December 23, 2024 – Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”，688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections. This designation marks a significant milestone for MicuRx in the field of NTM infection treatment.MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria (NTM). In recent years, NTM diseases have been increasing rapidly and have become one of the major public health threats worldwide[1]. However, current treatment options for NTM infections are limited, and traditional drugs face common challenges such as drug resistance, poor efficacy, and numerous adverse effects[1,2].MRX-5 is a new drug specifically aimed at treating drug-resistant NTM infections, demonstrating good antibacterial activity against common NTM strains. It has also shown potent antibacterial activity against NTM pathogens in both animal studies and human trial, along with favorable safety and pharmacokinetic profiles. Additionally, MRX -5 features minimal interactions, low potential for resistance, and high oral bioavailability, making it suitable for long-term use in treating chronic infections.The granting of ODD is not only an important milestone in the development of MRX-5,…

December 18, 2024, the Expert Consensus on the Use of Contezolid in the Treatment of Tuberculosis was officially launched online on the China National Knowledge Infrastructure (CNKI) platform, published in the Chinese Journal of Antituberculosis (Certificate No.: 202412189916). This landmark consensus from Chinese experts in the field of tuberculosis not only provides new treatment strategies and scientific evidence for the clinical management of tuberculosis but also marks a new phase in the application of Contezolid in tuberculosis treatment. It injects new vitality into the global tuberculosis prevention and control efforts.Tuberculosis remains one of the most significant public health threats worldwide, with treatment success rates still at a relatively low level[1]. In this context, oxazolidinone drugs are playing an increasingly important role in the treatment of drug-resistant tuberculosis (DR-TB) and in the development of new drugs and treatment regimens. As a new generation of oxazolidinone drugs, Contezolid has seen continuous clinical exploration and scientific research in tuberculosis treatment since its launch. Clinical physicians have expressed an increasing demand for guidelines or standards regarding its clinical application.To standardize and guide healthcare professionals in the use of Contezolid for tuberculosis treatment, addressing issues such as indications, dosage, and duration that are not adequately…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of its Phase III clinical trial of MRX-4 for injection transitioning to oral Contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI) in China. The trial achieved its primary efficacy endpoint, and the company will actively move forward with the New Drug Application (NDA) process of MRX-4 for injection in China.Clinical Trial Results and Key FindingsThis clinical trial was designed to evaluate MRX-4 for injection transitioning to oral Contezolid tablets in comparison to intravenous Linezolid for treating adult patients with cSSTI (including those caused by methicillin-resistant Staphylococcus aureus (MRSA)). The results of the study showed that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (subsequent oral administration of 800 mg Contezolid tablets, referred to as “MRX-4/Contezolid”), administered every 12 hours for a duration of 7-14 days, demonstrated good clinical and microbiological efficacy. Statistical analysis showed that MRX-4/Contezolid were non-inferior to the Linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study.Regarding safety, the study showed that the MRX-4/Contezolid regimen had good safety and tolerability. No adverse events related to…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, 688373.SH) announced the successful completion of Phase I clinical trial of MRX-5 in Australia, a self-developed oral antibacterial agent in development for the treatment of nontuberculous mycobacterial (NTM) infections. Details and Results of the Phase I Clinical Trial in AustraliaThis trial represents the first time MRX-5 was administered to humans in a Phase I clinical trial, conducted at the Nucleus Network Research Center in Australia. This trial evaluated the safety, tolerability, PK and food effect of orally administered MRX-5 at single and multiple oral doses.The results of the phase 1 study indicate that MRX-5 was generally well tolerated among the healthy adult subjects participating in this study. There were no serious adverse events reported and all participants completed the trial, and there were no drug-related adverse events rated CTCAE Grade 3 or higher. The majority of TEAEs were CTCAE Grade 1(mild), and resolved without intervention.Pharmacokinetic analysis showed that MRX-6038, the active metabolite of MRX-5, exhibited linear and predictable pharmacokinetic profile after single oral doses ranging from 50mg~1200mg. Food intake did not significantly affect its absorption. Impact of the Study and Future PlansThe Phase 1 data supports the further development of MRX-5 ,and boosts…

San Francisco, CA – October 15, 2024 – Dr. Regis Vilchez, Chief Medical Officer of MicuRx Pharmaceuticals, presented the latest advancements of company’s development program, MRX-5 and MRX-8, at the BIO Investor Forum (BIF). These development programs offer new potentials for the future treatment of Nontuberculous Mycobacterial (NTM) pulmonary diseases and Pseudomonas aeruginosa (PsA) pulmonary infections. MRX-5, a novel benzoxaborole antibiotic, is developed for the treatment of rare chronic pulmonary disease caused by NTM infection. MRX-5 exhibits excellent antibacterial activity against common NTM pathogens and demonstrates good safety in animal trials.MABC affects approximately 12,000 to 20,000 patients in the US and requires treatment durations exceeding 12 months. MRX-5 holds promise for addressing NTM infections.MRX-8, a novel antibiotic in the polymyxin class, is designed to treat severe infections caused by multidrug-resistant Gram-negative bacteria. Traditional polymyxins are limited in clinical use due to high risks of nephrotoxicity and neurotoxicity. MRX-8, with its novel chemical structure, maintains or improves therapeutic efficacy while significantly reducing these risks.The company also aims to explore the clinical and commercial potential of developing an inhaled formulation targeting chronic lung infections. In mouse models of PsA lung infections, nebulized MRX-8 demonstrated significant reduction in bacterial load in lung tissues,…

Foster City, CA – Oct. 8, 2024 – MicuRx Pharmaceuticals is excited to announce the publication of groundbreaking research on MRX-5, a novel oral oxaborole prodrug, demonstrating significant potential in the treatment of pulmonary infections caused by Mycobacterium abscessus (Mab), a severe nontuberculous mycobacterium (NTM) infection. The research was led by Dr. Gyanu Lamichhane, Associate Professor at Johns Hopkins University School of Medicine.The study, published in Antimicrobial Agents and Chemotherapy, evaluated MRX-5 against clinical isolates of M. abscessus in a validated mouse model. The results revealed that MRX-5 achieved a dose-dependent reduction in lung bacterial burden, with dose of 15 mg/kg showing efficacy comparable to the current standard-of-care.Key Findings:• MRX-5 demonstrated significant efficacy against a variety of M. abscessus isolates, including drug-resistant strains, offering hope for patients with limited treatment options.• At dose of 15 mg/kg, MRX-5 achieved a reduction in lung bacterial loads comparable to established therapies.• MRX-5 showed dose-linear pharmacokinetics, indicating the potential for predictable and manageable dosing in clinical settings.• The study marks the first evaluation of MRX-5, the oral prodrug of MRX-6038, in an animal model, demonstrating MRX-5 is well tolerated and effective over extended treatment durations."We are excited about the potential of MRX-5 to provide…

Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx"，688373.SH) presented the latest research progress on their novel antibiotic pipeline products, MRX-5 and MRX-8, at the 7th World Bronchiectasis Conference (WBC) held in Dundee, Scotland, from July 4 to 6, 2024. These research results provide new hope for the future treatment of Nontuberculous Mycobacteria (NTM) lung disease and Pseudomonas aeruginosa infections. Conference BackgroundThe World Bronchiectasis Conference is a leading global academic conference focused on the research and treatment of bronchiectasis. This conference brings together top scientists and clinical experts from around the world to discuss the latest research developments, clinical management strategies, and the development of new therapies for bronchiectasis. Research HighlightsAs a biopharmaceutical company dedicated to developing innovative anti-infective drugs, MicuRx presented three significant research results in poster presentation at the conference. These studies further support the potential of MRX-5 and MRX-8 in the treatment of specific infections： In Vitro and In Vivo Activity of A Novel Leucyl-tRNA Synthetase Inhibitor Against Mycobacterium AbscessusThe active drug MRX-6038 was very potent against M. abscessus clinical isolates in vitro with MIC90 0.5 mg/L while the control drug clarithromycin MIC90 was 4 mg/L. MRX-6038 greatly reduced the resistance frequency of standard of care drugs (Ethambutol, Clarithromycin, Rifabutin,…

MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation under the Generating Antibiotic Incentives Now (GAIN) Act for contezolid (MRX-I) tablet and contezolid acefosamil (MRX-4) tablet and intravenous as novel new oxazolidinone antibiotics for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis. The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII–Generating Antibiotic Incentives Now (GAIN) Act, to encourage development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. Once a new drug is qualified for QIDP, it will be granted two incentive policies: an additional five years of market exclusivity after launch, and a priority review during the review phase. Dr. Zhengyu Yuan, chairman and CEO of MicuRx Pharmaceutical, said, "We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common…