This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.

开始日期2023-12-06

申办/合作机构

AstraZeneca PLC

NCT05465876 / Withdrawn临床2期

A Multi-Center, Open-Label, Single-Arm Phase II Trial of Antibody Combination EVUSHELD (Tixagevimab and Cilgavimab) to Provide Passive Immunity Against COVID-19 in Vaccine Non-responsive Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia (CLL) is a common lymphoid malignancy affecting older adults. CLL patients are immunocompromised by the disease itself and by several of its therapies. It has now been shown that many CLL patients do not mount an antibody response following COVID-19 vaccination and are therefore at risk of COVID-19 infection. Furthermore, patients with hematologic malignancies are known to be at increased risk of severe infection if they do acquire COVID-19 infection.
The purpose of this trial is to document evidence of passive immunity to COVID-19 infection after EVUSHELD administration with serologic and neutralization assays at multiple post administration time points in patients with no response to standard of care vaccination to COVID-19.
This trial will include a single dose of EVUSHELD to be administered, with a 1-year follow-up period, comprising of 8 health status visits.
Blood samples will be taken at screening, baseline and at multiple health status visits over the course of the year for various antibody testing and analysis. T cell reactivity to COVID-19 epitopes will be studied at baseline and again monthly for 3 months in any participants that become infected with COVID-19.

开始日期2023-10-01

申办/合作机构

Sunnybrook Health Sciences Centre

[+1]

NCT05569408 / Not yet recruitingN/A

An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System

An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system.

开始日期2023-09-30

申办/合作机构

AstraZeneca PLC

100 项与西加韦单抗/替沙格韦单抗相关的临床结果

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100 项与西加韦单抗/替沙格韦单抗相关的转化医学

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100 项与西加韦单抗/替沙格韦单抗相关的专利（医药）

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125

项与西加韦单抗/替沙格韦单抗相关的文献（医药）

2024-03-01·The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation

Evolving impact of the COVID-19 pandemic on lung transplant recipients: A single-center experience

Article

作者: Tokman, Sofya ; Padiyar, Josna ; Abdelrazek, Hesham ; Grief, Katherine ; Walia, Rajat ; Schaheen, Lara ; Mohamed, Hesham ; McAnally, Kendra ; Bay, Curt ; Omar, Ashraf ; Sindu, Devika ; Buddhdev, Bhuvin ; Razia, Deepika ; Arjuna, Ashwini

BACKGROUND:

Lung transplant recipients (LTRs) are at increased risk of morbidity and mortality from coronavirus disease 2019 (COVID-19); however, the disease course has changed as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants have mutated. We compared COVID-19-related clinical outcomes in LTRs at different stages of the pandemic. We also identified risk factors for developing severe COVID-19 independent of the dominant SARS-CoV-2 variant.

METHODS:

This single-center, retrospective cohort study of LTRs with COVID-19 used Cox regression analyses and bootstrapping to identify factors affecting COVID-19 severity.

RESULTS:

Between March 2020 and August 2022, 195 LTRs were diagnosed with COVID-19, almost half (89 [45.6%]) during the Omicron period. A total of 113 (58.5%) LTRs were hospitalized and 47 (24.1%) died. Age >65 years increased the risk of hospitalization and death. Although infection with the Omicron variant was associated with a lower risk of hospitalization, the median length of hospital stay (10 days, [interquartile range, 5-19]) was similar between the variants. Intensive care unit (ICU) admission and death were more common with the Delta variant but comparable between the original, Alpha, and Omicron variants. Remdesivir and molnupiravir reduced the risk of hospitalization, and monoclonal antibody therapy reduced the risk of ICU admission, intubation, and death. Vaccination and pre-exposure prophylaxis (PrEP) with tixagevimab-cilgavimab did not significantly reduce COVID-19-related ICU admission, intubation, or mortality among LTRs.

CONCLUSIONS:

LTRs with COVID-19 continue to have high hospitalization rates and prolonged hospital stays, despite the reduced virulence of the Omicron variant. More effective PrEP and therapeutic interventions for COVID-19 among vulnerable patient groups are needed.

