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Recently, Shanghai Mengke Pharmaceutical Co.
, Ltd.
("Mengke Pharmaceutical", 688373) announced that its self-developed new drug against gram-negative resistant bacteria MRX-8 China Phase I clinical trial completed the dosing
of the first subject.
This marks a substantial stage
in the clinical development of MRX-8 in China.
MRX-8 is a polymyxin mainly used to treat multidrug-resistant gram-negative infections, has the same antibacterial spectrum as the existing drugs colistin and polymyxin B, and is still effective
against carbapene-resistant negative bacteria, the "superbug" that is defined by the World Health Organization as the most "serious threat" to human health.
MRX-8 has previously completed Phase I clinical trials
in the United States.
The ongoing China Phase I clinical trial is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic profile of intravenous infusion of MRX-8 in healthy subjects in China, and is expected to be completed
within 2023.
Mengke Pharmaceutical has carried out targeted development
based on the safety and production process problems of polymyxins.
In the early stage of compound design, the company introduced innovative "soft medicine" design ideas, established an evaluation model of nephrotoxicity, combined with antibacterial activity screening, and simultaneously studied structure-activity relationship and structure-toxicity relationship, and finally obtained MRX-8 molecules
with both efficacy and safety.
Contezolide, which has been approved for marketing in China, and MRX-4, which is undergoing international multi-center phase III clinical studies, are new oxazolidinone drugs that can effectively treat gram-positive drug-resistant infections
.
Mengke Pharmaceuticals is constantly improving its pipeline of new anti-bacterial infections to basically cover the major "superbugs"
that pose a major threat to human health.