Linezolid

CHICAGO--( BUSINESS WIRE )--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago focused on the development and commercialization of generic, fertility, biologic, and branded injectable products, announced it has secured exclusive commercial rights in the U.S. to XENLETA ® (lefamulin acetate) through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industrial Co., Ltd. (HKF). XENLETA ® belongs to a new class of novel antibiotics and is approved in intravenous and oral formulations in the U.S. and multiple other countries for the treatment of community-acquired bacterial pneumonia (CABP) in adults. HKF has acquired global rights to XENLETA ® (with the exception of Greater China) from Nabriva Therapeutics. Through the acquisition, HKF has obtained substantially all global assets related to XENLETA ® , including results of development and regulatory activities. “The licensing of XENLETA ® bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As the first approved medicine of an entirely new class of antibiotics, XENLETA ® is an innovative therapeutic option that will be available to the patients affected by CABP and has been shown to be active against various bacterial strains. We look forward to leveraging our end-to-end expertise in biopharmaceutical development and commercialization to bring this important therapeutic to patients in need.” XENLETA ® is a first-in-class semi-synthetic pleuromutilin antibiotic. As a monotherapy offering a complete spectrum of coverage for the main CABP pathogens and with a low propensity for the development of bacterial resistance, XENLETA ® represents a critical step in addressing the growing global public health crisis of antimicrobial resistance (AMR) and supports the principles of antimicrobial stewardship. “Antimicrobial resistance, unfortunately, undermines the treatment paradigms of many infectious diseases globally, leading to poor patient outcomes and increased costs to healthcare systems,” said Brett Novak, Meitheal’s Senior Vice President of Commercial Operations. “XENLETA ® provides a unique and well-tolerated product profile for the more than five million annual cases of CABP in the U.S., where it has the potential to serve as a first-line monotherapy option in both the inpatient and outpatient settings. We are pleased that this agreement will allow us to unlock synergies with our existing franchises and deliver critical medicines that address large gaps in the antibiotic treatment landscape.” Global approvals of XENLETA ® in CABP are based on the results of two global, pivotal Phase 3 trials, LEAP 1 and LEAP 2, in which XENLETA ® met all primary endpoints. Meitheal recently added the first anti-infective to its portfolio through an exclusive commercialization agreement with HKF—CONTEPO™. Meitheal will leverage its new aligned-to-CONTEPO ™ marketing, sales, and medical science liaison teams to support the launch of XENLETA ® , which shares similar hospital call points. Meitheal will further establish practice-based support for key prescribers and patients that could benefit from XENLETA ® . “We are pleased to have acquired the rights to XENLETA ® and look forward to supporting Meitheal as it delivers this important medication to patients in the U.S.,” said Eric Tang, President of HKF. “We are committed to supporting Meitheal’s work to deliver accessible, sustainable, and innovative healthcare solutions and we remain focused on continuing to invest in the research, development, and commercialization of branded pharmaceuticals to achieve this goal.” HKF and its related entities have invested over $300 million in capital and research and development in recent years to support sustainable product supply across key focus areas, including branded biopharmaceuticals. The licensing agreement for XENLETA ® adds a third branded biopharmaceutical and first on-market branded product to Meitheal’s portfolio. ABOUT COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. CABP is among the most common types of pneumonia, with five million cases in the U.S. each year. 1 In the U.S., CABP is the leading cause of infection-related death 2 and the fourth leading cause of hospitalization, 3 a setting where mortality rates are approximately 15% 4 . Certain bacteria that cause CABP have become resistant to one common antibiotic, macrolides, at a rate on average of 50%. 5 The U.S. FDA has also issued multiple warnings about the resistance of one current class of CABP treatments called fluoroquinolones. 6 Antimicrobial resistance (AMR) is a top global public health threat that creates challenges treating infections and performing medical procedures and increases the risk of death and disability. 