |
