A Phase 2, Randomized, DB, Placebo-controlled Study to Determine the Efficacy, Safety and PK Profile of ARV-1801 in Combination With Optimized Background Therapy for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis

This study will evaluate the efficacy and safety of an oral ARV-1801(ACG-701) plus optimized background therapy (OBT) compared to oral placebo plus OBT, each administered for 14 days, in the treatment of participants with Cystic Fibrosis-related pulmonary exacerbations (PEx).

开始日期2023-02-10

申办/合作机构

Aceragen, Inc.

NCT05105035 / Completed临床2期

A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Assess the Efficacy, Safety and Tolerability of Oral ARV-1801 Given in Combination With Intravenous Ceftazidime or Meropenem for Intensive Phase Therapy of Melioidosis in Hospitalized Patients

The study investigates the effect of 14 days of twice daily doses of ARV-1801 or placebo in combination with meropenem or ceftazidime in patients hospitalized with melioidosis.

开始日期2022-06-14

申办/合作机构

Arrevus, Inc.初创企业

ISRCTN14019371 / Recruiting临床2期

A randomized, double-blind, placebo-controlled, exploratory study to assess the efficacy, safety, and tolerability of oral ARV-1801 given in combination with intravenous ceftazidime or meropenem for intensive phase therapy of melioidosis in hospitalized patients

开始日期2022-05-01

申办/合作机构

Arrevus, Inc.初创企业

100 项与夫西地酸钠相关的临床结果

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100 项与夫西地酸钠相关的转化医学

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100 项与夫西地酸钠相关的专利（医药）

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项与夫西地酸钠相关的文献（医药）

2025-02-01·FOOD CHEMISTRY

Dual cross-linking with tannic acid and transglutaminase improves microcapsule stability and encapsulates lemon essential oil for food preservation

Article

作者: Gong, Yuxi ; Zhang, Xiangyu ; Wang, Yansong ; Wu, Chao ; Wu, Dongmei ; Yang, Wei ; Li, Jinlian

The microencapsulation of essential oils by complex coacervation technology has attracted considerable attention. This paper deals with the preparation of gelatin-chitosan microcapsules through dual cross-linking using transglutaminase (TGase) and tannic acid (TA). Lemon essential oil (LEO) was successfully encapsulated with 82.5 % encapsulation efficiency. Compared to single cross-linking microcapsules (TG), dual cross-linking microcapsules (TG-TA) exhibit superior thermal stability and swell stability. In vitro release studies demonstrated that TG-TA exhibited better controlled-release behavior with a longer duration of action. Meanwhile, the lipid oxidation of TG-TA was 1.45 mg MDA/kg that of control group was 2.23 mg MDA/kg which showed their excellent antioxidant effects. Moreover TG-TA have higher antibacterial rate, more inhibition zone diameters and better effect for preventing the growth of total viable count than TG and LEO. This study has theoretical implications for the use of TG-TA ideal carriers for protecting various active substances, thus facilitating their applications in food preservation.

2025-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Lavender improves sleep through olfactory perception and GABAergic neurons of the central amygdala

Article

作者: Gao, Jin-Xian ; Wang, Can ; Yang, Xing-Wen ; Xin, Le ; Lin, Jian-Sheng ; Ren, Yan-Li ; Hou, Yi-Ping ; Chen, Yu-Nong ; Xie, Jun-Fan ; Spruyt, Karen ; Chu, Wei-Wei ; Shao, Yu-Feng ; Yan, Gui-Zhong

ETHNOPHARMACOLOGICAL RELEVANCE:

The use of lavender as sleep aid or hypnotic agent can be traced back as early as ancient Romans and Greeks. Yet, objective experimental data on whether and how lavender enhances sleep duration or/and sleep quality remain lacking.

AIM OF THE STUDY:

We aimed to characterize the sleep-wake regulating effects of lavender in the mouse and to demonstrate the brain targets and neural circuits involved.

MATERIALS AND METHODS:

A self-made precise odor delivery system combined with chronic polysomnographic recordings was employed to assess the sleep-wake effects of inhalation with lavender essential oil (LEO, extracted from lavender) and its different constituents during the light and dark phases in free-moving C57BL/6J mice. Neuroviral labeling, in situ hybridization and pharmacogenetics were combined to identify the neural circuits and targets involved. Finally, an insomniac model of DL-4-Chlorophenylalanine (PCPA)-treated mice was established to examine the sleep-inducing potential of LEO.

