Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-09-02

申办/合作机构

Bayer AG

[+3]

NCT05688436 / RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

NCT04079088 / Withdrawn临床2期

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.

开始日期2021-06-30

申办/合作机构

Biogen, Inc.

100 项与聚乙二醇干扰素β-1a 相关的临床结果

登录后查看更多信息

100 项与聚乙二醇干扰素β-1a 相关的转化医学

登录后查看更多信息

100 项与聚乙二醇干扰素β-1a 相关的专利（医药）

登录后查看更多信息

108

项与聚乙二醇干扰素β-1a 相关的文献（医药）

2024-01-01·European review for medical and pharmacological sciences

Utilization of peginterferon-β-1a in the real-world practice for relapsing-remitting multiple sclerosis.

Article

作者: Brescia Morra, V ; Palladino, R ; Caliendo, D ; Lanzillo, R ; Moccia, M ; Triassi, M ; Rubba, F ; Santoni, L ; Affinito, G ; Vaccari, I

OBJECTIVE:

Peginterferon β-1a (PEG-IFN-β-1a) is the most recent interferon beta formulation approved for treating relapsing-remitting multiple sclerosis (RRMS). We aim to describe the real-world utilization of PEG-IFN-β-1a in RRMS and compare it with other injectable disease-modifying therapies (DMTs).

PATIENTS AND METHODS:

In this population-based study, we used 2015-2019 routinely collected healthcare data of the Campania region of Italy from National Healthcare System DMT prescriptions, inpatient and outpatient clinical records of hospitals in Campania, and the Federico II University MS clinical registry for a subset of patients. We included individuals with RRMS receiving new prescriptions of PEG-IFN-β-1a [n=281; age = 38.8±12.3 years; females=70.5%; disease duration = 8.4±8.3 years; Expanded Disability Status Scale (EDSS) at baseline=2.0 (1.0-6.5)], glatiramer acetate [n=751; age = 46.0±11.4 years; females=67.1%; disease duration = 9.8±8.2 years; EDSS=4.0 (1.5-8.5)], and subcutaneous (SC) IFN-β-1a [n=1,226; age = 39.7±11.7 years; females=66.5%; disease duration = 8.2±6.5 years; EDSS 2.5 (1.5-6.5)]. Adherence [medication possession ratio (MPR)], escalation to more effective DMTs, hospitalization rates and costs were measured. We used mixed-effect linear regression models (for adherence, hospitalization rates and costs) and Cox regression models (for escalation) to assess differences between PEG-IFN-β-1a (statistical reference), glatiramer acetate, and SC IFN-β-1a. All models included age, sex, previous treatment/untreated, year of treatment initiation, treatment duration, and adherence as covariates.

RESULTS:

Adherence was lower in glatiramer acetate (MPR = 0.91±0.1; Coeff=-0.11; p<0.01), and IFN-β-1a (MPR = 0.92±0.1; Coeff=-0.08; p<0.01), compared with PEG-IFN-β-1a (MPR = 1.01±0.1). The probability of escalating to more effective DMTs was higher for glatiramer acetate (14.9%; HR=4.09; p<0.01) and IFN-β-1a (9.1%; HR=3.35; p=0.01), compared with PEG-IFN-β-1a (4.9%). No differences in annualized hospitalization rates were identified between glatiramer acetate [annualized hospitalization rates (AHR) = 0.05±0.30; Coeff=0.02; p=0.31), IFN-β-1a (AHR = 0.02±0.21; Coeff=0.01; p=0.97], and PEG-IFN-β-1a (AHR = 0.02±0.24); however, monthly costs for MS admissions were higher for glatiramer acetate (€49.45±€195.27; Coeff=-29.89; p=0.03), compared with IFN-β-1a (€29.42±€47.83; Coeff=6.79; p=0.61), and PEG-IFN-β-1a (€23.91±€43.90).

CONCLUSIONS:

SC PEG-IFN-β-1a and IFN-β-1a were used in relatively similar populations, while glatiramer acetate was preferred in older and more disabled patients. PEG-IFN-β-1a was associated with higher adherence and lower escalation rates toward more effective (and costly) DMTs.

2023-09-01·Multiple sclerosis and related disorders

Impact of interferon beta exposure on birth outcome and child development - Results from the post-authorisation safety study PRIMA.

Article

作者: Niemczyk, Gabriele ; Taipale, Kirsi ; Begus-Nahrmann, Yvonne ; Klehmet, Juliane ; Rehberg-Weber, Karin

BACKGROUND:

Interferon beta therapies are well-established disease-modifying treatments for patients with relapsing multiple sclerosis (MS). Based on clinical evidence from two large cohort studies, both, the EMA and FDA updated the labels of the interferon beta class in terms of pregnancy and breastfeeding in 2019 and 2020, respectively. To complement pregnancy label updates with patient-reported real-world data, this study examined German pregnancy and outcome reports including available data on child development from women with MS treated with peginterferon beta-1a or intramuscular (IM) interferon beta-1a.

METHODS:

The post-authorisation safety study PRIMA included adult women diagnosed with relapsing-remitting MS or clinically isolated syndrome, who were treated with peginterferon beta-1a or IM interferon beta-1a before or during pregnancy and registered in the marketing authorisation holder's MS Service center patient support program. In the prospective part of the study, conducted from April to October 2021, data on developmental milestones of the newborns were collected via telephone interview from mothers reporting live births.

RESULTS:

In total, 426 women were enrolled, reporting 542 pregnancies that resulted in 466 live births. A total of 162 women completed the questionnaire for 192 live births (53.1% male). Newborns had Apgar scores indicative of healthy infants. Weight, length and head circumference at birth and physical growth curves up to 48 months lay within the expected range of the German general population. Most newborn screenings and examinations during check-ups were inconspicuous over the study period of 48 months. Out of 158 breastfed infants, 112 (70.9%) were breastfed exclusively until month 5.

CONCLUSION:

Study results confirmed former reports indicating that exposure to interferon beta therapies during pregnancy or lactation had no adverse effects on intrauterine growth and child development over the study period, which covered the first 4 years of life. These real-world data obtained within the scope of a patient support program for peginterferon beta-1a or IM interferon beta-1a corroborate German and Scandinavian registry data and support the label update of all interferon beta therapies.

REGISTRATION:

NCT04655222, EUPAS38347.

2023-08-01·EClinicalMedicine

Interferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial

Article

作者: Ho, Joseph ; Iturriaga, Carolina ; Perret, Cecilia ; Pérez-Mateluna, Guillermo ; Kollmann, Tobias R ; Borzutzky, Arturo ; Hartnell, Lucy ; Ben-Othman, Rym ; Gidi-Yunge, Francisca ; Karpievitch, Yuliya ; Balshaw, Robert ; García-Huidobro, Diego ; Castro-Rodriguez, José A ; Shannon, Casey ; Tebbutt, Scott J ; Chen, Virginia ; Urzúa, Marcela ; Hancock, David G ; Aniba, Radhouane ; Fish, Eleanor N ; Stick, Stephen M ; Montgomery, Samuel T

Background:

Accumulating evidence indicates that an early, robust type 1 interferon (IFN) response to SARS-CoV-2 is important in determining COVID-19 outcomes, with an inadequate IFN response associated with disease severity. Our objective was to examine the prophylactic potential of IFN administration to limit viral transmission.

Methods:

A cluster randomised open label clinical trial was undertaken to determine the effects of pegylated IFNβ-1a administration on SARS-CoV-2 household transmission between December 3rd, 2020 and June 29th, 2021. Index cases were identified from databases of confirmed SARS-CoV-2 individuals in Santiago, Chile. Households were cluster randomised (stratified by household size and age of index cases) to receive 3 doses of 125 μg subcutaneous pegylated IFNβ-1a (172 households, 607 participants), or standard care (169 households, 565 participants). The statistical team was blinded to treatment assignment until the analysis plan was finalised. Analyses were undertaken to determine effects of treatment on viral shedding and viral transmission. Safety analyses included incidence and severity of adverse events in all treatment eligible participants in the standard care arm, or in the treatment arm with at least one dose administered. Clinicaltrials.gov identifier: NCT04552379.

Findings:

5154 index cases were assessed for eligibility, 1372 index cases invited to participate, and 341 index cases and their household contacts (n = 831) enrolled. 1172 participants in 341 households underwent randomisation, with 607 assigned to receive IFNβ-1a and 565 to standard care. Based on intention to treat (ITT) and per protocol (PP) analyses for the primary endpoints, IFNβ-1a treatment did not affect duration of viral shedding in index cases (absolute risk reduction = -0.2%, 95% CI = -8.46% to 8.06%) and transmission of SARS-CoV-2 to household contacts (absolute risk reduction = 3.87%, 95% CI = -3.6% to 11.3%). Treatment with IFNβ-1a resulted in significantly more treatment-related adverse events, but no increase in overall adverse events or serious adverse events.

