排名前五的靶点	数量

Nrf2(核转录因子的激活红细胞2相关因子)	7
SOD1(超氧化物歧化酶)	3
BTK(酪氨酸蛋白激酶BTK)	2
HSP90(Heat shock 90kDa proteins)	2
F10(凝血因子X)	2

关联

项与 Biogen, Inc. 相关的药物

Motixafortide

莫替沙福肽

靶点

CXCR4

作用机制

CXCR4拮抗剂

在研机构

BioLineRx Ltd. [+5]

原研机构

Biokine Therapeutics Ltd.

在研适应症

多发性骨髓瘤 [+12]

非在研适应症

淋巴母细胞淋巴瘤 [+2]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-09-08

Zuranolone

祖拉诺龙

靶点

GABAA receptor

作用机制

GABAA receptor 正变构调节剂

在研机构

Biogen, Inc. [+1]

原研机构

SAGE Therapeutics, Inc.

在研适应症

产后抑郁症 [+2]

非在研适应症

躁郁症1型 [+6]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-08-04

Tofersen

托夫生

靶点

SOD1

作用机制

SOD1基因抑制剂

在研机构

Biogen, Inc. [+5]

原研机构

Ionis Pharmaceuticals, Inc.

在研适应症

肌萎缩侧索硬化 [+1]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-04-25

722

项与 Biogen, Inc. 相关的临床试验

NCT06628687

/ Not yet recruitingN/A

A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation

In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program."
The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life.
The main question researchers want to answer in this study is:
· Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects?
Researchers will also learn more about:
* Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects?
* Does taking BIIB141 during pregnancy or breastfeeding affect the following:
* Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar
* Pre-eclampsia, a pregnancy-related high blood pressure disease
* Unborn baby being small for its expected age (usually in weeks)
* Loss of an unborn baby
* Live birth
* Premature birth
* Loss of a newborn
* Growth or developmental delays in the baby
* Serious illness in the baby resulting in hospitalization
* Serious infections in the baby, or ones in babies with a weakened immune system
This study will be done as follows:
* Participants will join the study after signing an informed consent form, also known as an ICF.
* During the study, health information from the participants' regular visits to their doctor will be collected based on whether participant joined the study while pregnant or after the baby is born.
* Each participant will be in the study for up to 1 year after the birth of their child, unless they decide to leave early. Overall, this study is expected to last at least 10 years.

开始日期2026-10-26

申办/合作机构

Biogen, Inc.

NCT06454721

/ Not yet recruiting临床1期

A Phase 1, Open-Label Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults

In this study, researchers will learn more about a study drug called BIIB080. BIIB080 is currently a drug under investigation for treatment of Alzheimer's disease. The main question researchers are trying to answer in this study is how radiolabeled BIIB080 distributes in the brain and spinal cord. To help answer this question, researchers will use positron emission tomography (PET) scanner that can detect radiolabeled BIIB080 after a single injection of a small dose of radiolabeled BIIB080 ([89Zr]Zr-DFO-BIIB080) and a dose of BIIB080 together via an intrathecal (IT) injection in healthy volunteers. Researchers will also learn about the safety of injecting radiolabeled BIIB080 and BIIB080 together.

开始日期2025-03-20

申办/合作机构

Biogen, Inc.

NCT06555419

/ Recruiting临床1期

An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered Via the ThecaFlex DRx™ System (PIERRE-PK)

In this PIERRE-PK study, researchers will learn how the body processes nusinersen when it is given through the ThecaFlex DRx™ System, compared to when nusinersen is given by lumbar puncture (LP). The ThecaFlex DRx system is an investigational implantable medical device developed by Alcyone Therapeutics, Inc. It consists of a catheter, which is a flexible tube, connected to a port which is placed under the skin. Alcyone Therapeutics, Inc. has an ongoing study called PIERRE to test the ThecaFlex DRx system. Participants with spinal muscular atrophy (SMA) in the PIERRE study may be enrolled in the PIERRE-PK study.
The main objective of the PIERRE-PK study is to learn how the body processes nusinersen when given by the ThecaFlex DRx system compared to a lumbar puncture. The main questions researchers want to answer are:
* What is the highest amount of nusinersen found in the blood after dosing?
* How much nusinersen is found in the blood over the first 24 hours after dosing?
The PIERRE-PK study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 30 days for this study and may overlap with the PIERRE study.
* Participants will receive a dose of nusinersen by lumbar puncture.
* The ThecaFlex DRx system will be implanted after the lumbar puncture, as part of the PIERRE study.
* Participants will receive a dose of nusinersen by the ThecaFlex DRx system, as part of the PIERRE study.
* Researchers will take blood samples before and after each dose. The last blood sample will be taken 24 hours after the dose.
* The total study duration for each participant in the PIERRE-PK study will be up to 5 months. This period will overlap with the participant's first 5 months in the PIERRE study.

