Ribociclib Succinate

近日，路透社发布一则重磅消息：瑞士制药巨头诺华公司在周四宣布，面对特朗普政府再次发出的药品进口关税威胁，决定拿出一份价值230亿美元的投资计划，用于在美国建设和扩建10个设施。这一举措在医药行业内引起了广泛关注。诺华的投资计划涵盖多个领域。公司将在加利福尼亚州圣地亚哥新建6家制造厂，其中部分工厂会负责生产药物原料药，同时还将新建一处研发基地。目前，诺华的药品，像治疗心力衰竭的Entresto和治疗乳腺癌的Kisqali，在全球33个地点进行生产。诺华称，新设施和扩建项目将在未来5年内完成，预计会为工程师、科学家等技术人员创造1000多个工作岗位，还会为辅助人员和建筑工人提供3000个工作机会。不过还有4处尚未确定具体位置，但有两家用于生产某些癌症治疗药物的工厂已经确定将分别建在佛罗里达州和得克萨斯州。诺华首席执行官Vas Narasimhan在接受采访时，对这次投资的动机进行了详细解读。他明确表示，虽然关税问题给公司带来了不小的压力，但这并非投资的主要原因。诺华真正的目标是实现所有销往美国的药品都在美国本土生产，从而大幅减少对进口的依赖。诺华总部位于瑞士巴塞尔，此前就曾表示，作为“美国优先”战略的一部分，希望能在全球最大的药品市场——美国占据前五的市场地位。并且，诺华透露，未来5年，公司在美国业务的总投资预计将接近500亿美元。值得一提的是，今年早些时候，礼来、强生等美国制药公司也纷纷宣布了在美国的制造投资计划。其中，礼来承诺在5年内投资270亿美元建设美国工厂。这一系列现象背后，是特朗普在竞选时承诺推动美国国内制造业发展，上任后不断向制药公司施压，要求它们将药品生产转移至美国。不过，行业组织美国药品研究与制造商协会（PhRMA）也曾表示，受监管要求等多种因素影响，在美国新建一个生产设施可能需要5-10年时间，成本更是高达20亿美元。诺华此次大规模投资计划的实施，无疑要面临诸多挑战。来源：一度医药作者：Mandy点击 阅读原文 了解更多

Truqap has been approved patients with the most common type of breast cancer on the NHS. Image credit: Shutterstock/Yakobckuk Viacheslav. AstraZeneca’s Truqap (capivasertib) has been approved for use by the National Health Service (NHS) in England and Wales, providing a new targeted therapy option that significantly increases progression-free survival (PFS) in breast cancer patients. National Institute for Health and Care Excellence (NICE), the spending watchdog for the NHS, has recommended the drug to be used in combination with AstraZeneca’s already-marketed breast cancer drug Faslodex (fulvestrant). Adults with hormone receptor (HR)-positive HER2-negative breast cancer that has one or more PIK3CA, AKT1 or PTEN gene alterations and is locally advanced or metastatic are eligible for the therapy. NICE estimates around 1,100 patients will be able to take the new twice-a-day tablet, with London’s Institute of Cancer Research (ICR) forecasting that the combo therapy will eventually benefit around 3,000 a year. Truqap will likely become a key revenue driver for AstraZeneca. The drug is forecast to reach blockbuster status by 2027, whilst 2031 global sales are expected to hit nearly $2bn, as per GlobalData’s Pharma Intelligence Centre. As well as the UK, Truqap is also approved in the US , the European Union (EU), and Japan, amongst others. GlobalData is the parent company of Pharmaceutical Technology . The HR-positive HER2-negative breast cancer drug market also includes Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). Breast cancer is the most common cancer in the UK, affecting one in seven women. Treatments have progressed over the past few decades, meaning 75% of patients survive for 10 years or more after diagnosis. HR-positive HER2-negative breast cancer is the most common type of breast cancer. Results from the Phase III CAPItello-291 trial (NCT04305496) showed that Truqap doubled the time it took for cancer to progress in 708 women with HR-positive HER2-negative breast cancer patients. The median PFS was 7.3 months in those who received Truqap and Faslodex, compared to 3.1 months in patients who received hormone therapy alone. The NHS availability of Truqap is a ‘triumph’ according to Professor Kristian Helin, chief executive of ICR. “This announcement is a triumph that will improve treatment for these patients with the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes and for these patients, Truqap can halt disease progression. I’m delighted that access to the drug is being expanded to NHS patients in England and Wales who are in desperate need of better options,” Professor Helin commented. Patients with advanced HR-positive HER-2 negative breast cancer in the UK are currently offered the option to continue Faslodex or chemotherapy. Faslodex on its own is often ineffective and chemotherapy carries side effects, the ICR stated. “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects,” NICE’s director of medicines evaluation Helen Knight said. Truqap works by inhibiting all three isoforms of the AKT protein. AKT kinases enable cancer cell growth and multiplication. NICE said that whilst there have been no clinical trials directly comparing the new combo therapy to existing approved regimens, indirect comparisons suggest non-inferiority. The recommendation by NICE represents a U-turn after the agency initially rejected the therapy due to uncertainties over its cost-effectiveness. Breast Cancer Now’s chief executive Claire Rowney said this meant “patients faced unnecessary delays in accessing” the treatment. She added that “NHS England must now put in place prompt genetic testing to ensure those eligible to receive [Truqap] without further delay.”