March 5, 2025, Shanghai - Recently, Mengke Pharmaceutical announced that its core product, MRX-4 sequential cantizolomide for injection, has made important progress in the global multi center phase III clinical trial for the treatment of moderate to severe diabetes foot infection (DFI). The Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment, confirmed that the drug meets expectations, and recommended that the trial proceed as originally planned. This milestone event not only marks the international recognition of Mengke Pharmaceutical's R&D strength in the field of anti infection, but also injects strong momentum into its global commercialization strategy.


It is reported that this global Phase III clinical trial is an international multicenter, randomized, double-blind controlled study, using linezolid as the control, to evaluate the efficacy and safety of MRX-4 sequential ketoconazole tablets for injection in the treatment of moderate to severe DFI patients. If the trial is successful, the drug will bring new hope to many patients with diabetes foot infection around the world. Mengke Pharmaceutical stated that this evaluation was conducted strictly in accordance with the DMC charter, and a comprehensive and in-depth analysis was conducted on the safety and efficacy data of the first 33% of participants (285 cases) who were enrolled and completed the study. The results showed that MRX-4 sequential cantizolomide for injection showed satisfactory safety and effectiveness in the treatment of moderate to severe diabetes foot infection (DFI) patients.


Diabetes foot infection is one of the most serious complications of diabetes, and the global patient population is huge and growing. According to Frost&Sullivan data, the number of DFI patients in China is expected to increase from 5.2 million in 2024 to 5.42 million in 2035; The number of patients in the United States will increase from 3.76 million to 3.89 million during the same period. Currently, antibiotic treatment remains the core approach for DFI, but traditional drugs such as linezolid and vancomycin have side effects such as bone marrow suppression and hepatotoxicity, which limit their long-term use. Kangtezomib and its prodrug MRX-4 from Mengke Pharmaceutical are a new generation of oxazolidinone antibiotics. Through molecular structure optimization, they reduce the common risks of traditional drugs such as bone marrow suppression, making them particularly suitable for infected patients who require long-term treatment.


It is worth mentioning that in 2023, this combination therapy was awarded by the US FDA as a qualified infectious disease product (QIDP) and a fast track for the treatment of moderate to severe diabetes foot infections without osteomyelitis indications, paving the way for its global layout. The positive evaluation of DMC this time confirms the good efficacy and safety of injectable MRX-4 and clotrimazole tablets, which is a key milestone in their entry into the global market.


Mengke Pharmaceutical stated that the company adopts a differentiated strategy of "oral first+injection breakthrough", completing doctor education in advance through the use of Kangtezomib tablets, paving the way for the launch of MRX-4 injectable form. This combination not only achieves full course coverage for patients, but also extends the market monopoly period through patent layout. At present, the Phase III trials of MRX-4 sequential therapy are steadily advancing in the United States, Europe, Latin America, and other regions, with an expected global launch by 2026-2027. This indication has a global patient population of 40-60 million people, and there is no designated antibiotic use in clinical treatment guidelines. If MRX-4 sequential therapy is successfully launched, it will undoubtedly bring huge commercial value.