• According to the data from the World Health Organization (WHO), millions of patients face difficulties in treatment or even life-threatening situations due to drug-resistant infections every year.
• Not only does MRX-8 perform well in terms of safety and tolerability, it also has strong antibacterial activity against multidrug-resistant gram-negative bacteria, with significant potential for clinical applications.
• In China, the total number of days of antibiotic treatment for multidrug-resistant gram-negative bacterial infection increased from 43 million days in 2018 to 68.4 million days in 2023, with a compound annual growth rate of 10.3% during this period.^"

SHANGHAI, June 5, 2024 /PRNewswire/ -- Recently, Mengke Pharmaceuticals Co., Ltd. ("Mengke Pharmaceuticals", 688373.SH) announced that it has independently developed a new injection-type polymyxin antimicrobial drug.MRX-8, a new injection-type polymyxin antimicrobial drug developed independently by Mengke Pharmaceuticals.MRX-8's phase I clinical trial in China was successfully completed and achieved the expected goals. MRX-8 is mainly used to treat multidrug-resistant gram-negative bacterial infections, and this significant achievement marks a key step for MRX-8's development as a safe and effective new antibacterial drug.

ChinaPhase I Clinical Trial Results in China

This phase I clinical trial in China was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of MRX-8 in healthy Chinese subjects. The trial was divided into a single dose escalation part and a multiple dose escalation part, and the results showed that the exposure of MRX-8 in the human body increased in proportion to the dose.

The study showed that MRX-8 could achieve ideal therapeutic effects on multidrug-resistant gram-negative bacterial infections at the expected clinical dosage of 2.5 mg/kg once a day. In addition, MRX-8 demonstrated good safety in healthy Chinese adults. Throughout the study, no subjects withdrew from the study prematurely or terminated the study due to adverse events, and adverse events of CTCAE grade 3 or higher did not occur. The most common adverse events were mild hypoesthesia and decreased glomerular filtration rate, both of which were of CTCAE grade 1 and recovered without intervention. Adverse events of CTCAE grade 2 were only observed in two subjects in the multiple dose group, both of which were injection site reactions.

Research Impact and Future Plans

As one of the important new drug development products in the company's pipeline, the successful completion of this phase I clinical trial in China for MRX-8 is of great significance. The research results showed that MRX-8 demonstrated good safety in healthy Chinese adults at the expected clinical dosage, laying a solid foundation for its clinical application after successful development. The success of this clinical trial not only provides strong data support for follow-up clinical development, but also adds confidence in the future application of MRX-8 in the treatment of multidrug-resistant gram-negative bacterial infections. This marks a key step for MRX-8 to become a safe and effective new antibacterial drug.

The company will formulate the next clinical development plan for MRX-8 based on the results and data of the phase I clinical trials in the United States and China. The company will actively evaluate different development paths for different potential indications, with the goal of making MRX-8 a significant clinically valuable new antibacterial drug that addresses the rapidly growing clinical treatment needs, creates maximum value for society and the company, and promotes the early launch of MRX-8, bringing new hope to patients.

About JSKN003: MRX-8

MRX-8 is a new injection-type polymyxin antimicrobial drug independently developed by Mengke Pharmaceuticals, mainly used to treat severe infections caused by multidrug-resistant gram-negative bacteria. Traditional polymyxin drugs are limited in clinical use due to the high risk of kidney and nerve toxicity. MRX-8 has been carefully designed to significantly reduce these toxicity risks while maintaining or improving therapeutic effects.

Results from the US phase I clinical trial completed in 2022 showed that MRX-8's drug exposure in the human body can achieve ideal therapeutic effects against various types of multidrug-resistant gram-negative bacterial infections caused by Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumannii, etc., at the expected clinical treatment dosage.

About Multi-drug Resistant Gram-negative Bacteria and Its Market Demand

Gram-negative bacteria have resistance to multiple drugs, and their resistance to most available antibacterial drugs is increasing. Multidrug-resistant gram-negative bacteria (MDR-GNB) are a special type of gram-negative bacteria whose multi-drug resistance is defined as having resistance to three or more commonly prescribed antibacterial drugs (cefotaxime, ciprofloxacin, meropenem, gentamicin, ampicillin/sulbactam, or piperacillin/tazobactam) and causes infections with a mortality rate five times higher than those caused by conventional gram-negative bacteria. Multidrug-resistant gram-negative bacterial infections have become a major challenge in the field of public health worldwide. According to data from the World Health Organization (WHO), millions of patients face difficulties in treatment or even life-threatening situations due to drug-resistant infections every year. Particularly in hospitals and intensive care units, the high mortality and treatment costs caused by multidrug-resistant gram-negative bacterial infections pose enormous pressure on the medical system.

SHANGHAI, June 5, 2024 /PRNewswire/ -- Recently, Mengke Pharmaceuticals Co., Ltd. ("Mengke Pharmaceuticals", 688373.SH) announced that it has independently developed a new injection-type polymyxin antimicrobial drug.

In China, the total antibiotic treatment days for Multidrug-resistant Gram-negative Bacilli infections increased from 43 million days in 2018 to 68.4 million days in 2023, with a compound annual growth rate of 10.3% during this period.^"

Currently, there are limited options for effective treatment of Multidrug-resistant Gram-negative Bacilli infections on the market, and the serious side effects of traditional polymyxin drugs further limit their clinical use. The development and clinical trial results of MRX-8 perfectly meet this unmet market demand. MRX-8 not only performs well in safety and tolerability, but also demonstrates strong antibacterial activity against Multidrug-resistant Gram-negative Bacilli, with significant clinical potential.

_{[1] Data Source: Frost & Sullivan Analysis}