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2024-03-20

申办/合作机构

Bayer AG

[+3]

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.

EUCTR2020-000620-18-FR / Not yet recruiting临床2期IIT

Human recombinant interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a double-blind, international phase 2, randomized, placebo-controlled trial - the PREV-HAP study - PREV-HAP

开始日期2021-02-19

申办/合作机构

Nantes University Hospital

100 项与重组人干扰素β-1b 相关的临床结果

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100 项与重组人干扰素β-1b 相关的转化医学

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100 项与重组人干扰素β-1b 相关的专利（医药）

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1,156

项与重组人干扰素β-1b 相关的文献（医药）

2024-07-01·Neurotherapeutics

Long-term effectiveness of natalizumab in secondary progressive multiple sclerosis: A propensity-matched study

Article

作者: Marfia, Girolama ; Patti, Francesco ; Maniscalco, Giorgia Teresa ; Morra, Vincenzo Brescia ; Pesci, Ilaria ; Paolicelli, Damiano ; Moiola, Lucia ; Maimone, Davide ; Di Sapio, Alessia ; Bertolotto, Antonio ; Bonavita, Simona ; Gasperini, Claudio ; Cocco, Eleonora ; Solaro, Claudio ; Aguglia, Umberto ; Trojano, Maria ; Cottone, Salvatore ; Rovaris, Marco ; Lus, Giacomo ; Granella, Franco ; Conte, Antonella ; Zaffaroni, Mauro ; Filippi, Massimo ; De Luca, Giovanna ; Cavalla, Paola ; Amato, Maria Pia ; Salemi, Giuseppe ; Lepore, Vito ; Bergamaschi, Roberto ; Gallo, Antonio ; Ragonese, Paolo ; Totaro, Rocco ; Chisari, Clara G ; Vianello, Marika

Treatment options for secondary progressive MS (SPMS) are limited, especially considering that the new drugs recently approved are licensed for actively relapsing patients. We aimed to compare the disability progression in a real-world cohort of SPMS patients treated with natalizumab (NTZ) or interferon beta-1b (IFNb-1b). This multicenter retrospective enrolled patients with a diagnosis of SPMS according to 2014 Lublin criteria, who received NTZ or IFNb-1b for at least 48 months between the 1st June 2012 and the 15th May 2018 at 33 Italian MS centers contributing to the Italian MS Registry NTZ or IFNb-1b. Confirmed Expanded Disability Status Scale worsening (CEW) and progression independent of relapse (PIRA) were evaluated. In order to correct for non-randomization, a propensity score matching of the groups was performed. Out of 5206 MS patients identified at the time of data extraction, 421 SPMS patients treated with NTZ (224 [53.2%] females, mean age 45.3 ± 25.4 years) and 353 with IFNb-1b (133 [37.8%] females, mean age 48.5 ± 19.8 years) were enrolled. After applying the matching procedure, 102 patients were retained in the NTZ group and 98 in the IFNb-2b group. The proportion of patients who reached the 48-month 1-point CEW was significantly higher in IFNb-1b compared to NTZ group (58.2% versus 30.4%, p = 0.01). The proportion of patients who developed PIRA at 48 months were significantly higher in IFNb-1b compared to NTZ (72.4% versus 40.2%, p = 0.01). EDSS before treatment initiation and SPMS duration were risk factors for disability progression in terms of PIRA (HR 2.54, 25%CI 1.67-5.7; p = 0.006 and HR 2.04, 25%CI 1.22-3.35; p = 0.01, respectively). Patients treated with IFNb-1b were 1.64 times more to likely to develop PIRA (HR 1.64, 25%CI 1.04-4.87; p = 0.001). Treatment with NTZ in SPMS patients showed more favorable disability outcomes compared to IFNb-1b with beneficial effects over 48 months.

2024-07-01·JOURNAL OF NEUROLOGY

Long-term clinical outcomes in patients with CIS treated with interferon beta-1b: results from the 15-year follow up of the BENEFIT trial

Article

作者: Wicklein, Eva-Maria ; Hartung, Hans-Peter ; Edan, Gilles ; Freedman, Mark S ; Montalbán, Xavier ; Barkhof, Frederik ; MacManus, David G ; Koelbach, Ralf ; Kappos, Ludwig

Abstract:

Multiple sclerosis (MS) treatment intervention with immunomodulating therapy at early disease stage improves short term clinical outcomes. The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial. In BENEFIT patients were assigned to “early” IFNB-1b treatment or placebo (“delayed” treatment). After 2 years or conversion to clinically definite multiple sclerosis (CDMS), all patients were offered IFNB-1b and were reassessed 15 years later. Of 468 patients, 261 (55.8%) were enrolled into BENEFIT 15 (161 [55.1%] from the early, 100 [56.8%] from the delayed treatment arm). In the full BENEFIT analysis set, risk of conversion to CDMS remained lower in the early treatment group ( – 30.5%; hazard ratio 0.695 [95% CI, 0.547–0.883]; p = 0.0029) with a 15.7% lower risk of relapse than in the delayed treatment group (p = 0.1008). Overall, 25 patients (9.6%; 9.9% early, 9.0% delayed) converted to secondary progressive multiple sclerosis. Disability remained low and stable with no significant difference between groups in Expanded Disability Status Scale score or MRI metrics. Paced Auditory Serial Addition Task-3 scores were better in the early treatment group (p = 0.0036 for treatment effect over 15 years). 66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b.

2024-06-01·CNS & neurological disorders drug targets

The Peripheral Profile of the Chitinase 3-like-1 in Benign Multiple Sclerosis – A Single Centre’s Experience

Article

作者: Andone, Sebastian ; Barcutean, Laura ; Hutanu, Adina ; Balasa, Rodica ; Maier, Smaranda

Background::

A limited subgroup of multiple sclerosis (MS) patients present with a longterm disease evolution characterized by a limited disease progression, known as benign MS (BMS). Chitinase 3-like-1 (CHI3L1) levels are sensitive to inflammatory processes and may play a role in the pathogenesis of MS. In this observational, cross-sectional study, we aimed to evaluate the implications of serum CHI3L1 and inflammatory cytokines in BMS patients treated with interferon β-1b for over a decade.

Methods::

We collected serum samples from 17 BMS patients and 17 healthy controls (HC) to measure serum CHI3L1 levels and a Th17 panel of inflammatory cytokines. Serum levels of CHI3L1 were analysed using the sandwich ELISA method and the Th17 panel was assessed using the multiplex XMap technology on a Flexmap 3D Analyzer.

Results::

Serum CHI3L1 levels did not differ significantly from HC. We identified a positive correlation between CHI3L1 levels and relapses during treatment.

Conclusions::

Our findings suggest that there are no differences in serum CHI3L1 levels between BMS patients and HC. However, serum CHI3L1 levels are sensitive to clinical inflammatory activity and may be associated with relapses in BMS patients.

项与重组人干扰素β-1b 相关的新闻（医药）

2024-01-28

·阿基米德Biotech

口头脱钩阴影

2019年初夏，一位中航基金经理，被蝴蝶的翅膀拍了一下，发生风格偏移，把药明康德买成军民融合基金的重仓，最终卷入一场风暴。药明康德，一家被美国人控制的企业，现在却受到美国的制裁威胁。意外性造成的荒诞感，在地缘关系的阴影中被放大。你可能不再记得这是药明系第几次带崩生物医药板块，但谁也不能肯定是最后一次。2024年是美国大选之年，来自政客的jump scare绝不会是最后一次。无论制裁提议能否变成法律，每次恐吓都会对市场带来实质性影响。需要直面的问题是，为何我们的生物科技产业如此脆弱，任何口头脱钩都能引发雪崩？01 谁是最大受损者？跨国药企是全球化受益者，在中国创新药领域占有主导地位。2022年，8家跨国药企（阿斯利康、默沙东、拜耳、赛诺菲、罗氏、诺华、诺和诺德、礼来）制药业务中国市场合计收入约289亿美元。据青桥阳光统计，56家通过18A通道上市的港股未盈利生物科技公司（剔除康希诺）的合计产品营收，2022年为254亿人民币，2023年超过400亿人民币，仍不及外资零头。2款率先直接在美国销售的国产创新药泽布替尼、西达基奥仑赛，预计2023年美国市场合计收入约15亿美元，在美国创新药（2021年销售额4565亿美元）中可谓沧海一粟。跨国药企才是全面脱钩的最大直接受损者。中国成为阿斯利康第二大市场，2023H1阿斯利康中国区营收30.43亿美元，同比增长7%，占比全球业绩14%。中国成为默沙东第三大市场，2023H1中国区销售额35.81亿美元，约为同期恒瑞医药销售额2.5倍，同比增长45%。中国成为赛诺菲第二大市场，2023Q3中国市场销售额7.28亿欧元。诺华、武田制药都把中国纳入第二大目标市场。截至2023H1，中国有7家CDMO海外收入占比超过75%，主要发展逻辑是承接海外药企研发生产外包订单的转移，其行业平均薪酬是海外同行一半左右，这也使得国内服务的收费仅为发达国家30%-60%。如果CDMO供应链全面脱钩，跨国药企在控制成本上将受到第二波损害。全世界新增小分子CDMO产能主要集中在中国，既能获得美国FDA和欧盟EMA多个产品GMP认证，又是成本洼地的产能并不多，跨国药企可选择余地不大。从另一组数据可以看到，中国西药类产品出口以低附加值的原料为主（占比80%），呈现量增价减态势，为全球制药业提供高质低价的精细化学及中间体，对平抑药价有关键作用。据中国医药保健品进出口商会统计，2023年前三季度，中国西药类产品出口额388.5亿美元，进口额403.6亿美元，其中西药原料出口额311.4亿美元，进口额74.1亿美元，西成药出口额47.4亿美元，进口额191.7亿美元，生化药出口额29.7亿美元，进口额137.9亿美元。中国在西成药、生化药上严重依赖进口，存在触目惊心的贸易逆差，这与上述跨国药企在中国创新药领域的主导地位是一致的。02 无法简单切割全球医药产业链的深度融合和相互依存，已经超出民粹主义的认知，无法进行简单切割。高性价比常用药断供，后果严重，已构成全球性挑战。美国持续出现药荒，2023年，美国短缺化疗药物顺铂注射液，紧急向齐鲁制药采购，连中文包装盒都没来得及换。据美国国家癌症研究所的数据，高达20%的癌症患者依赖铂类化疗药物进行治疗。这次药物短缺与供应顺铂材料的印度工厂因质量问题停产有关。占美国90%处方量的仿制药主要来源是印度，这种对单一供应商的依赖存在较大风险。2022年，WHO和各国卫生部门将印度止咳糖浆与冈比亚、乌兹别克斯坦和喀麦隆的至少141名儿童死亡关联起来。2023年，印度生产的两款眼药水没消毒，造成美国3人死亡，4人眼球被摘除。全美药品短缺的另一个原因是，制药公司停止生产许多挽救生命的非专利药物，因为利润太低，造成约300种基本药物都常年供不应求。长春新碱是一种治疗儿童白血病的低利润基本药物，每剂成本仅为约5美元，2019年美国仅有两家制造商，Teva在放弃生产长春新碱后，辉瑞表示无法跟上市场需求量。跨国药企一个小涟漪，可能造成供应链大波澜，甚至掀起患者群体生命中的大海啸。跨国药企在配置全球产能时，立足于经济效益，人道主义不是考量重点，如果产药无利可图，有时会以客观因素为由牺牲掉别国市场。