Posaconazole

精彩内容 近段时间，集采消息频出：广东将牵头开展基药集采和国采接续，江苏拟组建47个品种联盟集采，重庆10省联盟短缺药及常用药集采正式启动；河南132个品种接续集采提上日程，不乏重酒石酸间羟胺注射剂、尼莫地平口服常释剂等同为国家基药和医保甲类药品种，以及烟酰胺注射剂、盐酸氨溴索注射剂等2023年在河南省公立医院终端销售额超3000万元的畅销品种。国家继续发文推进集采“提质扩面”，提升省级联盟采购规模和规范性，集采有望迎来新变局。 集采规则再优化，中选条件较温和 日前，河南省医保局发布《关于开展部分集中带量采购协议期满药品接续采购的通知（征求意见稿）》，向社会公开征求意见，标志着新一轮河南联盟药品接续集采正式提上日程。来源：河南省医保局官网据悉，此次接续集采涉及6个批次，分别为河南省首批集采、河南省中部联盟集采、江西联盟集采、十三省国采接续、十四省联盟集采以及重庆联盟集采。采购周期约定为两年，采购周期结束后可根据采购和供应等实际情况延长采购期限。拟中选条件上较为温和，大体可分为两种情况：①曾在全国范围集采中选的产品，若拟供应价格不高于该品种在全国集采的最低中选价，且不高于河南原集采中选产品最高中选价的，即可作为接续集采拟中选产品；若拟供应价格高于河南原集采最高中选价，但企业拟供应价格降至不高于河南原集采最高中选价的，也可作为拟中选产品。②未曾在全国范围集采中选的产品，若拟供应价格不高于同采购目录曾中选产品最低价的，作为接续集采拟中选产品，并参与剩余量的分配；若拟供应价格高于同采购目录曾中选产品最低价，但不高于同采购目录曾中选产品平均价的，可增补为备选产品，没有分配采购量，不参与待分配采购量分配，医疗机构完成中选产品协议量后，可根据临床需求选择使用。值得一提的是，此次接续集采采购协议量与企业中选价格、采购目录最低中选价格挂钩，按采购量换算公式，各中选产品分配采购量＝各产品医疗机构需求量×（采购目录最低中选价/企业中选价）。这意味着，企业中选价与同组最低中选价相比，价格越高获得的采购量越少，体现了量价挂钩的原则。 超5亿市场迎洗牌，重庆药友、白云山......蓄势待发 此次河南省接续集采拟纳入132个品种，河南省首批集采、河南省中部联盟集采、江西联盟集采、十三省国采接续、十四省联盟集采以及重庆联盟集采分别占11个、8个、1个、49个、43个和20个。按治疗大类统计，心脑血管系统药物在数量上领跑，有51个品种入围；消化系统及代谢药（23个）、抗肿瘤和免疫调节剂（10个）、全身用抗感染药物（9个）位居其后；神经系统药物、生殖泌尿系统和性激素类药物则各有7个品种在列。从医保分类上看，除他达拉非片、注射用比伐芦定，其余品种均已纳入国家医保目录，其中医保甲类药有41个，医保乙类药有89个。拟纳入河南省接续集采药品目录来源：河南省医保局官网，米内网整理此次河南省接续集采中，既有重酒石酸间羟胺注射剂、尼莫地平口服常释剂等同为国家基药及全国医保甲类药品种，也有新斯的明注射剂、硫代硫酸钠注射剂等临床（易）短缺药品种，亦有烟酰胺注射剂、盐酸氨溴索注射剂等2023年在河南省公立医院终端销售额超3000万元的畅销品种。硫代硫酸钠注射剂是一种解毒剂，临床用于氰化物中毒，也可用于砷、汞、铅、铋、碘等中毒，2021-2023年在河南省公立医院终端销售额增速分别达628%、573%和35%；2023年销售额再创新高，超过2800万元，市场份额方面，注射用硫代硫酸钠、硫代硫酸钠注射液分别由上药新亚药业和重庆药友制药独揽。米内网数据显示，目前已有5家企业的硫代硫酸钠注射液获批上市，3家企业以新分类提交上市申请，其中，四川汇宇制药于2023年5月获批生产、首家视同过评，倍特药业、南京海辰药业均在审评审批的路上。硫代硫酸钠注射液新分类申报上市情况来源：米内网中国申报进度（MED）数据库重酒石酸间羟胺注射剂是一种升压药物，主要用于治疗各种休克及手术时低血压，目前已被纳入国家基药目录和全国医保甲类药目录。作为急救药品，该产品曾多次被纳入短缺药名单。近年来，重酒石酸间羟胺注射剂在河南省公立医院终端销售额均保持两位的同比增速，2021-2023年先后突破3000万元、4000万元和5000万元，市场潜力逐步释放。目前，重酒石酸间羟胺注射液有16家企业拥有生产批文，倍特药业、天津医药、振东泰盛制药等8家企业获批过评，浙江医药新昌制药提交补充申请在审，远大医药、湖南华纳大药厂、中山万汉制药等13家企业以新分类报产在审。近年来河南省公立医院终端重酒石酸间羟胺注射剂销售趋势（单位：万元）来源：米内网重点省市公立医院药品终端竞争格局烟酰胺注射剂为维生素类药物，参与体内的代谢过程，是脂类代谢、组织呼吸的氧化作用和糖原分解所必需物质。该药适用于防治烟酸缺乏的糙皮病、冠心病、病毒性心肌炎、风湿性心肌炎、及少数地黄中毒等伴发的心律失常。在河南省公立医院终端，烟酰胺注射剂2023年销售规模超过1.7亿元，同比增长5.84%。品牌格局方面，白云山明兴制药以超九成的份额领跑市场，吉林津升制药、武汉爱民制药和武汉滨湖双鹤药业合计市占比约为2%。2023年河南省公立医院终端烟酰胺注射剂品牌格局来源：米内网重点省市公立医院药品终端竞争格局在重点省市公立医院终端，河南省近年来销售规模呈稳步增长趋势，2021-2023年销售额均在160亿元以上，本次接续集采拟纳入132个品种，2023年在河南省公立医院终端的合计销售规模超过5亿元。河南省公立医院终端销售规模（单位：亿元）来源：米内网重点省市公立医院药品终端竞争格局 集采提质扩面不断加速，省级联盟采购持续升级 5月下旬及6月初，国家医保局及国务院办公厅先后发布《关于加强区域协同做好2024年医药集中采购提质扩面的通知》、《深化医药卫生体制改革2024年重点工作任务》等文件（下文统称《文件》），均提出继续大力推进医药集中带量采购工作，加强区域协同，提升联盟采购规模和规范性等集采新要求。来源：国务院官网其中，《文件》内容明确：2024年年内，国家医保局药开展新批次国家组织药品集中采购（即“第十批国采”），以及各省份至少完成一批药品集采，实现国家和省级集采（含参与联盟采购）药品数累计达到500个以上。据不完全统计，截至6月7日，至少有140余个品种未纳入国采且满足5家及以上的企业竞争格局，初步具备纳入第十批国采的条件。从剂型分布上看，注射剂仍是主力，不乏拉考沙胺注射液、泊沙康唑注射液、盐酸艾司洛尔注射液等热门品种，涵盖神经系统药物、全身用抗感染药物、心脑血管系统药物等治疗大类。米内网数据显示，140余个品种2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售规模合计超过1000亿元，其中32个品种竞争激烈，参与竞争企业数（按集团计，下同）达10家及以上。