Ceftobiprole Medocaril Sodium

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。PART 01周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年4月14日至2025年4月20日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。PART 02国内52款新药IND获批根据摩熵医药数据库统计，2025年4月14日至2025年4月20日期间共有62个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号44个，进口药品受理号18个。本周共计52款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药16款，生物药32款，中药4款。本周获批临床创新药/改良型新药（部分）信息速览(不含补充申请)注：完整数据可识别“文末”二维码下载查看PART 03本周全球TOP10创新药研发进展在全球创新药研发领域，4月14日，ALX Oncology公司宣布，其针对EGFR表达实体瘤的潜在“best-in-class”及“first-in-class”抗体偶联药物（ADC）ALX2004的IND申请已获FDA批准。ALX2004是通过该公司专有的拓扑异构酶I抑制剂有效载荷平台设计的，由三部分组成，分别是经优化的抗EGFR抗体骨架、稳定性增强的连接子，以及能产生强旁观者效应的专有拓扑异构酶I载荷，旨在克服早期EGFR靶向ADC因药物设计、脱靶毒性及传统载荷局限性导致的临床瓶颈。同日，默沙东宣布，佳达修9[九价人乳头瘤病毒疫苗(酿酒酵母)]（后称“九价HPV疫苗”）多项新适应证已获得中国国家药品监督管理局（NMPA）的上市批准，适用于16~26岁男性接种。这一获批使佳达修9成为中国获批、可适用于适龄男性女性接种的九价HPV疫苗。佳达修9覆盖6、11、16、18、31、33、45、52 和 58 型，共九种HPV型别。此次获批的男性适应证可预防HPV16、18引起的肛门癌，HPV6和11引起的生殖器疣（尖锐湿疣），由HPV6、11、16、18引起的以下癌前病变或不典型病变：1级、2级、3级肛门上皮内瘤样病变（AIN）。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报PART 04本周全球TOP10临床试验结果本周全球TOP10临床结果中，4月14日，Cerevance公司公布了其钾双孔结构域通道亚家族K成员13（KCNK13）抑制剂CVN293的积极1期临床试验结果。CVN293是一种高选择性口服KCNK13抑制剂，旨在通过抑制神经炎症减缓神经退行性疾病进展，KCNK13是一种潜在的NLRP3炎性小体激活的新型调节因子。1期临床试验结果显示，接受CVN293单次和14天内多次给药的健康成人对该药物的耐受性良好，100%的受试者完成了试验，未出现剂量限制性毒性、治疗相关停药或具临床意义的生命体征异常，所有不良事件均为轻度。CVN293还显示出强大的脑渗透性，支持KCNK13抑制剂对以神经炎症为特征的神经退行性疾病的效用。本周全球 TOP10 积极/失败临床结果截图来源：摩熵咨询周报PART 0552款品种过评，山东新时代领跑根据摩熵医药数据库统计，2025年4月14日至2025年4月20日期间共有93项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号81项（包括化药3类，4类），新注册分类临床申请受理号7项（包括化药3类，4类），一致性评价申请5项。本周11个品种通过一致性评价（按受理号计20项），本周41个品种视同通过一致性评价（按受理号计55项）。本周有2项生物类似物注册申报动态，分别是亿帆医药（上海）有限公司的甘精胰岛素注射液和成都康弘生物科技有限公司的KH-813注射液。截图来源：摩熵咨询周报本周过评/视同过评品种主要为系统用抗感染药物；过评/视同过评产品剂型主要为注射剂；本周注射用头孢他啶过评/视同过评受理号数量最多达6个，本周注射用头孢他啶和磷酸奥司他韦干混悬剂过评/视同过评企业最多达3家；本周山东新时代药业有限公司、广东金城金素制药有限公司、江苏知原药业股份有限公司和江苏万高药业股份有限公司过评/视同过评品种数最多达2种，其余各企业过评/视同过评品种数紧随其后，本周过评/视同过评企业共包括山东新时代药业有限公司、广东金城金素制药有限公司和江苏知原药业股份有限公司等57家企业。截图来源：摩熵咨询周报本周有蒙脱石混悬液、盐酸伐地那非口腔崩解片、盐酸拉贝洛尔氯化钠注射液、盐酸哌甲酯缓释片、注射用头孢比罗酯钠、注射用硫酸多粘菌素B 6个品种首次过评/视网过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有洛索洛芬钠凝胶贴膏、硝酸甘油注射液2个品种过评/视同过评达7家企业。本周过评/视同过评达7家企业品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载往期周报回顾#43款新药IND获批！59款品种过评，石家庄四药过评领跑…#64款新药IND获批！12款品种过评，河北天成药业领跑…#58款新药IND获批！47款品种过评，齐鲁制药领跑…#43款新药IND获批！67款品种过评，晖致医药过评领跑…END本文为原创文章，转载请留言获取授权近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

April 16, 2025, Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today scientific presentations on Basilea’s clinical-stage novel antifungal fosmanogepix given at ESCMID Global 2025, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 11 to 15, 2025 in Vienna, Austria. Further presentations covered the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®). Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Invasive fungal infections are an increasing global health problem and novel antifungals are urgently needed. To date more than 250 patients suffering from difficult-to-treat invasive fungal infections have received fosmanogepix via expanded access. The data presented at ESCMID highlight the potential of fosmanogepix as a life-saving treatment option in severe fungal infections, based on the results from a large cohort of patients with invasive fusariosis, as well as from patients with