Interpretation:

Based upon the primary analyses, IFNβ-1a treatment did not affect duration of viral shedding or the probability of SARS-CoV-2 transmission to uninfected contacts within a household.

Funding:

Biogen PTY Ltd. Supply of interferon as 'Plegridy (peginterferon beta-1a).' The study was substantially funded by BHP Holdings Pty Ltd.

项与聚乙二醇干扰素β-1a 相关的新闻（医药）

2024-04-04

·PRNewswire

Cadenza Bio, Inc. Appoints Michael A. Panzara, MD, MPH, to its Board of Directors

OKLAHOMA CITY, April 4, 2024 /PRNewswire/ -- Cadenza Bio, Inc., a pioneering preclinical biotechnology company dedicated to developing innovative small-molecule drugs for the treatment of multiple sclerosis (MS) and other demyelinating and inflammatory diseases, proudly announces the appointment of Michael A. Panzara, MD, MPH, to its esteemed board of directors. Dr. Panzara brings over 22 years of invaluable biopharmaceutical experience to Cadenza Bio. He currently serves as chief medical officer at Neurvati Neurosciences, a neuroscience-focused biotechnology company working to advance the development of clinical-stage product candidates for neurological and neuropsychiatric disorders. Prior to his role at Neurvati, Dr. Panzara held key leadership positions at Wave Life Sciences, Sanofi, Genzyme, and Biogen, showcasing his deep understanding of neurological disorders and drug development. He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company. Over his career, Dr. Panzara oversaw development activities and global regulatory approvals for several MS drugs. He served as the head of the Multiple Sclerosis, Neurology, and Ophthalmology Therapeutic Area for Global Development at Sanofi Genzyme, where he oversaw global regulatory approvals of LEMTRADA® (alemtuzumab) and AUBAGIO® (teriflunomide) and was responsible for development strategy and oversight within these therapeutic areas. During his time at Biogen, he served as global clinical lead for the development of TYSABRI® (natalizumab) for MS and managed clinical development activities for all late-stage MS products including AVONEX® (interferon beta-1a), PLEGRIDY® (PEG-interferon beta-1a), and TECFIDERA® (dimethylfumarate). "We are delighted to welcome Dr. Panzara to our board of directors," said Dr. Carol Curtis, chief executive officer of Cadenza Bio. "His extensive experience in developing therapies for MS and other neurological disorders aligns perfectly with our mission at Cadenza Bio. Dr. Panzara's strategic insights and deep understanding of the industry will be invaluable as we continue to advance our innovative drug pipeline and work towards bringing transformative treatments to patients in need." Dr. Panzara received his undergraduate degree in biology from the University of Pennsylvania and his medical degree from Stanford University School of Medicine. He completed his neurology training at Massachusetts General Hospital and received postdoctoral training in immunology and rheumatology at Brigham and Women's Hospital. Additionally, Dr. Panzara earned his master of public health degree from the Harvard School of Public Health. With Dr. Panzara joining the board of directors, Cadenza Bio is in a stronger position to achieve its goal of developing groundbreaking therapies for MS and other demyelinating and inflammatory diseases. "I look forward to joining the board of directors at Cadenza Bio at such an exciting time in the growth of the company," said Dr. Panzara. "Their approach in developing innovative dual-action therapeutic agents with neuroprotective and immunomodulatory effects has great potential to significantly expand our ability to address the unmet needs that remain for many MS patients." For more information about Cadenza Bio and its groundbreaking research, please visit . About Cadenza Bio, Inc. Cadenza Bio, Inc. is a preclinical biotechnology company focused on developing innovative small-molecule drugs for the treatment of demyelinating and inflammatory diseases. The company's mission is to break the cycle of disease and transform lives by developing therapies that not only alleviate symptoms but also halt progression, promote repair, and restore quality of life for patients. Cadenza Bio's MS drug pipeline, emerging from a collaboration between leading researchers, demonstrates promising preclinical results and offers hope for patients suffering from these debilitating conditions. SOURCE Cadenza Bio, Inc.

