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On June 2, Shanghai Mengke Pharmaceutical Co.
, Ltd.
, a leading biopharmaceutical company focusing on the development and commercialization of anti-drug-resistant infection drugs, announced that China National Medical Products Administration (NMPA) has approved it to target drug-resistant bacteria.
A new drug application for the infection of the global original innovative drug Contizolamide (Uxitai®) for the treatment of complex 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.
On June 2, Shanghai Mengke Pharmaceutical Co.
Youxitai® is Mengke Pharmaceutical's first new-generation oxazolidinone original innovative drug that has been independently developed and approved for marketing
.
The founder and CEO, Dr.
Contizolamide, approved this time, has received strong support from the state during its development process.
It has received continuous funding from the "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "13th Five-Year Plan" national major new drug creation special projects, and its listing The application was also included in the priority review and approval procedure by the State Drug Administration
.
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.
Mengke Pharmaceutical is a biopharmaceutical company that is about to enter the commercialization stage, focusing on the research and development of antibacterial drugs
.
In addition to the approval of the first new drug, Mengke Pharmaceuticals is also preparing for the Phase III clinical trial of the second anti-multidrug resistant gram-positive bacteria drug MRX-4, and the third anti-multidrug resistant gram-negative bacteria innovation Phase I clinical trial of the drug MRX-8 in the United States