7 Novel antibiotics that kill bacteria, including those that cause CABP, in a different way are essential to addressing AMR. 8 ABOUT XENLETA ® XENLETA ® (lefamulin acetate) is a first-in-class, semi-synthetic pleuromutilin antibiotic for systemic administration in humans. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA ® ’s binding occurs with high affinity, high specificity, and at molecular sites that are different than other antibiotic classes. Two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP demonstrated XENLETA ® ’s efficacy. In these trials, XENLETA ® was compared with moxifloxacin, and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA ® had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. CONTRAINDICATIONS XENLETA ® is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA ® . Concomitant use of XENLETA ® tablets with CYP3A substrates that prolong the QT interval is contraindicated. WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile-associated Diarrhea: Evaluate patients who develop diarrhea. ADVERSE REACTIONS The most common adverse reactions associated with XENLETA ® Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia and headache. The most common adverse reactions associated with XENLETA ® Tablets include diarrhea, nausea, vomiting, hepatic enzyme elevation. Please see Full Prescribing Information for more information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly-priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Company, founded in 2010. ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of the world’s leading manufacturers of heparin-related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA-approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. NKF is publicly listed on the Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. ABOUT NABRIVA THERAPEUTICS PLC Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. FDA approval for XENLETA ® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics also previously developed CONTEPO™ (fosfomycin for injection), a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI). ___________________________ 1 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 -2010. https://archive.cdc.gov/#/details?url=https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed December 4, 2024). 2 el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA.2018;319(12):1248–1260. doi:10.1001/jama.2018.2089. 3 McDermott KW, Roemer M. Most frequent principal diagnoses for inpatient stays in U.S. Hospitals, 2018: Statistical Brief, no 277. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality. 2021. https://hcup-us.ahrq.gov/reports/statbriefs/sb277-Top-Reasons-Hospital-Stays-2018.pdf . 4 2017 CHARTBOOK STATIC ANALYSES -Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation -Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017. 5 Classi P, Landsman-Blumberg P, Carroll C, et al. The relationship between macrolide-resistant streptococcus pneumoniae and treatment failure in adults with community-acquired pneumonia by CDC region in the United States. Abstract J03. In: Meeting abstracts, Academy of Managed Care Pharmacy Nexus 2016; October 3-6, 2016; National Harbor, MD. 6 Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse . Accessed December 4, 2024. 7 World Health Organization. Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance . Accessed December 4, 2024. 8 Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013, US Department of Health and Human Services.

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。 12月10日，据NMPA官网公示，石家庄四药申报的化学药品4类地拉罗司分散片（125mg）获批，并视同通过一致性评价，成为国内第3家过评该品种的药企。 截图来源：NMPA官网 地拉罗司由诺华公司研发，主要用于治疗2岁及以上因输血造成的慢性铁过载疾病，以及10岁及以上非输血依赖性地中海贫血（NTDT）患者的慢性铁过载。目前，它是输血导致的慢性铁过载患者的一线用药。 3亿美元畅销祛铁剂，原研药企份额超96% 作为首个获FDA批准的可常规使用的口服铁螯合剂，目前地拉罗司分散片已在全球超过80个国家获得批准。据摩熵医药数据库显示，地拉罗司在2022年全球的销售总额超3亿美元。 截图来源：摩熵医药全球药物研发数据库 在国内市场，2019年地拉罗司分散片通过国家谈判进入医保目录，2021年起进入医保常规目录。在医保政策的助力下，地拉罗司分散片在2023年全国医院销售（全终端）的总额达到1.68亿元，同比增长15.03%。在这一激烈的市场竞争中，原研药企占据了96.76%的市场份额，稳居全国医院销售（全终端）榜首。 截图来源：摩熵医药（原药融云）全国医院销售(全终端)数据库 在仿制药方面，2021年6月奥赛康拿下了地拉罗司分散片的首仿以及首家过评。2024年8月，中美华世通生物医药成为国产第2家过评的药企。此次，石家庄四药成为国产第3家过评地拉罗司分散片的药企。 截图来源：摩熵医药（原药融云）过评药品汇总数据库 45款品种重磅过评，6大品种迎来首家 石家庄四药坚持“仿创结合”，凭借创新团队、平台及机制，持续奔跑在创新路上。产品管线清晰，研发成果丰硕，品种储备增强，质效领先。截至目前，共有112个品种通过或视同通过一致性评价。 截图来源：摩熵医药（原药融云）过评药品汇总数据库 2024年至今，石家庄四药已有45款品种获批并过评，其中利奈唑胺干混悬剂、卡左双多巴缓释片、恩他卡朋双多巴片(Ⅱ)、甲磺酸倍他司汀片、盐酸奈福泮注射液、碳酸氢钠注射液6款是首家过评的品种。 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 后台回复关键词“深度报告”，获取价值18600元，报告大礼包 后台回复关键词“2023首仿”，获取2023年首仿药物获批名单 后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。 后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。 后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。 后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。 后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。 后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。 后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。 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！