在国内创新药大发展前夕，2016年新华社曾经发文发问：专利药受制于人，中国如何摆脱“进口药物依赖”？背景是拜耳两款药物在中国市场面临断货，先是治疗肺动脉高压的特效药物“万他维”，后是中国市场上唯一可降低多发性硬化症发作频率的药物“倍泰龙”。2015年12月10日，一封由1400余名患者、医生、人大代表联名签署的公开信，发送到拜耳医药总部，请求留下“万他维”。这封信指出，在美国并未出现“万他维”退市的情况，中国患者对其在中国市场的退出行为感到难以接受，并尖锐提问：难道中国患者的生命比不上美国患者的生命吗？2016年两会期间，针对国内缺乏进口专利药品的替代品，导致部分进口专利药品不仅价格高，而且形成“药物依赖”的危险局面，有全国人代表忧心忡忡：我们不能被跨国药企卡住脖子。据《中国震颤患者白皮书》，2019年中国帕金森病患者约284万人，数量居全球首位。米内网数据显示，2021年上半年，国内公立医院帕金森进口原研药占据90.97%，国产药份额不到10%。默沙东的帕金森神药息宁（卡左双多巴缓释片）发生过3次断货。息宁在国外生产，国内进行分包装，2016年第一次大范围断货，默沙东解释为生产因素所致，2019年第二次断货，默沙东再次表示为生产工厂原因，2021年第三次断货的原因默沙东未公布，医院内息宁单盒价格只需要50元，供应紧张后，网上药店标准装价格暴涨到799元~996元。阿糖胞苷作为血液肿瘤常用药，因为辉瑞决定对意大利生产工厂进行停产检修, 导致2019年1月起在全球范围内出现供货不足的情况。辉瑞占据阿糖胞苷市场份额97%以上，直到2022年12月，才有首家国产阿糖胞苷仿制药通过一致性评价。03 在外部冲击中成长固定的用药习惯，以及对原研药或进口药的固化信任，也是造成供应链失衡的原因之一。辉瑞阿糖胞苷断供期间，患者及家属焦虑不安，其实有5家国产药企持有注射用盐酸阿糖胞苷的批准文号。本土制药需要更多信任。2015年1月，毕井泉执掌国家食药监局，中国进入创新药元年，成长至今不足10年，源头创新能力和商业化体量仍然弱小，抗风险能力差，面对外部冲击，难免泥沙俱下。而创新药定价机制、入院限制、融资困境，又意味着国际化才能打开更高的天花板。中国药企的适应能力超强，在海外非美市场、长尾市场提前布局。国产PD-1、生物类似药以性价比优势，将在出海史上写下浓重一笔。复宏汉霖汉曲优在海外获批上市时间其实比国内还早半个月，成为首个登陆欧盟的国产曲妥珠单抗，2022年海外销售和BD收入约2.04亿元，目前在超过30个国家和地区成功获批上市。2023年底PD-1单抗H药（汉斯状）在印度尼西亚获批用于治疗广泛期小细胞肺癌，成为首个在东南亚国家上市的国产PD-1。这也是H药首次在海外市场获批，今年1月H药完成首批海外发货。未来复宏汉霖将继续携手合作伙伴KGbio推动H药在东南亚、中东、北非等“一带一路”市场的商业化。目前H药对外授权已达70多个国家和地区，全面覆盖欧美主流法规市场和新兴市场。君实生物PD-1特瑞普利单抗通过对外授权已覆盖50多个国家和地区，包括鼻咽癌高发的东南亚。科兴制药的商业模式比较独特，一边在国内捡18A公司的漏，另一边卖给海外下沉市场。商业逻辑完美闭环，但这家公司的经营能力有待验证。科兴制药经过20多年的海外积淀，在海外产品注册、海外开拓和营销、海外GMP合规审计方面有着丰富资源与商业化经验，已通过40个国家和地区的市场准入并实现销售，销售网络已100%覆盖人口过亿的新兴国家市场。公司从2021年开始通过引进产品的方式快速扩充产品池，已获得10款生物类似药、化学药在欧盟及海外新兴市场国家的销售权益，在60多个国家及地区提交80多份引进产品的注册申请，其中从挣扎在生死线上的东曜药业、迈博药业低价（首付款分别为3000万、5000万）引进贝伐珠单抗、英夫利西单抗。进度上，埃及药监局对英夫利西单抗和贝伐珠单抗完成了现场GMP审计，巴西药监局对英夫利昔单抗的现场GMP审计于2024年1月中旬完成。若海外注册顺利推进，引进产品将于2024年陆续在海外实现商业化。地缘风险的阴影投射到每家创新药企的厂牌上，2024年注定不平静，但中国生物医药产业已经深度融入全球产业链。据医药魔方统计，截至2024年1月18日，跨国药企在中国投资Biotech多达132起，涉及123家医药企业。处于生命周期早期的中国创新药企，将在与世界的博弈和共振中成长壮大。