2024-02-01·Transplant infectious disease : an official journal of the Transplantation Society

Breakthrough SARS‐CoV‐2 infections among recipients of tixagevimab‐cilgavimab prophylaxis: A citywide real‐world effectiveness study

Article

作者: Li, Linda ; Jordan, Leirah ; Lendacki, Frances R ; Seo, Jennifer Y ; Black, Stephanie R ; Ison, Michael G ; Zelinski, Christy ; Forrest, Graeme N

Abstract:

There are limited real‐world data on the effectiveness of tixagevimab‐cilgavimab as pre‐exposure prophylaxis of COVID‐19. We describe lessons learned when coordinating data collection and identifying breakthrough SARS‐CoV‐2 infections among patients across indications and institutions in a major US city. The Chicago Department of Public Health requested patient‐level tixagevimab‐cilgavimab administration data from all prescribing providers in Chicago, for treatments December 8, 2021 through June 30, 2022. Records were matched to COVID‐19 vaccinations and laboratory‐confirmed SARS‐CoV‐2 infections through December 31, 2022. Due to difficulty collecting data from all providers, targeted follow‐up was conducted to improve completeness on key variables (demographics, vaccination status, clinical indication for prophylaxis). Over half of reported tixagevimab‐cilgavimab administrations were to patients residing outside Chicago. Five hundred forty‐four Chicago residents who received at least one dose of tixagevimab‐cilgavimab were included in this analysis. Most were age 50 years or older (72%), Black non‐Latinx (33%) or White non‐Latinx (29%), and fully vaccinated (80%). Seventy‐five patients (14%) had laboratory‐confirmed COVID‐19. Patients with and without breakthrough infections were demographically similar. Clinical indication was missing for >95% of cases, improved to 64% after follow‐up; the most frequently specified was hematologic malignancy (10%). Severe outcomes were uncommon: 16% had documented COVID‐19‐related hospitalizations, one death was identified. Tixagevimab‐cilgavimab recipients in Chicago had a lower rate of severe SARS‐CoV‐2 infection than reported among other untreated high‐risk patients, including during predominance of non‐neutralizing variants. Improving stakeholder collaboration is essential for generation of real‐world effectiveness data, informing pandemic preparedness and optimizing use of medical countermeasures. image

