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▎药明康德内容团队编辑 SFJ Pharmaceuticals和SERB Pharmaceuticals今天宣布，美国FDA已接受为在研疗法bentracimab递交的生物制品许可申请（BLA）并授予其优先审评资格，预计在2025年第一季度完成审评。 Bentracimab是一种人源化单克隆抗体片段，正在开发作为一种特定的逆转剂，用于在使用替格瑞洛（商品名Brilinta）的患者中，逆转替格瑞洛及其活性代谢物的抗血小板作用。Bentracimab在2019年获得了FDA授予的突破性治疗认定。替格瑞洛是一种靶向P2Y12的血小板抑制剂，通过抑制血小板功能防止血栓的产生，可用于预防和治疗心脑血管血栓事件和减少急性冠状动脉综合征（ACS）。然而，抑制血小板功能也让患者的出血风险增加。Bentracimab通过与替格瑞洛结合，中和其抗血小板的作用。 BLA的提交基于3期临床试验REVERSE-IT的第二次中期分析结果。REVERSE-IT试验的首次中期分析结果已于2021年发表在NEJM Evidence期刊上。结果显示，在需要接受紧急手术和大出血患者中，bentracimab可以立即和持续逆转替格瑞洛的抗血小板作用，达到主要研究终点。接受治疗5-10分钟后，血小板抑制率降低135%（p<0.01)，持续24小时以上。在绝大多数病例中，该药的有效止血被评为良好或优秀，且没有发生药物相关的严重不良事件或过敏反应。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review. Retrieved August 2, 2024, from https://www.globenewswire.com/news-release/2024/08/02/2923626/0/en/FDA-has-accepted-a-BLA-for-bentracimab-the-first-and-only-ticagrelor-reversal-agent-for-filing-and-priority-review.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

New York, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Hermetic Packaging Market with COVID-19 impact by Configuration, Type, Application, Industry And Region - Global Forecast to 2025" - 3% from 2020 to 2025. The growth of this market is attributed to the increasing use of hermetic packaging for protecting highly sensitive electronic components and increasing demand from industries such as aerospace and automotive electronics. However, factors such as stringent leak requirements for hermetic packaging and supply chain disruptions due to the COVID-19 pandemic are expected to restrain the market growth. COVID-19 has emerged as a global pandemic that has spread across 215 countries worldwide and disrupted various industries around the world.The prominent players across industries have been affected by this pandemic. The foreseeable decline in the growth of end-user industries may have a considerable direct impact on the hermetic packaging market. Hermetic packaging market for multilayer ceramic packages to witness high-growth potential during the forecast period The multilayer design of the package helps package designers incorporate electrical enhancements such as a large number of electrical feedthroughs within small spaces. Multilayer ceramic packages are widely adopted for high-frequency applications such as data communication, wireless communication, and optical communication because they offer better hermeticity than other configurations, and also enable a large number of electrical feedthroughs within very small spaces. The market for Ceramic-Metal Sealing (CERTM) to grow at highest CAGR during the forecast period CERTM exhibits very high electrical conductivity for conductor paths; this is essential for the transmittance of extremely high-frequency electrical signals.CERTM sealed sensors, such as heating, ventilation, and air conditioning (HVAC) sensors, chassis-level sensors, and proximity sensors find potential applications in the automotive industry as they assure the safety of passengers and enable failure-free operations. This factor is expected to propel the growth of the CERTM market during the forecast period. MEMS switches market to grow at highest CAGR during the forecast period “ Given that MEMS switches are mechanical, there is a critical requirement to support and protect the devices from thermal and mechanical shock, vibration, and other physical damage during storage and operation.Hermetic packaging helps MEMS switches to sustain even in environmental conditions such as high temperature and high mechanical stress. The increase in the demand for complete automatization of automobiles is the key factor driving the growth of the market for MEMS switches. APAC to be the largest market for hermetic packaging during the forecast period APAC is expected to lead the hermetic packaging market in terms of size, from 2020 to 2025.Increasing energy needs, emerging economies, and increasing defense spending are some of the factors driving the growth of this market in the region. In the last few years, the demand for hermetic packaging has significantly increased for the military & defense, aeronautics & space, automotive, and energy & nuclear safety industries.The rising military capabilities of emerging countries such as China, India, and South Korea are boosting the demand for hermetic packaging for sensitive electronic components. However, the implementation of lockdowns in several countries to contain the spread of COVID-19 has significantly affected the operations of end-use industries such as automotive, military & defense, aeronautics & space, due to which the market for hermetically packaged products is expected slowdown in 2020 in the Asia Pacific. Break-up of the profiles of primary participants: • By Company Type – Tier 1 – 55%, Tier 2 – 20%, and Tier 3 – 25% • By Designation – C-level – 23%, Director-level – 59%, and Others – 18% • By Region – North America - 30%, Europe – 40%, APAC – 20%, and RoW – 10% Key players in the market include SCHOTT (Germany), AMETEK, Inc. (US), Amkor Technology, Inc. (US), Texas Instruments Incorporated (US), Teledyne Technologies (US), Kyocera Corporation (Japan), Materion Corporation (US), Egide (France), Micross Components Inc. (US), Legacy Technologies Inc. (US), Willow Technologies (UK), Renesas Electronics Corporation (US), SGA Technologies (UK), Complete Hermetics (US), Special Hermetic Products Inc. (US), Coat-X (Switzerland), Hermetics Solutions Group (US), StratEdge (US), Bel Fuse, Inc., ITT Inc. (US), Rosenberger (Germany), Mackin Technologies (US), Palomar Technologies (US), CeramTec (Germany), and Aptiv PLC - Winchester Interconnect (Ireland). The global hermetic packaging market is segmented into the configuration, type, application, industry, and geography.The market based on configuration is segmented into pressed ceramic packages, multilayer ceramic packages, and metal can packages. Based on the types of materials, the hermetic packaging market has been split into passivation glass, reed glass, transponder glass, glass, and metal in combination (glass-metal sealing (GTMS)), and ceramic and metal in combination (ceramic–metal (CERTM) sealing).Based on the application, the market is segmented into transistors, sensors, leasers, airbag ignitors, photodiodes, oscillating crystals, MEMS switches, and others. Industries that are included in the study of the market include military & defense, aeronautics & space, automotive, energy nuclear safety, medical, telecommunications, consumer electronics, and others. The hermetic packaging industry is segmented into four regions—North America, Europe, Asia Pacific (APAC), and the Rest of the World (RoW). Reasons to buy the report: • Illustrative segmentation, analysis, and forecast for markets based on configuration, type, application, industry, and region have been conducted to give an overall view of the hermetic packaging market. • The value chain analysis has been performed to provide an in-depth insight into the hermetic packaging industry. • Major drivers, restraints, opportunities, and challenges pertaining to the hermetic packaging market have been detailed in this report. • Detailed information regarding the COVID-19 impact on the hermetic packaging market has been provided in the report. • The report includes a detailed competitive landscape along with key players, in-depth analysis, and revenue of key players. Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. 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