高管变更

2024-02-20

·药融圈

渤健财报解读

▲3月7-8日成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2月13日，美国biotech渤健公司发布了2023年财报，该公司全年营收98.36亿美元，同比下降2%，其中四季度营收23.86亿美元，同比下降6%。其业绩下滑的最主要原因是多发性硬化管线销售额下降，多发性药物共卖出54.30亿美元，同比下降14%。该公司在2023年的销售成本为25.33亿美元，占销售额的26%，毛利水平为74%，相比去年同期下降4%。研发投入24.62亿美元，约占销售额的25%，市场和一般管理费22.77亿美元，约占销售额的23%。因为毛利下降和研发投入增加，该公司的利润水平出现了明显下降，2023年净利润为11.62亿美元，仅为销售额的11.80%。渤健的业务营收分为三个部分，包括产品销售收入、产品授权费、CMO费，分别收入72.47亿美元、16.90亿美元和8.99亿美元。而产品销售收入又主要来自多发性硬化管线、罕见病管线和生物类似药管线，2023年净销售额分别为46.62亿美元、18.03亿美元和7.70亿美元。多发性硬化方面，富马酸二甲酯（TECFIDERA）因为专利已经失效，仅卖出10.13亿美元，相比去年同期销售额下降4亿多美元；VUMERITY是为了应对TECFIDERA专利悬崖而开发的505b2，全年卖出5.76亿美元，几乎相比去年同期持平。β干扰素（AVONEX）是渤健卖了20年的老产品，2023年营收8.11亿美元，相比去年同期也出现了下降。PLEGRIDY是AVONEX的升级品，2023年销售额为2.94亿美元，相比去年同期也存在下降。那他珠单抗(TYSABRI) 营收18.77亿美元，相比去年同期下降约2亿美元，氨吡啶缓释片(Fampridine）虽未出现销售额下滑，但营收不足1亿美元。罕见病管线方面，渤健拥有诺西那生钠(Spinraza）、Qalsody(tofersen)和Skyclarys(omaveloxolone)三款药物，全年营收分别为17.41亿美元、0.06亿美元和0.6亿美元，整个管线销售额几乎与去年持平。生物类似物方面，渤健主要有BENEPALI（依那西普）、IMRALDI（阿达木单抗）、英夫利昔单抗（FLIXABI）和BYOOVIZ（雷珠单抗）四款产品，2023年销售额分别为4.39亿美元、2.22亿美元、0.77亿美元和0.32亿美元，biosimilar总销售额几乎与去年同期持平。相关阅读诺和诺德2023年财报：司美格鲁肽大卖212亿美元诺华2023年业绩：营收454亿美元，同比增长10%GSK 2023年业绩：营收303亿英镑，盈利能力大幅提升辉瑞公布2023年业绩：营收同比下降42%，净利润同比下降93%强生2023年业绩公开，营收852亿美元，同比增长6.5%（附产品销售额）默沙东营收601亿美元，其中药王K药大卖250亿美元赛诺菲2023年营收431亿欧元，Dupixent突破110亿美元，氯吡格雷和甘精胰岛素在中国逆势增长再生元财报：度普利尤单抗卖出116亿美元，阿柏西普94亿美元艾伯维财报：修美乐销售额大幅下跌，正式让出药王宝座罗氏年报：营收下降7%，净利润下降9%礼来财报：GLP-1大卖125亿美元Vertex：囊性纤维化药物比增长11%，破百亿在即吉利德公开业绩：营收271亿美元，其中CAR-T 19亿美元安进2023年业绩：营收282亿美元，同比增长11%阿斯利康2023：中国区收入423亿元，增长7%BMS业绩：总营收450亿美元，同比下降2%版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

财报生物类似药

2023-09-12

·药渡Daily

渤健如何度过“中年危机”？

渤健（Biogen），成立于1978年，是一家以科学驱动研发的生物技术公司。1991年，渤健在纳斯达克上市。1996年，治疗复发性多发性硬化症（MS）的干扰素β-1a（商品名：Avonex）获FDA批准上市，这是首款被证明能够减缓残疾进展、降低病情恶化频率的药物，日后为渤健赚取丰厚利润的同时也奠定了其在神经科学领域领军地位的关键一步。然而今时不同往日，如今的渤健压力山大。2022年财报显示，渤健全年总营收101.73亿美元，同比下降7.36%，其中，产品净销售额79.88亿美元，同比下降9.7%。今年7月25日，渤健发布的2023H1财报显示：上半年营收49.19亿美元，同比下滑4%，净利润为9.81亿美元，同比下滑23.2%。不仅如此，近4年来，渤健的营收都在持续下降。在其优势领域，多发性硬化症和髓性肌萎缩症产品的增长也不如人意。由于重磅产品遭遇专利悬崖，以及新药不断涌现等因素影响，2022年渤健多发性硬化产品总营收54.30亿美元，同比下降11%；2023H1，该领域产品销售额更是呈现持续下滑态势，上半年总收入仅为23.35亿美元。成立45年的渤健正在遭遇“中年危机”。那么，渤健会如何突围呢？成也MS，“败”也MS多发性硬化症（multiple sclerosis，MS）药物一直是渤健的主要收入来源。MS是一种发生在中枢神经系统的自身免疫性脱髓鞘和神经退行性疾病。在发病初期，MS的症状类似于普通感冒，通常是头痛、四肢无力，渐渐地，身体不受控制，行走困难，甚至大小便失禁。反复发作后，患者可能会致残甚至死亡。全球约有300万人受MS的折磨。由于其发病机制尚不清晰，因此目前尚无一款药物能治愈MS。大多数药物只能延缓发作时间，患者需要终身服药。作为最早探索单抗治疗MS可行性的企业之一，渤健在20世纪初期，推出了治疗复发缓解型MS（RRMS）的单抗--Tysabri（Natalizumab，那他珠单抗），这是一款重组人源化IgG4κ单克隆抗体，能够结合除中性粒细胞以外的所有白细胞表面上表达的α4β1和α4β7整联蛋白的α4亚基，白细胞依靠α4-整联蛋白与内皮细胞上的受体粘附从而进入组织，因此Tysabri可以防止白细胞穿过内皮迁移到发炎的组织中，从而用于治疗炎性疾病。2004年，FDA通过加速审批途径批准Tysabri上市，用于治疗RRMS。不过在获批上市后仅4个月，有两例接受Tysabri的患者发生了进行性多灶性白质脑病（PML），渤健主动将Tysabri从市场上撤回。两年后，通过对临床试验期间的患者重新进行数据收集，证实该副反应在可接受的范围内，FDA再次批准了Tysabri的上市销售。2008年，FDA又批准Tysabri用于治疗克罗恩病。除了Tysabri之外，渤健在MS治疗领域还有几款明星产品，如Avonex（Interferon beta-1a，销售峰值一度超过30亿美金）、Tecfidera（富马酸二甲酯）、Plegridy（干扰素）、Fampyra（4-氨毗R定）、Vumerity（diroximel fumarate）。其中Tecfidera是继芬戈莫德（S1P调节剂）、特立氟胺（DHODH酶抑制剂）之后全球上市的第4款MS口服药物。Tecfidera是一种烟酸受体，通过激活Nrf2相关的抗氧化信号通路，启动中枢神经系统自我保护系统，以减少神经髓鞘质受损。临床研究显示，Tecfidera可将MS复发频率降低53%，残疾进程缩短38%，且副作用小。Tecfidera于2013年获FDA批准上市，当年销售额便达到8.76亿美金，2019年达到销售峰值44.33亿美元，迅速在MS治疗市场站稳了阵脚。长久以来，MS治疗产品都是渤健的中流砥柱。直到2017年，罗氏（基因泰克）的Ocrevus（Ocrelizumab，奥瑞珠单抗）横空出世，力压市面上所有MS治疗药物，迅速卷走MS市场份额。到了2022年，Ocrevus销售额高达65.39亿美元，比渤健所有MS药物销售额加起来都多。同样是在2017年，渤健的核心产品Tecfidera遭遇了仿制药巨头迈兰（Mylan，现属于Viatris）的专利挑战，原本Tecfidera核心专利2028年才会到期。但是在经过了4年官司拉锯战之后，渤健败诉，迈兰的Tecfidera仿制药在2021年8月成功上市销售，随后其它仿制药企业也蜂拥而上。自此，渤健的Tecfidera销售就面临巨大危机，其他多发性硬化症药物的销售情况也不甚乐观。如今，MS治疗药物在渤健总营收中的占比已由最高峰时的82.51%降至50%以下，渤健总营收也在急剧萎缩。根据渤健2023H1财报，上半年MS产品营收23.35亿美元，而2022年同期卖了28.21亿美元。渤健的“中年危机”已上市药物后续乏力，替补产品缺位由于仿制药和生物类似药的冲击，渤健的MS药物销售前景陷入低迷。再看看渤健增长较快的产品——脊髓性肌萎缩症(SMA)药物Spinraza。这是一种靶向SMN2的反义寡核苷酸，是全球首个获批治疗SMA的药物。自2016年获批上市以来，目前已经在包括中国在内的50多个国家获批。2018年，该药销售额增幅高达98%；但到2019年，该药的销售额增幅直接下跌至22%，为20.97亿美元。主要原因是诺华在2019年上市了基因疗法Zolgensma，抢走了SMA的部分市场。后来罗氏的SMA口服药Evrysdi（利司扑兰）也加入战局，Spinraza的市场份额被快速挤压。在已上市药物业绩下滑明显的同时，新药开发也不顺利。