150

项与西加韦单抗/替沙格韦单抗相关的新闻（医药）

2024-07-01

·PipelineReview

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID‑19 in an immunocompromised patient population LONDON, UK I July 01, 2024 I AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure. The MAA is based on positive results from the SUPERNOVA Phase III trial which demonstrated sipavibart’s safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, compared to control, in a variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants. 1 SUPERNOVA is the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients. 2 Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases department, Nîmes University Hospital, France, and SUPERNOVA trial investigator, said: “The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination. With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment.” Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “Immunocompromised patients currently have no options for COVID-19 protection in Europe beyond vaccination, which often is not sufficient to protect them against serious COVID-19 outcomes. We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and will work to bring sipavibart to these highly vulnerable patients.” Data from the SUPERNOVA trial will be presented at a forthcoming medical meeting. In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorisation or approval pathways for sipavibart. Notes COVID-19 and the continued unmet need in the immunocompromised population Despite the World Health Organization declaring an end to the pandemic a year ago, COVID-19 remains a significant problem for immunocompromised patients today and severe COVID-19 outcomes can fluctuate significantly throughout the year. People who are immunocompromised including blood cancer patients, those who have organ transplants, those with end-stage renal disease requiring dialysis and those taking immunosuppressive medications typically have an insufficient immune response to COVID-19 vaccination, leaving them at high risk of severe outcomes from COVID-19, even when fully vaccinated. 3-8 Findings from INFORM , a large real-world evidence study, reinforce the ongoing, significant and disproportionate burden of COVID-19 for the immunocompromised compared to the general population. Despite accounting for up to 4% of the INFORM study population, about 25% of COVID-19 hospitalisations, ICU admissions and deaths are borne by immunocompromised patients, even after multiple doses of COVID-19 vaccines. 3 SUPERNOVA SUPERNOVA is a large Phase III, global, randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of sipavibart compared to control (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19, providing the only COVID-19 efficacy data in immunocompromised patients. 2 Positive high-level results from SUPERNOVA showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population. 1 The trial met both dual primary endpoints; relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation. 1 SUPERNOVA demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants. 1 All participants in the trial had an immunocompromising condition and/or were on immunosuppressive treatments, which put them at risk to mount an inadequate immune response to vaccination and at high risk of developing severe COVID-19. Participants enrolled in the study included patients with conditions such as hematologic malignancies, solid organ transplant recipients, hematopoietic stem cell transplants, end stage kidney disease/dialysis, and being within one year of receipt of B cell depleting therapy. 1,2 Sipavibart was generally well-tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms. 1 Sipavibart Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2. 9 Sipavibart was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Sipavibart has been engineered using the same antibody scaffold as Evusheld and was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform. 9 The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease. Sipavibart was licensed by AstraZeneca in May 2022 from RQ Biotechnology . 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 1. AstraZeneca. (16 May 2024). SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population [Press Release]. Las Accessed June 2024 https://www.astrazeneca.com/media-centre/press-releases/2024/supernova-trial-met-covid-19-prevention-endpoint.html . 2. Clinialtrials.gov. Last Accessed June 2024 https://clinicaltrials.gov/study/NCT05648110?term=AZD3152&rank=3 3. Evans RA et al. Impact of COVID-19 on Immunocompromised Populations during the Omicron Era: Insights from the Observational Population-Based INFORM Study. The Lancet Regional Health – Europe . 2023;0(0):100747. doi:10.1016/J.LANEPE.2023.100747 4. Dube S. Continued Increased Risk of COVID-19 Hospitalisation and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024. 5. Turtle L. Individuals with Multiple Sclerosis Are at High Risk for COVID-19 Hospitalisation and Death Despite High Rates of Vaccination: Results from the England INFORM Study. Oral Presentation at ECCMID 2024. 6. Meeraus W. High Prevalence of Immunocompromising Conditions Among Patients with Severe Acute Respiratory Infection, Including SARS-CoV-2: Results from a Multicentre, Test-Negative Case Control Study. Abstract #01796 at ECCMID 2024. 7. Meeraus W. Immunocompromise, Cancer and Other Comorbidities in Patients with Severe Acute Respiratory Infection Testing Positive Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE Data from May 2021 to May 2023. Abstract #01800 at ECCMID 2024. 8. Ketkar A et al. Assessing the Risk and Costs of COVID-19 in Immunocompromised Populations in a Large United States Commercial Insurance Health Plan: The EPOCH-US Study. Curr Med Res Opin. 2023 . 39 (8):1103-1118. 9. Francica JR, Cai Y, Diallo S, et al. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-risk Individuals . Open Forum Infect Dis . 2023 Nov 27;10(Suppl 2):ofad500.1192. doi: 10.1093/ofid/ofad500.1192. SOURCE: AstraZeneca