财报核酸药物IPO

2023-09-18

·BioSpace

Atriva Therapeutics Announces Exclusive Letter Agreement for Reverse Takeover Transaction with Biocure Technology

Atriva Therapeutics and Canadian Biocure Technologies, Inc. entered into an exclusive letter agreement for a reverse takeover transaction. Upon successful completion of the transaction, the resulting entity will continue the business of Atriva Therapeutics. Shareholders of Atriva will receive not less than 75% of the securities of the resulting issuer, with the current shareholders of Biocure Technology holding the remainder. The transaction is subject to various terms and conditions, including satisfactory due diligence, successful implementation of a private placement and shareholder approvals. TÜBINGEN, Germany and MUNICH, Germany, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Atriva Therapeutics GmbH (“Atriva”) is pleased to disclose the signing of an exclusive letter agreement, dated September 14, 2023, with Biocure Technology Inc. (“CURE”) (CSE: CURE), based in Vancouver, Canada. This agreement marks a significant step forward in Atriva’s commitment to combating severe RNA virus infections through innovative host-cell-targeting therapies. “We are delighted to have entered into this exclusive letter agreement with Biocure. Our discussions with the Biocure management and board of directors have been exceptionally productive and constructive. We are eager to embark on this journey and combine the strengths of both companies. Together, we aim to address the urgent medical need for safe and effective therapies for patients suffering from severe RNA virus infections. This agreement marks a significant milestone in our commitment to advancing innovative solutions for the benefit of global healthcare,” said Christian Pangratz, Chief Executive Officer of Atriva. “This letter agreement underscores our commitment to leverage this transaction with CURE as an attractive growth option for Atriva and its stakeholders. We are enthusiastic about the prospect of our companies joining forces and continuing to contribute to improving pandemic preparedness on an extended international scale,” stated Ulrich Dauer, PhD, Chairman of the Advisory Board of Atriva. Highlights of the Transaction: Upon transaction completion, Atriva shareholders and concurrent financing subscribers will collectively hold not less than 75% of the securities of the resulting issuer. Current CURE shareholders will retain a maximum of 25% on a fully diluted basis. The letter agreement stipulates no advances from CURE to Atriva. Atriva will provide CURE with an exclusivity fee of CA$15,000 per month for a minimum of three months. Additionally, a finder's fee of US$2,000,000 is payable through the issuance of CURE shares, with pricing to be determined, aligning with concurrent private placement terms. Transaction Conditions: The completion of the Transaction is contingent upon various terms and conditions, including the successful completion of due diligence, the execution of a definitive agreement by November 30, 2023, (inclusive of typical transaction elements), and the successful completion of a private placement by Atriva or CURE to raise gross proceeds of at least US$15,000,000. Additionally, approval from both companies' shareholders and the endorsement of the CSE and other relevant regulatory authorities are essential prerequisites for finalization. For additional information on this transaction, please visit . About Atriva Therapeutics Atriva Therapeutics’ mission is to develop an antiviral therapy platform against severe respiratory and systemic diseases with a high unmet medical need induced by RNA viruses, e.g., influenza and COVID-19. The clinical-stage biopharmaceutical company is pioneering the development of host-targeting antiviral therapies, making development of viral resistance unlikely, and thereby significantly contributing to pandemic preparedness. The Atriva lead product zapnometinib (ATR-002) is a first-in-class, host-targeting agent that aims to inhibit viral replication and to favorably modulate the body’s immune response to RNA viruses. Atriva Therapeutics was founded in 2015 in Tübingen by a team of leading scientists in viral research and seasoned industry experts and is based with its administrative/operations office in Martinsried (near Munich), Germany. For further information, please visit and follow us on LinkedIn and X (formerly Twitter). About Biocure Biocure owns approximately 45% stakes of BiocurePharm in Korea who is a leading biotech company developing its CAR-T cell therapy for leukemia, lung, breast and pancreatic cancer. BiocurePharm is in the process of pre-clinical trials of three major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim as well as Ranibizumab. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis (“MS”). Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. Contact: Atriva Therapeutics GmbH Christian Pangratz, CEO Phone: +49 69 9999 162 10 pangratz@atriva-therapeutics.com

