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,…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) successfully completed the Phase I clinical trial of its self-developed new injectable polymyxin antibacterial drug MRX-8 in China, achieving the expected goals. MRX-8 is primarily used to treat infections caused by multidrug-resistant Gram-negative bacteria. This significant milestone marks a crucial step towards MRX-8 becoming a safe and effective new antibacterial drug. China Phase I Clinical Trial ResultsThe 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 included single ascending dose and multiple ascending dose components, demonstrating that MRX-8's drug exposure in the human body increases proportionally with the dose.The study demonstrated that at the expected clinical dose of 2.5 mg/kg once daily, MRX-8 can achieve ideal therapeutic effects against infections caused by multidrug-resistant Gram-negative bacteria. Moreover, MRX-8 exhibited good safety in healthy Chinese adults. Throughout the study, no subjects withdrew or terminated the trial due to adverse events, and no CTCAE Grade 3 or higher adverse events occurred. The most common adverse events were mild sensory reduction and decreased glomerular filtration rate, all of which were CTCAE Grade 1 and resolved without…

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…

Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. announced the official launch of its independently developed anti Gram positive bacteria injection MRX-4 phase III clinical trial in China for cSSTI (complex skin and soft tissue infections). The Antibiotics Research Institute of Huashan Hospital affiliated to Fudan University, as the leader unit of this study, enrolled the first subject, This is also the sixth subject enrolled in this clinical trial. The trial of MRX-4 for injection against cSSTI is a multi-center, randomized, double-blind and double simulation phase III clinical trial, which mainly evaluates the safety and effectiveness of MRX-4 for injection in the treatment of cSSTI, and helps MRX-4 for injection to be approved and marketed in Chinese Mainland. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, greatly expanding the usage scenarios. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration. It is worth noting that the Phase III clinical trial was led by Professor Zhang Yingyuan and Professor Huang Haihui from Huashan Hospital affiliated to Fudan University. Professor Zhang Yingyuan is a lifelong professor and former director of the Antibiotics Research Institute…

On July 25, 2023, MicuRx Pharmaceutical Co., Ltd. announced that its independently developed new drug against Gram positive drug-resistant bacteria - MRX-4 for injection sequential oral Contezolid Tablets, a global phase III clinical trial project for diabetes foot infection indications, was successfully enrolled in the first patient in West China Hospital of Sichuan University in China. The study of MRX-4 sequential Contezolid for injection on the indications of diabetes foot infection is a three-phase, international, multi-center, randomized, double-blind study, which mainly evaluates the safety and effectiveness of MRX-4/Contezolid for injection in moderate or severe diabetes foot infection (DFI). This trial will be conducted at approximately 70 clinical research centers in major countries including China, the United States, and Europe. Starting from 2022, the trial officially began the enrollment of phase III clinical trials worldwide, and in December 2022, drug clinical trial applications were submitted and approved in several EU countries. China, as a constituent country of the global third phase clinical research, will bring more first-hand data to the enrolled subjects, promoting the clinical progress of the experiment. It is worth noting that Professor Ran Xingwu, director of the diabetes Foot Diagnosis and Treatment Center of West China Hospital of…

From June 5th to June 8th in accordance with the PST, , the BIO International Convention, a leading biotechnology exhibition, took place successfully in Boston Convention and Exhibition Center. MicuRx Pharmaceuticals (Stock code: 688373 SH.) made its appearance at the convention. Mr. Jerry Li, CFO of MicuRx Pharmaceuticals and President of MicuRx Pharmaceuticals USA, participated in the company's exhibition session and introduced the company's profile and R&D pipeline to the attendees. Established in 1993, BIO is an annual meeting of the global biotechnology innovation organization in the United States. It is the largest, most professional, and influential biotechnology event in the world. The conference focuses not only on trade transactions but also on exhibitions and meetings, providing a comprehensive platform for companies, technology parks, and research institutions from around the world to promote and showcase their innovations. At the afternoon of June 7th PST, Mr. Jerry Li, President of MicuRx Pharmaceuticals USA, attended the event and provided detailed information to the attendees regarding company's R&D progress, pipeline, and commercialization plans in China, the United States, and Europe. Currently, the core product of company, MRX-4 and Contezolid Tablets, are undergoing global multi-center Phase III sequential trials in an orderly manner. Both…

Recently, the selection for the 3rd Pharmaceutical Innovation for Public Welfare Awards, organized by Securities Times, came to a close. After self-recommendation, recommendations, online voting, and expert evaluations, the list of winners was officially announced. In this edition of the awards, MicuRx Pharmaceuticals' Contezolid tablets R&D Team was recognized as one of the "Top Ten Pharmaceutical Innovation Research Teams," affirming company's research and development capabilities and commercial value. Established in 2021, the Pharmaceutical Innovation for Public Welfare Awards aims to recognize and reward outstanding innovative drug projects, companies, institutions, and scientists who have made significant progress in the past year. The awards rely on the "People's Finance·Innovative Drug Index" database for evaluation. Contezolid Tablets is oxazolidinone antibiotics and represent a new generation of antibacterial drugs independently designed and developed by MicuRx Pharmaceuticals. It is used to treat Gram-positive bacterial infections. Building upon the previous generation of antibacterial drug Linezolid, MicuRx's R&D team made changes to the molecular structure of the drug, creatively alleviating spinal cord suppression toxicity. Clinical trials have also demonstrated that Contezolid Tablets achieve both effectiveness and safety. They were approved for market launch in China in June 2021 and entered the National Medical Insurance Negotiation in December…

On May 11, 2023, on the occasion of the 7th "China Brand," the "2023 New China Health Industry and Capital Summit Forum," hosted by Economic Information Daily, grandly opened in Deqing, Zhejiang. MicuRx Pharmaceuticals' product, Contezolid tablets, was successfully selected as an "Excellent Case of Innovative Health Product," fully showing MicuRx Pharmaceuticals’ innovative capabilities and product value. This event was jointly organized by Xinhua News Agency, government of Zhejiang Province, and China Brand Building Promotion Association, among other institutions. Its aim was to show the high-quality development in the health industry and promote greater responsibilities and contributions of health enterprises in the new era. The event attached great importance to high-quality health cases and set up the "Excellent Case of Health Industry" evaluation segment. Considering various dimensions such as technological barriers, market performance, brand building, and corporate culture, MicuRx Pharmaceuticals' contezolid tablets were recognized as an "Excellent Case of Innovative Health Product." MicuRx Pharmaceuticals' main product is Contezolid tablets (Youxitai®), which belongs to the oxazolidinone class of antibiotics and was approved for market launch in China in June 2021. Contezolid tablets has made molecular structural improvements to the previous generation of super-antibiotics, incorporating an innovative structure. This structure enables a…