临床结果临床3期免疫疗法疫苗

2024-05-23

·药通社

绝地翻盘：阿斯利康的转型与管线建设

对话决策层！如何打剂型差和产品差？产品立项和开发如何塑造壁垒？创新药企业都是产品为王，产品决定一个企业的胜败。小企业的成功靠产品，中型企业的成功靠一条产品管线，而大企业的成功靠管线管理——不同管线的推陈出新、各管线内产品的生命周期维持与延续。管线强则企业强，管线差则企业弱，制药巨头亦是如此。本文以阿斯利康为例，介绍管线管理的重要性、以及管线搭建与维护的方法。因为创新乏力，管线青黄不接，阿斯特拉与捷利康在1998年进行了合并，组建了阿斯利康。通过合并与整合，两个公司的资源与能力产生了很大的协同性，并推出了洛赛克（奥美拉唑）的迭代品耐信（埃索美拉唑，奥美拉唑的一种手性单体），形成以了以消化、中枢神经、抗肿瘤、心血管，呼吸和抗感染为特色的六大管线，具体产品如下表所示：虽然合并之后，阿斯利康的管线得到了明显的强化，业绩在强化销售力量和耐信等核心产品的带动下，实现了持续、稳步增长，但是创新乏力的问题并未得到解决，专利悬崖始终是挥之不去的阴影。2010年之后，阿斯利康陷入了爆品后时代的危机——销售额下滑，产品管线青黄不接，研发管线储备不足，股价一蹶不振。在阿斯利康最黑暗的时候，辉瑞曾两次报价欲收购该公司。然而令阿斯利康更为气愤的是，辉瑞对这家百年巨头的两次报价均远远不及新生的“牛犊”艾尔建。这样的阿斯利康，要么接受被收购的命运，要么背水一战——逐步完成管线的升级与延伸。幸运的是，阿斯利康在至暗的时刻迎来了救世主——总裁Pascal Soriot和研发副总裁Mene Pangalos。Pascal Soriot霸气回绝了辉瑞的收购邀约，并放出豪言，要让阿斯利康的销售额在未来的十年里翻两倍，随后便对阿斯利康进行了大刀阔斧地改革。Mene Pangalos则提出5R决策框架，在该框架的影响下，阿斯利康的研发效率在短短几年间发生了显著的变化，研发成功率几乎翻了5倍。The 5R framework2012年10月，原罗氏首席运营官Pascal Soriot加入了阿斯利康，出任阿斯利康的CEO。2013年3月，阿斯利康制定了实现销售额恢复增长和建立科学领导者地位的战略目标，其核心内容包括以下六点：1）扭转因专利悬崖和收入下滑所致的不利局面，驱动业绩恢复增长；2）加速二期临床管线的开发，以扩充三期临床管线的规模和提升生物制品管线的潜力；3）坚定不移地推出专科药，以抹平阿斯利康在普药领域的历史优势；4）通过各地团队的共同努力和获取全球认可的科学集群，以创新和差异化定位的科研重塑阿斯利康的研发平台；5）显著性简化业务，提高生产力，建立支持长期成功的文化；6）利用商务拓展和收购机遇，强化产品管线。为了达成该战略目标，阿斯利康停掉了大量夕阳性领域的产品研发，聚焦于朝阳性的领域。在开发新分子实体的同时，也不断投资产品的生命周期管理（如，开发埃索美拉唑新剂型、新规格、新用法、新适应症、新复方、OTC等）。为了支持研发，阿斯利康大幅增加了研发投入，平均研发投入强度从2008-2012年间的16.4%，迅速提升至2013-2017年间的25.5%；为了在专利悬崖之下提振业绩，阿斯利康也大幅增加了销售投入，通过在专利悬崖效应不显著的区域市场提升销售力量来最大化产品价值。为此，该公司的平均市场&一般管理费投入强度从2008-2012年间的34.2%，迅速提高至2013-2017年间的50.2%（在跨国巨头中，几乎已是最高水平）。除此以外，阿斯利康还以“不惜血本”的态度引进、投资或收购产品或管线资产。在2013-2017年间，阿斯利康收购了Ardea Biosciences、百时美施贵宝的糖尿病业务部门、Amplimmune、Spirogen、Pearl Therap、Omthera Pharma、Definiens、ZS pharma、阿特维斯在北美的呼吸系统品牌药管线，控股了Acerta Pharma，总合同金额高达140亿美元。除了企业兼并，阿斯利康还花掉了41亿美元，用以授权引进了纳洛西醇、罗沙司他、monalizumab（phase 3）等20多个产品或研发项目。高强度的研发投入、高强度的销售费用和高频率的收购，必然导致阿斯利康的利润下跌。平均净利润水平从2008-2012年间的15.3%下降至2013-2017年间的10.7%，加之销售额的逐渐下滑，年平均净利润也从2008-2012年间的48.71亿美元下降至25.81亿美元。为此，阿斯利来不得不在2016年进行资产重组，剥离大量的非核心资产套现，以推动战略的继续执行。