开始日期2025-01-16

申办/合作机构

Biogen, Inc.

100 项与 Biogen, Inc. 相关的临床结果

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0 项与 Biogen, Inc. 相关的专利（医药）

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2,749

项与 Biogen, Inc. 相关的文献（医药）

2025-02-25·Annals of Clinical and Translational Neurology

Longitudinal Trajectories of Digital Cognitive Biomarkers for Multiple Sclerosis.

Article

作者: Darby, David ; Hyde, Robert ; Simpson-Yap, Steve ; Butzkueven, Helmut ; Lechner-Scott, Jeannette ; Dobay, Pamela ; Merlo, Daniel ; van der Walt, Anneke ; Taylor, Bruce V ; Zhu, Chao ; Foong, Yi Chao ; Gresle, Melissa ; Kalincik, Tomas ; Buzzard, Katherine ; Wang, Chenyu ; Kilpatrick, Trevor ; van Beek, Johan ; Barnett, Michael

BACKGROUND:

Cognitive impairment is one of the most common and debilitating symptoms of relapsing-remitting multiple sclerosis (RRMS). Digital cognitive biomarkers require less time and resources and are rapidly gaining popularity in clinical settings. We examined the longitudinal trajectory of the iPad-based Processing Speed Test (PST) and predictors of PST scores.

METHODS:

We prospectively enrolled RRMS patients between 2017 and 2021 across six Australian MS centres. Longitudinal data was analysed with mixed effect modelling and latent class mixed models. We then examined whether latent class group membership predicted confirmed decrease in correct PST responses.

RESULTS:

We recruited a total of 1093 participants, of which 724 had complete baseline data with a median follow up duration of 2 years. At a population level, PST trajectory was stable. A small practice effect was present up to the 4th visit. Age, baseline disability, T2 lesion volume, male sex and depression were associated with lower correct PST responses, whilst years of education and full/part-time employment were associated with more correct PST responses. We identified four latent class trajectories of PST. The worst latent class was typified by low baseline PST and lack of a practice effect. Being in the worst latent class was associated with a greater hazard of time to sustained 5% decrease in PST (HR 2.84, 95% CI 1.16-6.94, p = 0.02).

CONCLUSION:

Worse baseline cognitive performance and lack of a practice effect predicted future cognitive decline in RRMS.

2025-02-01·PSYCHOPHARMACOLOGY

Effects of zuranolone on next-day simulated driving in healthy adults

Article

作者: Vaudreuil, Carrie ; Kay, Gary ; Nandy, Indrani ; Morelli, Gaetano ; Ona, Victor ; Jain, Rakesh ; Dunbar, Joi ; Moseley, Margaret K ; Levin, Seth

RATIONALE:

Zuranolone is an oral positive allosteric modulator of GABA_A receptors. Due to its central nervous system (CNS) activity, zuranolone may impact activities requiring complex cognition, including driving.

OBJECTIVE:

Evaluate the effect of zuranolone on simulated driving performance.

METHODS:

In this randomized, double-blind, active- and placebo-controlled, four-period crossover study, treatments included once-nightly zuranolone 50 mg on days 1-7, zuranolone 50 mg on days 1-6 and zuranolone 100 mg on day 7, zopiclone 7.5 mg on days 1 and 7, and placebo on days 1-7. Driving was assessed using a validated simulator. Primary endpoint was standard deviation of lateral position (SDLP), evaluated 9 h post-dose on days 2 and 8. Secondary endpoints included additional driving assessments, cognitive tests, pharmacokinetics, and safety.

RESULTS:

Healthy adults (N = 67) enrolled and received ≥ 1 dose. Zuranolone 50 mg increased SDLP versus placebo on days 2 (least squares mean difference [LSMD]: 7.4 cm; p < 0.0001) and 8 (LSMD: 4.6 cm; p = 0.0106). Zuranolone 100 mg evoked a larger increase in SDLP versus placebo on day 8 (LSMD 18.9 cm; p < 0.0001). Reduced performance in other driving assessments and cognition were observed with zuranolone 50 mg on day 2; many resolved by day 8. Despite the SDLP observations, most participants judged themselves capable of driving. Frequent adverse events (≥ 20%) were CNS-related; most were mild/moderate.

CONCLUSION:

Zuranolone impaired simulated driving and reduced cognitive function versus placebo 9 h after administration. Although many impairments resolved after 7 days of dosing, driving remained impaired. These results may inform prescriber decision-making.

