Flutemetamol F-18

看点 view 本周，2024上半年医药工业统计数据出炉，中纪委点名医院招标腐败，知名医院涉骗保遭严查；药品市场迎变局，447个产品拟中选医药大省集采，25个品种主动降价，29款国谈药医保支付价公开；企业大新闻，两大国资药企“牵手”推动中医药现代化，一创新药企业闯关IPO折戟，恒瑞医药、君实生物1类新药亮眼......医药行业一周大事件，精彩不容错过！ 米内一周TOP榜 米内数据口服高血压药TOP20，施慧达、华润双鹤突围 23个独家品种厉害了！扬子江2大品种亮眼 软膏剂TOP20洗牌，华润三九、华邦上榜 药企动态倍特拿下25个重磅品种，126个过评品种霸屏 奥赛康首仿药大涨454%，5款重磅新品获批 石药发力改良型新药，超600亿市场起波澜 审评药闻 海思科1类新药来袭！抢攻1400亿市场 5亿畅销产品，石四药入局抢食 9亿大品种，浙江药企获批了 覆盖全国18省！“六病共管”集采蓄势待发 9月24日，三明采购联盟第六次联席会议暨开展“六病共管”用药（第一批）集采工作会议在福建省三明市召开，会议指出：“六病共管”用药集采被列入国家招采重点工作；鼓励集采药品落地向民营医疗机构、零售药店和村卫生室延伸；大力推进集采药品追溯码工作，遏制医保药品“回流”、“重复销售”等违规行为；黑龙江全省加入三明采购联盟等。截至目前，三明采购联盟成员已覆盖全国18个省份、42个地级市、4个全国医改示范县，覆盖区域人口逾1.8亿人。（三明采购联盟） 延伸阅读： “六病共管”是三明市与上海瑞金医院的深度合作管理模式，该项目以三明医改为背景，依托瑞金医院的优质资源，从人出生到死亡的全生命周期中，选取肿瘤、心脑血管、呼吸、代谢、生殖医学以及老年医学六类高发病率疾病，由瑞金医院和三明市医疗机构共同对患者进行诊疗和管理。“六病共管”项目于今年2月正式启动，目前瑞金医院已与三明市10余家总医院开展协作。 中纪委再发文，点名医院招标腐败 9月26日，中央纪委国家监委发布题为《深度关注|营造风清气正招投标环境》的头条文章，其中提到，部分省（市）公共资源交易中心场所管理不严、现场监督不实、交易秩序混乱，有的评标专家在评标过程中肆无忌惮，频繁违法。比如：江苏省公共资源交易中心工作人员腐败窝案中，某开评标现场管理人员利用职务便利，经常随意进出招投标现场，并通过暗示评标专家、泄露答辩题目、向投标企业提供评标专家名单、协助将项目运作到省平台交易等方式帮助企业中标，受贿共计690余万元。今年以来，中纪委围绕招投标腐败问题密集发文，其中评标专家管理被多次点名。（中央纪委国家监委） 2024上半年医药工业发展“遇冷”，子行业表现各异 9月26日，中国医药企业管理协会披露《2024年上半年医药工业经济运行情况》，2024上半年，我国规模以上医药工业增加值同比增长1.2%；规模以上企业实现营业收入14465.5亿元，同比下降1.4%；实现利润2111.2亿元，同比下降1.2%。分子行业看，化学原料药和化学制剂营业收入小幅下降，但利润实现了正增长，分别为+8.2%和+5.7%；中药饮片是唯一营收（+6.1%）、利润（+2.8%）均实现正增长的子行业；生物制品摆脱了新冠疫苗影响因素，营业收入恢复正增长（+0.7%）；中成药、卫生材料及医药用品、医疗仪器设备及器械、制药专用设备等4个子行业营收和利润均为负增长。（中国医药企业管理协会） 5款独家中成药申请保护获准 9月24日，国家药监局发布公告称，对5款独家中成药给予二级保护，其中，批准贵州汉方药业的芪胶升白胶囊、山东凤凰制药的复方川芎片、重庆华森制药的六味安神胶囊、哈尔滨市康隆药业的炎宁糖浆为首家中药二级保护品种，对青岛华仁太医药业的蒲元和胃胶囊延长二级保护期。（国家药监局）本周获批中药二级保护的品种 两大国资药企“牵手”，推进中医药现代化 9月23日，重药控股官方微信公众号发布消息，由华润三九（华润医药子公司）和重庆医药（重药控股子公司）共同出资组建的重庆医药集团九隆现代中药有限公司（下文简称“重药九隆”）正式开业投产，主营业务包括中药配方颗粒、中药饮片、中药材以及中成药生产等。重药九隆成立于2020年10月，项目于2022年5月开工建设，总投资约4亿元，目前由华润三九持股51%，重庆医药持股49%。（企业官微） 延伸阅读： 今年6月，经过股权无偿划转后，重药控股间接控股股东变更为通用技术集团，实际控制人变更为国资委，其与华润三九的合作可以视为一次国资“牵手”。 447个产品拟中选！医药大省集采结果出炉 9月27日，福建省医保局发布《福建省第五批药品集中带量采购公告（第7号）》，对本省第五批药品集采拟中选清单进行公示，公示时间为9月28日至10月10日。据悉，本次集采共有447个产品拟中选，其中，接续采购产品有129个，新一轮采购产品有318个。经对比，接续采购目录中的西尼地平口服常释剂型、美洛西林舒巴坦(4:1)注射剂，及新一轮采购目录中的氟比洛芬贴剂、青霉素注射剂拟流标。（福建省医保局） 狙击超200亿市场，恒瑞1类新药临床报喜 9月24日、26日，恒瑞医药连发两则公告称，旗下1类新药HRS-2129片、3类仿制药氟[18F]美他酚注射液获批临床。其中，HRS-2129片拟用于治疗急慢性疼痛，目前国内外尚无同类产品获批上市，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）止痛药销售规模首破200亿元，同比涨逾8%。氟[18F]美他酚注射液是一款放射性诊断剂，拟用于评估阿尔茨海默病或其他原因导致的认知障碍的成年患者脑内β-淀粉样蛋白聚集形成的神经炎斑密度的PET成像。（米内网整理） 29个国谈药，医保支付标准公开 9月23日，山西省药械集采网发布《关于对2023年国谈药品（竞价药品）同通用名药品（第二批）医保支付标准进行公示的函》，拟公开29个国谈药医保支付标准，不乏沙库巴曲缬沙坦钠片、注射用头孢他啶阿维巴坦钠、复方氨基酸注射液(14AA-SF)等2023年在中国三大终端六大市场销售额超10亿元的大品种。按品规及最小包装数量统计，正大天晴药业、齐鲁制药、海南广升誉制药等均有3个及以上产品在列。（山西省药械集采网） 最高88%！25个品种主动降价 9月23日，河南省医药集中采购平台发布了一则下调药品价格公示。据梳理，此次共有20家企业、25个药品提交了降价申请，医保品种占比超过八成。其中，丙酚替诺福韦片剂、法舒地尔注射剂等品种降幅较大，均超过70%，而成都国为医药的纳美芬注射剂价格仅下降0.003%，为本次降幅最小的产品。（米内网整理） 超11亿大品种！君实1类新药再下一城 9月25日，君实生物发布公告称，公司自主研发的1类新药特瑞普利单抗于近日获欧盟委员会批准上市，用于转移性鼻咽癌（NPC）一线治疗，及晚期/复发或转移性食管鳞癌（ESCC）一线治疗。此前，特瑞普利单抗已先后于2018年和2023年在中国、美国等地获批上市。（公司公告）米内数据：特瑞普利单抗是国内首个获批上市的国产PD-1单抗，2020年通过谈判进入医保后市场实现快速放量，2023年在中国三大终端六大市场销售额超过11亿元，同比增长37.11%。 采购不合规！一医药企业被罚157万 9月25日，重庆市药监局公开的一则行政处罚决定书中显示，益百家医药（重庆）有限公司未从药品上市许可持有人或者具有药品生产、经营资格的企业购进强骨生血口服液、复方木芙蓉涂鼻软膏、射干利咽口服液，依据《中华人民共和国药品管理法》相关规定，重庆市药监局依法对其作出没收违射干利咽口服液16681盒、强骨生血口服液1809盒、复方木芙蓉涂鼻软膏186盒，罚款合计约157万元等行政处罚。（重庆市药监局） 原拟募13亿元！