2016年阿斯利康集中甩出的资产：2016年2月，将高血压药非洛地平和单硝酸异山梨酯缓释片的中国权益以5亿美元卖给康哲；2016年3月，将便秘药Naloxegol的欧洲权益卖给ProStrakan，交易金额未知；2016年4月，将痛风药lesinurad的美国权益以2.65亿美元卖给Ironwood；2016年6月，将麻醉部门的区域权益以7.7亿美元转让给Aspen；2016年6月，将痛风药lesinurad的欧洲和拉美权益以2.3亿美元卖给Gruenenthal；2016年8月，将小分子感染部门以15.75亿美元卖给辉瑞；2016年7月，将tralokinumab和brodalumab以10亿美元卖给Leo pharma；2016年10月，将在研的IL-23单抗MEDI2070以15.2亿美元卖给艾尔建；2016年10月，将在研的COPD药物AZD7986以1.5亿美元卖给强生子公司；2016年10月，将Rhinocourt Aqua的美国以外权益以3.3亿美元卖给强生子公司；2016年10月，将艾塞那肽的中国权益以1亿美元卖给三生制药。通过资产重组，阿斯利康完成了二次战略聚焦，不仅大幅压缩了人员规模，而且显著提升了资产利用率和运营效率。经过资产的重组，阿斯利康仅剩下抗肿瘤、心血管&代谢、呼吸三条特色管线，2017年总销售额分别为40.42亿美元，72.66亿美元和47.06亿美元，其它无法归类、低收益或专利失效的产品，进行了集中化管理，总销售额为41.56亿美元。因为资产的大量剥离和长期的产品管线青黄不接，阿斯利康的销售收入在2017年达到2004年以来的历史低谷，仅为201.52亿美元。但相比2012年，阿斯利康不仅基本完成了产品管线的推陈出新，而且研发管线中储备了多个高潜力值的产品。经过2016年的资产重组，阿斯利康放弃了夕阳性的抗感染、消化管线，整合了心血管和糖尿病等普药管线，强化了朝阳性的抗肿瘤管线。随着管线的不断强化，阿斯利康在随后的几年里，大量甩出了老旧的产品权益或管线资产，用以套现并换取新的管线资源。除此以外，阿斯利康为了最大化资产的价值，除了生命周期管理（如奥拉帕利开发新适应症、新疗法），还将部分产品的权益授权给了其它公司。例如，将奥拉帕利的部分适应症权益授权给默沙东，让其与Keytruda形成捆绑销售，从而提升经济效益。2017年的形势虽然有了明显的好转，但仍需坚持才能达到战略意义上的成功。为此，阿斯利康在研发投入强度保持不变的前提下，大幅增加了产品引进的强度。2018-2022年间，阿斯利康的项目交易总金额达329亿美元，引进了Evusheld（Cilgavimab/tixagevimab）、Vimovo（奥美拉唑/碳酸氢钠）、Wainua（eplontersen）、Andexxa（andexanet alfa）、Enhertu（trastuzumab deruxtecan）、新冠疫苗等产品，以及Sipavibart（phase 3）、camizestrant（phase 3）、ceralasertib（phase 3）、IPH5201（phase 2）、monalizumab（phase 3）等重要研发项目。除此以外，阿斯利康在此期间还兼并了5家公司，总合同金额约为425亿美元。通过对Alexion的收购，阿斯利康不仅快速布局了罕见病，还成为了赛道的领头羊。经过10年的苦心经营，阿斯利康的变化是显而易见的。通过对老化的、非核心的产品的剥离与出售，产品管线实现了推陈，通过内部研发、投资引进、交易并购等多重方式，产品管线又实现了出新。如今的阿斯利康，不仅形成了以抗肿瘤、心血管&肾病与代谢、呼吸与免疫、疫苗与免疫、罕见病为特色的五大管线。而且还在抗肿瘤、罕见病等领域建立了领先的优势，不论是产品管线还是研发管线的稀缺性都有了显著的提升。正因为此，最近两年来，阿斯利康逐渐降低了销售投入，市场&一般管理费支出已经下降至销售额的42%左右。对于创新药企业而言，现有的产品管线只能代表过去和现在的成功，而能代表未来的是研发管线。所以，相比现有产品，研发管线是影响企业市值高低的最重要因素。根据阿斯利康2023年年报披露的数据，该公司一共有178个产品处于研发管线中，项目高度聚焦于抗肿瘤、生物制药和罕见病三大领域，其中处于开发晚期阶段的新分子实体有17个，123个新分子实体或产品生命周期管理的项目处于临床二期或三期阶段。因为阿斯利康逐渐形成了强大产品管线和研发管线，股价也一路飙升，2023年的市值已相比2014年翻了两倍有余，销售额方面，该公司2023年的总营收达458亿美元，相比2014年几乎也翻了两倍，Soriot成功兑现了他的承诺。本文作者：魏利军，北京药眼信息咨询有限公司创始人，著有《跨国药企成功启示录》和《仿制药企兴衰启示录》，本文内容来自正在撰写新书《制药企业的战略设计与产线规划》中的实例。因为内容是初稿，可能存在表达和内容的轻微偏误，欢迎广大朋友提供宝贵的意见。推荐阅读

