Capivasertib

本周，“科创板八条”“创投十七条”的发布带来暖风。 资本市场也颇具看点：一家CAR-T公司暴涨480%；一家核药Biotech前脚要IPO，半个月后“变卦”，取消上市。国内，诺泰生物20cm涨停，两家公司IPO终止，其中一家又是CXO公司。 医保谈判前夕，多款药物“突击式”降价，其中包括两款明星ADC产品。 产品研发上市方面，AZ、武田遇挫，吉利德长效HIV疗法III期试验结果亮眼，股价涨超8%。另外，默沙东21价肺炎疫苗正式获批上市。 近期，医药反腐深入全产业链，中纪委点名，反垄断局曝光，全面“围剿”药企不合规。军队采购网上公布一系列处理公告，大批企业因围标串标、虚假投标等违规行为遭到处罚，国药、华润、九州通、重药控股等均包括在内。 其中，广西九州通医药有限公司因涉嫌存在串通投标、虚假投标等违规行为，依法拟给予终身禁止参加处理全军物资工程服务采购活动处罚。 一起看看本周医药行业都有哪些亮点值得关注？ 政策动态 广东省药品交易中心发布《关于征询药品拟带量采购意向品种清单的通知》：文件显示，广东将探索带量采购新机制，向相关企业征询2024年药品拟带量采购意向品种，品种范围包括两大类产品，一类是基药，一类是国谈产品，涉及20个基药以及431款国谈药物。企业填报的需求仅代表企业产品拟参与带量采购的意向，最终是否纳入带量采购品种范围以公布的采购文件为准。 证监会发布“科创板八条”具体举措：6月19日上午，中国证监会主席吴清在2024陆家嘴论坛的发言中提到将推出“科创板八条”。同日下午，证监会发布《关于深化科创板改革 服务科技创新和新质生产力发展的八条措施》，从科创板入手，支持创新药发展，规范市场、发展市场、搞活市场的政策基调呼之欲出。 国办出台支持创投“十七条”：6月19日，国务院办公厅印发《促进创业投资高质量发展的若干政策措施》，措施共六项、十七条细则，涵盖募、投、管、退等全链条，支持创业投资高质量发展。文件指出，发挥政府出资的创业投资基金作用，通过“母基金+参股+直投”方式支持战略性新兴产业和未来产业；对突破关键核心技术的科技型企业，建立上市融资、债券发行、并购重组绿色通道；加快解决银行保险资产管理产品投资企业的股权退出问题。 江苏耗材价格治理发力：6月20日，江苏省医保局发布《关于进一步推进医用耗材阳光挂网价格治理工作的通知》。其中，外省省级带量采购中选产品，可以带量采购中选记录申报挂网，但申报价格不得高于该产品全国各省级现执行挂网价、带量采购中选价格和省内医疗机构应急采购价三者中最低值。已撤网产品同注册证产品申报阳光挂网的，申报价格应不高于同注册证同品种已撤网产品撤网前价格的1.5倍。 大型制药 国药、华润、九州通、重药控股等头部流通公司子公司禁入军队采购：近期，军队采购网上公布了一系列处理公告，大批企业因围标串标、虚假投标等违规行为遭到处罚，程度较轻的2-3年内被禁止再参加采购，严重的则是终身禁入。相关公告点到了一批著名的头部流通企业，国药、华润、九州通、重药控股等均包括在内。 华东医药口服GLP-1R激动剂I期研究积极：6月20日，华东医药宣布口服小分子GLP-1受体激动剂HDM1002片在中国Ia及Ib期临床试验中取得了积极结果。HDM1002片是由中美华东自主研发并拥有全球知识产权的创新型小分子药物，是具有口服活性、强效、高选择性的GLP-1受体小分子完全激动剂。临床前研究显示，HDM1002具有强效的改善糖耐受、降糖和减重作用并且显示出良好的安全性。 九洲药业拟注销瑞博生命科学、瑞博欧洲两家子公司：目的在于以优化资源配置、降低管理成本、提高运营管理效率。注销子公司不会对公司整体业务发展和股东利益产生影响。据悉，瑞博生命科学未开展实际经营活动，而瑞博欧洲为全资孙公司，有一定资产和营收。 华润医药商业集团有限公司聘任新总经理：6月19日，华润医药商业集团有限公司发布公告，称经公司董事会审议，决定聘任郭霆为新的总经理。郭霆曾任北京双鹤药业财务总监、北京双鹤药业副总裁、华润北贸副总经理等职务。 中国生物制药依奉阿克获批上市：6月17日，国家药监局显示，中国生物制药下属企业正大天晴药业集团申报的1类创新药依奉阿克胶囊（商品名：安洛晴）获批上市，适用于未经过间变性淋巴瘤激酶（ALK）抑制剂治疗的ALK阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。这也是4月底以来，中国生物制药获批的第三款1类创新药。 阿斯利康一项临床试验失败：6月18日，据阿斯利康官网披露，其全球首创AKT抑制剂Truqap在全人群和携带特定标志物改变的亚组患者的III期临床试验中，联合化疗一线治疗三阴性乳腺癌（TNBC）未达到生存期的双重主要终点。此前，Truqap被FDA批准治疗HR阳性、HER2阴性的晚期或转移性乳腺癌。 吉利德长效HIV疗法III期试验结果亮眼：近期，吉利德宣布，每半年注射一次的HIV-1衣壳抑制剂lenacapavir（来那卡帕韦）关键III期PURPOSE 1试验的中期分析结果显示，该产品在女性中的HIV预防用途上显示出100%的有效性，且效果优于吉利德现有口服抗HIV药物Truvada。吉利德表示，这是显示首个无患者感染的预防HIV的III期试验。 默沙东21价肺炎疫苗获批上市：6月17日，默沙东宣布FDA已批准其21价肺炎球菌结合疫苗Capvaxive（V116）的生物制品许可申请（BLA），用于预防18岁及以上成人侵袭性肺炎球菌疾病和肺炎球菌肺炎，这意味着V116成为了首个专为成人设计的肺炎球菌结合疫苗。据了解，Capvaxive专为成年人设计，涵盖导致50岁及以上成年人中约84%侵袭性肺炎球菌疾病的血清型。 武田同类首创CH24H抑制剂错失2项III期研究主要终点：6月17日，武田和Ovid Therapeutics共同公布了CH24H抑制剂soticlestat（TAK-935）治疗癫痫的两项III期SKYLINE和SKYWAY研究的初步数据。SKYLINE研究显示，与安慰剂相比，soticlestat错过了惊厥性癫痫发作频率的主要终点。在另一项针对难治性Lennox-Gastaut综合征患者的SKYWAY研究中，与安慰剂相比，该药物未能降低癫痫发作频率。 生物技术 康方生物卡度尼利降价53.4%：据悉，医保谈判前夕，康方生物自主研发的全球首个肿瘤免疫双抗新药卡度尼利单抗注射液的价格将下调，单支价格从原来的13220元降为6166元，降幅为53.4%。此外。德曲妥珠单抗（DS-8201）、维泊妥珠单抗等产品也有价格调整。 迪哲医药高瑞哲在中国获批上市：迪哲医药近日宣布，公司自主研发的I类新药——淋巴瘤领域全球首个且唯一高选择性JAK1抑制剂高瑞哲（通用名：戈利昔替尼胶囊）正式获得国家药监局批准，单药适用于既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者。 沃森生物终止重组新冠疫苗研发：6月17日，沃森生物发布公告，称公司决定终止重组新型冠状病毒疫苗（CHO细胞）和重组新型冠状病毒变异株疫苗（CHO细胞）的后续临床试验。 BioNTech/宜联 HER3 ADC 临床部分暂停：6月17日，BioNTech在提交给SEC的一份文件中表示，在研究人员观察到多起死亡事件后，美国FDA部分暂停在研HER3 ADC药物BNT326/YL202的多中心、开放标签、首次人体I期临床（NCT05653752），原因是担心 BNT326/YL202“在较高剂量下可能会使受试者面临不合理且显著的患病或受伤风险”。 科伦博泰又一款ADC创新药获批临床：6月18日，科伦博泰宣布其自主开发的创新ADC注射用SKB518在中国获批临床，拟在晚期实体瘤患者中开展临床试验。注射用SKB518是一款由科伦博泰针对靶点生物学特点研发的创新ADC，在临床前展现了良好的有效性和安全窗。 麦科思生物PTK7 ADC授权给Day One：6月18日，Day One Biopharmaceuticals宣布，公司已与麦科思生物达成独家许可协议，Day One将拥有在大中华区以外地区开发、生产和商业化PTK7  ADC产品MTX-13的全球独家权利。根据协议条款，MabCare 将获得5500万美元的预付款，并有资格获得额外的11.52亿美元的开发、监管和商业成功里程碑，以及大中华区以外地区净销售额的低至个位数特许权使用费。 首款DMD基因疗法获FDA完全批准：Sarepta Therapeutics在近期宣布，美国FDA批准了其与罗氏联合开发的基因疗法Elevidys扩展适应证，将年龄至少为4岁的杜氏肌营养不良（DMD）患者纳入其中，这些患者确认带有DMD基因突变。 18亿美元，Ascidian 与罗氏达成药物研发合作：6月18日，生物技术公司Ascidian Therapeutics宣布，与罗氏达成一项总额高达约18亿美元的研究合作与许可协议，两家公司将共同发现和开发针对神经疾病的RNA外显子编辑疗法。根据协议，Ascidian将针对未披露的神经疾病靶点，向罗氏提供AscidianRNA外显子编辑技术的独家、特定靶点的使用权。 首个获FDA双重认定的同种异体细胞疗法诞生：近期，眼科细胞疗法公司Aurion Biotech宣布美国FDA授予其同种异体细胞疗法AURN001突破性疗法认定（BTD）和再生医学先进疗法（RMAT）认定，用于角膜内皮疾病继发的角膜水肿。据悉，AURN001是同时获得美国FDA的BTD与RMAT认定的首个同种异体细胞疗法。 资本市场 复星医药出售子公司6.01%股权：6月19日，复星医药称公司控股子公司复星医药新加坡公司通过大宗交易以均价1771.81印度卢比/股（税前）出售所持有的990万股Gland Pharma股份（约占截至2024年6月19日Gland Pharma股份总数的6.01%），交易总对价为175.41亿印度卢比（税前），折合约2.11亿美元（税前）。本次交易完成后，集团持有Gland Pharma的股权比例约为51.83%（本次交易前约为57.84%）。 上海莱士正式并入海尔：6月18日，海尔集团宣布成功完成战略入股上海莱士的交易交割，海尔集团通过海盈康（青岛）医疗科技有限公司以总价125亿人民币收购全球医疗健康企业基立福所持有的上海莱士20%股份，全部交易完成后，海盈康将合计获得26.58%的表决权。此后，上海莱士正式并入海尔集团的大健康版图，成为大健康生态品牌“盈康一生”新成员。 又两家公司IPO终止：6月17日，上交所官网显示，上海生生医药冷链撤回上市申请，该公司占比最大的业务板块是创新药研发和生命科学冷链服务，整个业务板块中占比约70%，其次是药械商业流通冷链物流。6月19日，上海熙华检测技术服务股份有限公司创业板上市申请终止。熙华检测是一家以生物分析、药物分析为核心的医药研发外包服务提供商。 诺泰生物半年报预告出炉，开盘涨停：6月19日晚，科创板上市生物医药企业诺泰生物披露2024年上半年业绩预告，报告期内，预计实现归母净利润1.8亿元-2.5亿元，同比增长330.08%-497.34%。诺泰生物称，得益于公司自主选择产品的持续放量及收入占比提升，公司2024年半年度业绩同比实现较大增长。受此消息影响，诺泰生物股价次日开盘20％涨停。 蓝帆医疗子公司增资扩股引入外国产业投资者：6月19日，蓝帆医疗发布公告，称为提高子公司的综合竞争力，充分发挥和扩大其在技术、自动化、能源方面的优势，共享合作方的产业资源，实现多个层面的业务协同，公司全资子公司山东蓝帆健康科技有限公司拟以增资扩股方式引入泰国产业投资者Hua Kee Co.,Ltd。 明星核药公司紧急撤回IPO：近期，远大医药海外合作伙伴取消IPO。Telix在6月5日刚刚宣布IPO，拟定价11.87美元，募资约2亿美元。谁承想，才刚刚过了半个月，这家Biotech就决定取消IPO，起因似乎是在产品连传喜讯拉动股价增长后，“嫌弃”IPO定价太低。 一家CAR-T公司股价暴涨近480%：6月17日，Mustang Bio公司宣布其MB-106——靶向CD20的自体CAR-T细胞疗法的I/II期临床试验数据显示，该疗法在华氏巨球蛋白血症（WM）患者中显示出良好的安全性和有效性。消息一出，Mustang Bio当天股价暴涨近480%。 最大私营医院集团破产：日前，美国最大的私营医院运营商Steward Health Care宣布，其原计划于夏季进行的资产出售程序将有所延迟。据悉，该公司由于数亿美元的债务堆积，已经陷入了经营困境，目前正处于第11章破产重组阶段，计划出售其在八个州内的31家医院。此外，公司近3万名员工也受到破产影响。 波士顿科学产生今年第二笔收购：6月18日，波士顿科学宣布收购纳斯达克上市公司Silk Road Medical，收购价格为每股27.5美元，总价约为11.6亿美元。交易完成后，Silk Road Medical将成为波士顿科学的全资子公司，此次收购，是波士顿科学对TCAR（经颈动脉血管重建）术式及产品在治疗颈动脉疾病和预防中风上的一次创新布局。 精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海 启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册 创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药 跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

First and only AKT inhibitor approved in the EU for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN) Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population LONDON, UK I June 20, 2024 I AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine . 1 In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K, AKT or PTEN alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months). 1 In Europe, breast cancer remains the leading cause of cancer death, with more than 140,000 deaths in 2022 and more than 550,000 patients diagnosed in the same year. 2 Hormone receptor (HR)-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 3 More than 97% of HR-positive breast cancer tumours are ER-positive. 4,5 Collectively, mutations in PIK3CA, AKT1 and alterations in PTENoccur frequently, affecting approximately 50% of patients with advanced HR-positive breast cancer. 6-8 Mafalda Oliveira, MD, PhD, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: “Patients with advanced ER-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control. Today’s approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “ Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumours harbouring these specific biomarkers. Breast cancer continues to be the leading cause of cancer-related death in Europe, and today’s news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.” In the CAPItello-291 trial, the safety profile of Truqap plus Faslodex was similar to that observed in previous trials evaluating this combination. 1 Regulatory applications are currently under review in China and several other countries. Similar indications for Truqap in combination with Faslodex are already approved in the US , Japan and several other countries based on the CAPItello-291 trial. Financial considerations Following this approval in the EU, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the EU as well as royalties on future sales in line with the agreement between the two companies. Notes HR-positive breast cancer The growth of HR-positive breast cancer cells is often driven by estrogen receptors, and endocrine therapies that target ER-driven disease are widely used as 1st-line treatment in the advanced setting, and often paired with CDK4/6 inhibitors. 