The 2025 European Congress of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) will take place in Vienna from April 11 to 15, 2025. As one of the largest, most comprehensive, and influential global academic conferences in the fields of clinical microbiology, infectious diseases, and infection control, ESCMID Global serves as a pivotal platform for scientific exchange. Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, Stock Code: 688373) will present 15 new clinical and preclinical research datasets related to its pipeline products in poster presentations during the conference. The presentations will focus on two core products: Contezolid and MRX-5.MRX-5: Preclinical and Phase 1 data supporting its potential as a novel treatment for nontuberculous mycobacterial (NTM) pulmonary disease, particularly Mycobacterium abscessus (MAB) infections. Four studies on MRX-5 presented at the conference “We are excited to share our latest clinical and scientific advancements at ESCMID Global 2025,” Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, stated，“These data highlighted our ongoing commitment to developing innovative therapies to address urgent unmet needs in infectious and chronic pulmonary diseases.” MicuRx invites attendees to visit the poster sessions to engage with the team and learn more about the company's clinical progress and future development plans.

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, 688373.SH) announced significant progress in its global multicenter Phase III clinical trial evaluating MRX-4 Injection followed by Contezolid Tablets for the treatment of DFI. The DMC has completed its first safety and efficacy assessment, confirming that the drug’s safety and efficacy profiles meet favorable expectations and recommending the trial proceed as planned. DMC Endorsement: Safety and Efficacy Meet Favorable ExpectationsThis evaluation was conducted in accordance with the DMC charter, analyzing the safety and efficacy data of the first 33% of enrolled subjects (285 cases) who completed the study. The results showed that MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in treating moderate-to-severe DFI patients, meeting expectations. Based on this, the DMC unanimously recommended no adjustments to the trial, injecting confidence into subsequent clinical advancement. Addressing Unmet Needs and Targeting Global MarketsDFI is one of the severe complications of diabetes. In China, the number of DFI patients was 4.76 million in 2018, growing to 5.2 million by 2024 at a compound annual growth rate (CAGR) of 1.5%. It is projected to reach 5.36 million by 2030 and 5.42 million by 2035. In the United States, 3.65 million patients suffered…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”, 688373.SH) received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) for MRX-5 tablets, intended for the treatment of infections caused by non-tuberculous mycobacteria (NTM) sensitive to the drug.Approval Details:• Drug Name: MRX-5 Tablets• Applicant: Shanghai MicuRx Pharmaceutical Co., Ltd.• Acceptance Number: CXHL2401055• Notice Number: 2024LP03026• Indication: Intended for the treatment of infections caused by NTM sensitive to the drug• Approval Conclusion: The clinical trial application for MRX-5 tablets meets the requirements for drug registration, and the NMPA has approved the company to proceed with clinical trials for this drugOther Relevant Information:MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by NTM. NTM includes a variety of species, and the incidence and prevalence of NTM diseases are continuously increasing. Currently, the treatment of NTM infections primarily relies on a combination of multiple antibiotics, requiring prolonged treatment durations, and traditional drugs face widespread issues such as drug resistance, poor efficacy, and numerous side effects. MRX-5 is a novel therapeutic agent for NTM infections with good antibacterial activity against common NTM species. It has also shown potent antibacterial activity against NTM pathogens in…

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,…