并购临床3期临床2期

2024-05-16

·FierceBiotech

AstraZeneca prepares fresh COVID push to regulators after antibody's phase 3 success

AstraZeneca said its study “demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.” While AstraZeneca’s globally used COVID-19 vaccine is leaving the scene, the British Big Pharma is hoping it will be taking a fresh therapeutic option to regulators soon. Results from the phase 3 SUPERNOVA study show that the company’s investigational long-acting antibody (LAA) sipavibart produced a statistically significant reduction in the incidence of symptomatic COVID‑19. The global trial of 3,335 immunocompromised patients saw half receive a 300-mg intramuscular dose of sipavibart and the others receive either AstraZeneca’s previously authorized LAA combo COVID-19 treatment Evusheld or placebo. The study had two primary endpoints: reducing the number of cases of COVID-19 caused by any variant of the virus and the relative risk reduction of infections caused by variants not containing the F456L mutation. SUPERNOVA hit both these goals, said AstraZeneca, although it didn’t provide any details of the data. Still, the Big Pharma said the study had “demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.” The participants involved were aged 12 years and over and included patients with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, those receiving B-cell depleting therapy within the past year and people taking immunosuppressive medications. “Immunocompromised patients currently have limited or no options for COVID-19 protection and continue to face a significant burden of disease, despite often being fully vaccinated,” AstraZeneca’s executive vice president of vaccines and immune therapies Iskra Reic said in the release. “Sipavibart has the potential to prevent COVID-19 in the immunocompromised and we will now work with regulatory authorities globally to bring sipavibart to these vulnerable patients,” Reic added. Sipavibart was derived from B cells donated by convalescent patients who had previously been infected with COVID-19. The treatment is engineered using the same antibody scaffold as Evusheld. The FDA rescinded its authorization of Evusheld in January 2023 when it became clear it was ineffective against some of the newer variants of COVID-19.

临床结果临床3期疫苗紧急使用授权免疫疗法

100 项与西加韦单抗/替沙格韦单抗相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
新型冠状病毒感染	美国	AstraZeneca PLC	2021-12-08