140余个品种中，涉及过评品种数达10个及以上的企业有9家，包括正大制药、齐鲁制药、科伦药业、石药集团、扬子江药业、倍特药业等国内知名大药企。此外，值得关注的是，《文件》中还提出要扩大联盟范围，形成全国联盟集中采购的格局，“条件具备的省级联盟采购”提升为“全国性联盟采购”。这似乎也在释放一个新信号：今年医保局组织完一批国家集采之后，未来的集采可能以各省组织为主了。事实上，上述说法亦是有迹可循。近年来，国家药品集采持续推进的同时，国内省级联盟集采也在快速发展。比如：京津冀“3+N”医药集采联盟是全国第一家跨省带量采购区域联盟，其中“3”是指北京、天津、河北三个省市，“N”则是其他愿意参加联动项目的省、市及自治区。据统计，2023年至今，该联盟已开展三批、共200余个品种的药品集采，化学药、中成药和生物药均有覆盖，不乏多款罕见病（血友病等）治疗药，涉及领域之广、品种之多。此外，在刚过去的5月，重庆市医保局发布了“2024渝鄂桂等10省市联盟药品接续采购工作实施方案”，重庆、湖北、广西、海南、贵州、云南、青海、宁夏、新疆、新疆生产建设兵团等10个省、市及自治区将参与本次接续集采，拟纳入品种包括间羟胺注射剂、新斯的明注射剂等20个短缺药，以及法莫替丁注射剂、玻璃酸钠注射剂等26个常用药。来源：重庆市医保局官网同在今年5月，河南省医保局公布了13省国采品种接续中选结果，参与省份包括河南、山西、内蒙古、湖北、湖南、广西、海南、重庆、贵州、青海、宁夏、新疆及新疆生产建设兵团等，合计58个品种、519个产品成功中选，涉及232家生产及投标企业。集采规则上采取询价与竞价相结合的方式，并加入复活机制。今年2月，广东省药品交易中心公布了广东联盟阿莫西林等药品集采中选结果，广东、山西、江西、湖南、湖北、广西、海南、贵州、甘肃、青海、宁夏、新疆、新疆生产建设兵团等13个省、市及自治区参与了本次联盟集采。据其文件要求，中选及生产企业应保证中选药品配送覆盖全省所有参加药品采购的各类医疗机构，确保药品按时保质保量供应。不难发现，近几来，省级/省联盟集采与国采同步推进的同时也在飞速成长，参与省份数量逐步递增，品种覆盖范围不断扩大，集采规则进一步完善......或许，距离国家集采“暂别”历史舞台，省采及省联采作为“接棒者”继续完成其使命的日子已不远了。 来源：米内网数据库、河南省医保局等注：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；米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；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7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

Results from a randomized, placebo-controlled study of TRIKAFTA® in people with cystic fibrosis with rare, non-F508del CFTR mutations showed statistically significant and clinically meaningful improvements in the primary and all secondary endpoints Interim results of largest real-world study of TRIKAFTA® showed sustained improvement in lung function at three years as well as lower rates of lung transplant and death in people with cystic fibrosis, compared to pre-TRIKAFTA® initiation BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, were presented at this year’s European Cystic Fibrosis Society’s (ECFS) 47th European Cystic Fibrosis Conference held June 5-8, 2024, in Glasgow, Scotland. Data from a randomized, double-blind, Phase 3 study (abstract WS06.04) demonstrated that people with CF who have rare, non-F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to TRIKAFTA® in vitro demonstrated clinical benefit from receiving TRIKAFTA®. Compared to placebo, lung function improved by 9.2 percentage points as measured by ppFEV1, CFTR function improved (as measured by mean sweat chloride concentration reductions of 28.3 mmol/L), and pulmonary exacerbations were reduced by 72% per year. Safety and tolerability were generally consistent with the established safety pro TRIKAFTA®. Vertex also presented the interim analysis (IA) of a registry-based study of real-world data collected from people with CF initiating TRIKAFTA® from 2019-20 in the U.S. and KAFTRIO® plus ivacaftor from 2020-21 in Germany (abstract WS01.04). The ongoing five-year post-authorization