9-11 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 10 Once this occurs, treatment options are limited– with chemotherapy being the current standard of care – and survival rates are low with approximately 35% of patients anticipated to live beyond five years after diagnosis. 3,10,12 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. CAPItello-291 CAPItello-291 is a Phase III, double-blind, randomised trial evaluating the efficacy of Truqap in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced (inoperable) or metastatic HR-positive (ER-positive and ER-positive, progesterone receptor-positive), HER2-low or negative (immunohistochemistry (IHC) 0 or 1+, or IHC 2+/in-situ hybridisation (ISH)-negative) breast cancer. The global trial enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN genes). In the trial, approximately 40% of tumours had these alterations and approximately 70% of patients received a prior CDK4/6 inhibitor. Truqap Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition. Truqap is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results. Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments. Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). Faslodex Faslodex is an endocrine therapy indicated for the treatment of ER-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy. In the US, EU and Japan , Faslodex is also approved in combination with CDK4/6 inhibitors for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine . Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the estrogen receptor – a key driver of disease progression. Faslodex is approved as monotherapy or in combination with medicines from various drug classes including CDK4/6, PI3K and AKT inhibitors for the treatment of patients with HR-positive advanced breast cancer and is being evaluated in combination with medicines from other drug classes. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap , and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of datopotamab deruxtecan alone and in combination with immunotherapy Imfinzi (durvalumab), and Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu . AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca References SOURCE: AstraZeneca