Molnupiravir

精彩内容日前，国家医保局发布通知，2024年集采提质扩面将再上一个台阶，全国联采时代来临，第十批集采即将开展。全身用抗感染药是国采的重点对象，米内网数据显示，目前已有20个抗感染化药满足5家及以上的充分竞争条件，包括15个抗细菌药、3个抗病毒药、2个抗真菌药。20个品种2023年在中国公立医疗机构终端的销售额合计超过178亿元，其中超10亿大品种有8个；科伦药业、倍特药业、齐鲁制药、鲁抗医药、石药集团等为主力，分别有7个、6个、6个、5个、5个品种在列。暂未纳入国采且符合5家及以上的全身用抗感染化药注：部分药品因专利期、产品属性等可能不会被纳入集采，一切信息以官方为准！手工整理，如有疏漏，欢迎指正。来源：米内网综合数据库抗细菌药千亿市场洗牌！2款30亿大品种或承压受集采执行影响，近两年来中国城市公立医院、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）终端全身用抗细菌化药市场持续承压，2023年接近1100亿元。2023年全身用抗细菌化药TOP20产品中，有13个产品已被纳入国采。未被纳入的产品中，排位第3、第18的注射用头孢唑肟钠、注射用硫酸多黏菌素B暂无企业过评，排位第15的注射用苯唑西林钠仅1家企业过评，排位第7、第8、第11、第14的注射用亚胺培南西司他丁钠、注射用拉氧头孢钠、注射用盐酸万古霉素、注射用哌拉西林钠已满足国采入围条件。2023年中国公立医疗机构终端全身用抗细菌化药TOP10产品来源：米内网中国公立医疗机构药品终端竞争格局15个符合国采入围条件的全身用抗细菌化药涉及7个治疗小类，其中5个为头孢类，4个为β-内酰胺类/青霉素类抗菌药，其它抗菌药有2个，氨基糖苷类抗菌药、大环内酯类/林可酰胺类/链阳霉素类、喹诺酮类抗菌药、碳青霉烯类各有1个。亚胺培南西司他丁注射剂为碳青霉烯类抗菌药，是15个产品中销售额最高的，2023年在中国公立医疗机构终端的销售额超过31亿元，原研厂家默沙东主导市场，市场份额超过70%；联邦制药（已过评）、瀚辉制药（已过评）位居第二、第三。目前该产品有5家企业过评，竞争格局尚好。近年来中国公立医疗机构终端亚胺培南西司他丁注射剂销售情况（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5个头孢类产品中，拉氧头孢注射剂、头孢他啶阿维巴坦注射剂均为超10亿大品种。近年来，拉氧头孢注射剂在中国公立医疗机构终端的销售额逐年上涨，2023年接近30亿元，同比增长23%，海南海灵化学制药（已过评）独占市场超6成。该产品目前已有8家企业过评，此外还有江苏江丰医药、山东晶辉生物、齐鲁安替制药等企业的产品以新分类报产在审。近年来中国公立医疗机构终端拉氧头孢注射剂销售情况（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4个β-内酰胺类/青霉素类抗菌药中，哌拉西林注射剂、氨苄西林注射剂、青霉素注射剂均为超10亿大品种。其中，哌拉西林注射剂近年来在中国公立医疗机构终端放量迅速，2023年突破20亿元，同比增长约44%。目前国内有20余家企业布局注射用哌拉西林钠一致性评价，鲁抗医药、瑞阳制药、科伦制药、苏州二叶制药、倍特药业、华北制药等14家企业的产品已过评/视同过评。近年来中国公立医疗机构终端哌拉西林注射剂销售情况（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抗病毒新药“霸榜”！10亿注射剂竞争激烈在疫情及创新药快速放量拉动下，近两年来，中国公立医疗机构终端全身用抗病毒化药市场规模均以两位数的增速增长，2023年已逼近集采前（2018年）约190亿的水平。2023年全身用抗病毒化药TOP20产品中，多个独家创新药上榜，包括辉瑞的奈玛特韦片/利托那韦片组合包装、河南真实生物的阿兹夫定片、吉利德的比克恩丙诺片及索磷布韦维帕他韦片、豪森的艾米替诺福韦片、先声药业的先诺特韦片/利托那韦片组合包装、默沙东的莫诺拉韦胶囊、ViiV的拉米夫定多替拉韦片等。剩余的品种中，6个已被纳入国采。2023年中国公立医疗机构终端全身用抗病毒化药TOP10产品来源：米内网中国公立医疗机构药品终端竞争格局目前符合国采入围条件的3个全身用抗病毒化药中，帕拉米韦注射剂为超10亿大品种，已满足14+1的竞争格局，是20个全身用抗感染化药中，竞争最为激烈的一个品种。米内网数据显示，近两年来帕拉米韦注射剂在中国公立医疗机构终端的销售额均以两位数的增速增长，2023年突破10亿元，广州南新制药主导市场。近年来中国公立医疗机构终端帕拉米韦注射剂销售情况（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抗真菌药90亿市场！大品种“无一幸免”近年来，全身用抗真菌化药在中国公立医疗机构终端的销售额有所波动，但均维持在80亿元以上，2023年接近90亿元，同比增长6.7%。2023年全身用抗真菌化药TOP20产品中，已纳入国采的品种约占“半壁江山”，包括位列前三的注射用醋酸卡泊芬净、注射用伏立康唑及伏立康唑片，这3个均为超10亿大品种。此外，位列第四、第七的氟康唑氯化钠注射液、注射用米卡芬净钠也已纳入国采。2023年中国公立医疗机构终端全身用抗真菌化药TOP10产品来源：米内网中国公立医疗机构药品终端竞争格局符合国采入围条件的泊沙康唑肠溶片、泊沙康唑注射液均为第二代三唑类抗真菌药物，其中泊沙康唑肠溶片2023年跻身全身用抗真菌化药TOP10产品，该产品近年来在中国公立医疗机构终端的销售额持续快速增长，2023年突破2亿元，同比增长约163%。从厂家格局看，原研厂家默沙东主导市场，但随着仿制药的获批，其市场份额逐渐被蚕食。泊沙康唑肠溶片目前已满足10+1的竞争格局，包括科伦、扬子江、齐鲁、正大天晴药业、倍特药业等10家过评企业，竞争较为激烈。近年来中国公立医疗机构终端泊沙康唑肠溶片销售情况（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5月21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

Shionogi's ensitrelvir won an emergency COVID approval in Japan back in November 2022. Japan’s Ministry of Health, Labor and Welfare upgraded the emergency nod to a standard approval in March. While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage. But a clinical misfire unveiled Monday has likely put a damper on those plans, at least in the U.S. In the global phase 3 trial SCORPIO-HR, once-daily ensitrelvir—which goes by the brand name Xocova in Japan and falls into the same class of drugs as Pfizer’s Paxlovid and Merck & Co.’s Lagevrio—failed to chart a statistically significant reduction in time to sustained resolution of 15 common COVID-19 symptoms, missing the study’s primary endpoint. For the study, Shionogi defined sustained