2025-01-01·JAMA Neurology

Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease

Article

作者: Grundman, Michael ; Aldea, Roxana ; Mazzo, Francesca ; Barkhof, Frederik ; Bittner, Tobias ; Klein, Gregory ; Wojtowicz, Jakub ; Lane, Christopher A. ; Voyle, Nicola ; Schneider, Andres ; Boada, Mercè ; Rossomanno, Simona ; Smith, Janice ; Bullain, Szofia ; Doody, Rachelle ; Lyons, Marco ; Salloway, Stephen

Importance:

Data from 2 phase 3 studies of gantenerumab, GRADUATE I/II, and their open-label extensions represent a resource to further characterize amyloid-related imaging abnormalities (ARIA), including long-term sequelae.

Objectives:

To describe the characteristics of ARIA and risk factors and clinical consequences of ARIA-edema (ARIA-E).

Design, Setting, and Participants:

Secondary data collection from the GRADUATE I/II phase 3 randomized, double-blind, placebo-controlled, 116-week parallel-group studies and their open-label extensions, including PostGraduate, with up to 210 (mean, 125) weeks of total gantenerumab treatment were conducted between 2018 and 2023. The study included multicenter trials at 288 sites across 30 countries. GRADUATE I/II enrolled 985 and 980 participants, respectively, with early symptomatic Alzheimer disease (AD) and amyloid-beta (Aβ) pathology who were aged 50 to 90 years. PostGraduate enrolled 1382 participants (671 previously randomized to gantenerumab). Data were analyzed from November 2, 2022, to October 10, 2023.

Interventions:

GRADUATE I/II participants were randomized 1:1 to gantenerumab or placebo. Nine-month uptitration was used to mitigate ARIA risk.

Main outcomes and measures:

Postbaseline safety monitoring, including brain magnetic resonance imaging (MRI) findings, and adverse events and cognitive assessments.

Results:

The safety-evaluable MRI population of GRADUATE I/II comprised 1939 participants (mean age, 71.7 years; 1105 female [57.0%]). Severity of AD–related Aβ neuropathology (lower cerebrospinal fluid [CSF] Aβ42, hazard ratio [HR] for CSF Aβ42: 0.4; 95% CI, 0.2-0.7) and comorbid cerebrovascular pathology (Fazekas score: HR, 1.6; 95% CI, 1.3-2.0; total superficial siderosis count: HR, 1.9; 95% CI, 1.3-2.6; total microhemorrhage count: HR, 1.3; 95% CI, 1.0-1.5) may be important baseline risk factors for ARIA-E, in addition to apolipoprotein E (APOE) ε4 status (APOE ε4 heterozygous carrier: HR, 2.0; 95% CI, 1.4-2.8 and APOE ε4 homozygous carrier: HR, 4.7; 95% CI, 3.2-6.7). At the group level, ARIA-E did not impact long-term cognitive and functional performance (relative difference in adjusted means for Clinical Dementia Rating–Sum of Boxes was −9% in pooled GRADUATE analysis at week 116 and when censored at first ARIA-E). While taking gantenerumab, ARIA-E and ARIA-hemosiderin occurred in 24.9% (247 of 993) and 22.9% (227 of 993) participants, respectively; first ARIA-E occurred by week 64 in 86.2% (213 of 247) of participants with ARIA-E. Narratives are provided for all serious symptomatic ARIA-E cases.

Conclusions and Relevance:

These results show that in addition to APOE ε4 allele count, severity of Aβ neuropathology and comorbid cerebrovascular pathology may be relevant for clinicians prescribing anti-Aβ monoclonal antibodies for early AD and developing individualized safety monitoring plans. Evaluation of these risk factors in other anti-Aβ monoclonal antibodies is recommended.

Trial registrations:

ClinicalTrials.gov Identifiers: NCT03444870, NCT03443973, NCT04374253.

3,909

项与 Biogen, Inc. 相关的新闻（医药）

2025-03-08

·EndPoints

FDA and NIH nominees sail through Senate hearings; Tariffs’ early impact on drug manufacturing; AbbVie’s move into the obesity market; and more

