Ceftobiprole Medocaril Sodium

精彩内容近期，业内传出#第十一批集采 药品清单，或再有3个头孢类产品被盯上，涉及两款超10亿注射剂。前十批集采已累计有28个头孢类产品中标，涉及的19个品种2024年在中国公立医疗机构终端的合计市场规模比2018年缩水超过280亿元。2025年Q1头孢类产品再有超过10%的降幅，惊现“8连跌”，齐鲁制药近几年逆势飞涨，首次挺进TOP4集团。第十一批集采要来了！两款超10亿注射剂将洗牌#头孢类 产品是临床常用药，也是集采常客，从2018年4+7城市试点开始到第十批国采（不含第六批胰岛素专项）已累计有28个头孢类产品中标（按产品名统计），涉及19个品种。2018年（4+7城市试点执行前）在中国城市公立医院、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，19个品种的合计市场规模接近590亿元，到了2024年仅剩303亿元左右，缩水超过287亿元。表1：已中标集采的头孢类药物情况（单位：亿元）注：销售额低于1亿元用*表示来源：米内网综合数据库今年6月中下旬，业界流出一份关于征求《第十一批国家组织药品集中采购拟采购药品清单》意见的函，3个头孢类产品出现在名单内。据上海阳光医药采购网最新消息，7月22日药事所将开展“政府开放日”活动，议程包含介绍国家集采相关工作，第十一批集采官宣如箭在弦。表2：网传拟纳入第十一批集采的头孢类药物情况（单位：亿元）注：最终名单以正式公布为准来源：米内网中国公立医疗机构终端竞争格局头孢丙烯在第四批集采(2021年2月)已纳入了头孢丙烯分散片、头孢丙烯片，目前头孢丙烯干混悬剂已有上海现代制药、金鸿药业等8家药企集团（二级，下同）过评/视同过评。2024年在中国公立医疗机构终端，头孢丙烯干混悬剂的销售额超过1.6亿元，南京亿华药业（已过评）以超过70%的份额领军。头孢唑肟和头孢他啶阿维巴坦则是首次出现在集采名单，2024年两大品种的销售规模分别为42亿元、13.7亿元。注射用头孢唑肟钠目前由太极集团旗下西南药业（原研地产化）以超过30%的份额领军，华北制药、倍特药业、济川药业等40多家药企集团过评/视同过评。注射用头孢他啶阿维巴坦钠目前由辉瑞以超70%的份额领军，华润三九、正大天晴、瑞阳制药等15家药企集团过评/视同过评，注射用头孢他啶阿维巴坦钠/氯化钠注射液是科伦药业在2023年拿下的首仿药。百亿市场惊现“8连跌”，齐鲁首进TOP4集团图1：中国公立医疗机构终端头孢类的销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局在中国公立医疗机构终端，头孢类的销售规模在2017年达到了峰值795亿元，2018年起持续下滑，2024年跌破400亿元，2025年Q1再有10.98%的降幅。2025年Q1头孢类TOP5集团（二级）分别为辉瑞、上海现代制药、长江健康、齐鲁制药、润泽制药，合计市场份额超过35%。图2：近几年齐鲁制药的头孢类销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局近几年，#齐鲁制药 的头孢类产品销售高速飞涨，2024年涨至9.9亿元，2025年Q1再有27.61%的增长，全年有望突破10亿元关口。集团排名从2020年的TOP50之外，一路提升至2024年的TOP8，2025年Q1首次跃升至TOP4。表3：2025年Q1中国公立医疗机构终端头孢类TOP20品牌来源：米内网中国公立医疗机构终端竞争格局2025年Q1头孢类TOP20品牌仅1个口服药，19个注射剂品牌中5个销售额有正增长，辉瑞的注射用头孢哌酮钠舒巴坦钠(2:1)销售额增长3.08%，继续排在榜首，公司另一个产品注射用头孢他啶阿维巴坦钠(4:1)销售额增长12.83%，排名上升2位至TOP3。南京优科制药的注射用头孢噻肟钠他唑巴坦钠（2021年获批）销售额增长151.74%，排名上升13位至TOP6；齐鲁制药的注射用头孢他啶阿维巴坦钠(4:1)（2021年获批）销售额增长251.55%，排名上升21位至TOP10；南京力博维制药的注射用头孢他啶阿维巴坦钠(4:1)（2023年获批）为新上榜品牌，销售额增长876.53%，排名TOP16。进口原研药热情不减，科伦首仿药大爆发截至2025年7月13日，头孢类在今年已累计有2个进口新品、30个国产仿制药新品获批。其中，默沙东的注射用头孢洛生他唑巴坦钠（进口5.1类）是首次进入中国市场，据米内网预测，盐野义制药的注射用头孢地尔（进口5.1类）有望在今年下半年获批，头孢类进口原研药对中国市场依然充满热情。表4：2025年已获批的头孢类新品来源：米内网中国申报进度（MED）数据库国产仿制药方面，泊诺(天津)创新医药研究的注射用氟氧头孢钠、深圳华润九新药业的注射用头孢比罗酯钠、湖南科伦制药的注射用头孢唑林钠/氯化钠注射液均为首仿药（按仿制上市申请并首家获批的产品），可为患者提供更多、更实惠的用药选择。表5：冲刺上市的头孢类首仿药来源：米内网中国申报进度（MED）数据库2023年至今申报仿制上市并在审的头孢类新品（按产品名+企业统计）超过70个，其中头孢地尼干混悬剂、头孢托仑匹酯颗粒、头孢妥仑匹酯片、盐酸头孢卡品酯颗粒、注射用头孢噻肟钠/氯化钠注射液、注射用头孢唑肟钠/氯化钠注射液、注射用盐酸头孢替安/氯化钠注射液将迎来国内首仿。湖南科伦制药将争夺3个新品的国内首仿，其中注射用头孢噻肟钠/氯化钠注射液、注射用盐酸头孢替安/氯化钠注射液仅有1家企业报产在审，拿下首仿是大概率事件。近几年，#科伦药业 在头孢类市场深耕粉液双室袋产品，该类产品凭借即配即用、安全高效等特点被广泛认可。2025年Q1在中国公立医疗机构终端，科伦药业的注射用头孢呋辛钠/氯化钠注射液（首仿）、注射用头孢曲松钠/氯化钠注射液（首仿）分别增长了352.19%、205.4%，市场潜力正在爆发。资料来源：米内网数据库注：米内网《中国公立医疗机构终端竞争格局》，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7月13日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

July 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased to receive the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients. Infections with difficult-to-treat rare molds or with resistance to current therapies are increasing. Hence, there continues to be a high medical need for new innovative antifungals.” He added: “This second tranche of funding within the BARDA OTA will support the ongoing phase 3 study with fosmanogepix in yeast infections and the second phase 3 study, in mold infections, which is expected to start soon. It also provides funding for the preparation for the start of the phase 2 study for our antifungal BAL2062.” The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321 K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909 ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: July 07, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 The content above comes from the network. if any infringement, please contact us to modify.