善康医药闯关IPO折戟 9月24日，上海证券交易所官网显示，深圳善康医药科技股份有限公司（下文简称“善康医药”）主动撤回科创板上市申请，IPO终止。据悉，善康医药主要从事以预防阿片类毒品复吸、治疗酒精使用障碍为代表的成瘾治疗药物等创新药的研发、生产和销售。今年6月，公司的核心产品盐酸纳曲酮植入剂（2.2类新药）获批上市，用于预防阿片类物质依赖患者脱毒后的复吸，有效时长达150天，是国内目前唯一一款进入商业化阶段的长效戒毒药物。（中国经济网）延伸阅读：善康医药原计划选择“科创板第五套”标准上市，即“预计市值不低于40亿元，主要业务或产品需经国家有关部门批准，医药企业需至少有一项核心产品获准开展Ⅱ期临床等相关条件”。公司此次原拟募资13.27亿元，用于新药研发项目、创新药高端制剂生产基地建设项目、营销网络建设项目、补充流动资金项目等。 知名医院出事了！法人、院长等被采取刑事措施 9月24日，无锡市医保局发布情况通报称，近日，无锡市医保局会同公安、卫健委等部门继续对无锡虹桥医院涉嫌骗取医保问题进行全面调查，目前该医院骗保情况基本查实。9月22日，无锡市医保局取消其医保定点资格，公安机关刑事立案。9月23日，无锡虹桥医院法定代表人、院长等15名涉案人员已被公安机关依法采取刑事强制措施。该民营医院现已停业。（无锡市医保局） 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。 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

GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD Available as a unit dose - or ready-to-use, Flyrcado has the potential to expand clinician and patient access to PET myocardial perfusion imaging (MPI) ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women 1 . With a half-life of 109-minutes—significantly longer than existing PET MPI tracers—Flyrcado removes the need for on-site tracer production and generator maintenance and enables distribution to a wide network of hospitals and imaging centers. This longer half-life also means Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD, enabling the most robust protocol for evaluating ischemia in patients. Furthermore, clinicians would have the ability to rescan a patient during the same imaging session in the event of technical difficulties, rather than rescheduling an additional scan. Dr. Jamshid Maddahi, MD, FACC, MASNC, principal investigator of the Flyrcado clinical trials, clinical professor of medicine (cardiology) and molecular and medical pharmacology (nuclear medicine) at UCLA School of Medicine and director of the Biomedical Imaging Institute, said, “Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI 2 , only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world.” CAD is the most common form of heart disease and remains the leading cause of death for men and women in the U.S. 3 , with 695,000 deaths recorded in 2021 4 . During the multicenter international AURORA Phase III trial, flurpiridaz F 18 was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Around six million MPI procedures are undertaken each year in the U.S. 5 to show blood flow through the heart muscle, and evaluate the presence, extent and degree of myocardial ischemia or infarction. Dr. Mouaz Al-Mallah, MD, MSc, MASNC, immediate Past President of the American Society of Nuclear Cardiology (ASNC) and Director of Cardiac PET at Houston Methodist Hospital, said “Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients. There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients.” Kevin O’Neill, CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said, “As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs.” Flyrcado is one of three F 18 imaging agents in GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, joining radiopharmaceutical PET imaging agents Cerianna™ (fluoroestradiol F 18) injection, used to detect estrogen receptor positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer, and Vizamyl™ (flutemetamol F 18) injection which is a PET tracer for imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline. GE HealthCare acquired exclusive global commercialization rights for flurpiridaz F 18 from Lantheus in 2017 and has led the funding and development of the product through to approval. Lantheus collaborated on the development and will also collaborate on commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales milestones. Flyrcado will be available in initial U.S. markets in early 2025 with expanding availability thereafter. As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiopharmaceuticals used across cardiology, neurology and oncology. The PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn , X , Facebook , Instagram , and Insights for the latest news, or visit our website for more information. INDICATIONS AND USAGE OF FLYRCADO™: FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information IMPORTANT SAFETY INFORMATION Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or For full prescribing information, click here . For important safety information, please click here . INDICATIONS AND USAGE OF CERIANNA™: INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). CONTRAINDICATIONS None. ADVERSE REACTIONS In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or . For full Prescribing Information click here . INDICATIONS AND USAGE OF VIZAMYL™: PRODUCT INDICATIONS AND USE VIZAMYL™ (Flutemetamol F 18) injection is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. Important Safety Information About VIZAMYL ™ (Flutemetamol F 18) injection CONTRAINDICATIONS • Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80 ADVERSE REACTIONS • The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%) For full prescribing information, including additional important safety information, please click here . 1 Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, BermanDS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients with Suspected Coronary Artery Disease. J AmColl Cardiol. 2023; 82:1598–1610 2 Schindler, T. H., Bateman, T. M., Berman, D. S., Chareonthaitawee, P., De Blanche, L. E., Dilsizian, V., Dorbala, S., Gropler, R. J., Shaw, L., Soman, P., Winchester, D. E., Verberne, H., Ahuja, S., Beanlands, R. S., Di Carli, M. F., Murthy, V. L., Ruddy, T. D., & Schwartz, R. G. (2020). Appropriate use criteria for PET myocardial perfusion imaging. Journal of Nuclear Medicine, 61 (8), 1221-1265. 3 Friede A, O’Carroll PW, Thralls RB, Reid JA. CDC WONDER on the web. Proc AMIA Annu Fall Symp. 1996:408–412. 4 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart disease and stroke statistics—2023 update: A report from the American Heart Association. Circulation. 2023;147: e93–e621. . 5 Miller, R. J. H., Bednarski, B. P., Pieszko, K., Kwiecinski, J., Williams, M. C., Shanbhag, A., Liang, J. X., Huang, C., Sharir, T., Hauser, M. T., Dorbala, S., Di Carli, M. F., Fish, M. B., Ruddy, T. D., Bateman, T. M., Einstein, A. J., Kaufmann, P. A., Miller, E. J., Sinusas, A. J., Acampa, W., Han, D., Dey, D., Berman, D. S., & Slomka, P. J. (2024). Clinical phenotypes among patients with normal cardiac perfusion using unsupervised learning: A retrospective observational study. EBioMedicine , 99, 104930. Contacts GE HealthCare Media Contact: Emmy Elguizaoui +1 (978) 243-7503 Emmy.Elguizaoui@gehealthcare.com