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适应症	最高研发状态	国家/地区	公司	日期
冠状病毒感染	临床1期	美国	AstraZeneca PLC	2021-11-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AASLD2023	N/A	-	1,149	Evusheld	鬱簾襯廠廠願簾齋襯醖(範遞夢夢膚膚襯鹹鏇憲) = 繭構壓衊網鏇艱積齋鬱築鬱廠鑰夢鏇鏇繭構蓋 (艱夢鏇鏇鏇鏇廠艱艱鹽 ) 更多	-	2023-11-10
PROVENT study (ICML2023)	临床3期	霍奇金淋巴瘤 \| B细胞淋巴瘤	101	Tixagevimab-cilgavimab	餘鬱蓋構選築願顧網鏇(簾鹹獵夢餘膚淵夢構淵) = 顧糧繭壓製艱窪獵簾襯衊顧糧鬱壓憲獵構構簾 (壓鹽積窪夢餘窪積鹹積 ) 更多	不佳	2023-06-09
NCT04625725 (PROVENT, EHA2023)	N/A	血液肿瘤	93	AZD7442	淵鹹窪窪壓醖遞鹹顧醖(鹽鏇鬱齋衊選鏇醖壓範) = 廠顧醖廠觸構夢鬱鬱選衊積鬱窪選網餘積鬱積 (選艱遞製構願範醖衊憲 )	-	2023-06-08
EHA2023	N/A	血液肿瘤	96	Prophylactic dose of Evusheld	鏇願糧衊衊鹹夢糧簾餘(鑰憲夢繭鬱夢襯蓋製鹽) = 範襯醖遞鹹夢網簾襯襯願廠膚膚選鏇獵鑰願窪 (窪鹽範鹽廠窪構製選觸 )	-	2023-06-08
EHA2023	N/A	血液肿瘤	96	Therapeutic dose of Evusheld	鏇願糧衊衊鹹夢糧簾餘(鑰憲夢繭鬱夢襯蓋製鹽) = 遞襯築鹹鹽鹽夢膚遞鹽願廠膚膚選鏇獵鑰願窪 (窪鹽範鹽廠窪構製選觸 )	-	2023-06-08
EHA2023	N/A	血液疾病	202	Tixagevimab-cilgavimab	艱衊餘製憲範壓網遞遞(鏇襯餘築窪衊積廠鑰選) = 鹽膚願壓積憲窪窪築壓憲網獵鏇遞獵齋糧獵網 (夢觸網憲糧鏇廠壓鏇積 ) 更多	-	2023-06-08
EULAR2023	N/A	新型冠状病毒感染	115	Tixagevimab/Cilgavimab	襯艱範願獵網淵蓋鹽壓(構製憲繭繭獵膚範艱夢) = 艱糧網積夢選築憲構簾鹹顧簾壓鬱繭範鏇淵夢 (繭獵簾壓艱夢鹽顧窪憲 )	积极	2023-05-31
ASCO2023	N/A	新型冠状病毒感染 \| 肿瘤	228	Evusheld	繭製觸餘簾壓壓觸網觸(夢鹹繭構選繭選壓積艱) = 憲繭鑰壓淵構膚顧壓艱築淵簾網遞廠鬱膚選襯 (獵壓積糧餘願網衊獵艱 )	不佳	2023-05-31
AAAAI2023	N/A	普通可变性免疫缺陷	47	Tixagevimab-Cilgavimab	餘築繭簾齋構繭糧獵鏇(顧願獵糧繭膚襯膚鬱願) = 餘願衊壓選簾築觸築壓齋糧顧鏇憲膚鏇鏇積顧 (餘簾鑰糧壓艱選餘夢遞 ) 更多	-	2023-02-01
AAAAI2023	N/A	普通可变性免疫缺陷	47	No Tixagevimab-Cilgavimab	餘築繭簾齋構繭糧獵鏇(顧願獵糧繭膚襯膚鬱願) = 範獵醖鏇範廠憲鹽鹹糧齋糧顧鏇憲膚鏇鏇積顧 (餘簾鑰糧壓艱選餘夢遞 ) 更多	-	2023-02-01
NCT04625725 (PROVENT, CTgov)	临床3期	新型冠状病毒感染	5,197	AZD7442 (AZD7442)	齋鑰淵夢齋網廠築獵壓(艱衊築艱廠獵築簾淵鏇) = 膚餘觸廠範襯淵淵鬱襯膚鏇築網鑰繭範艱廠糧 (顧壓蓋壓繭齋鹽醖憲製, 顧壓糧鹹廠壓鏇衊遞鬱 ~ 製遞獵鏇衊製醖觸蓋醖) 更多	-	2022-12-20
NCT04625725 (PROVENT, CTgov)	临床3期	新型冠状病毒感染	5,197	Placebo (Placebo)	齋鑰淵夢齋網廠築獵壓(艱衊築艱廠獵築簾淵鏇) = 醖製獵糧範選製鹽襯窪膚鏇築網鑰繭範艱廠糧 (顧壓蓋壓繭齋鹽醖憲製, 艱壓選繭蓋夢衊餘餘壓 ~ 艱觸醖蓋憲鏇願築糧築) 更多	-	2022-12-20
NCT04723394 (TACKLE, CTgov)	临床3期	新型冠状病毒感染	910	AZD7442 (AZD7442)	選鹽網鑰選鏇廠觸觸鏇(獵艱餘積襯願餘廠範鹽) = 膚餘遞網選夢選簾鏇艱蓋壓廠壓鏇壓鏇蓋醖憲 (選艱鑰築選衊構遞範遞, 顧憲簾顧廠網顧壓醖鏇 ~ 窪選壓構窪顧鬱遞糧齋) 更多	-	2022-12-20
NCT04723394 (TACKLE, CTgov)	临床3期	新型冠状病毒感染	910	Placebo (Placebo)	選鹽網鑰選鏇廠觸觸鏇(獵艱餘積襯願餘廠範鹽) = 壓選壓餘觸鏇憲築夢製蓋壓廠壓鏇壓鏇蓋醖憲 (選艱鑰築選衊構遞範遞, 鏇網願繭遞繭窪憲鹽獵 ~ 衊憲壓壓鏇鹹製襯獵繭) 更多	-	2022-12-20