resolution as complete absence of COVID symptoms for at least two days. Patients in the trial received ensitrelvir or placebo within three days of symptom onset, Shionogi said in a release. In November 2022, ensitrelvir won an emergency approval in Shionogi’s home country of Japan. Japan’s Ministry of Health, Labor and Welfare upgraded the emergency nod to a standard approval in March. Outside Japan, Xocova is also approved in Singapore. Despite the misfire in SCORPIO-HR, Shionogi said that a pre-defined supportive analysis showed a “significant difference” in the time to resolution of six COVID symptoms for patients on ensitrelvir. Ensitrelvir also displayed a “potent” antiviral effect by helping slash baseline viral RNA levels, Shionogi said.  SCORPIO-HR enrolled a range of symptomatic, non-hospitalized COVID patients in North and South America, Europe, Africa and Asia. Most of the enrollees were vaccinated and roughly 30% had health conditions that put them at risk for severe disease, including obesity, diabetes and hypertension, Shionogi said. The study took place when the omicron variant of the virus was predominant. Shionogi carried out SCORPIO-HR in collaboration with the National Institute of Allergy and Infectious Disease as part of the National Institutes of Health’s public-private partnership Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). The company’s 3CL protease inhibitor was previously blessed with fast-track designation from the U.S. FDA in 2023. “These topline results, while mixed, confirm an antiviral effect and add to the existing clinical data and real-world evidence that we have seen for ensitrelvir in Asia,” Simon Portsmouth, M.D., Shionogi’s head of clinical development, said in a statement. “We will continue working with regulatory bodies to explore routes to making ensitrelvir available.” Xocova’s original nod in Japan leveraged data showing the drug helped curb five typical omicron-related COVID-19 symptoms (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness) 24 hours faster than placebo. The initial emergency green light triggered a supply pact with Japan for the purchase of 1 million courses of the medicine. Shionogi ultimately bumped up its purchase agreement by another 1 million courses in December 2022 for a total sales haul of 100 billion Japanese yen ($642 million). Last February, Shionogi’s CEO Isao Teshirogi, Ph.D., told Reuters that Xocova could generate an estimated $2 billion in annual sales if approved in the U.S. For 2023, the CEO said he was hoping for the drug to secure sales of around $1 billion to $1.5 billion. Shionogi, which operates on the Japanese fiscal calendar, has yet to release its full-year results for the 2023 earnings period, which ended on March 31 of this year. Still, COVID drugs and vaccines of all stripes have suffered precipitous revenue declines ever since the switch from a pandemic to endemic market. The dearth of demand has led to the destruction of certain doses acquired by governments at the height of the pandemic, too. Over the weekend, Kyodo News reported that Japan is set to liquidate 77% of the oral COVID antivirals it purchased during the pandemic as they expire. The country’s reserve of oral COVID meds—which includes Shionogi’s Xocova, as well as Paxlovid and Lagevrio—is worth approximately 300 billion Japanese yen ($1.93 billion), the news outlet said.