免疫疗法细胞疗法

2023-07-21

·赛柏蓝

国家医保局重点指导！14个生物药集采开始（附名单）

继胰岛素专项国采之后，又一大范围的聚焦于治疗用生物制品的集采或将启动——江西牵头的干扰素省际集采，截至目前，胰岛素、血液制品、生长激素、单抗、肝素，以及接下来的干扰素几类生物制品均出现在了不同层级的集采之中。01江西牵头开展干扰素集采14个品种拟纳入继国家医保局年初的预告之后，江西干扰素集采迎来官方消息。 7月20日，江西省药品医用耗材集中采购联席会议办公室发布《关于干扰素省际联盟采购拟集采品种目录的公示》，拟对14个干扰素品种进行集采。在今年初国家医保局发布的《关于做好2023年医药集中采购和价格管理工作的通知》中，江西牵头开展干扰素省际联盟采购和湖北牵头扩大中成药省际联盟采购品种和区域范围，广东牵头开展易短缺和急抢救药省际联盟采购并列，均在国家医保局的重点指导之列。国家医保局重点指导的省际联盟集采，目前来看均规模不小。湖北牵头的第二批中成药省际联盟集采覆盖30个省份，已经进展到公布中选产品清单阶段。随着江西公布拟集采的干扰素目录，今年的3大省际药品集采联盟，仅广东牵头开展的易短缺和急抢救药省际联盟采购还没有动作。如无意外，这两大联盟的动作将集中在7月中下旬之后的下半年。江西通过梳理干扰素药品品种，分析联盟省份2022年度采购数量和金额等方式选定出注射剂、阴道泡腾片/胶囊、栓剂、凝胶剂、喷雾剂、滴眼剂在内的多类干扰素剂型纳入集采。具体包括：聚乙二醇干扰素α-2b注射剂、人干扰素α1b注射剂、人干扰素α2a注射剂、人干扰素α2b注射剂、人干扰素α2b阴道泡腾片/胶囊、人干扰素α2a软膏剂等（具体名单见文末附件），覆盖了一个长效干扰素和多个短效干扰素。从公示拟集采目录开始，后续还将有医疗机构报量、公布集采文件、开标、发布拟中选结果、确认中选结果等阶段。目录的公示时间为7月20日-27日。江西牵头的干扰素集采一旦开展，影响的将是数十亿市场。同时，生物药集采的品类再次扩充。02干扰素集采在即将怎样搅动市场干扰素集采核心还在于规则设定以及可能产生的降价幅度和市场划分。干扰素是人体分泌的一种蛋白质，具有广谱抗病毒、抗肿瘤和免疫功能，根据半衰期分为短效干扰素和长效干扰素。短效干扰素由于给药方式更加灵活，适用于大部分的病毒性疾病和某些恶性肿瘤的治疗，且治疗成本相对较低，一般每周注射三次；长效干扰素由于半衰期较长，适用于慢性乙型肝炎和丙型肝炎，每周注射一次，副作用低，依从性好，不过价格相对昂贵。随着肝病领域各类口服抗病毒药物上市并进入医保，长效干扰素的市场份额也受到影响。根据《中国干扰素市场发展现状分析与投资趋势预测报告（2022-2029年）》，2020年我国短效干扰素和长效干扰素市场规模分别为22.31亿元、9.99亿元。目前我国已批准生产的干扰素类产品有聚乙二醇干扰素α2a、聚乙二醇干扰素α2b、重组人干扰素α-1b、重组人干扰素α-2a、重组人干扰素α-2b、重组人干扰素β-1a、重组人干扰素β-1b、重组人干扰素γ等几种。其中聚乙二醇干扰素α2a和重组人干扰素α-2b在中国公立医疗机构终端销售额超过10亿元，重组人干扰素α-1b销售额在5亿元左右。根据PDB药物综合数据库，2022年样本医院市场干扰素注射剂各亚型的销售份额占比，以短效重组人干扰素α1b和重组人干扰素α2b为主。 10亿大品种重组人干扰素α2b涉及的喷雾剂、滴眼剂、凝胶剂、阴道泡腾片/胶囊和软膏剂等均在此次的拟集采名单中。长效干扰素中，聚乙二醇干扰素α2b注射剂被纳入。从销售额占比来看，重组人干扰素α2b的主要玩家有凯因科技、未名生物、兆科药业和上海华新。其中重组人干扰素α2b注射剂类市场份额较高的企业是——凯因益生（凯因科技生产）、安达芬（安科生物生产）以及安福隆（天津未名生产）。聚乙二醇干扰素α2b注射剂主要厂家是默沙东（佩乐能，先灵葆雅生产，后被收购），占据了3成左右的长效干扰素市场，我国本土企业厦门特宝生物研发生产的聚乙二醇干扰素α2b（派格宾），由于2016下半年才正式上市，市场份额不到1%。后续市场竞争如何，有待观察。生物药集采考虑企业产能、竞争格局、稳定医院临床需求等因素，规则的优化以及和缓的降幅是大概率事件。不过由于干扰素后续市场表现不明，企业的竞价动力或高于以往。江西省作为全国首个牵头开展多个干扰素品种集采的省份，具有一定的示范效应。目前来看，已经开展的省级/省际联盟集采正形成互补，如湖北和广东分别牵头过中成药联盟集采、八省二区等联盟对化药进行集采，地方集采还在推进，化药、中成药、生物药均被集采覆盖。根据国家医保局的通知，省级药品集采重点针对未纳入国家集采的品种和未过评品种，积极探索尚未纳入国家和省级集采的“空白”品种集采，鼓励对已有省份集采、价格竞争充分的品种开展带量价格联动。接下来，应采尽采仍是主旋律。附：扫描下方二维码，进入赛柏蓝热门产品交流群。更多行业资讯，欢迎交流~（如群人数已满，也可在赛柏蓝公众号对话框回复“产品”扫码进入）END作者 | 遥望颜色来源 | 赛柏蓝↓点击下方阅读原文，获取更多详情