study is the largest real-world study of people with CF treated with TRIKAFTA®/KAFTRIO® to date, including more than 16,000 people with CF from the U.S. Cystic Fibrosis Foundation Patient Registry (CFFPR) and approximately 3,000 people with CF from the German CF Registry. The IA showed clinically meaningful, disease-modifying benefits for TRIKAFTA®/KAFTRIO®, including a 76% and 70% reduction in the cumulative annual rate of pulmonary exacerbations in the U.S. and in Germany, respectively, compared to the year prior to TRIKAFTA®/KATRIO® treatment. In addition, there was a 62% lower rate of death in the U.S. and 84% lower in Germany; and an 86% lower rate of lung transplant in the U.S. and 96% lower in Germany compared to the 2019 U.S. CFFPR and German CF Registry populations (pre-TRIKAFTA®/KAFTRIO®). No new safety concerns were identified. “The breadth of TRIKAFTA data presented at ECFS is further evidence of the significant potential of this disease-modifying medicine,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “These studies demonstrate that TRIKAFTA is changing the course of CF treatment and the lives of those living with CF.” Additional Presentations Other Vertex presentations at the conference this year include: Abstract WS15.02, entitled “Real-World Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in People With Cystic Fibrosis and ELX/TEZ/IVA-Responsive, Non-F508del CFTR Genotypes” Abstract EPS10.08, entitled “LONGITUDE: An Observational Study of the Long-term Effectiveness of ELX/TEZ/IVA in People With CF Using Data From the UK CF Registry – Preliminary Results From the Subgroup Aged 6-11 Years” Abstract P096, entitled “Qualitative Interviews Confirming the Faithful Electronic Migration of the Preschool Pictorial Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Parent Preschool CFQ-R” Abstract EPS6.05, entitled “Clinical Outcomes in Concurrent Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Treated vs. Ineligible Cohorts in the US Cystic Fibrosis Foundation Patient Registry (CFFPR) During COVID-19” Abstract P063, entitled “ELX/TEZ/IVA has beneficial effects on clinical outcomes and quality of life in people with cystic fibrosis in the real-world TRAJECTORY study” Abstract P072, entitled “Real-World Impact of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Italy: A Retrospective Study From a CF Center” About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Today Vertex CF medicines are treating over 65,000 people with CF across 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. About TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways. TRIKAFTA U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age. IMPORTANT SAFETY INFORMATION Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: are allergic to TRIKAFTA or any ingredients