Welcome back to Endpoints Weekly! This week was another busy one in DC, with two Senate hearings for Trump’s picks to lead the NIH and FDA, more actions from the Department of Government Efficiency, talk of tariffs, and more. We’ll walk you through it. Plus, another big pharma is joining the obesity race — but not with a GLP-1. And a small Swiss biotech quietly disclosed that it would halt a trial for an oral Alzheimer’s drug after two of its top competitors Eli Lilly and Biogen also scrapped their own oral Alzheimer’s drugs. Endpoints’ Kyle LaHucik has the latest on those stories below. Stay tuned next week as we cover the Senate HELP Committee’s scheduled votes on FDA nominee Marty Makary and NIH pick Jay Bhattacharya. On the same day, the committee is set to hold a confirmation hearing for CDC nominee David Weldon. See you on Monday! — Nicole DeFeudis President Donald Trump’s picks to lead the NIH and FDA emerged from Senate confirmation hearings relatively unscathed this week. Here’s a run-down of where the nominees stand on key topics: 💉 Vaccines: FDA nominee Marty Makary said “vaccines save lives” during his hearing on Thursday. The statement is a departure from comments made by HHS Secretary Robert F. Kennedy Jr., who declined to refute his past claims about a link between vaccines and autism in a January Senate hearing. NIH pick Jay Bhattacharya said he “fully supports” measles vaccinations and does not believe there’s a link between autism and vaccines. However, he called for more study to combat falling vaccination rates in some parts of the country. “I’m convinced we have good data on MMR and autism, but if other people don’t agree with me and don’t vaccinate their children, the one lever I have is to give them good data,” he said. 💼 Staff cuts: Both nominees said they were not involved in recent staff cuts at the NIH and FDA. When pressed by Sen. Tim Kaine (D-VA) about his thoughts on “willy, nilly, random” layoffs at the FDA, Makary cited his surgical experience. “Look, I’m a surgeon, so you know, I’m going to give you a surgical answer,” he said. Bhattacharya said he would “look very carefully at the personnel decisions.” When repeatedly asked, he said, “the personnel decisions are hard to talk about unless I’m actually confirmed and I have more data.” 💵 NIH grants: Sens. Susan Collins (R-ME) and Patty Murray (D-WA) both raised concerns about the NIH’s planned 15% cap on indirect cost reimbursements for grant recipients. Bhattacharya didn’t contradict the Trump administration’s cuts or say he would reverse course. “I want to make sure that the money goes to the research,” he said. He told Collins he would “make sure that your concerns are addressed.” 💊 Medication abortion: Makary was asked numerous times about his stance on access to the abortion pill mifepristone . Some Republican senators asked if he would reinstate an in-person dispensing requirement for mifepristone, which was removed by the Biden administration in 2021. Makary said he has “no preconceived plans” on mifepristone, and will “take a solid, hard look at the data.” The Senate HELP committee is expected to vote on Bhattacharya and Makary’s nominations next Thursday. 🏭 President Donald Trump’s tariffs are causing the biopharma industry to rethink where it produces and manufactures its drug products, with several notable companies commenting on the topic this week. Pfizer CEO Albert Bourla, who has visibly tried to put himself in Trump’s good graces since the election, said his company could “quickly” onshore drug production if it needed to mitigate the effects of the tariffs. Pfizer is in a better position thanks to its US manufacturing network, Bourla said, potentially giving it an advantage over some rivals. But he cautioned the situation remains “volatile,” and he said last month that any tariffs in Europe would likely impact Pfizer in some form. Trump has yet to specifically impose tariffs against pharma goods produced in Europe, but has threatened a 25% tax import on all pharma goods into the US. Eli Lilly, meanwhile, is asking state governments to send pitches about why the company should invest in them as part of the company’s $27 billion US manufacturing promise . It’s an unusual move, but one that comes due to the “unprecedented nature” of the investment, according to a company spokesperson. Lilly is already in negotiations with an undisclosed number of states. At least one expert believes the company will likely select areas with universities and academic institutions to tap into their local talent pools. Merck KGaA also expects to be able to weather the tariffs thanks to its earlier efforts to move manufacturing sites to the US. CEO Belén Garijo believes the situation will be “manageable,” and in October the company announced plans to boost antibody-drug conjugate manufacturing in St. Louis. But one company that could see stronger headwinds is Bavarian Nordic , which has contracts with the US government to stockpile its drug in the event of smallpox and mpox outbreaks. CEO Paul Chaplin said the onshoring process would be doable, but he warned it could take five to 10 years to complete . One of the last Big Pharma holdouts in obesity is now in the game, as AbbVie partnered with the Danish biotech Gubra on an experimental medicine called GUBamy, also known as GUB014295. The program is not a GLP-1, but rather a long-acting amylin analog, which is a peptide-based drug that could be more complex to manufacture. It’s currently in the multiple ascending dose portion of Phase 1 testing, with interim results expected before July. There are multiple other companies in the amylin space, including Zealand, Metsera, Structure and AstraZeneca, among others. But recent attempts at amylin have not always succeeded. Novo Nordisk tested its GLP-1 drug Wegovy in combination with an amylin program and disappointed investors , while Zealand is still searching for a partner for its own amylin drug. 🥼Two days after announcing plans to shut down an FDA lab devoted to ensuring the US drug supply remains safe and potent, the Trump administration changed its plans . The St. Louis lab, known as the Office of Testing and Research, tests the quality of drugs and investigates high-profile drug safety issues. The lab was one of about 30 FDA facilities whose leases were marked for termination by DOGE. “They are the FDA’s premier drug analysis lab,” former FDA Acting Commissioner Janet Woodcock told Endpoints. “Congress has been constantly on FDA to make sure imported drugs are of adequate quality, and the St. Louis lab is the foundation of that.” A small Swiss biotech called Asceneuron quietly disclosed it would halt a trial for an oral Alzheimer’s drug this week, posting an update to the government’s clinical trials registry saying it was due to a “strategic decision.” The company’s CEO, Barbara Angehrn Pavik, declined to provide a reason for the trial termination. Asceneuron’s decision comes after two top competitors, Eli Lilly and Biogen, both scrapped their own oral Alzheimer’s drugs. DON’T MISS:

临床1期

2025-03-07

·医药健闻

辉瑞、阿斯利康、强生、罗氏、礼来、诺和诺德等35家大药厂2024年第四季度和全年财报汇总

注：各大公司财政年度的起始时间不同于自然年，因此会出现财政季度、年度等与自然年不一致的情况。美国美国医药巨头辉瑞(Pfizer)公布2024年第四季度和全年业绩。第四季度总营收177.63亿美元，上年同期为145.7亿美元，同比增长22%。季度持续业务的营业利润4.11亿美元，上年同期营业亏损33.35亿美元。季度归属公司普通股东的净利润4.1亿美元，上年同期净亏损33.69亿美元。全年总营收636.27亿美元，上年为595.53亿美元，同比增长7%。全年持续业务的营业利润80.51亿美元，上年为21.72亿美元。全年归属公司普通股东的净利润80.31亿美元，上年为21.19亿美元。艾伯维(AbbVie)公布2024年第四季度和全年业绩。季度净营收151亿美元，上年同期为143亿美元。季度营业亏损14.9亿美元，上年同期营业利润31.95亿美元。季度归属公司的净亏损2200万美元，上年同期净利润8.22亿美元。全年净营收563.34亿美元，上年为543.18亿美元。全年营业利润91.37亿美元，上年为127.57亿美元。全年归属公司的净利润42.78亿美元，上年为48.63亿美元。强生(Johnson & Johnson)公布2024年第四季度和全年业绩。第四季度销售额为225.2亿美元，上年同期为213.95亿美元，同比增长5.3%。季度净利润34.31亿美元，上年同期为41.32亿美元，同比下降17%。制药业务销售额143.32亿美元，医疗器械业务销售额81.88亿美元。全年销售额为888.21亿美元，上年为851.59亿美元，同比增长4.3%。全年净利润140.66亿美元，上年为133.26亿美元，同比增长5.6%。制药业务销售额569.65亿美元，医疗器械业务销售额318.57亿美元。默沙东(Merck & Co., Inc.)公布2024年第四季度和全年业绩。第四季度销售额156.24亿美元，上年同期为146.3亿美元，同比增长7%。季度净利润37.43亿美元，上年同期净亏损12.26亿美元。其中，制药业务销售额140.42亿美元，同比增长7%。动物保健业务销售额13.97亿美元，同比增长9%。全年销售额641.68亿美元，上年为601.15亿美元，同比增长7%。全年净利润171.17亿美元，上年为3.65亿美元。礼来(Eli Lilly and Company)公布2024年第四季度和全年业绩。第四季度营收135.33亿美元，上年同期为93.53亿美元，同比增长45%。季度营业利润51.49亿美元，上年同期为23.88亿美元，同比增长116%。季度净利润44.1亿美元，上年同期为21.9亿美元，同比增长101%。全年营收450.43亿美元，上年为341.24亿美元，同比增长32%。全年营业利润128.99亿美元，上年为64.58亿美元，同比增长100%。全年净利润105.9亿美元，上年为52.4亿美元，同比增长102%。百时美施贵宝(Bristol Myers Squibb)公布2024年第四季度和全年业绩。第四季度总营收123.42亿美元，上年同期为114.77亿美元。季度归属公司净利润7200万美元，上年同期为17.62亿美元，同比增长101%。全年总营收483亿美元，上年为450亿美元。全年归属公司净亏损89.48亿美元，上年净利润80.25亿美元。生物技术公司安进(Amgen)公布2024年第四季度和全年业绩。第四季度总营收90.86亿美元，上年同期为81.96亿美元。季度营业利润23.11亿美元，上年同期为12.71亿美元。季度净利润6.27亿美元，上年同期为7.67亿美元。全年总营收334.24亿美元，上年为281.9亿美元。全年营业利润72.58亿美元，上年为78.97亿美元。全年净利润40.9亿美元，上年为67.17亿美元。吉利德科学(Gilead Sciences)公布2024年第四季度和全年业绩。第四季度总营收75.69亿美元，上年同期为71.15亿美元。季度营业利润24.51亿美元，上年同期为16.12亿美元。季度归属公司的净利润17.83亿美元，上年同期为14.29亿美元。全年总营收287.54亿美元，上年为271.16亿美元。全年营业利润16.62亿美元，上年为76.05亿美元。全年归属公司的净利润4.8亿美元，上年为56.65亿美元。再生元制药(Regeneron)公布2024年第四季度和全年业绩。第四季度总营收37.89亿美元，上年同期为34.34亿美元，同比增长10%。季度净利润9.18亿美元，上年同期为11.6亿美元，同比下降21%。全年总营收142.02亿美元，上年为131.17亿美元，同比增长8%。全年净利润44.13亿美元，上年为39.54亿美元，同比增长12%。晖致(Viatris)公布2024年第四季度和全年业绩。第四季度总营收35.28亿美元，上年同期为38.37亿美元。季度营业亏损1.8亿美元，上年同期营业亏损4.55亿美元。季度净亏损5.17亿美元，上年同期净亏损7.66亿美元。全年总营收147.39亿美元，上年为154.27亿美元。全年营业利润1010万美元，上年营业利润7.66亿美元。全年净亏损6.34亿美元，上年净利润5470万美元。福泰制药(Vertex Pharmaceuticals)公布2024年第四季度和全年业绩。第四季度净产品营收29.12亿美元，上年同期为25.18亿美元。季度营业利润10.26亿美元，上年同期为9.89亿美元。季度净利润9.13亿美元，上年同期为9.69亿美元。