带量采购

100 项与重组人干扰素β-1b 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00746	重组人干扰素β-1b	L03AB08	DB00068

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
复发-缓解型多发性硬化	欧盟	Bayer AG	1995-11-30
复发-缓解型多发性硬化	冰岛	Bayer AG	1995-11-30
复发-缓解型多发性硬化	列支敦士登	Bayer AG	1995-11-30
复发-缓解型多发性硬化	挪威	Bayer AG	1995-11-30
继发进展型多发性硬化	欧盟	Bayer AG	1995-11-30
继发进展型多发性硬化	冰岛	Bayer AG	1995-11-30
继发进展型多发性硬化	列支敦士登	Bayer AG	1995-11-30
继发进展型多发性硬化	挪威	Bayer AG	1995-11-30
多发性硬化症	美国	Bayer HealthCare Pharmaceuticals, Inc.	1993-07-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性多发性硬化	临床3期	美国	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	阿根廷	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	澳大利亚	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	奥地利	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	比利时	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	巴西	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	加拿大	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	丹麦	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	芬兰	Bayer AG	2007-05-01
复发性多发性硬化	临床3期	法国	Bayer AG	2007-05-01

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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


ECTRIMS2022	N/A	复发-缓解型多发性硬化	140	Actoferon®	築廠繭廠築鏇壓獵製網(獵願蓋願製願鏇顧觸齋) = 齋繭範夢積鑰廠簾艱襯憲鹹網襯積簾襯製範遞 (網選鏇襯網願製餘鏇遞 ) 更多	积极	2022-10-12
ECTRIMS2022	N/A	复发-缓解型多发性硬化	140	Betaferon®	築廠繭廠築鏇壓獵製網(獵願蓋願製願鏇顧觸齋) = 範壓醖製顧構鏇憲襯繭憲鹹網襯積簾襯製範遞 (網選鏇襯網願製餘鏇遞 ) 更多	积极	2022-10-12
Pubmed	临床2期	新型冠状病毒感染	-	Interferon beta-1b + Remdesivir	淵顧鑰膚夢繭範鬱淵鬱(鹹選鏇鹽窪壓簾簾選鑰) = 築衊餘鏇鹹製齋願獵壓糧淵夢壓鹹遞衊醖鏇膚 (窪鏇廠製鬱衊繭襯夢窪 ) 更多	积极	2022-06-28
Pubmed	临床2期	新型冠状病毒感染	-	Remdesivir	淵顧鑰膚夢繭範鬱淵鬱(鹹選鏇鹽窪壓簾簾選鑰) = 艱網窪鹽獵顧廠壓夢夢糧淵夢壓鹹遞衊醖鏇膚 (窪鏇廠製鬱衊繭襯夢窪 ) 更多	积极	2022-06-28
