Ceftriaxone Sodium

12月11日，云顶新耀宣布：其全资附属公司云顶新耀医药科技有限公司与海森生物医药有限公司签署两项战略合作协议，包括6款产品的商业化服务协议，以及PCSK9抑制剂莱达西贝普大中华区的一项授权许可协议。 6款产品都是“原研药”，包括头孢曲松钠“罗氏芬”、醋酸奥曲肽“思他宁”，盐酸乌拉地尔注射液“亚宁定”、伏格列波糖“倍欣”等，都经过了长期市场检验，能给云顶新耀带去稳定的现金流支持。 另外的PCSK9抑制剂莱达西贝普是美国公司LIB Therapeutics研发的降脂药，2023年海森生物获得在大中华区的开发和商业化独家专有权。与传统的PCSK9抑制剂，莱达西贝普更贴近患者需求，是更加便捷的每月一针、单次小体积皮下注射制剂，居家旅行皆可方便储存或携带。 根据协议，云顶新耀将按相关产品季度净销售总额的20%-55%收取服务费。2026至2028年，海森生物年度支付金额上限分别为5.60亿元、6.16亿元和6.77亿元。 这两项战略协议的签署，代表着云顶新耀从单一产品到平台化运营的一次重大跨越，在财务与战略上形成了显著的协同效应： 协议达成后，云顶新耀不仅扩充了急重症、心血管及代谢三大治疗领域的产品管线，成熟产品直接能为当期贡献稳定收入。尤其是拿下了莱达西贝普后，云顶新耀正式进军心血管重大疾病领域，加快云顶新耀产品全生命周期、全渠道覆盖的商业化能力建设，同时为公司在心血管疾病领域打造具有吸引力的业务版图。 PCSK9抑制剂市场正处于快速增长阶段。当前中国已有多款PCSK9抑制剂获批上市，2024年总市场规模约人民币30亿元，同比增长95%。尽管中国4亿血脂异常人群中，只有14%的人接受降脂治疗，降脂产品还有很大的渗透空间。弗若斯特沙利文预计，该市场将于2030年进一步扩大至约100亿元，拥有巨大的商业化潜力。 云顶新耀披露，2026年上半年将在大中华区递交莱达西贝普的上市申请，最快有望于2027年获批上市。 新产品或将得到良好的放量。云顶新耀“耐赋康”依靠其优秀的商业化成绩，被视作行业中国创新药物商业化推广的成功案例。2025年前9个月，“耐赋康”销售额已突破10亿元。新增的急重症、代谢、心血管等领域的药物能通过云顶新耀的1000家核心医疗机构渠道销售，加速实现未来五年年收入突破150亿元人民币的目标。 资本市场普遍看好此次合作的协同效应，分析认为，此次双项协议实现了“短期收益可期、中长期成长清晰”的平衡，云顶新耀借助已建立的医学、准入、市场与销售一体化协同体系推动商业能力输出，提升资源利用效率，彰显商业化平台的可扩展性与运营韧性，并展现出高效率、可持续的增长潜力。 云顶新耀正在用亲身向行业践行一家中国创新药企的发展路径：从biotech向具备全球竞争力的综合性生物制药公司，从聚焦单一靶点或产品，构建可复制、可持续、平台化的商业生态。立足当下，放眼高远，才能走得长久。 撰稿丨杨曦霞 编辑丨江芸 贾亭 运营｜李木子 声明：健识局原创内容，未经许可请勿转载 “奥司他韦贵9倍”事件发酵，一批药品网络价低于医院价被挖出 广州医药花5亿元收购，踏入江浙市场 翼思生物抗癫痫发作新药在华获批

With a decision on Innoviva's rival therapy looming next week, US regulators have handed GSK's oral antibiotic Blujepa (gepotidacin) its second approval of the year, extending its reach to uncomplicated urogenital gonorrhoea. Blujepa was first cleared in March for uncomplicated urinary tract infections (see – Spotlight On: GSK swims against the tide to address growing AMR crisis).Health agencies have for years been warning that gonorrhoea is becoming harder to treat, as cases climb past 600,000 annually in the US and resistance squeezes the utility of older antibiotics.New class in 30 yearsBlujepa now becomes the first new class of gonorrhoea treatment in more than three decades, according to Chief Scientific Officer Tony Wood, and offers an oral option to US patients, who currently rely on injectables to treat the sexually transmitted infection.GSK says the triazaacenaphthylene antibiotic targets bacterial DNA replication at a distinct binding site and provides "well-balanced inhibition" of two Type II topoisomerase enzymes, which supports activity against Neisseria gonorrhoeae and most target uropathogens such as Escherichia coli and Staphylococcus saprophyticus, including strains resistant to current antibiotics."The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments," said Wood in a release Thursday.GSK's priority review filing was supported by data from the roughly 600-patient EAGLE-1 trial, which tested two 3g oral doses of Blujepa against the combination of intramuscular ceftriaxone plus oral azithromycin. Investigators found Blujepa to be non-inferior, with microbiological response at test-of-cure demonstrating success rates of 92.6%, compared to 91.2% in the ceftriaxone plus azithromycin group. Mild-to-moderate gastrointestinal complaints were the most common side effects, and there were no serious drug-related safety issues.Single-dose option on horizonThere soon may be another new treatment option on the market, however. The Lancet published Phase III results this week for Innoviva's investigational single-dose oral therapy zoliflodacin, showing the drug was non-inferior to dual therapy with ceftriaxone plus azithromycin. The 930-patient study, led by the Global Antibiotic Research & Development Partnership, also found comparable safety across urogenital, pharyngeal and rectal infections.The FDA has set a Dec. 15 deadline for its review of the spiropyrimidinetrione antibiotic.