mucormycosis, who received fosmanogepix via expanded access. We look forward to the start of our second phase 3 study with fosmanogepix covering a broad range of mold infections, including aspergillosis, fusariosis and mucormycosis.” More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128). As presented at ESCMID, treatment with fosmanogepix resulted in favorable response rates of 70% or higher in patients with invasive fusariosis or mucormycosis and it was tolerated for long treatment durations. Further presentations reported on the activity of fosmanogepix against diverse yeast and mold species collected as part of a worldwide surveillance program. — Presentation IPT13: Fosmanogepix – a novel clinical phase 3 stage antifungal agent – M. Engelhardt — Presentation O0419: Fosmanogepix expanded access in patients withFusariuminfections – S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner — Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis – A. Puing, A. Kaur, Y. J. Lee, P.Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens — Poster E0237:Activity of manogepix against a worldwide collection of mould isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2891:Activity of manogepix against a worldwide collection of yeast isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2944: Deciphering Connections between Isavuconazole (ISAV) Drug Exposures and Responses Among Different Infections: Mucorales – L. Kovanda, A. Desai — Poster P2945: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Dimorphic Fungi/Mould/Other Filamentous Fungi and Mixed Infections – A. Desai, L. Kovanda — Poster P2946: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Invasive Candidiasis – L. Kovanda, A. Desai — Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Population (PPK) Model from Three Phase 3 Trials and Covariate Exploration – A. Desai, L. Kovanda — Poster E0055: High-dose isavuconazole therapy is well-tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis – S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis Ceftobiprole (Zevtera) data presented at ESCMID Global 2025 — Poster E0792: Ceftobiprole alone versus in combination with ampicillin against borderline penicillin-resistant, vancomycin-resistant Enterococcus faecalis – O. Funk, I. Khan, J. Li, J. Cusumano Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.3 Isavuconazole is also approved in the United States (US)4 and several additional countries in Europe and beyond, including the United Kingdom5, the Middle East and North Africa region, the Asia Pacific region, China and Japan.6 It has orphan drug designation in the US, Europe and Australia for its approved indications. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.7 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).7 In the United States, ZEVTERA® is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).8 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC): ClinicalTrials.gov identifier: NCT05421858 European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 15, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 15, 2025] Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 15, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 15, 2025] The content above comes from the network. if any infringement, please contact us to modify.