Amoxicillin/Clavulanate Potassium

精彩内容 6月11日，国家药监局官网显示，华北制药先泰药业的注射用氨苄西林钠舒巴坦钠通过一致性评价。米内网数据显示，2023年中国公立医疗机构终端氨苄西林舒巴坦注射剂销售额超过8亿元，同比增长约77%。 注射用氨苄西林钠舒巴坦钠是由氨苄西林钠（青霉素类抗生素）和舒巴坦钠（半合成β-内酰胺酶抑制药）组成的复方制剂，两药联用后不仅保护氨苄西林免受酶的水解破坏，而且还有利于扩大其抗菌谱，对葡萄球菌产酶株、不动杆菌属和脆弱拟杆菌等细菌也具有良好的抗菌活性。 米内网数据显示，近年来中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端氨苄西林舒巴坦注射剂销售额快速增长，2021-2022年分别同比增长119.99%、145.79%，2023年其销售额突破8亿元，同比增长76.91%。 近年来中国公立医疗机构终端氨苄西林舒巴坦注射剂销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局 含原研厂家辉瑞在内，国内共有30余家药企拥有注射用氨苄西林钠舒巴坦钠生产批文。其中，福安药业庆余堂制药、成都倍特药业、江苏海宏制药、山东鲁抗医药、杭州沐源生物医药、湖南科伦制药、山东道齐生物、苏州二叶制药、海南通用三洋药业、华北制药集团先泰药业10家企业的产品已过评或视同过评，满足国采的初步入围条件。 在抗感染领域，华北制药已有27个品种过评或视同过评，其中有17个为注射剂，注射用阿莫西林钠克拉维酸钾、注射用阿莫西林钠舒巴坦钠、注射用哌拉西林钠他唑巴坦钠(8:1)等为首家过评。 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至6月11日，如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

The big announcement was made at the BIO International Convention, where top policy and health leaders gathered to discuss the future of pandemic preparedness and antimicrobial resistance. The new lab, established through Shionogi's group company Qpex Biopharma, is set to boost their capabilities in infectious disease and pandemic preparedness. The new Shionogi Qpex Lab will expand the existing R&D facility for Qpex Biopharma, located at the SD Tech by Alexandria mega campus in San Diego. In 2023, Shionogi Inc., a New Jersey-based subsidiary, acquired Qpex Biopharma, bringing along Qpex's novel internally discovered pipeline, including an investigational beta-lactamase inhibitor. This acquisition has significantly expanded Shionogi's antimicrobial pipeline and strengthened their R&D capabilities. During the BIO panel discussion, which included representatives from the White House Office of Pandemic Preparedness and Response Policy, BARDA, and CIDRAP, Shionogi highlighted the urgent need for new antimicrobial research and development. Shionogi infectious disease research ​ “It is vital that we invest in the development of new medicines to help mitigate future threats, including pandemics and antimicrobial resistance. In addition, we must lower barriers and create incentives to support the training and development of the next generation of scientists and researchers, particularly in antimicrobial resistance, or AMR, where the workforce has been declining for decades,” said Phyllis Arthur, executive vice president and head of healthcare policy and programs at BIO. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Michael Dudley, president and CEO of Qpex, emphasized the importance of addressing both known and emerging health threats. “We need to address known health threats, including antibiotic-resistant bacteria, as well as prepare for rapidly emerging threats that could lead to future pandemics. This is a landmark opportunity to build upon the excellent track record of our organizations in discovering innovative antimicrobial drugs and bringing them to patients,” he said. Antimicrobial resistance ​ “Together, with our government and academic partners, we have the capabilities and the capacity to face the known public health crises of today and to prepare for the impact future pathogens may have on society.” The world is more connected than ever, increasing the risk of global health events. Pathogens that can spread rapidly have the potential to destabilize economies, threaten national security, and cause millions of deaths. Infectious diseases are becoming harder to treat, and antimicrobial resistance (AMR) already causes 1.27 million deaths annually. Without action, AMR could kill over 10 million people each year by 2050. The antibiotic R&D pipeline has been declining, creating an urgent need for new treatments. Shionogi has a long history of discovering and introducing novel antibiotics and innovative medicines for HIV, influenza, and COVID-19 since the 1950s. The Qpex senior leadership team has worked together for over 25 years and completed four regulatory approvals for antibiotics in the past decade. Pandemic preparedness ​ John Keller, senior executive officer and senior vice president of R&D at Shionogi, said: “Combining the deep expertise of the Qpex team with Shionogi’s decades of successful infectious disease R&D in Japan, this expansion has the potential to accelerate critically needed innovation in infectious disease like never before. “In the race between antibiotic drug development and increasing resistance, the pathogens are winning. If new antibiotics are not discovered and developed, we cannot overcome this public health crisis and are at risk of jeopardizing global health security.” The expansion of Shionogi’s U.S. presence will also enhance their ability to form partnerships with both public and private sector researchers. Qpex's antibiotic clinical development programs are funded by BARDA under a contract with the U.S. Department of Health and Human Services. Recently, Qpex announced additional funding from BARDA to support the advancement of its antibiotic development programs. Public health security ​ Addressing AMR is critical as it poses a major health burden globally. In 2019, bacterial AMR was responsible for 1.27 million deaths. Infections caused by carbapenem-resistant Gram-negative bacteria are often fatal. If no action is taken, AMR could kill 10 million people annually by 2050, with treatment costs reaching $412 billion annually up to 2035. Shionogi is one of the few large pharmaceutical companies continuing to focus on anti-infectives research and development. For over 60 years, Shionogi has been committed to developing antimicrobial therapies and remains dedicated to fighting AMR. Shionogi's latest move to enhance its infectious disease research capabilities in the U.S. highlights the company's commitment to tackling current and emerging health threats, providing new hope for combating antimicrobial resistance and future pandemics.