全年净产品营收110.2亿美元，上年为98.69亿美元。全年营业亏损2.33亿美元，上年营业利润38.32亿美元。全年净亏损5.36亿美元，上年净利润36.2亿美元。渤健(Biogen)公布2024年第四季度和全年业绩。第四季度总营收24.55亿美元，上年同期为23.86亿美元。季度归属公司净利润2.67亿美元，上年同期为2.5亿美元。全年总营收96.76亿美元，上年为98.36亿美元。全年归属公司净利润16.32亿美元，上年为11.61亿美元。欧加隆(Organon)公布2024年第四季度和全年业绩。第四季度营收15.92亿美元，上年同期为15.98亿美元。季度净利润1.09亿美元，上年同期5.46亿美元。全年营收64.03亿美元，上年为62.63亿美元。全年净利润8.64亿美元，上年为10.23亿美元。雅培(Abbott)公布2024年第四季度和全年业绩。季度净销售额109.74亿美元，上年同期为102.41亿美元。季度净利润92.29亿美元，上年同期为15.94亿美元。季度不包括特殊项目的净利润23.49亿美元。按业务划分，医疗设备部门销售额50.52亿美元，营养业务销售额21.29亿美元，诊断业务销售额25.2亿美元，仿制药业务销售额12.68亿美元。全年净销售额419.5亿美元，上年为401.09亿美元。全年净利润134亿美元，上年为57.23亿美元。不包括特殊项目的净利润82亿美元。美德纳(Moderna)公布2024年第四季度和全年业绩。第四季度总营收9.66亿美元，上年同期为28.11亿美元。季度净亏损11.2亿美元，上年同期净利润2.17亿美元。全年总营收32.26亿美元，上年为68.48亿美元。全年净亏损35.61亿美元，上年净亏损47.14亿美元。欧洲阿斯利康(AstraZeneca)公布2024年第四季度和全年业绩。第四季度总营收148.91亿美元，上年同期为120.24亿美元，同比增长24%。季度营业利润20.36亿美元，上年同期为12.34亿美元，同比增长65%。季度税后利润15亿美元，上年同期为9.59亿美元，同比增长56%。全年总营收540.73亿美元，上年为458.11亿美元，同比增长18%。全年营业利润100.03亿美元，上年为81.93亿美元，同比增长22%。全年税后利润70.41亿美元，上年为59.61亿美元，同比增长18%。罗氏(Roche)公布2024年业绩。集团全年销售额604.95亿瑞士法郎，上年为587.16亿瑞士法郎，同比增长3%。集团全年营业利润134.17亿瑞士法郎，上年为153.95亿瑞士法郎，同比下降13%。全年归属公司股东的净利润82.77亿瑞士法郎，上年为114.98亿瑞士法郎，同比下降28%。其中，制药业务全年销售额461.71亿瑞士法郎(约519亿美元)，营业利润155.87亿瑞士法郎。诊断业务全年销售额143.24亿瑞士法郎，营业利润19.46亿瑞士法郎。诺华制药(Novartis)公布2024年第四季度和全年业绩。第四季度净销售额131.53亿美元，上年同期为114.23亿美元，同比增长15%。季度营业利润35.3亿美元，上年同期为25.82亿美元，同比增长37%。季度净利润28.2亿美元，上年同期为26.38亿美元，同比增长7%。全年净销售额503.17亿美元，上年为454.4亿美元，同比增长11%。全年营业利润145.44亿美元，上年为97.68亿美元，同比增长49%。全年净利润119.39亿美元，上年为85.72亿美元，同比增长39%。赛诺菲(Sanofi)公布2024年第四季度和全年业绩。第四季度净销售额105.64亿欧元(约114亿美元)，上年同期为96.87亿欧元，同比增长9.1%。季度营业利润11.85亿欧元，上年同期为3.84亿欧元。季度归属公司股东的净利润6.83亿欧元，上年同期净亏损5.55亿欧元。2024年净销售额410.81亿欧元(约444亿美元)，上年为378.17亿欧元，同比增长8.6%。全年营业利润74.91亿欧元，上年为69.6亿欧元。全年归属公司股东的净利润57.44亿欧元，上年为54亿欧元，同比增长6.4%。诺和诺德(Novo Nordisk)公布2024年业绩。全年净销售额2904.03亿丹麦克朗(约421亿美元)，上年为2322.61亿丹麦克朗，同比增长25%。全年营业利润1283.39亿丹麦克朗，上年为1025.74亿丹麦克朗，同比增长25%。全年净利润1009.88亿丹麦克朗，上年为836.83亿丹麦克朗，同比增长21%。葛兰素史克(GSK)公布2024年第四季度和全年业绩。第四季度营业额81.17亿英镑(约105亿美元)，营业利润6.96亿英镑，归属股东的税后利润4.14亿英镑。全年营业额313.76亿英镑(约405亿美元)，营业利润40.21亿英镑，归属股东的税后利润25.75亿英镑。拜耳集团(Bayer Group)公布2024年业绩。全年销售额466.06亿欧元，上年476.37亿欧元。全年特别项目之前EBITDA利润101.23亿欧元，上年117.06亿欧元。全年净亏损25.52亿欧元，上年净亏损29.41亿欧元。第四季度集团销售额117.29亿欧元，特别项目之前EBITDA利润23.49亿欧元，净亏损3.35亿欧元。其中，作物科学业务销售额53.85亿欧元，EBITDA利润9.17亿欧元。处方药业务销售额46.58亿欧元(约50.4亿美元)，EBITDA利润11.04亿欧元。健康消费品业务销售额15.67亿欧元，EBITDA利润3.61亿欧元。德国制药和化工巨头默克集团(Merck Group)公布2024年全年业绩。