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On June 2, Shanghai Mengke Pharmaceutical Co.
, Ltd.
announced that the National Medical Products Administration (NMPA) has approved its new drug listing application for the global original innovative drug Contizolamide Tablets (Uxitai) for drug-resistant bacterial infections.
, The drug will be used to treat complicated skin and soft tissue infections.
Contizolamide is a new generation of oxazolidinone antibacterial drug independently designed by the Chinese-American R&D team of Mengke Pharmaceutical, a Chinese company, after 12 years of development.
It is a major breakthrough in domestically produced innovative drugs in the field of infectious diseases.
The global demand for drugs for the treatment of drug-resistant bacteria has experienced a "starvation period" for nearly 30 years.
In order to cope with the resistance of bacteria and solve the unmet clinical needs, we have developed effective and safe "super antimicrobials" that specifically fight drug-resistant bacteria.
It has become an urgent strategic need for China.
According to reports, through a lot of exploration and screening work, Mengke Pharmaceuticals discovered in 2008 a new generation of oxazolidinone drug candidates with independent intellectual property rights (code name MRX-I), intended to be used in the treatment of leather Infections caused by blue-positive bacteria (including multi-drug resistant bacteria).
After twelve years of unremitting efforts, a large amount of data has confirmed that Contizolamide can effectively treat infections caused by drug-resistant Gram-positive bacteria, and at the same time significantly reduce the toxic and side effects related to myelosuppression of this type of antibacterial drug and the trend of inducing resistance.
So far, Contizolamide has completed nine clinical trials at home and abroad.
The approval in China this time is based on a multi-center randomized double-blind double simulation III for complex skin and soft tissue infections involving 719 patients.
Efficacy and safety data obtained in phased clinical trials.
Contizolamide was approved in China as the world's first release, and its advent opened a new journey of original innovative drugs in the field of anti-infection in China.
At present, Contizolamide has successfully completed the Phase II clinical trial for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the United States, and obtained the Qualified Anti-infective Product (QIDP) and Fast Review (Fast) granted by the US FDA.
Track) identified. Mengke Pharmaceutical is about to launch an international multi-center phase III clinical trial to support the approval of Contizolamide in other countries and/or regions such as Europe and the United States.
End References: [1] Previously selected by Mengke Pharmaceutical's official website to watch Cell Breakthrough: The foodies are moved and cry! Scientists have found a new fat-burning pathway with the potential for long-lasting effect.
Finally! Sinopharm officially announced the Phase 3 clinical data of two new crown inactivated vaccines, both of which are more than 70% effective in preventing COVID-19.
Scientists from Peking University publish the top issue of Cell: Using spliceosome inhibitors to produce all-round stem cells in mice.
The world's "popular fried chicken"! New research reveals: Nicotinamide can also regulate retinal function, effectively improve glaucoma craze and write a new legend in gene therapy.
Optogenetic therapy has revived blind people who have been blind for 40 years for the first time.
Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Fundamental Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegenerative Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | 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 | Filing System | Registrant System | Healthy China | New Edition of Essential Medicines Directory | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext | R&D Investment | Acquisitions | Market & Consumption
, Ltd.
announced that the National Medical Products Administration (NMPA) has approved its new drug listing application for the global original innovative drug Contizolamide Tablets (Uxitai) for drug-resistant bacterial infections.
, The drug will be used to treat complicated skin and soft tissue infections.
Contizolamide is a new generation of oxazolidinone antibacterial drug independently designed by the Chinese-American R&D team of Mengke Pharmaceutical, a Chinese company, after 12 years of development.
It is a major breakthrough in domestically produced innovative drugs in the field of infectious diseases.
The global demand for drugs for the treatment of drug-resistant bacteria has experienced a "starvation period" for nearly 30 years.
In order to cope with the resistance of bacteria and solve the unmet clinical needs, we have developed effective and safe "super antimicrobials" that specifically fight drug-resistant bacteria.
It has become an urgent strategic need for China.
According to reports, through a lot of exploration and screening work, Mengke Pharmaceuticals discovered in 2008 a new generation of oxazolidinone drug candidates with independent intellectual property rights (code name MRX-I), intended to be used in the treatment of leather Infections caused by blue-positive bacteria (including multi-drug resistant bacteria).
After twelve years of unremitting efforts, a large amount of data has confirmed that Contizolamide can effectively treat infections caused by drug-resistant Gram-positive bacteria, and at the same time significantly reduce the toxic and side effects related to myelosuppression of this type of antibacterial drug and the trend of inducing resistance.
So far, Contizolamide has completed nine clinical trials at home and abroad.
The approval in China this time is based on a multi-center randomized double-blind double simulation III for complex skin and soft tissue infections involving 719 patients.
Efficacy and safety data obtained in phased clinical trials.
Contizolamide was approved in China as the world's first release, and its advent opened a new journey of original innovative drugs in the field of anti-infection in China.
At present, Contizolamide has successfully completed the Phase II clinical trial for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the United States, and obtained the Qualified Anti-infective Product (QIDP) and Fast Review (Fast) granted by the US FDA.
Track) identified. Mengke Pharmaceutical is about to launch an international multi-center phase III clinical trial to support the approval of Contizolamide in other countries and/or regions such as Europe and the United States.
End References: [1] Previously selected by Mengke Pharmaceutical's official website to watch Cell Breakthrough: The foodies are moved and cry! Scientists have found a new fat-burning pathway with the potential for long-lasting effect.
Finally! Sinopharm officially announced the Phase 3 clinical data of two new crown inactivated vaccines, both of which are more than 70% effective in preventing COVID-19.
Scientists from Peking University publish the top issue of Cell: Using spliceosome inhibitors to produce all-round stem cells in mice.
The world's "popular fried chicken"! New research reveals: Nicotinamide can also regulate retinal function, effectively improve glaucoma craze and write a new legend in gene therapy.
Optogenetic therapy has revived blind people who have been blind for 40 years for the first time.
Drug Targets| Healthy Life| Pharmaceutical News| Drug Inventory| Pharmaceutical Technology| Fundamental Research on Drug Side Effects/ Translational Medicine Leukemia| Lung Cancer| Gastric Cancer| Colorectal Cancer| Liver Cancer| Breast Cancer| Pancreatic Cancer| Cardiovascular Disease| Neurodegenerative Diseases | Intestinal microbial medical devices/biotechnological in vitro diagnostics | 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 | Filing System | Registrant System | Healthy China | New Edition of Essential Medicines Directory | AI Medical Devices | Telemedicine | Same Equity Different Equity Market/Capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | ChiNext | R&D Investment | Acquisitions | Market & Consumption
