ST. LOUIS--(BUSINESS WIRE)--The API Innovation Center (APIIC) today announced that it has been awarded funding by the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used in the treatment of asthma, diabetes, and anxiety disorders.

圣路易斯--（商业新闻短讯）--API创新中心（APIC）今天宣布，它已获得美国战略准备和反应管理局（ASPR）工业基地管理和供应链中心（IBMSC）的资助，以领导用于治疗哮喘，糖尿病和焦虑症的三种关键活性药物成分（API）的开发和国内生产。

APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience..

APIC将利用先进的制造技术和前沿研究，进一步增强国家在制药创新和供应链弹性方面的实力。。

The BioMaP-Consortium is a multi-purpose acquisition vehicle comprised of industry partners across the drug and vaccine manufacturing supply chain supported by ASPR’s Biomedical Advanced Research and Development Authority (BARDA). IBMSC will provide $14 million in funding and APIIC will invest an additional $2.4 million into the development of these critical APIs.

BioMaP财团是一个多用途收购机构，由ASPR生物医学高级研究与发展局（BARDA）支持的整个药物和疫苗制造供应链的行业合作伙伴组成。IBMSC将提供1400万美元的资金，APIC将另外投资240万美元开发这些关键的API。

This funding marks a significant step forward in securing the U.S. pharmaceutical supply chain and addressing national health security risks..

这笔资金标志着在确保美国药品供应链安全和应对国家健康安全风险方面迈出了重要的一步。。

At least 83% of the nation’s top 100 generic medicines have no U.S.-based source for the small-molecule APIs found in today’s medication. This dependency on foreign manufacturers has left the U.S. pharmaceutical supply chain vulnerable to shortages and geopolitical conflicts while domestic facilities operate below capacity.

在美国排名前100位的仿制药中，至少有83%的仿制药没有美国的小分子原料药来源。。

The decrease in U.S.-based production for APIs and key starting materials (KSMs) used to make them is widely recognized as a major driver behind this significant national health security risk. While much work remains to improve the return on investment for developing medicines domestically, funding through the BioMaP-Consortium represents a key investment in the ongoing efforts to reshore critical medicines and address ever-increasing drug shortages..

美国原料药和用于生产原料药的关键原料（KSMs）产量的下降被广泛认为是这一重大国家健康安全风险背后的主要驱动因素。虽然要提高国内药物开发的投资回报率还有很多工作要做，但通过BioMaP财团提供的资金是对正在进行的重新储存关键药物和解决日益严重的药物短缺问题的关键投资。。

Initiative to Address Availability of Essential Medications

解决基本药物供应问题的举措

This initiative will see APIIC lead the development and production of three critical APIs, each chosen for their vital role in U.S. health care, shortage history, as well as inclusion on essential medicines lists:

这一举措将使APIC领导三种关键原料药的开发和生产，每种原料药都因其在美国医疗保健、短缺历史以及基本药物清单中的重要作用而被选中：

Albuterol: Used to treat asthma and other respiratory conditions.

沙丁胺醇：用于治疗哮喘和其他呼吸系统疾病。

Desmopressin Acetate: Used to treat diabetes insipidus & blood coagulation conditions.

醋酸去氨加压素：用于治疗尿崩症和凝血疾病。

Lorazepam: Used to treat anxiety.

劳拉西泮：用于治疗焦虑症。

'This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines. By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country,' said Tony Sardella, chair and founder of APIIC..

“这笔资金既是一项财政承诺，也是朝着确保美国的药物弹性和患者获得关键药物迈出的重要一步。APIC主席兼创始人托尼·萨德拉（TonySardella）说，通过专注于开发这些高影响力分子，我们正在为推动自力更生创造一个公私蓝图，这对国家健康安全至关重要，可以在全国范围内推广。。

Partnership and Impact

伙伴关系和影响

This project harnesses the strengths of APIIC’s extensive partner network, including collaborations with leading universities, pharmaceutical manufacturers, and suppliers of KSMs. APIIC will unite the resources and advanced manufacturing technologies of Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St.

该项目利用了APIC广泛合作伙伴网络的优势，包括与领先大学、制药制造商和KSM供应商的合作。APIC将整合Mallinckrodt特殊仿制药、Apertus Pharmaceuticals、MilliporeSigma和密苏里大学圣路易斯分校的资源和先进制造技术。

Louis (UMSL) to enhance the quality, efficiency, and global competitiveness of U.S.-based pharmaceutical manufacturing. These strategic collaborations form a dynamic product team, capitalizing on each member's specific expertise, with APIIC providing funding and support to harness their strengths and advanced manufacturing capabilities..

路易斯（UMSL）致力于提高美国制药制造业的质量、效率和全球竞争力。这些战略合作形成了一个充满活力的产品团队，利用每个成员的特定专业知识，APIC提供资金和支持，以利用其优势和先进的制造能力。。

“Mallinckrodt Specialty Generics is proud to partner with the API Innovation Center on this critical initiative to bolster the U.S. pharmaceutical supply chain. Our proven expertise in the development, manufacture, and commercialization of active pharmaceutical ingredients in the U.S. positions us extremely well to contribute to this effort.

“Mallinckrodt Specialty Generics很荣幸能与API创新中心合作，开展这项关键举措，以加强美国的药品供应链。我们在美国开发、制造和商业化活性药物成分方面的成熟专业知识使我们能够为这项工作做出贡献。

By collaborating with APIIC and its partners, we are both addressing the nation’s drug shortage challenges and strengthening the nation’s ability to manufacture essential medicines domestically,” said Stephen Welch, executive vice president & head of Mallinckrodt Specialty Generics..

通过与APIC及其合作伙伴的合作，我们既解决了国家的药物短缺挑战，也加强了国家在国内生产基本药物的能力，”马林克罗特专业仿制药执行副总裁兼负责人斯蒂芬·韦尔奇（StephenWelch）说。。

APIIC will collaborate closely with Apertus Pharmaceuticals on research and development work, leveraging advanced manufacturing technology to produce these critical molecules. 'Collaborating with the API Innovation Center has enabled us to scale our cutting-edge research and play a key role in this national initiative to strengthen our pharmaceutical supply chain,' said David Gindelberger, chief executive officer of Apertus Pharmaceuticals..

APIC将与Apertus Pharmaceuticals在研发工作上密切合作，利用先进的制造技术生产这些关键分子。”Apertus Pharmaceuticals首席执行官大卫·金德尔伯格（DavidGindelberger）说，与API创新中心的合作使我们能够扩大尖端研究的规模，并在这项加强我们药品供应链的国家举措中发挥关键作用。。

MilliporeSigma, a small and large molecule contract development and manufacturing organization (CDMO) with facilities in St. Louis, will also play a pivotal role. “We are excited to bring our 25 years of CDMO expertise in organic synthesis and bioconjugation of ADCs, producing Active Pharmaceutical Ingredients (API), excipients and critical raw materials, to this partnership.

MilliporeSigma是一家在圣路易斯拥有设施的小分子和大分子合同开发和制造组织（CDMO），也将发挥关键作用。“我们很高兴能将我们25年来在ADC的有机合成和生物缀合方面的CDMO专业知识，生产活性药物成分（API），赋形剂和关键原料，带入这一合作伙伴关系。

This initiative will not only mitigate risks associated with supply disruptions but can also enhance the U.S. bioeconomy,” said Mark Cooley, site director of one of the St. Louis MilliporeSigma facilities involved in the consortium..

。。

“Partnering with the API Innovation Center on this important initiative allows us to leverage our strengths in research, workforce development, and community engagement to support a more secure and self-reliant pharmaceutical supply chain. UMSL is proud to play a key role in advancing these critical efforts, which will have lasting impacts on both our region’s economy and the nation’s health security,” said Dr.

“在这一重要举措上与API创新中心合作，使我们能够利用我们在研究、劳动力发展和社区参与方面的优势，支持更安全和自力更生的药品供应链。UMSL自豪地在推进这些关键努力方面发挥关键作用，这将对我们地区的经济和国家的健康安全产生持久影响，”Dr。

Chris Spilling, vice chancellor for research and economic and community development at the University of Missouri-St. Louis..

密苏里大学圣路易斯分校研究、经济和社区发展副校长克里斯·斯皮林（ChrisSpilling）。。

A Roadmap for a Resilient Supply Chain in Missouri

密苏里州弹性供应链路线图

APIIC, together with the State of Missouri and the Missouri Technology Corporation, has been developing a state-supported model in the St. Louis region and a strategic framework for creating a resilient national pharmaceutical manufacturing ecosystem. This model is designed to be a replicable blueprint that compliments Missouri’s strengths in infrastructure and workforce development to restore U.S.

APIC与密苏里州和密苏里州技术公司一起，一直在圣路易斯地区开发州支持的模型和战略框架，以创建一个有弹性的国家制药制造生态系统。该模型旨在成为一个可复制的蓝图，以补充密苏里州在基础设施和劳动力发展方面的优势，从而恢复美国的竞争力。

leadership in pharmaceutical production..

制药生产的领导地位。。

To date, the State of Missouri has committed approximately $18 million to API reshoring efforts, demonstrating to other states how to support the “Missouri Model” and take the lead in addressing national supply chain challenges.

迄今为止，密苏里州已承诺约1800万美元用于API再外包工作，向其他州展示了如何支持“密苏里模式”，并带头应对国家供应链挑战。

'Missouri is leading in restoring America's pharmaceutical manufacturing strength. By focusing on developing active pharmaceutical ingredients right here in Missouri, we are tackling a pressing national health security issue—our over-reliance on foreign suppliers,” said Gov. Mike Parson. “Recognizing our strengths, particularly in pharmaceutical manufacturing, we collaborated with the General Assembly to invest in bringing critical medicine production back to the U.S.

密苏里州在恢复美国制药制造业实力方面处于领先地位。密苏里州州长迈克·帕森（MikeParson）表示：“通过专注于开发活性药物成分，我们正在解决一个紧迫的国家健康安全问题，即过度依赖外国供应商。”。。

The state’s investment, now bolstered by federal support, is a clear indicator that what we are doing in Missouri is working. We are not just talking about solutions. We’re delivering results that are necessary steps toward safeguarding the health and security of our nation.'.

该州的投资现在得到了联邦政府的支持，这清楚地表明我们在密苏里州所做的工作正在发挥作用。我们不仅仅是在谈论解决方案。我们正在取得成果，这是保障我们国家健康和安全的必要步骤。”。

As it looks to the future, APIIC is committed to driving the U.S. towards pharmaceutical self-reliance, ensuring every hospital, pharmacy, and patient has access to domestically produced critical medication to support national health security.

展望未来，APIC致力于推动美国实现制药自力更生，确保每家医院、药房和患者都能获得国内生产的关键药物，以支持国家健康安全。

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Office of Industrial Base Management and Supply Chain (IBMSC), under OT number #75A50123D00003.

该项目全部或部分由卫生与公众服务部的联邦资金资助；；工业基地管理和供应链办公室（IBMSC），OT编号#75A50123D00003。

About the API Innovation Center:

关于API创新中心：

The API Innovation Center (APIIC) is a 501(c)(3) nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to driving health security and economic growth for the nation and its citizens through U.S.-based production of critical medicines. By investing in and collaborating along the supply chain, APIIC’s model contracts with leading U.S.-based specialists within their pharmaceutical ecosystem to develop and manufacture high-quality domestically produced Active Pharmaceutical Ingredients.

API创新中心（APIC）是一家501（c）（3）非营利公益组织，总部位于密苏里州圣路易斯，致力于通过美国生产关键药物来推动国家及其公民的健康安全和经济增长。通过对供应链的投资和合作，APIC的模式与美国制药生态系统中的领先专家签订合同，开发和制造国内生产的高质量活性药物成分。

APIIC is also committed to expanding access to critical medications through strategic partnerships to commercialize market-competitive supplies of finished drug products and build resiliency in the supply chain. Their mission is to ensure every hospital, pharmacy, and patient has access to domestically produced critical medication to fortify national health security.

APIC还致力于通过战略合作伙伴关系扩大关键药物的使用范围，以商业化具有市场竞争力的成品药供应，并在供应链中建立弹性。他们的使命是确保每家医院、药房和患者都能获得国内生产的关键药物，以加强国家健康安全。

APIIC is supported by the state of Missouri through the Advanced Manufacturing Resiliency Grant awarded by the Missouri Technology Corporation. To learn more, visit: apicenter.org..

APIC由密苏里州通过密苏里技术公司授予的先进制造业弹性补助金提供支持。要了解更多信息，请访问：apicenter.org。。

About Apertus Pharmaceuticals:

关于Apertus制药公司：

Apertus Pharmaceuticals is a contract development and manufacturing organization (CDMO) that develops and manufactures device, OTC and prescription pharmaceutical products. Services include product de-formulation, formulation development, process development, and manufacturing (clinical batch to intermediate scale), including product serialization.

Apertus Pharmaceuticals是一家合同开发和制造组织（CDMO），负责开发和制造设备、OTC和处方药产品。服务包括产品去配方、配方开发、工艺开发和制造（临床批量到中等规模），包括产品系列化。

Apertus performs an extensive range of analytical method development and validation as well as provides stability programs for all of the medications it produces. Apertus currently manufactures solid oral dose, suppository, liquid and cream products. Apertus is cGMP compliant and maintains Drug Enforcement Administration research and analytical registrations for Schedules II-V.

Apertus执行广泛的分析方法开发和验证，并为其生产的所有药物提供稳定性程序。Apertus目前生产固体口服制剂、栓剂、液体和乳膏产品。Apertus符合cGMP的要求，并为附表II-V维护药物执法局的研究和分析注册。

To learn more about Apertus Pharmaceuticals, visit: apertuspharma.com..

。。

About Mallinckrodt Specialty Generics:

关于Mallinckrodt特殊仿制药：

Mallinckrodt’s Specialty Generics business segment is a 150+ year-old business that manufactures approximately 50 FDA-approved active pharmaceutical ingredients and approximately 100 FDA-approved finished dose pharmaceutical products across our network of U.S.-based manufacturing sites. To learn more about Mallinckrodt Specialty Generics, visit www.mallinckrodt.com..

马林克罗特（Mallinckrodt）的特种仿制药业务部门拥有150多年的历史，在我们位于美国的生产基地网络中生产大约50种FDA批准的活性药物成分和大约100种FDA批准的成品药物。要了解有关Mallinckrodt专业仿制药的更多信息，请访问www.Mallinckrodt.com。。

About the Life Science business of Merck KGaA, Darmstadt, Germany

关于德国达姆施塔特默克公司的生命科学业务

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 27,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services.

德国达姆施塔特默克公司（Merck KGaA）的生命科学业务在美国和加拿大作为MilliporeSigma运营，在全球拥有27000多名员工和55多个总制造和测试站点，拥有300000多种产品，专注于科学发现、生物制造和测试服务。

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn..

德国达姆施塔特默克公司（Merck KGaA）是一家领先的科技公司，经营医疗保健、生命科学和电子产品。关注Twitter@MilliporeSigma、Facebook@MilliporeSigma和LinkedIn上的MilliporeSigma。。

About the University of Missouri–St. Louis:

关于密苏里大学。路易斯：

A Tier 1 national university and Carnegie R2 classification—Doctoral University with High Research Activity— public research university, UMSL, and its four-campus University of Missouri System, provides strong research programs in chemical organic synthesis and advanced pharmaceutical manufacturing methods, such as continuous flow technologies, along with strong industry partnerships.

一所拥有高研究活动的一级国立大学和卡内基R2分类博士大学-公共研究大学，UMSL及其四校区密苏里大学系统，在化学有机合成和先进药物制造方法（如连续流动技术）方面提供强大的研究项目，以及强大的行业合作伙伴关系。

To learn more about the University of Missouri–St. Louis, visit: umsl.edu..

了解更多关于密苏里大学-圣路易斯分校的信息。路易斯，访问：umsl。edu。。