in TRIKAFTA, have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin. Patients should avoid food or drink that contains grapefruit while taking TRIKAFTA. TRIKAFTA can cause serious side effects, including: Liver damage and worsening of liver function in patients with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in patients without liver disease. High liver enzymes in the blood, which is a common side effect in patients treated with TRIKAFTA. These can be serious and may be a sign of liver injury. The patient’s doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips and/or tongue; difficulty swallowing; and light-headedness or dizziness. Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts. The most common side effects of TRIKAFTA include headache, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, diarrhea, rash, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, flu (influenza), inflamed sinuses, and increase in blood bilirubin. Patients should tell their doctor if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of TRIKAFTA. For more information, patients should ask their doctor or pharmacist. Please click here to see the full U.S. Prescribing Information for TRIKAFTA. About KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface by binding to different sites on the CFTR protein. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of ivacaftor, tezacaftor and elexacaftor help hydrate and clear mucus from the airways. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is approved in the European Union and in the U.K. for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the CFTR gene. For complete product information, please see the Summary of Product Characteristics that can be found on and on . About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and Twitter/X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Carmen Bozic, M.D. in this press release, and statements regarding our expectations for the benefits of TRIKAFTA/KAFTRIO. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s studies may not be indicative of final clinical trial results, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, or other reasons, that data may not be available on the anticipated timeline, or at all, that our development programs may experience delays, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent filings filed with the Securities and Exchange Commission at and available through the company's website at . You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) View source version on businesswire.com: Contacts Vertex Pharmaceuticals Incorporated Investors: InvestorInfo@vrtx.com Media: mediainfo@vrtx.com or U.S.: 617-341-6992 or International: +44 20 3204 5275 Source: Vertex Pharmaceuticals Incorporated View this news release online at: