Contezolid

数据监查委员会（DMC）已完成本次全球III期临床试验的首次安全性及有效性评估，并建议按照原计划继续推进 注射用MRX-4序贯康替唑胺片在糖尿病足感染（DFI）患者中展现出符合良好预期的安全性和有效性 上海 2025年2月25日 /美通社/ -- 近日，上海盟科药业股份有限公司（"盟科药业"，688373.SH）注射用MRX-4序贯康替唑胺片用于治疗糖尿病足感染（DFI）的全球多中心III期临床试验取得重要进展。数据监查委员会（DMC）已完成首次安全性及有效性评估，确认药物安全性和有效性符合良好预期，并建议试验按照原计划继续推进。 DMC权威认可，安全性和有效性符合良好预期 此次评估依据DMC章程约定进行，对入组并完成研究的前33%受试者（285例）的安全性和有效性数据进行了全面分析。结果显示，注射用MRX-4序贯康替唑胺片在治疗中度至重度糖尿病足感染（DFI）患者中展现出符合良好预期的安全性和有效性。基于此，DMC一致建议试验无需调整，为后续临床推进注入强心剂。 填补未满足需求，瞄准全球市场 DFI是糖尿病严重并发症之一，中国2018年有476万人患有糖尿病足感染，到2024年，增长至520万人，年复合增长率1.5%。预计到2030年和2035年，中国的糖尿病足感染人数将达到536万和542万。美国2018年有365万人患有糖尿病足感染，到 2024年，增长至376万人，年复合增长率0.5%。预计到2030年和2035年，美国的糖尿病足感染人数将达到384万和389万。 [1] 抗生素治疗是治疗DFI的核心方法。注射用MRX-4以及康替唑胺片作为新一代噁唑烷酮类抗生素，通过结构优化降低了骨髓抑制等传统药物的常见风险，尤其适合需长期治疗的感染患者。康替唑胺片自2021年在中国获批用于治疗复杂性皮肤及软组织感染以来，其临床安全性和有效性已获广泛验证。MRX-4为康替唑胺的水溶性前药，在体内转化为康替唑胺发挥疗效。2023年康替唑胺片及MRX-4获美国FDA授予用于治疗中度至重度糖尿病足感染且不伴有骨髓炎适应症合格传染病产品（QIDP）和快速通道（Fast Tack）资格认定。 本次全球III期临床试验为国际多中心、随机、双盲对照研究，以利奈唑胺为对照，评估注射用MRX-4序贯康替唑胺片治疗中度至重度DFI患者的有效性和安全性，计划共纳入865名患者，疗程14至28天。 盟科药业CFO兼盟科美国总裁李峙乐先生表示："DMC的积极评价印证了注射用MRX-4以及康替唑胺片的良好有效性和安全性，这是其迈向全球市场的关键里程碑。我们期待该药物能为DFI患者提供更安全的治疗选择，同时为应对抗生素耐药性挑战提供新方案。" 公司董事长兼总经理袁征宇博士强调："注射用MRX-4以及康替唑胺片的研发始终聚焦于解决未被满足的临床需求。DFI患者亟需可长期安全使用的更优的创新疗法，而现有数据进一步验证了其适合长期用药的潜力。" 数据来源：[1] 弗若斯特沙利文 声明 ： 1. 本文仅作为盟科药业新闻发布，旨在促进医药信息的沟通与交流，非广告用途。相关信息并非针对患者，仅供医疗卫生专业人士参考之用。 2. 本文所包含的任何医疗医药信息只作为科学信息以供参考，不能取代向医生或其他有资格的医疗卫生专业人士进行的咨询，不能替代医生或医疗卫生专业人士提供的医疗建议，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 3. 本公司不对任何药品和/或适应症作推荐。 4. 本公司对本文内容的准确性、时效性和完整性不做任何形式的保证或承担任何责任。 前瞻性声明： 本新闻稿中包含若干前瞻性陈述，该等前瞻性陈述并非历史事实，为公司基于当前所掌握的数据和信息对未来事件所做的预测或期望。"预期"、"相信"、"继续"、"可能"、"估计"、"期望"、"有望"、"打算"、"计划"、"潜在"、"预测"、"预计"、"应该"、"将"、"拟"、"会"和类似表达旨在识别前瞻性陈述，但并非所有前瞻性陈述都包含这些识别词。这些前瞻性陈述涉及已知和未知的不确定性和其他重要因素，可能因受到政策、研发、市场及监管等不确定因素或风险的影响，而导致实际结果与前瞻性陈述有重大差异。请现有或潜在的投资者审慎考虑可能存在的风险，并不能完全依赖本新闻稿中的前瞻性陈述。本新闻稿中包含的任何前瞻性陈述仅代表截至本新闻稿发布之日的情况。除非法律要求，本公司无义务因新信息、未来事件或其他情况而对本新闻稿中任何前瞻性陈述进行更新或修改。

Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued progression as planned MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in patients with diabetic foot infections (DFI), meeting expectations SHANGHAI, Feb. 25, 2025 /PRNewswire/ -- 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 Expectations This 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 Markets DFI 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 from DFI in 2018, increasing to 3.76 million by 2024 at a CAGR of 0.5%. The number is expected to rise to 3.84 million by 2030 and 3.89 million by 2035. Antibiotic therapy is the cornerstone of DFI treatment. MRX-4 Injection and Contezolid Tablets, as a new generation of oxazolidinone antibiotics, reduce risks such as myelosuppression—common with traditional therapies—through structural optimization, making them particularly suitable for patients requiring long-term treatment. Contezolid Tablets, approved in China in 2021 for complicated skin and soft tissue infections (cSSTI), have already demonstrated robust clinical safety. MRX-4, a water-soluble prodrug of Contezolid, converts into Contezolid in vivo to exert therapeutic effects. In 2023, both Contezolid Tablets and MRX-4 received U.S. FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating moderate-to-severe DFI without concurrent osteomyelitis. This global Phase III trial is an international multicenter, randomized, double-blind, controlled study comparing MRX-4 Injection followed by Contezolid Tablets with linezolid in treating moderate-to-severe DFI patients. The trial plans to enroll 865 patients, with a treatment duration of 14 to 28 days. Mr. Jerry Li, CFO and President of MicuRx U.S., stated, "The DMC's positive evaluation underscores the promising efficacy and safety of MRX-4 Injection and Contezolid Tablets, marking a critical milestone toward global market entry. We anticipate this therapy will offer DFI patients a safer treatment option while addressing antibiotic resistance challenges." Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, emphasized, "The development of MRX-4 and Contezolid has always focused on unmet clinical needs. DFI patients urgently require better-tolerated innovative therapies suitable for long-term use, and the current data further validate their potential." Forward-Looking Statements This press release contains certain forward-looking statements. These statements are not historical facts but are based on the Company's current predictions or expectations regarding future events based on available data and information. Words such as "anticipate," "believe," "continue," "may," "estimate," "expect," "intend," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, though not all such statements include these specific terms. These forward-looking statements involve known and unknown uncertainties and other significant factors that may cause actual results to differ materially from those expressed or implied due to risks associated with policy, R&D, market conditions, regulatory uncertainties, and other variables. Existing and potential investors are cautioned to carefully evaluate these risks and not to rely unduly on the forward-looking statements herein. Any forward-looking statements contained in this press release are made only as of the date of this press release. Unless required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED