预约演示

更新于：2026-07-11

Efmoroctocog alfa(Sobi Analytics)

更新于：2026-07-11

概要

概要

基本信息

药物类型

Fc融合蛋白、重组凝血因子

别名

Antihemophilic Factor (Recombinant BDD), FC Fusion Protein、Antihemophilic Factor (Recombinant), Fc Fusion protein、Antihemophilic factor (recombinant, FC fusion protein)

+ [18]

靶点

F10

作用方式

调节剂

作用机制

F10调节剂(凝血因子X调节剂)、凝血因子VIII替代物

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Swedish Orphan Biovitrum ABSanofi KK

Biogen, Inc.

+ [1]

非在研机构

Bioverativ, Inc.

Bioverativ Therapeutics, Inc.

权益机构

Biogen, Inc.

Swedish Orphan Biovitrum AB

Bioverativ Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2014-06-06),

血友病A

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

Sequence Code 169138

来源: *****

Sequence Code 611893858

来源: *****

关联

项与 Efmoroctocog alfa(Sobi Analytics) 相关的临床试验

NCT06158334

/ Unknown statusN/AIIT

Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)

Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with haemophilia is commonly managed with replacement therapy.
In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.
Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.

开始日期2022-06-01

申办/合作机构

Hospices Civils de Lyon

NCT04728217

/ Completed临床4期IIT

Health Related Quality of Life of Youth and Young Adults With Haemophilia A Treated With Efmoroctocog Alfa in Russia

Research question:
Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?
A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.

开始日期2021-04-15

申办/合作机构-

NCT04690322

/ Withdrawn临床4期IIT

POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

This is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor VIII based replacement therapy or non-FVIII based replacement therapy, which are both standard of care treatment for persons with Hemophilia A.

开始日期2021-04-15

申办/合作机构

The University of Texas Southwestern Medical Center

100 项与 Efmoroctocog alfa(Sobi Analytics) 相关的临床结果

登录后查看更多信息

100 项与 Efmoroctocog alfa(Sobi Analytics) 相关的转化医学

登录后查看更多信息

100 项与 Efmoroctocog alfa(Sobi Analytics) 相关的专利（医药）

登录后查看更多信息

116

项与 Efmoroctocog alfa(Sobi Analytics) 相关的文献（医药）

2025-12-31·Hematology

A-SURE: intra-patient comparison of prophylactic effectiveness of a recombinant factor VIII Fc fusion protein versus standard half-life factor VIII in hemophilia A

Article

作者: Anna-Elina Lehtinen ; Eva Bednar ; Stefan Lethagen ; Flora Peyvandi ; Charles Hay ; Ingrid Pabinger ; Håkan Malmström ; Johannes Oldenburg ; Eveline Nüesch

BACKGROUND:

Despite recent advances, factor replacement therapy remains a cornerstone in hemophilia A treatment. Efmoroctocog alfa, a recombinant FVIII Fc fusion protein (rFVIIIFc), has an extended half-life allowing higher FVIII levels and less frequent dosing than standard half-life (SHL) products, without increasing factor consumption.

METHODS:

A-SURE was a 24-month prospective, non-interventional study assessing real-world effectiveness of rFVIIIFc prophylaxis. This post-hoc, intra-patient analysis included patients with hemophilia A (PwHA) who switched from SHL FVIII to rFVIIIFc prophylaxis. Effectiveness endpoints included annualised bleeding rate (ABR), annualised joint bleeding rate (AjBR), weekly injection frequency and weekly factor consumption.

RESULTS:

Of 131 PwHA eligible for analysis, mean ABR and AjBR decreased from 3.7 and 2.4 to 1.8 and 1.1, respectively, after switching (mean [95% confidence interval (CI)] change of -1.9 [-3.0, -0.8] and -1.2 [-2.0, -0.5]). Mean weekly injection frequency decreased from 3.1 to 2.3 (mean [95% CI] change of -0.8 [-1.0, -0.7]); weekly factor consumption reduced from 89.7 to 84.1 international units (IU)/kg, respectively (mean [95% CI] change of -5.7 [-10.7, -0.6]). These trends were consistent across age groups.

CONCLUSION:

This intra-patient comparison demonstrates switching from SHL FVIII to rFVIIIFc prophylaxis reduces frequency of bleeds, injection frequency, and factor consumption, complementing previously reported data from A-SURE.Trial registration:ClinicalTrials.gov identifier: NCT02976753.

2025-11-26·Expert Review of Pharmacoeconomics & Outcomes Research

Switching hemophilia A patients to an extended half-life agent on a prophylactic basis: an economic appraisal

Article

作者: Ariston Karagiorgis ; Sofia Vakalopoulou ; Efrosyni Nomikou ; Helen Pergantou ; Olga Katsarou ; Konstantinos Drakos ; Marina Economou

BACKGROUND:

Gaining an understanding of transitioning hemophilia patients to an extended half-life (EHL) agent requires real-world data, encompassing various outcomes, which would help assessing the impact of the switch, for patients and the healthcare system. We investigate the economic implications of switching from standard half-life (SHL) recombinant factor VIII (rFVIII) from either prophylaxis or on-demand, to EHL rFVIII efmoroctocog alfa (FVIIIFc) prophylaxis.

RESEARCH DESIGN AND METHODS:

The study involved 48 patients with hemophilia A from the 5 specialized hemophilia centers in Greece. Patients switched from prophylactic or on-demand treatment using a SHL factor VIII to a rFVIIIFc on prophylaxis only. Data was gathered for the 12-month period before and after switch. Using standard t-tests and regression analysis, we compared the direct treatment cost between the pre and post switch time, focusing on regimens' differential costs.

RESULTS:

There is no statistically significant cost increase compared to the core rFVIII regimen used before the switch, when only patients that were previously on prophylaxis were considered. However, there is a statistically significant reduction in cost across treatment styles.

CONCLUSIONS:

The analysis confirms the advantages offered by prophylaxis with rFVIIIFc from an economic standpoint for the Greek healthcare system, in accordance with other studies.

2025-08-01·CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS

Clinical and Surgical Experiences with Efmoroctocog Alfa in Pediatric Population with Hemophilia A

Article

作者: Hüseyin Avni Solgun ; Mustafa Ozay

Introduction:

Hemophilia A is a rare inherited bleeding disorder. Less than 1% of FVIII level in plasma is classified as severe, 1%–5% as moderate, and above 5% as mild disease. The aim of this study is to share clinical and surgical experiences in Hemophilia A with extended half-life (EHL) recombinant FVIII preparations.

Material and Methods:

A retrospective observational study between 2024 and 2025, inpatient or outpatient follow-up was carried out in the Pediatric Hematology clinic of our university hospital. A total of 18 patients diagnosed with severe FVIII deficiency were included in this study.

Results:

The average age of the patients was 8.4 years (min. 20 months—max. 17 years). All patients were male and inhibitor negative severe FVIII deficiecy patients. Patients were numbered as P1-18 respectively. P1, P4, and P8 are 20 months, 3 years, and 4 years old respectively. They were evaluated as previously untreated patients (PUP) with a new diagnosis of severe FVIII deficiency and the other patients were previously treated patients (PTPs). P10 had 2 infected decayed molars and 1 incisor extracted in the same dental session. P13 underwent circumcision operation. P18 had refixation surgery due to a left arm radius and ulna bone fracture, and a cast was applied. All three surgical operations were performed under treatment of recombinant FVIII Efmoroctocog alfa (Ealfa/Elocta ® ) successfully.

Conclusion:

Efmoroctocog alfa seems to be effective in EHL FVIII replacement therapy and surgical management of hemophilia A. Compared with standard half-life (SHL) FVIII products, EHL FVIII products such as Ealfa have the potential to optimize prophylactic outcomes by decreasing the burden of treatment or increasing the level of bleed protection.

108

项与 Efmoroctocog alfa(Sobi Analytics) 相关的新闻（医药）

2026-07-09

·FiercePharma

Sobi earns top spot in bleeding disorder patient groups' pharma reputation rankings

The bleeding disorder-specific corporate reputation results are in, and Sobi has landed the top spot. That’s according to PatientView’s annual corporate reputation survey (PDF) for 2025/2026, which drew its results after polling 65 bleeding disorder patient groups across 31 countries between December 2025 and March 2026. Respondents were asked to weigh nine bleeding disorder companies across several different factors to determine which have the highest reputation between Bayer, BioMarin, CSL Behring, Novo Nordisk, Pfizer, Sanofi, Sobi, Takeda and Roche and its subsidiaries Genentech and Chugai Pharmaceutical. The top three showed no difference between the two categories PatientView uses to differentiate companies that respondents have worked with firsthand or companies that respondents are familiar with. For both categories, Sobi topped the list at No. 1, while Roche/Genentech/Chugai came in second and Novo took third. Although they didn’t make the top three this year, two companies still notably climbed the ranks in Sanofi and CSL Behring. Sanofi took the crown for the fastest-rising company in the group of drugmakers respondents were familiar with, zooming up two places from its last ranking. CSL Behring, meanwhile, jumped up a spot when ranked by respondents who have experience working with the company. The bleeding disorder patient groups, which together supported 204,000 patients over the last year, made their picks based on a wide set of indicators of corporate reputation, including safety, pricing transparency, equitable access and integrity. Over the past five years since PatientView’s 2021/2022 survey, the patient groups view of the corporate reputation of the pharma industry as a whole has declined. Specific areas in which the industry weakened over that timeframe, according to the respondents, lay in access to medicines, services ‘beyond the pill’, patient engagement in R&D and the provision of patient information. However, the patient groups also reported boosts in transparency in clinical data, innovation ability, commitment to patient safety and more, while “slight” increases were perceived in fair pricing policies, price transparency and products of benefit to patients with bleeding disorders. “Our needs regarding our entire population have not been met yet, although we have preventative treatment for all patients through the Unified Health System/SUS [Sistema Único de Saúde, the National Health System of Brazil],” one bleeding disorders patient group out of Brazil commented in PatientView’s press release. Sobi and Roche’s corporate reputations have earned high marks as of late, with Sobi nabbing the top spot for overall corporate reputation in rare disease in 2024. In that report, Roche took second place under Sobi as ranked by 518 rare disease patient groups. Roche also claimed the No. 1 spot when it comes to cancer rankings in a recent PatientView report released last week. Swedish pharma Sobi’s biggest drug sector is hematology, where it markets a number of bleeding disorder drugs including Sanofi-partnered Altuviiio and Eloctate, both of which treat hemophilia A. Roche, for its part, sells hemophilia A mainstay Hemlibra, which remains a top growth driver for the company.

2026-06-30

·PRNewswire

Sobi to showcase new data across haemophilia portfolio at ISTH 2026

New analyses and real-world evidence highlight outcomes with Altuvoct®, Elocta® and Alprolix® in haemophilia A and B STOCKHOLM, June 30, 2026 /PRNewswire/ -- Sobi® today announced new data across its haemophilia portfolio will be presented at the 2026 Congress of the International Society on Thrombosis and Haemostasis (ISTH), taking place in Paris, from 11–15 July 2026. Presentations include new analyses and real-world evidence evaluating treatment outcomes with Altuvoct, Elocta and Alprolix in people living with haemophilia A and B. The data being presented include oral and poster presentations evaluating joint health outcomes, bleeding outcomes, perioperative management and real-world treatment experience across multiple patient populations and clinical settings. "People living with haemophilia continue to seek treatment approaches that can support long-term bleed protection, joint health and quality of life in everyday clinical practice," said Lydia Abad-Franch, MD, Chief Medical Officer at Sobi. "The breadth of data being presented at ISTH 2026 reflects our continued commitment to advancing care through both clinical development and real-world evidence generation to help improve outcomes for people living with haemophilia." About ALTUVOCT® ALTUVOCT (efanesoctocog alfa) [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is the first high-sustained FVIII replacement therapy with the potential to deliver near-normal factor activity levels for a significant part of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. Efanesoctocog alfa builds on the established Fc fusion technology by innovatively adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. The European Commission granted Orphan Drug designation in June 2019. It is approved and marketed as ALTUVOCT™ by Sobi in Europe, Israel, Saudi Arabia, United Arab Emirates and Kuwait. It is approved and marketed as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the United States, Japan and Taiwan. About Elocta®/Eloctate® Elocta®/Eloctate® (efmoroctocog alfa) is a recombinant clotting factor therapy developed for haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Elocta is manufactured using a human cell line in an environment free of animal and human additives. Elocta is approved and marketed by Sobi for the treatment of haemophilia A in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Bosnia & Herzegovina, Israel, North Macedonia, Oman, Serbia, Tunisia, Turkey, Saudi Arabia and Switzerland. It is approved and marketed as Eloctate® (Antihemophilic Factor [Recombinant], Fc Fusion Protein) by Sanofi in the United States, Canada Japan, Australia, New Zealand and other countries, where Sanofi has the marketing rights. About Alprolix® Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy developed for haemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Alprolix to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). Alprolix is manufactured using a human cell line in an environment free of animal and human additives. Alprolix is approved and marketed by Sobi for the treatment of haemophilia B in the EU, the UK, Iceland, Kuwait, Liechtenstein, Norway, Saudi Arabia and Switzerland. It is also approved in the United States, Canada, Japan, Australia, New Zealand and other countries where Sanofi has the marketing rights. About the Sanofi and Sobi collaboration Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory. Sobi® Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. Visiting address Norra Stationsgatan 93A, Stockholm +46 8 697 20 00 [email protected] This information was brought to you by Cision The following files are available for download: 21% more press release views with Request a Demo

2026-06-02

·GMP知识传播

2025年全球营收前20强的制药公司

2025年，强生公司再次荣登榜首，销售额达942亿美元。自2012年以来，强生公司除2022年外，每年都稳居榜首。2022年，辉瑞公司跃居第一，成为历史上首家销售额突破 1000亿美元的制药公司。辉瑞的这一飞跃主要归功于其新冠产品Comirnaty和Paxlovid合计567亿美元的销售额。强生公司今年有望突破100亿美元的营收大关，预计销售额将在995亿美元至1010.8亿美元之间。自 2023年分拆消费者健康部门Kenvue以来，强生公司的营收增速逐年加快，去年达到6%。礼来公司在年度全球营收前20强排名中跃升六位，成为生物制药行业第三大公司。这家总部位于印第安纳波利斯的制药商去年的销售额从2024年的450亿美元增长至652亿美元，排名超越了百时美施贵宝、诺华、阿斯利康、艾伯维、辉瑞和默克。礼来公司2025年销售额增长202亿美元，其中几乎全部来自其糖尿病和肥胖症药物Mounjaro和Zepbound。2025年，这两种药物合计销售额达365亿美元，高于2024年的165亿美元。替拉帕肽疗法在2025年占礼来公司总收入的56%，高于2024年的37%。在这十年间，礼来公司从 2020 年的排名第 15 位跃升至目前的排名第 3 位。诺和诺德在本世纪初也曾走上类似的增长轨道，排名从 2020年的第17位跃升至2024年的第11位。在此期间，诺和诺德的收入翻了一番多，但这家丹麦公司的增长势头已经停滞，去年销售额增长6%后，排名仍维持在第11位。这也是本世纪以来诺和诺德首次未能实现两位数的销售增长。诺和诺德预计2026年的情况将恰恰相反，销售额将下降5%至13%。首席执行官迈克·杜斯塔尔将公司预期的销售额下滑归咎于“前所未有的价格压力”，他还提到了“日益激烈的竞争”以及公司去年秋天与特朗普政府达成的最惠国待遇（MFN）定价协议。这一年也象征性地将火炬从诺和诺德传递给了礼来，因为其司美格鲁肽双雄 Ozempic 和 Wegovy 的总销售额为 310 亿美元，首次未能超过 Mounjaro 和 Zepbound 的总销售额。第1强生公司作者：埃里克·萨戈诺夫斯基 2025年营收： 942亿美元； 2024年营收： 888亿美元；增长率： +6.1%；总部：新泽西州新不伦瑞克多年来，强生公司一直稳居该报告榜首，2022 年因新冠疫情而出现短暂变动。但即便强生公司近年来决定剥离其消费者保健部门，也未能撼动这家制药巨头的领先地位。强生公司旗下制药和医疗技术部门去年的销售额达到942亿美元，较上年的888亿美元增长了6.1%，增幅显著。增长主要得益于几款关键产品，包括强生领先的多发性骨髓瘤治疗药物、抑郁症鼻喷剂Spravato、抗凝血剂Xarelto以及其他多种药品。除了自身产品外，强生公司近年来在并购领域也相当活跃。去年，该公司收购了Intra-Cellular Therapies及其前景广阔的精神分裂症和双相情感障碍治疗药物Caplyta。收购完成后不久，Caplyta的适应症范围便大幅扩展，获批作为重度抑郁症的辅助治疗药物。该药物去年的总收入达7亿美元。第2罗氏作者：刘安格斯 2025年营收： 615亿瑞士法郎（740亿美元）2024年营收： 605亿瑞士法郎（687亿美元）变化： +1.7%总部：瑞士巴塞尔曾几何时，赫赛汀、阿瓦斯汀和利妥昔单抗这三大传奇肿瘤药物是罗氏成功的基石。如今，该公司销量前三的药物均非癌症药物，而眼科药物Vabysmo已在罗氏的商业产品组合中占据了重要地位。 VEGF-AxAng-2 双特异性抗体于 2022 年初首次获得 FDA 批准，预计到 2025 年销售额将达到 41 亿瑞士法郎（52 亿美元）。但第四季度出现了放缓迹象，罗氏公司指出，整个品牌玻璃体内注射剂市场正在萎缩。罗氏目前最畅销的肿瘤产品是Tecentriq，预计2025年销售额将达到36亿瑞士法郎，按固定汇率计算，同比增长3%。该公司预计，这款PD-L1抑制剂在2026年将继续保持个位数低增长。第3礼来作者：弗雷泽·坎施泰纳 2025年营收： 652亿美元；2024年营收： 450亿美元；增长： +45%；总部：印第安纳波利斯随着品牌减肥药市场持续繁荣，礼来公司不断加大对先行者和主要竞争对手诺和诺德的压力，其2025年的业绩反映了礼来公司在当前GLP-1处方趋势中的强势地位，尤其是在美国市场。现在，礼来公司正预告其治疗糖尿病和肥胖症的双 GIP/GLP-1 重磅药物 Mounjaro 和 Zepbound 将再次取得佳绩，并预计在备受关注的减肥药上市后，2026 年的销售额将达到更高水平。然而，这家印第安纳波利斯制药公司的光环不可能永远持续下去，至少有一位分析师指出，今年可能会出现裂痕。与此同时，礼来和诺和诺德都在努力寻找各自商业化肠促胰岛素药物帝国的接班人，而随着两家公司各自的口服GLP-1药物于2026年上市，肥胖症领域的竞争将迎来新的战场，礼来在该领域的统治地位将不再稳固。礼来公司2025年的全年销售额增长了惊人的45%，超过650亿美元，其中Mounjaro和Zepbound，以及该公司的乳腺癌疗法Verzenio，贡献了大部分的销售额。礼来公司用于治疗糖尿病和肥胖症的两种替拉肽药物去年共创造了365 亿美元的收入，占该公司 2025 年总收入的 56%，超过了诺和诺德基于索马鲁肽的同类药物 Ozempic 和 Wegovy 330 亿美元的总销售额。第4默克作者：凯文·邓利维 2025年营收： 650亿美元；2024年营收： 642亿美元；增长： +1%；总部：新泽西州拉威市在世界最畅销药品Keytruda的鼎盛时期，默克公司理应成为业内增长最快的公司之一。但那是在Gardasil令人震惊的失败之前。这种有助于预防人乳头瘤病毒（HPV）相关疾病的疫苗，在上市后的前十年发展势头迅猛。但到了2024年，其销量突然停滞，这主要归因于中国市场的需求问题，因为本土企业推出了价格更低的替代疫苗。该公司表示，去年这个问题蔓延到了日本。2024年加德西疫苗销量下降3%后，2025年供应短缺问题更加严重，加德西疫苗销售额从86亿美元降至52亿美元，降幅达39%。今年，加德西疫苗在美国的销售额也可能出现下滑，因为美国疾病控制与预防中心（CDC）已将11至12岁儿童HPV疫苗的接种建议从两到三剂调整为一剂。杰富瑞分析师阿卡什·特瓦里（Akash Tewari）在1月份表示，这项新指令可能导致该公司2026年的销售额减少3.15亿美元至6.3亿美元。 Gardasil 的销量暴跌伴随着 Keytruda 增长放缓，其销售额从 2024 年的 295 亿美元降至 2025 年的 317 亿美元。2025 年 7% 的增幅是在此前四年每年 18% 至 22% 的增长率之后出现的。今年，随着加德西疫苗销量下滑趋势趋于平缓，该公司预计营收将在655亿美元至670亿美元之间。按中间值计算，这意味着2026年营收将增长2%。第5辉瑞作者：埃里克·萨戈诺夫斯基 2025年营收： 626亿美元；2024年营收： 636亿美元；变化： -1.6%；总部：纽约市与过去五年中的大多数年份一样，辉瑞公司 2025 年的销售总额主要反映了其核心业务的潜在增长，减去了与 COVID 相关的产品收入波动带来的不确定性。辉瑞公司去年营收为626亿美元，较2024年预计的636亿美元减少了10亿美元。尽管其肿瘤业务销售额增长了8%，专科护理业务销售额增长了5%，但其初级保健业务却下降了11%。在该业务部门中，新冠疫苗Comirnaty的销售额下降了18%，而新冠抗病毒药物Paxlovid的收入更是暴跌了59%。考虑到这些因素，该公司在其年度业绩公告（PDF）中迅速强调了其非 COVID 产品组合 6% 的运营收入增长。在非新冠产品组合中，有几款关键产品值得关注。其中包括与百时美施贵宝合作开发的抗凝血剂艾乐妥（Eliquis），该产品去年的销售额增长了8%，接近80亿美元。辉瑞公司针对呼吸道合胞病毒的疫苗Abyrsvo也持续攀升，去年的销售额超过10亿美元。在专科护理领域，Vyndaqel 特许经营权代表着主要的增长动力，收入近 64 亿美元，同比增长 17%。 6艾伯维作者：佐伊·贝克尔 2025年营收： 612亿美元；2024年营收： 563亿美元；增长率： +8.3%；总部：伊利诺伊州北芝加哥艾伯维最畅销的免疫学药物修美乐（Humira）在2023年专利到期，导致这家伊利诺伊州制药商当年出现公司历史上首次年度销售额下滑。但在2024年重回增长轨道后，艾伯维在2025年创下新的营收纪录，凭借其新型免疫学双雄——思瑞滋（Skyrizi）和瑞诺克（Rinvoq）的强劲表现，营收达到创纪录的612亿美元。 Skyrizi 和 Rinvoq 的销售额合计足以弥补自 2023 年以来 Humira 生物类似药业务 160 亿美元的下滑。仅 Skyrizi 一家在 2025 年的销售额就超过了这一数字，达到 176 亿美元，而 Rinvoq 去年的销售额也达到了 83 亿美元。与此同时，Humira 的销售额在 2025 年下降至 45 亿美元，使得艾伯维 (AbbVie) 的免疫学业务总收入降至 304 亿美元。首席执行官罗伯特·迈克尔在公司第四季度和全年收益电话会议上指出，这三人共同帮助艾伯维公司超额完成了其最初设定的 2025 年业绩目标 20 亿美元以上。第7阿斯利康作者：刘安格斯 2025年营收： 587亿美元；2024年营收： 541亿美元；增长率： +8.6%；总部：英国剑桥阿斯利康去年或许未能重现2024年18%的增长，但该公司2025年总收入8.6%的增长仍然位居大型制药公司前列。据管理层称，AZ 有望在2030年实现800亿美元的营收目标。但这一雄心壮志的很大一部分，即超过100亿美元的经风险调整后的峰值年营收机会，取决于预计在2026年公布的数据。阿斯利康认为，如果今年的三期临床试验成功率能与去年持平，那么800亿美元的营收目标将更容易实现。2025年，阿斯利康庆祝了16项三期临床试验的积极结果，并在主要市场获得了43项药物的批准。第8诺华作者：刘安格斯 2025年营收： 567亿美元；2024年营收： 517亿美元；增长率： +9.6%；总部：瑞士巴塞尔诺华公司为此准备了多年——其最畅销的产品，心力衰竭治疗药物Entresto，预计2024年销售额将达到78亿美元，将于2025年失去美国市场独占权。在7月份仿制药上市后，Entresto的全球销售额从第二季度同比增长24%转为第三季度环比下降20%，第四季度环比进一步下降33%，部分原因是由于一次性收入扣减调整。由于沙库巴曲和缬沙坦的药物组合将于 2026 年 11 月失去欧洲知识产权保护，预计价格将进一步下跌。与此同时，诺华公司于 2025 年开始面临其白血病药物 Tasigna 和血小板治疗药物 Promacta 的仿制药竞争对手。第9赛诺菲作者：佐伊·贝克尔 2025年营收： 462亿欧元（522亿美元）2024年营收： 439亿欧元（476亿美元）变化： +10.3%总部：法国巴黎尽管疫苗的不确定性威胁到其在美国的一些核心药物，但赛诺菲通过年中收购总部位于马萨诸塞州的Blueprint Medicines公司，巩固了其2025年的收入基础，并希望在未来几年也能保持这一增长势头。这笔交易价值高达95亿美元，是这家法国制药公司七年来规模最大的一笔交易，并为其带来了一款已获批准的重磅药物——治疗系统性肥大细胞增多症（SM）的药物Ayvakit。据Blueprint报道， Ayvakit的销售峰值有望达到20亿美元，这主要得益于其近期在惰性SM领域的拓展。该药物在赛诺菲旗下已累计获得1.68亿欧元（约合1.93亿美元）的销售额，但赛诺菲在其全年财报中指出，其全年预估销售额已达7.25亿美元。如果Ayvakit能够达到重磅炸弹级的销量，它将与赛诺菲于2023年获批的A型血友病治疗药物Altuviivo一起，成为该公司最新的重磅炸弹级药物之一。Altuviivo在2025年实现了10亿美元的销售额，全年销售额达到11.6亿欧元（约合13.3亿美元）。赛诺菲将这一增长归功于患者从包括其自身研发的Eloctate在内的老药转而使用Altuviivo。第10百时美施贵宝作者：弗雷泽·坎施泰纳 2025年营收： 482亿美元；2024年营收： 483亿美元；变化： -0.2%；总部：新泽西州普林斯顿尽管百时美施贵宝目前的增长驱动因素表现相对较好——到 2025 年销售额增长了 17%——但这一速度还是太慢了，无法抵消该公司传统药物专利到期带来的复合压力。去年，这家总部位于新泽西州的制药公司推出的新产品引领了市场潮流，例如淋巴瘤药物Opdualag、CAR-T疗法Breyanzi和心脏病药物Camzyos。这些药物各自都取得了巨大的销售成功，同比增长30%甚至更高，助力百时美施贵宝(BMS)的增长型产品组合实现了264亿美元的营收。与此同时，该公司的主打产品——免疫检查点抑制剂 Opdivo（于 2014 年首次获批）——继续引领公司整体销售额，斩获 100 亿美元的销售额。布里斯托尔的成长型产品收益占其全年总收入 482 亿美元的一半以上，比上年的 483 亿美元略有下降。近期BMS销售业绩面临的主要压力来源是其多款老牌重磅药物的专利保护到期，而且未来还可能面临更多独家销售压力。尤其是血液癌症治疗药物瑞复美和施达赛，近来销量下滑；该公司另一款肿瘤治疗主力药物波莫利斯特将于 2026 年面临美国仿制药的竞争。与此同时，Opdivo 和血液稀释剂 Eliquis 也紧随其后，正朝着专利悬崖迈进。百时美施贵宝(BMS)旗下传统药物组合（包括艾乐妥(Eliquis)、瑞复美(Revlimid)和泊马度胺(Pomalyst)）2025年的销售额下滑16%至217亿美元，其中艾乐妥(Eliquis)是该系列药物中唯一实现增长的。百时美施贵宝预计艾乐妥(Eliquis)的销售额在2026年将再增长10%至15%，但由于美国专利悬崖将于2028年到期，欧洲专利保护也将于明年失效，该公司商业化负责人亚当·伦科夫斯基(Adam Lenkowsky)在2月份告诉分析师，他预计艾乐妥(Eliquis)的销售额将从2027年开始出现“快速且急剧的下滑”。 11诺和诺德 2025 年收入： 3090 亿丹麦克朗（467 亿美元）2024 年收入： 2904 亿丹麦克朗（421 亿美元） 12葛兰素史克作者：刘安格斯 2025年营收： 327亿英镑（431亿美元） 2024年营收： 314亿英镑（401亿美元） 13安进作者：凯文·邓利维 2025年营收： 368亿美元；2024年营收： 334亿美元； 14武田作者：佐伊·贝克尔 2025年营收： 4.46万亿日元（298亿美元）2024年营收： 4.57万亿日元（302亿美元） 15勃林格殷格翰作者：凯文·邓利维 2025年营收： 278亿欧元（314亿美元）2024年营收： 268亿欧元（290亿美元） 16吉利德作者：佐伊·贝克尔 2025年营收： 294亿美元；2024年营收： 288亿美元； 17拜耳作者：凯文·邓利维 2025年营收： 236亿欧元（267亿美元）2024年营收： 240亿欧元（260亿美元） 18默克集团作者：安德里亚·帕克 2025年营收： 176亿欧元（198亿美元）2024年营收： 174亿欧元（188亿美元） 19梯瓦作者：佐伊·贝克尔 2025年营收： 173亿美元；2024年营收： 165亿美元； 20中光作者：弗雷泽·坎施泰纳 2025年营收： 154亿美元；2024年营收： 148亿美元；免责声明:平台部分文章内容、图片或视频来源于网络、作者投稿等，版权归原作者所有，仅供学习参考之用，不具有任何商业用途，如涉版权、侵权等问题，请及时向公众号留言联系，核实后立即删除上海示帕检测技术有限公司，简称 SPI;二十余年来一直致力于HVAC与洁净室的全系统调试、高效机房方案、FDA相关模拟评审，体系优化与GMP验证、绿色能源可持续等工作，是一家具备CMA国家法定计量认证、ISO9001国际质量体系认证、CNAS实验室认证的第三方专业机构。我们为客户提供全面的GMP注册咨询、验证、HVAC调试、测试、校准、认证、碳中和、能源评估服务，具有法定资质。我们出具的双语第三方测试报告，不仅完全符合国内外各类认证要求，且为众多知名企业的稳定高效运营与可持续发展提供有力支持。

100 项与 Efmoroctocog alfa(Sobi Analytics) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	Efmoroctocog alfa(Sobi Analytics)	B02BD02	DB11607

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
血友病A	美国	Biogen, Inc.	2014-06-06

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
出血	临床3期	日本	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	奥地利	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	比利时	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	中国香港	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	印度	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	以色列	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	南非	Bioverativ Therapeutics, Inc.	2010-11-01
出血	临床3期	瑞士	Bioverativ Therapeutics, Inc.	2010-11-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02976753 (A-SURE, Pubmed \| Hematology)	N/A	血友病A	131	rFVIIIFc prophylaxis	艱觸鹽醖膚壓壓壓艱齋(衊鹹遞夢選簾鹽淵獵製) = 鹽醖願鹹鬱顧築顧積餘鹽壓蓋鹹觸範廠蓋繭糧 (廠憲糧網襯廠壓襯鹽糧 )	积极	2025-12-31
NCT02976753 (A-SURE, Pubmed \| Hematology)	N/A	血友病A	131	SHL FVIII prophylaxis	艱觸鹽醖膚壓壓壓艱齋(衊鹹遞夢選簾鹽淵獵製) = 鹽鹽獵夢遞網艱製壓築鹽壓蓋鹹觸範廠蓋繭糧 (廠憲糧網襯廠壓襯鹽糧 )	积极	2025-12-31
NCT03103542 (ReITIrate, Pubmed \| Ther Adv Hematol)	临床4期	-	16	efmoroctocog alfa	艱遞鬱餘艱鏇觸願繭醖(遞構淵齋繭憲蓋蓋遞網) = 襯獵選淵餘獵醖夢鬱鹹簾積網鬱範膚膚鏇壓觸 (憲衊蓋糧網艱餘構積衊 ) 更多	积极	2024-01-01
NCT01181128 \| NCT01458106 \| NCT01454739 (Kids A-LONG \| A-LONG \| ASPIRE, Pubmed \| Ther Adv Hematol)	临床3期	血友病A	-	Efmoroctocog alfa prophylaxis	築構餘窪壓夢構衊憲願(窪構簾餘選顧觸衊餘獵) = 獵範醖夢簾觸鏇構壓築蓋衊淵淵廠網襯顧簾獵 (膚築蓋廠齋鹹餘餘顧夢 )	积极	2024-01-01
	临床3期	血友病A	-	Placebo	築構餘窪壓夢構衊憲願(窪構簾餘選顧觸衊餘獵) = 鑰選鏇窪遞鹽蓋膚窪製蓋衊淵淵廠網襯顧簾獵 (膚築蓋廠齋鹹餘餘顧夢 )	积极	2024-01-01
NCT03093480 (verITI-8, Pubmed \| Blood)	临床4期	-	16	Recombinant Factor VIII Fc Fusion Protein (efmoroctocog alfa; rFVIIIFc)	遞鏇廠衊選構構衊襯鹽(獵鹽鏇醖鬱簾鑰構壓餘) = 淵獵範鑰選淵製衊願顧鏇獵廠壓鏇範襯衊壓廠 (憲遞窪窪範網遞鹽積鏇 ) 更多	-	2023-02-03
NCT02976753 (A-SURE, Corporate Publications) 人工标引	N/A	血友病A	-	Efmoroctocog alfa	艱廠遞鬱願獵蓋鏇鹹獵(觸鏇窪糧鹽願積獵襯淵) = Results showed statistically significant improvements in all three primary endpoints 壓淵廠觸鹽獵獵窪鏇夢 (淵廠顧淵願蓋鏇選鏇淵 ) 更多	优效	2022-07-13
NCT02976753 (A-SURE, Corporate Publications) 人工标引	N/A	血友病A	-	FVIII		优效	2022-07-13
ISTH2022	N/A	血友病A	20	SHL FVIII	壓獵膚鏇繭繭膚鏇鏇窪(製衊醖糧糧遞選築窪顧) = 鑰淵願繭餘蓋築鑰衊鏇糧壓顧壓餘襯繭醖鑰淵 (遞衊製鏇蓋範觸觸鬱鏇 )	积极	2022-07-09
ISTH2022	N/A	血友病A	20	rFVIIIFc	壓獵膚鏇繭繭膚鏇鏇窪(製衊醖糧糧遞選築窪顧) = 夢襯淵齋鏇製觸網網齋糧壓顧壓餘襯繭醖鑰淵 (遞衊製鏇蓋範觸觸鬱鏇 )	积极	2022-07-09
NCT03103542 (ReITIrate, CTgov)	临床4期	血友病A	16	Recombinant coagulation factor	築構鑰蓋觸築膚艱製糧(夢構蓋鹹鑰醖獵蓋衊衊) = 廠繭選範鬱膚獵鹹繭獵願壓鹹繭顧餘憲窪積鹹 (鹹構選鹹壓遞窪鹽獵齋, 0) 更多	-	2021-11-30
NCT03103542 (ReITIrate, ISTH2021)	临床4期	-	16	rFVIIIFc (200 IU/kg/day)	遞鬱壓網醖衊膚遞淵鏇(鬱觸願憲衊製齋齋淵顧) = 艱築製餘衊鑰醖壓壓網鹽網願廠鬱廠簾齋獵顧 (淵廠範簾鹹觸鬱鬱遞壓 ) 更多	-	2021-07-17
NCT03093480 (verITI-8, CTgov)	临床4期	血友病A	16	rFVIIIFc	齋夢糧構鹽顧繭築齋範(窪鏇壓餘衊膚鬱齋簾觸) = 遞衊網構壓願觸簾願夢膚醖遞醖範蓋築憲齋壓 (鑰壓鹽願鬱鏇鏇艱窪憲, 襯獵製淵願憲遞糧糧範 ~ 鹽窪簾構簾醖願選糧獵) 更多	-	2021-07-07
NCT02234323 (ASH2020) 人工标引	临床3期	血友病A 一线	103	Efmoroctocog alfa	鏇鑰齋廠廠鹽獵鹽夢鹽(糧醖築網鹽鹹膚鹹壓鏇) = 積餘積築築衊願醖蓋鬱鬱餘範襯蓋顧襯齋襯淵 (範築窪艱醖觸淵網糧顧 ) 更多	积极	2020-11-07