NCT00176592 (BECOME, CTgov)	临床4期	多发性硬化症	75	Betaseron (Betaseron)	艱夢憲壓艱網鑰範積鏇(獵夢艱範製艱壓壓製鹹) = 糧範製鏇簾糧範蓋襯鏇糧製憲鑰觸遞淵遞糧廠 (觸醖範淵膚範鬱膚簾憲, 憲蓋蓋築鹹憲鑰糧淵衊 ~ 壓簾餘選顧築願醖觸製) 更多	-	2021-11-16
NCT00176592 (BECOME, CTgov)	临床4期	多发性硬化症	75	Copaxone (Copaxone)	艱夢憲壓艱網鑰範積鏇(獵夢艱範製艱壓壓製鹹) = 製鬱顧鹽衊襯範夢構構糧製憲鑰觸遞淵遞糧廠 (觸醖範淵膚範鬱膚簾憲, 廠築窪淵構夢製餘壓構 ~ 鏇繭鏇鏇夢選淵夢簾鹽) 更多	-	2021-11-16
ECTRIMS2020	N/A	新型冠状病毒感染 SARS-CoV-2	109	IFN β-1b	構範遞窪網餘艱窪齋醖(鏇餘襯觸襯簾蓋簾窪膚) = 淵構蓋廠壓膚顧構鬱艱膚蓋鬱觸餘製淵糧鬱鬱 (襯選範糧廠網襯觸簾選 ) 更多	-	2020-12-07
NCT03134573 (Pubmed \| J Med Internet Res)	N/A	多发性硬化症	96	Interferon Beta-1b (Patients using myBETAapp)	壓選鬱鏇網顧窪壓餘廠(齋襯襯觸艱壓簾範壓獵) = 簾築齋觸廠鹽選鏇鹹鑰願壓窪夢鹹遞積壓憲齋 (觸鑰構選簾繭壓顧鑰淵 ) 更多	-	2019-07-29
EAN2019	N/A	MRI lesions	261	Interferon beta-1b (early treatment)	廠壓網遞鑰醖窪壓膚觸(構積簾築遞壓範膚衊膚) = 簾鑰顧遞簾觸蓋艱艱網積醖糧憲窪積鹽鬱夢獵 (齋選鬱選鏇鹹醖壓壓觸 ) 更多	积极	2019-06-27
BENEFIT 15 (ACTRIMS2019)	N/A	MRI lesions	468	Interferon beta-1b (early treatment)	構繭願顧醖夢蓋鬱鹹範(艱廠繭鹹鏇憲襯獵範構) = mean 2.5 (1.76); median 2.0 (1.5, 3.5) (EDSS 0-2.5: 162 patients [62.1%], 3.0-5.5: 80 [30.7%], 6.0-6.5: 12 [4.6%], >=7: 7 [2.7%]) 願鹽範襯網鏇網築壓網 (獵艱糧觸構艱願鑰鏇窪 ) 更多	积极	2019-05-07
BENEFIT 15 (ACTRIMS2019)	N/A	MRI lesions	468	Placebo+Interferon beta-1b (delayed treatment)		积极	2019-05-07
BENEFIT 15 (AAN2019)	临床3期	子宫颈原位癌	468	Interferon beta-1b (early treatment)	構選膚夢觸艱夢築憲鏇(積鑰襯壓鹽夢淵夢鹽蓋) = 0.2083 overall over 15 years 膚憲糧鑰製獵壓餘鏇觸 (願願醖簾鏇鹽鹹遞夢鏇 ) 更多	积极	2019-04-09
AAN2019	N/A	怀孕	2,571	Interferon beta-1b	簾廠膚鹽壓齋鏇夢糧膚(製衊鬱襯範齋壓鬱壓鏇) = 齋艱積鬱廠築鏇衊憲顧衊窪齋餘築憲鬱獵糧鑰 (鏇襯淵積膚獵夢積餘憲 ) 更多	-	2019-04-09
ECTRIMS2018	N/A	怀孕	2,571	Pregnancies exposed to interferon beta-1b	膚鹽遞襯願糧積醖餘繭(鏇膚積齋願鏇積廠糧蓋) = 獵衊糧鹹繭膚觸襯築繭製壓鹽簾構網襯窪齋淵 (淵鑰糧繭廠衊遞艱願鬱 ) 更多	-	2018-10-09