全年净销售额211.56亿欧元，上年为209.93亿欧元。全年营业利润(EBIT)36.45亿欧元，上年为36.09亿欧元。全年税后利润27.86亿欧元，上年为28.34亿欧元。其中，第四季度净销售额54.18亿欧元，上年同期为52.25亿欧元。按业务划分，生命科学业务全年净销售额89.16亿欧元(约96.44亿美元)，医药健康业务全年净销售额84.55亿欧元(约91.46亿美元)，电子科技业务全年净销售额37.85亿欧元。仿制药企业山德士(Sandoz)公布2024年全年业绩。全年净销售额103.57亿美元，上年为96.47亿美元。全年营业利润3.07亿美元，上年为3.75亿美元。全年净利润100万美元，上年为8000万美元。费森尤斯集团(FRESENIUS GROUP)公布2024年第四季度和全年业绩。第四季度营收55.26亿欧元，上年同期为51.76亿欧元。季度EBIT利润6.46亿欧元，上年同期为6.08亿欧元。季度净利润3.9亿欧元，上年同期为3.06亿欧元。其中，费森尤斯卡比(Fresenius Kabi)营收21.48亿欧元(约23.24亿美元)，EBIT利润3.4亿欧元。费森尤斯赫里奥斯诊所(Fresenius Helios)营收32.73亿欧元，EBIT利润3.39亿欧元。全年营收215.26亿欧元，EBIT利润24.89亿欧元，净利润14.61亿欧元。基立福(Grifols)公布2024年业绩。全年净营收72.12亿欧元(约78亿美元)，上年为65.92亿欧元。全年营业利润11.92亿欧元，上年为7.82亿欧元。全年归属母公司净利润1.57亿欧元，上年为4232万欧元。优时比(UCB)公布2024年业绩。全年营收61.52亿欧元(约66.54亿美元)，上年为52.52亿欧元。全年调整后的EBITDA利润14.76亿欧元，上年为13.49亿欧元。全年归属公司股东的净利润10.65亿欧元，上年为3.43亿欧元。特药领域生物制药公司益普生(Ipsen)公布2024年全年财务业绩。全年总销售额34.01亿欧元(约36.79亿美元)，上年为31.28亿欧元。全年核心营业利润11.09亿欧元，上年为10.01亿欧元。国际财务报告准则合并净利润3.47亿欧元，上年为6.47亿欧元。亚太武田制药(Takeda Pharmaceutical)公布截至2024年12月31日的财年前九个月业绩。当期营收35281.52亿日元(约237亿美元)，上年同期为32128.93亿日元，同比增长9.8%。当期营业利润4175.18亿日元，上年同期为2241.44亿日元，同比增长86.3%。当期归属母公司所有者的净利润2110.83亿日元，上年同期为1470.85亿日元，同比增长43.5%。澳大利亚生物制药公司CSL Group公布截至2024年12月31日的上半财年业绩。当期总营收84.83亿美元，上年同期为80.53亿美元。当期归属公司股东的税后净利润20.07亿美元，上年同期为19.01亿美元。其中，CSL Behring总营收57.43亿美元，CSL Seqirus总营收16.61亿美元，CSL Vifor总营收10.79亿美元。梯瓦制药(Teva Pharmaceutical Industries)公布2024年第四季度和全年业绩。第四季度净营收42.29亿美元，上年同期为44.57亿美元。季度营业亏损2900万美元，上年同期营业利润7.55亿美元。季度归属公司净亏损2.17亿美元，上年同期净利润4.61亿美元。全年净营收165.44亿美元，上年为158.46亿美元。全年营业亏损3.03亿美元，上年营业利润4.33亿美元。全年归属公司净亏损16.39亿美元，上年净亏损5.59亿美元。安斯泰来(Astellas Pharma)公布截至2024年12月31日的财年前九个月业绩。当期营收14530亿日元(约97.5亿美元)，上年同期为11891亿日元，同比增长22.2%。当期营业亏损224.81亿日元，上年同期营业利润741.19亿日元。当期归属母公司所有者的净亏损241.49亿日元，上年同期净利润503.23亿日元。第一三共(Daiichi Sankyo Company, Limited)公布截至2024年12月31日的财年前九个月业绩。当期营收13675.67亿日元(约91.8亿美元)，上年同期为11732.69亿日元，同比增长16.6%。当期营业利润2483.11亿日元，上年同期为1945.51亿日元，同比增长27.6%。当期归属母公司所有者的净利润2086.03亿日元，上年同期为1635.64亿日元，同比增长27.5%。大冢控股(Otsuka Holdings)公布2024年全年业绩。全年营收23298.61亿日元，上年为20185.68亿日元，同比增长15.4%。营业利润3235.64亿日元，上年为1396.12亿日元，同比增长131.8%。归属母公司所有者的净利润3431.2亿日元，上年为1216.16亿日元，同比增长182.1%。其中，制药业务营收16290.32亿日元(约109亿美元)，利润3906.08亿日元。营养业务营收5570.43亿日元，利润641.47亿日元。消费产品业务营收337.6亿日元，利润236.62亿日元。卫材(Eisai Co., Ltd.)公布截至2024年12月31日的财年前九个月业绩。当期营收6012亿日元(约40.35亿美元)，上年同期为5513亿日元。当期营业利润554亿日元，上年同期为375亿日元。当期归属母公司所有者的净利润455亿日元，上年同期为291亿日元。联系美通社 +86-10-5953 9500 info@prnasia.com

