Lorazepam

2024年10月8日，国家药品监督管理局官网显示，药友集团两产品获批上市并视同通过仿制药质量和疗效一致性评价，分别为：药友制药的普伐他汀钠片（10mg）、湖南洞庭药业的马来酸氟伏沙明片（50mg）。 01/普伐他汀钠片 1989年在日本首次获批上市，用于高脂血症、家族性高胆固醇血症。 普伐他汀为3-羟基-3-甲基戊二酰辅酶 A（HMG-CoA）还原酶抑制剂。选择性地作用于合成胆固醇的主要脏器肝脏和小肠，迅速且强力降低血清胆固醇值，改善血清脂质。其通过二方面发挥降脂作用。第一为可逆性抑制 HMG-CoA还原酶活性使细胞内胆固醇的量有一定程度的降低，导致细胞表面的低密度脂蛋白（LDL）受体数的增加，从而加强了由受体介导的低密度脂蛋白胆固醇（LDL-C）的分解代谢和血液中 LDL-C的清除。第二，通过抑制 LDL-C的前体——极低密度脂蛋白胆固醇（VLDL-C）在肝脏中的合成从而抑制 LDL-C 的生成。 他汀类药物能显著降低血清总胆固醇（TG）、LDL⁃C和载脂蛋白B（ApoB）水平，适用于高胆固醇血症、混合型高脂血症和动脉粥样硬化性心血管疾病（ASCVD）的防治。普伐他汀是唯一不依赖细胞色素P450酶系统代谢的他汀，发生药物相互作用概率较低。此外，普伐他汀发生肝功能异常、肌肉痛、血糖升高等不良反应的风险亦更低。 他汀类药物是降脂药物的基石，被国内外多指南推荐用于血脂管理与心血管事件预防： 《中国血脂管理指南（2023年）》：中等强度的他汀类药物是中国人群降脂治疗的首选策略。普伐他汀40mg剂量属于中等强度。 《中国心血管病一级预防指南（2020年）》：他汀类药物用于ASCVD一级预防证据最为充分。大量研究证实他汀类药物可显著降低高、中甚至低危人群的ASCVD风险。 《美国预防临床服务指南工作组推荐声明（2022年）》：推荐40~75岁伴有≥1种CVD危险因素（血脂异常、糖尿病、高血压、吸烟）且10年CVD风险≥10%的成年人使用他汀类药物进行CVD的一级预防。  1995年，普伐他汀钠片在我国获批用于高脂血症、家族性高胆固醇血症。我国已上市片剂和胶囊剂，均为国家医保乙类品种。目前，我国普伐他汀市场规模已超6.6亿元，市场容量连续增长，现已超3.8亿片（以10mg计）。 数据来源：IQVIA，RPDB 截至发稿，普伐他汀钠片已有5家企业通过或视同通过一致性评价，尚有4家企业正在审评审批中，暂未纳入国家带量采购。 通过/视同通过一致性评价的企业 普伐他汀钠片是药友制药首个视同过评的降脂药物，进一步丰富了药友制药在三高（高血脂、高血压、高血糖）领域的产品集群。 02/马来酸氟伏沙明片 1983年在瑞士首次获批上市，用于抑郁症、强迫症。 氟伏沙明为选择性5-羟色胺再摄取抑制剂（SSRIs），是全球第一款SSRIs类药物，主要通过选择性抑制中枢神经突触前膜对5-羟色胺（5-HT）的再摄取，同时使5-HT受体脱敏，特别是5-HT1A受体，增强5-HT传递，增加突触间隙5-HT的有效浓度而发挥药理作用；同时亦可通过CYP1A2影响褪黑素在肝脏的代谢，提高血清褪黑素浓度，改善睡眠和生物节律，是唯一直接影响褪黑素浓度的SSRIs；氟伏沙明还具有激动σ-1受体调节谷氨酸释放，修复神经和改善认知功能，进一步增强其抗抑郁作用。 指南推荐： 《中国抑郁障碍防治指南（第二版）》推荐氟伏沙明等SSRIs类药物作为一线抗抑郁药物。 《中国强迫症防治指南（2016年）》推荐氟伏沙明为强迫症一线治疗药物。 《焦虑障碍防治指南（2010年）》推荐氟伏沙明作为焦虑障碍的一线推荐用药。 《创伤后应激障碍防治指南》中指出，氟伏沙明是治疗PTSD的常用药物。 马来酸氟伏沙明片为国家医保乙类品种，根据IQVIA CHPA数据，其医院市场规模5.9亿元，5年复合增长率25.7%，市场容量2.5亿片（以50mg计），近年连续保持快速增长。 数据来源：IQVIA 截至发稿，已有9家企业通过或视同通过一致性评价，尚有14家企业正在审评审批中，暂未纳入国家带量采购。 通过/视同通过一致性评价的企业 CNS领域是药友核心领域之一，仅2024年已有7个产品获批，截至目前，CNS领域共20个品种34个品规通过/视同通过一致性评价，多个品种为首家/独家。 相关链接 药友制药 药友制药成立于1939年中华民族危难时刻，10余名爱国大学师生以“谋医药之永远自给，药学之逐日昌明，分担建国复兴工作”的创始宗旨，创立了药友制药。 经过80余年的发展，药友制药已成为一家拥有完整医药产业链的集团化、国家级重点高新技术企业。公司自主研发生产的原料药及制剂产品已先后在欧美市场上市，重点冻干产品荣获“国家科技进步二等奖”。 药友制药成员企业 湖南洞庭药业 洞庭药业是药友制药旗下成员企业，创建于1958年，位于湖南常德，是国内精神科药物和化学止血药领域的领先企业。 经过多年的技术革新和市场竞争，止血药和精神科药成为洞庭药业的主导产品。止血药氨甲环酸、氨甲苯酸形成了产销规模大、质量好的超前优势；精神科药走上了品种、规格、剂型齐步发展的快车道，主要类别有抗精神分裂症药、抗抑郁药、抗癜痫药、镇静催眠药。 洞庭药业是湖南省级企业技术中心，省精神药物工程技术研究中心、拥有省著名商标、省国际知名品牌等荣誉称号以及“止血环酸的生产方法”、“制备药物纯富马酸喹硫平的生产方法”、“富马酸喹硫平缓控释制剂组合物及其应用”等多项国家发明专利和外观专利。 洞庭药业建立了可靠的产品质量保障体系，全部产品取得了国家GMP认证证书。氨甲环酸质量符合美国药典、英国药典、日本药局方和欧洲药典标准，并通过了美国FDA、英国MHRA、欧盟COS、日本PMDA认证，出口到30多个国家和地区，拥有劳拉西泮片、阿普唑仑片、氯硝西泮片等精神二类管制药品生产资质。

Biden-Harris Administration funds first Defense Production Act Title III award to onshore manufacturing of ingredients for essential medicines 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. APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience. 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. This funding marks a significant step forward in securing the U.S. pharmaceutical supply chain and addressing national health security risks. 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. 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. Initiative to Address Availability of Essential Medications 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: Albuterol: Used to treat asthma and other respiratory conditions. Desmopressin Acetate: Used to treat diabetes insipidus & blood coagulation conditions. Lorazepam: Used to treat anxiety. “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. Partnership and Impact 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. 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. “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. 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. 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. 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. 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. Chris Spilling, vice chancellor for research and economic and community development at the University of Missouri-St. Louis. A Roadmap for a Resilient Supply Chain in Missouri 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. leadership in pharmaceutical production. 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. “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. 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.” 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. 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. About the API Innovation Center: 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. 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. 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 . About Apertus Pharmaceuticals: 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 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. To learn more about Apertus Pharmaceuticals, visit: apertuspharma.com . About Mallinckrodt Specialty Generics: 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 . About the Life Science business of Merck KGaA, Darmstadt, Germany 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. 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 . About the University of Missouri–St. Louis: 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. To learn more about the University of Missouri–St. Louis, visit: umsl.edu . Contacts Kaylee Schreiner kaylee.schreiner@fleishman.com