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On May 27, the listing application for the category 1 antibacterial drug "Contezolid" (Contezolid) jointly declared by Mengke Medicine and Zhejiang Huahai Pharmaceutical entered into the approval status (acceptance number: CXHS1900044), and it is expected to be approved soon for skin use And soft tissue infection treatment.
On May 27, the listing application for the category 1 antibacterial drug "Contezolid" (Contezolid) jointly declared by Mengke Medicine and Zhejiang Huahai Pharmaceutical entered into the approval status (acceptance number: CXHS1900044), and it is expected to be approved soon for skin use And soft tissue infection treatment.
The first domestically produced oxazolidinone antibacterial drug,
12 years of research and development
In January 2020, the marketing application of Contazolamide was accepted by CDE and was included in the priority review range.
Globally, the first marketed oxazolidinone antibacterial drug was linezolid developed by Pharmacia, a subsidiary of Pfizer, under the trade name Zyvox.
According to public information, the results of a head-to-head study carried out by conzolid and linezolid showed that the clinical efficacy of conzolid on gram-positive bacteria, including multidrug-resistant MRSA infections, is comparable to that of linezolid.
In September 2019, Mengke Medicine announced its first new antibacterial drug, contezolid (also known as MRX-I), a key phase 3 clinical trial in China for the treatment of complex skin and soft tissue infections (cSSTI) Obtain positive results.
This double-blind study was conducted in 50 locations in China.
According to the Insight database, although no domestically-made oxazolidinone innovative drugs are currently on the market, there are many competitors for linezolid generic drugs.
From Insight database (http://db.
In addition, according to public information, the sales of terminal systemic antibacterial drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers in 2018 were 158.
Focus on the research and development of antibacterial drugs,
Mengke Pharmaceutical plans to be listed on the Science and Technology Innovation Board
According to the news of the IPO, Mengke Pharmaceutical has signed a listing counseling agreement with CICC on December 30, 2020, and filed it with the Shanghai Securities Regulatory Bureau on the same day, and plans to list on the Science and Technology Innovation Board.
Established in 2007, Mengke Medicine is an innovative biomedical company with global independent intellectual property rights and international competitiveness focusing on the treatment of infectious diseases, focusing on the increasingly serious problem of bacterial resistance in the world.
Currently, Mengke has a number of self-developed innovative drug product pipelines, focusing on the field of anti-multidrug-resistant "super bacteria" infections, and expanding to the field of anti-tumor and anti-inflammatory.
On May 27, the listing application for the category 1 antibacterial drug "Contezolid" (Contezolid) jointly declared by Mengke Medicine and Zhejiang Huahai Pharmaceutical entered into the approval status (acceptance number: CXHS1900044), and it is expected to be approved soon for skin use And soft tissue infection treatment.
Contazolamide is a new type of oxazolidinone antibacterial drug with a new drug structure independently developed by Mengke Medicine, which is used to treat Gram-positive bacteria, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) .
The first domestically produced oxazolidinone antibacterial drug,
12 years of research and development
In January 2020, the marketing application of Contazolamide was accepted by CDE and was included in the priority review range.
Globally, the first marketed oxazolidinone antibacterial drug was linezolid developed by Pharmacia, a subsidiary of Pfizer, under the trade name Zyvox.
It was approved by the US FDA in 2000 for the treatment of gram-positive (G+) Infectious diseases caused by cocci include methicillin-resistant Staphylococcus aureus (MRSA) infection and vancomycin-resistant enterococcus (VRE) infection.
Its dosage forms include injections, tablets and dry suspensions.
Linezolid has few competitors since it was listed for more than ten years.
The approval of conzolid will become the first domestically produced oxazolidinone class 1 new drug, which will compete with linezolid on the same stage after it is launched on the market.
According to public information, the results of a head-to-head study carried out by conzolid and linezolid showed that the clinical efficacy of conzolid on gram-positive bacteria, including multidrug-resistant MRSA infections, is comparable to that of linezolid.
In September 2019, Mengke Medicine announced its first new antibacterial drug, contezolid (also known as MRX-I), a key phase 3 clinical trial in China for the treatment of complex skin and soft tissue infections (cSSTI) Obtain positive results.
The clinical cure rate of contizolamide in the primary endpoint of the cure test period is not inferior to linezolid, and shows lower drug-related hematological adverse events.
This double-blind study was conducted in 50 locations in China.
Patients with cSSTI were randomized to receive 800 mg of oral conzolid or 600 mg of linezolid orally twice daily for 7 to 14 days.
Of the 719 patients recruited, 589 were eligible for clinical evaluation (CE) during the trial of treatment (TOC) visit.
For CE patients, the clinical cure rate of contazolamide (93.
0%) and linezolid (93.
4%) at the time of TOC visit was equivalent, reaching a non-inferiority of -10%.
All secondary efficacy endpoints were also reached, including the clinical cure rate at the end of treatment (EOT) visit, the microbial clearance rate at the TOC visit, and the overall response rate at the TOC visit, indicating the effects of conzolid and linezolid The treatment results are similar.
The adverse events between the treatment groups were also comparable.
According to the Insight database, although no domestically-made oxazolidinone innovative drugs are currently on the market, there are many competitors for linezolid generic drugs.
In China, including the original manufacturer Pfizer, 14 companies have approved linezolid for the market.
Covering tablets, injections and suspensions, another 11 companies are in the process of listing applications and competition is fierce.
From Insight database (http://db.
dxy.
cn/v5/home/)
In addition, according to public information, the sales of terminal systemic antibacterial drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers in 2018 were 158.
9 billion yuan, a year-on-year increase of 1.
74%, and the growth slowed year by year.
The arrival of Contazolamide is expected to stimulate the vitality of the antibacterial drug market.
Focus on the research and development of antibacterial drugs,
Mengke Pharmaceutical plans to be listed on the Science and Technology Innovation Board
According to the news of the IPO, Mengke Pharmaceutical has signed a listing counseling agreement with CICC on December 30, 2020, and filed it with the Shanghai Securities Regulatory Bureau on the same day, and plans to list on the Science and Technology Innovation Board.
Established in 2007, Mengke Medicine is an innovative biomedical company with global independent intellectual property rights and international competitiveness focusing on the treatment of infectious diseases, focusing on the increasingly serious problem of bacterial resistance in the world.
The founder and CEO of the company, Dr.
Zhengyu Yuan, has more than 30 years of experience in new drug research and development.
He participated in the establishment of the antibacterial new drug research and development company Vicuron.
The company was awarded US$1.
9 billion by Pfizer in 2005 and became the largest transaction in the field of antibacterial drug research and development that year.
Currently, Mengke has a number of self-developed innovative drug product pipelines, focusing on the field of anti-multidrug-resistant "super bacteria" infections, and expanding to the field of anti-tumor and anti-inflammatory.
In addition to the upcoming approval of Conzolamide (MRX-I), its water-soluble prodrug Conzolamide Phosphate (MRX-4) has completed the Phase II clinical trial of the US FDA in 2019, and the Phase I clinical trial in China is ongoing Medium; Phase I clinical trials of MRX-8, a multi-drug resistant gram-negative bacteria antibacterial drug research and development project in the United States, are also in progress.