财报

2025-03-07

·美通社

欧洲药品管理局CHMP重申对仑卡奈单抗治疗早期阿尔茨海默病的积极意见

东京 2025年3月7日 /美通社/ -- 卫材和渤健宣布，欧洲药品管理局（CHMP）已决定维持其在2024年11月通过的关于抗Aβ单克隆抗体仑卡奈单抗（商品名：乐意保 ® /Leqembi ® ）的批准建议 [1] 。基于CHMP的审查结果，欧洲委员会（EC）将重新启动对仑卡奈单抗上市许可的决策流程。 2025年1月，欧洲委员会（EC）在其决策流程中要求欧洲药品管理局（CHMP）根据2024年11月批准建议通过后所获取的仑卡奈单抗安全性信息，重新确认是否需要更新批准建议，并确认批准建议中关于风险最小化措施的描述是否足够明确。经审查，CHMP得出结论，认为无需更新对仑卡奈单抗的批准建议。在欧洲，阿尔茨海默病（AD）引起的轻度认知障碍（MCI）和阿尔茨海默型痴呆的患者人数分别估计为1520万人和690万人 [2] 。阿尔茨海默病（AD）会随时间逐渐恶化，病情的加重不仅对AD患者本人及其护理人员造成巨大负担，也对整个社会产生重大影响。目前迫切需要能够从早期阶段延缓AD进展的新治疗选择。如果仑卡奈单抗的上市许可申请获得EC批准，该批准将适用于所有27个欧盟成员国以及冰岛、列支敦士登和挪威。卫材和渤健将继续全力以赴，尽快将仑卡奈单抗提供给欧洲的早期AD患者。仑卡奈单抗的全球开发和注册申请由卫材主导，而产品则由卫材和渤健共同商业化和推广。其中，卫材拥有最终决策权。参考资料： [1]. Committee for Medicinal Products for Human Use. 2024. Leqembi (Lecanemab). Overview. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi#overview Last accessed: January 2025 [2]. Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer's disease continuum. Alzheimer's & Dementia. 2023;19:658-670. https://alzjournals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694 . 编号：ECN-2025-0019

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