渤健与卫材联合开发的治疗早期阿尔茨海默症（AD）患者的Aβ抗体Aduhelm于2021年6月获FDA加速批准上市，成为2003年以来首个在美上市的AD新药。不过Aduhelm并没有为渤健带来可观的收益，上市不到一年，就因安全性问题停止商业化。随后，渤健的首席研发官离职；Aduhelm商业化团队解散；渤健的CEO Michel Vounatsos也于2022年5月宣布离职。空缺半年后，该职位由赛诺菲前首席执行官Chris Viehbacher接任。畅销药业绩下滑、后续缺乏重磅产品替补，渤健陷入了“中年危机”。在动荡中立与定，渤健能绝地反击吗？重心转向潜力新药渤健现在急需寻找新的业绩增长点来拯救连年下滑的财报数据。除了MS以外，渤健也在积极投资临床巨大未满足需求的SMA、肌萎缩侧索硬化症（ALS）、产后抑郁症（PPD）、重度抑郁症（MDD）、天使症候群、帕金森病等神经学疾病新药开发。Christopher Viehbacher表示公司下一步需要转型，计划重组其药物管线并削减至少 2 个项目，还特别强调对免疫学和精神病学的聚焦。接下来渤健将全力推进抗抑郁药Zuranolone和第二款阿尔茨海默病药物Leqembi的上市和商业化，也是渤健寄托翻身的两款药物。Zuranolone是渤健/Sage开发的用于治疗成人产后抑郁症（PPD）的口服新药，于今年8月4日获FDA批准，也是首款治疗成人产后抑郁症的口服药物。Zuranolone是新一代的γ-氨基丁酸（GABAA）受体的正向变构调节剂。大脑中的GABAA受体和NMDA（N-甲基-D-天冬氨酸）受体分别发挥抑制和刺激大脑神经元产生神经冲动的作用，这两种受体活性之间的失衡是包括抑郁症在内的多种精神疾病的原因。Zuranolone能够同时调节位于神经突触内和突触外的GABAA受体的功能，恢复大脑内GABAA受体和NMDA受体活性之间的平衡，因此具有治疗包括抑郁症在内的精神疾病的潜力。来源：FDA官网Leqembi是渤健的第二款治疗阿尔茨海默病的药物，于今年7月6日获FDA完全批准上市，用于治疗成人阿尔茨海默症。Leqembi的完全获批意义重大，这是20年来首款完全获批的阿尔茨海默症新药，也是首款对因治疗并显示临床获益的阿尔茨海默症新药。美国医生对Leqembi持“谨慎乐观”的态度。这一观点是根据药物发布分析师Spherix Global Insights的一项新调查和报告得出的，该报告在今年三月份向在美国工作的73名神经科医生询问了他们对Leqembi的使用意愿和接受度。Leqembi的定价为2.65万美元/年，美国医疗保险与医疗补助服务中心（CMS）将在此次完全获批后扩大覆盖范围，进一步促进Leqembi的市场渗透。高盛预计，Lecanemab的销售峰值或可达到157亿美元。来源：FDA官网“Fit for Growth”（重塑增长）计划，开源节流在渤健2023H1财报中，推出了一项名为“Fit for Growth”（重塑增长）的计划。通过该计划，渤健预计到2025年将节省10亿美元运营费用，其中包括裁员1000人，占员工总数的11%。“Fit for Growth”计划来源：渤健2023H1财报其中，渤健还计划从节省的费用里抽出3亿美元，重新投入到新产品的推广和研发项目里，从而实现7亿美元的净节省。“Fit for Growth”计划旨在优化成本结构、提高研发生产力和减低风险，实现可持续增长。加大并购力度，快速提振营收在Chris Viehbacher的带领下，渤健一改往日保守并购的逻辑。为了快速提振疲软营收，今年7月29日，渤健宣布将以73亿美元价格收购Reata。Reata是一家全球性生物医药公司，致力于开发新型治疗药物，用于治疗患有严重或危及生命疾病的患者，这些疾病没有或具很少的获批疗法。此次收购，渤健将获得Reata的核心产品Skyclarys（omaveloxolone）。这是一款治疗弗里德赖希共济失调症的药物，于今年2月获FDA批准上市，也是FDA批准的首款针对弗里德赖希共济失调症的药物。Skyclarys与渤健自身的神经科学领域定位高度协同，交易达成后将成为渤健现有资产的有力补充，提升现有管线丰度。Reata产品管线来源：Reata官网此外，Reata正在开发口服HSP90靶向小分子Cemdomespib，用于治疗糖尿病神经病理性疼痛患者。由于具有高度复杂性，神经科学领域的药物研发一直是风险极高的领域。渤健从成立之初一直致力于这一领域的药物开发，多次勇闯“无人区”。这体现了渤健对科学的极致追求和创新精神。如今渤健正处于多发性硬化药物和新产品交接棒的转型时期，这一时期固然漫长，但渤健一直在坚持长期发展的策略。未来随着Lecanemab和Zuranolone的放量，相信渤健将穿越低谷。对于渤健这样的药企，我们还是要有足够的耐心。参考来源Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial.With Brukinsa launch, BeiGene seeks to avoid protracted pricing squabbles in Europe: exec（fiercepharma.com）.Biogen sends CEO to the exit, abandons Aduhelm sales team in $1B overhaul.From Devastation to Popping Champagne: Reata Pharmaceuticals’ Roller Coaster Year——Making Dallas an Even Better Place.END👇关注药渡数据媒体矩阵

财报上市批准

100 项与聚乙二醇干扰素β-1a 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10483	-	L03AB13	DB09122

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
多发性硬化症	美国	Biogen, Inc.	2014-08-15
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2014-07-18

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
流感样症状	临床3期	美国	Biogen, Inc.	2013-11-01
复发性多发性硬化	临床3期	美国	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	比利时	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	保加利亚	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	加拿大	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	智利	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	哥伦比亚	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	克罗地亚	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	捷克	Biogen, Inc.	2011-04-01
复发性多发性硬化	临床3期	爱沙尼亚	Biogen, Inc.	2011-04-01

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


German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2023)	N/A	多发性硬化症	247	Interferon beta-1a	鏇積淵製網窪糧選憲鹽(網壓範夢蓋蓋觸餘願範) = comparable between exposed children and controls during the observation period 鹹選蓋醖鏇繭觸顧衊淵 (積願鹹蓋糧獵襯鏇鹽鹹 ) 更多	积极	2023-09-30
NCT03870763 (CTgov)	临床3期	复发-缓解型多发性硬化	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	築簾構鹽醖艱淵艱壓鑰(願築窪鏇艱衊築繭夢蓋) = 築範衊窪夢選衊憲膚製顧積鬱襯範鹽壓繭夢鬱 (蓋憲窪餘製鏇糧遞糧淵, 淵衊簾淵積膚鹽醖艱顧 ~ 窪襯餘襯糧襯繭膚簾蓋) 更多	-	2023-05-16
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	築簾構鹽醖艱淵艱壓鑰(願築窪鏇艱衊築繭夢蓋) = 廠廠艱築顧廠願選鹹觸顧積鬱襯範鹽壓繭夢鬱 (蓋憲窪餘製鏇糧遞糧淵, 鏇憲選窪鏇鏇糧範艱繭 ~ 糧醖鹹廠糧遞廠鏇齋窪) 更多
German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2022)	N/A	多发性硬化症	70	Interferon-beta 1a exposure during pregnancy	繭願齋簾簾積襯製願範(範網顧衊膚顧鏇廠蓋襯) = 簾夢願積壓構壓廠齋鑰願遞築網膚網襯淵淵餘 (餘齋蓋糧壓遞淵構艱顧 )	积极	2022-10-12
P4-4.009 (AAN2022)	N/A	-	136	Peginterferon Beta-1a	鹹網構窪願廠壓膚衊膚(選構鹹積製製鹹願壓淵) = 範顧鑰憲廠選願膚膚膚糧夢窪願淵鏇廠鑰膚醖 (蓋蓋壓鹽觸鬱鏇餘鏇遞 ) 更多	-	2022-05-03
				Peginterferon Beta-1a	鹹網構窪願廠壓膚衊膚(選構鹹積製製鹹願壓淵) = 簾鑰鏇蓋鑰選糧窪鹹齋糧夢窪願淵鏇廠鑰膚醖 (蓋蓋壓鹽觸鬱鏇餘鏇遞 ) 更多
Plegridy Observational Program (ECTRIMS2021)	N/A	复发性多发性硬化	1,208	Peginterferon beta-1a	蓋衊鏇餘構淵憲廠鏇鏇(鏇齋構獵蓋夢齋壓壓簾) = 憲觸廠餘獵窪願醖醖製積蓋遞糧醖鹹膚夢獵顧 (鏇膚築願鹽鬱壓構範築 ) 更多	积极	2021-10-12
				Placebo	蓋衊鏇餘構淵憲廠鏇鏇(鏇齋構獵蓋夢齋壓壓簾) = 廠蓋觸築鏇獵願齋顧鑰積蓋遞糧醖鹹膚夢獵顧 (鏇膚築願鹽鬱壓構範築 ) 更多
ECTRIMS2021	N/A	-	393	Peginterferon beta-1a	鹽繭鏇淵網獵繭築繭膚(襯壓襯構簾蓋範壓衊鏇) = General disorders and administration site were also the most common for non-serious AEs (68%) 繭淵艱窪積積鏇構鑰蓋 (餘鏇艱鹽願餘網餘鬱顧 ) 更多	积极	2021-10-12
NARCOMS (ECTRIMS2020)	N/A	复发性多发性硬化	-	Intramuscular interferon beta-1a	廠膚遞窪製選鹹鑰鏇顧(鏇淵鹽襯蓋壓製餘壓網) = 艱鑰製夢夢窪餘窪範鹽齋獵齋鏇淵簾觸選鏇鏇 (積構網夢齋觸糧蓋鬱鬱 ) 更多	积极	2020-12-07
				Peginterferon beta-1a	廠膚遞窪製選鹹鑰鏇顧(鏇淵鹽襯蓋壓製餘壓網) = 廠壓齋顧範繭鏇醖窪膚齋獵齋鏇淵簾觸選鏇鏇 (積構網夢齋觸糧蓋鬱鬱 ) 更多
ECTRIMS2020	N/A	-	817	Peginterferon beta-1a	選選製壓糧鹹艱膚簾憲(淵鹽艱壓艱壓觸襯鑰窪) = 夢夢衊遞鏇襯築顧觸餘願製鑰鏇鹹簾鹽夢淵獵 (襯選壓衊壓醖夢廠蓋齋 ) 更多	积极	2020-12-07
				Intramuscular interferon beta-1a	選選製壓糧鹹艱膚簾憲(淵鹽艱壓艱壓觸襯鑰窪) = 餘遞齋齋齋顧遞遞醖選願製鑰鏇鹹簾鹽夢淵獵 (襯選壓衊壓醖夢廠蓋齋 ) 更多
PLEGRIDY Observational Program (ECTRIMS2020)	临床4期	复发性多发性硬化	1,208	peginterferon beta-1a	選構積壓繭窪壓網積簾(鑰艱觸簾鏇積鑰廠鏇壓) = 繭鑰鹽繭願顧憲顧憲範齋窪膚積餘遞簾鹹積顧 (淵鬱繭選膚願製鹹構築 ) 更多	-	2020-12-07
				peginterferon beta-1a	選構積壓繭窪壓網積簾(鑰艱觸簾鏇積鑰廠鏇壓) = 網選夢繭襯積觸衊窪鏇齋窪膚積餘遞簾鹹積顧 (淵鬱繭選膚願製鹹構築 ) 更多
ECTRIMS2020	N/A	多发性硬化症	2,479	Peginterferon beta-1a	鬱窪淵窪膚蓋蓋選鏇膚(願夢遞艱觸鏇鹹夢願齋) = 醖壓簾積窪夢構艱鹹顧顧餘鏇糧觸襯齋糧醖衊 (憲廠衊鑰願製範鏇顧顧 ) 更多	-	2020-12-07
				Intramuscular interferon beta-1a	夢範製範膚膚醖壓構鏇(糧鹽鑰窪觸鬱醖積範壓) = 鑰簾網淵遞衊網簾餘鏇夢壓觸鹽衊構範蓋夢鑰 (糧夢鬱憲壓糧餘築鑰齋 )