RESULTS:

We found that inhalation of LEO with a concentration at 25.0% during the light (inactive) phase significantly shortened the latency to non-rapid eye movement (NREM) sleep, increased the total amount of NREM sleep at the expense of wakefulness (W), and enhanced cortical EEG slow wave activities, notably delta power spectra density. We further identified linalool, d-limonene, 1,8-cineole, linalyl acetate and terpinene-4-ol as the major effective sleep-promoting monomer components. Importantly, we found that LEO no longer produced any of the above sleep-promoting effect following either nasal injection of zinc sulfate which interrupts the olfactory pathway, or pharmacogenetics silencing of central amygdala GABAergic neurons. Finally, LEO reestablished NREM sleep with short latency in PCPA-treated insomniac mice, effects comparable with those induced by a potent sedative diazepam.

CONCLUSIONS:

We have characterized the quantitative and qualitative sleep-promoting effects of LEO and its effective components via the olfactory pathway and central amygdala GABA neuronal targets. The hypnotic property of LEO is reinforced by its ability to restore sleep in insomnia. Our study thus establishes a neurobiological basis for aromatherapy of sleep disorders using lavender.

2024-12-01·Applied microbiology and biotechnology

Metabolomic analysis of hydroxycinnamic acid inhibition on Saccharomyces cerevisiae

Article

作者: Chen, Junxiao ; Yi, Wenbo ; Xu, Shujie ; Gu, Jie ; Tan, Liping ; Liu, Tongjun ; Ge, Xiaoli

Abstract:

Ferulic acid (FA) and p-coumaric acid (p-CA) are hydroxycinnamic acid inhibitors that are mainly produced during the pretreatment of lignocellulose. To date, the inhibitory mechanism of hydroxycinnamic acid compounds on Saccharomyces cerevisiae has not been fully elucidated. In this study, liquid chromatography-mass spectrometry (LC–MS) and scanning electron microscopy (SEM) were used to investigate the changes in S. cerevisiae cells treated with FA and p-CA. In this experiment, the control group was denoted as group CK, the FA-treated group was denoted as group F, and the p-CA-treated group was denoted as group P. One hundred different metabolites in group F and group CK and 92 different metabolites in group P and group CK were selected and introduced to metaboanalyst, respectively. A total of 38 metabolic pathways were enriched in S. cerevisiae under FA stress, and 27 metabolic pathways were enriched in S. cerevisiae under p-CA stress as identified through Kyoto Encyclopaedia of Genes and Genomes (KEGG) analysis. The differential metabolites involved included S-adenosine methionine, L-arginine, and cysteine, which were significantly downregulated, and acetyl-CoA, L-glutamic acid, and L-threonine, which were significantly upregulated. Analysis of differential metabolic pathways showed that the differentially expressed metabolites were mainly related to amino acid metabolism, nucleotide metabolism, fatty acid degradation, and the tricarboxylic acid cycle (TCA). Under the stress of FA and p-CA, the metabolism of some amino acids was blocked, which disturbed the redox balance in the cells and destroyed the synthesis of most proteins, which was the main reason for the inhibition of yeast cell growth. This study provided a strong scientific reference to improve the durability of S. cerevisiae against hydroxycinnamic acid inhibitors.

Key points:

• Morphological changes of S. cerevisiae cells under inhibitors stress were observed.• Changes of the metabolites in S. cerevisiae cells were explored by metabolomics.• One of the inhibitory effects on yeast is due to changes in the metabolic network.

项与夫西地酸钠相关的新闻（医药）

2024-10-30

·米内网

【瞩目】海思科拿下6亿大品种

精彩内容 10月29日，NMPA官网显示，海思科以仿制3类报产的地奈德乳膏获批上市并视同过评，为国产第5家。地奈德乳膏是外用糖皮质激素类药物，2023年在中国三大终端六大市场销售额超过6亿元。地奈德乳膏适用于对皮质类固醇治疗有效的各种皮肤病，如接触性皮炎、神经性皮炎、脂溢性皮炎、湿疹、银屑病、扁平苔藓、单纯性苔藓、汗疱症等引起的皮肤炎症和皮肤瘙痒的治疗。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）地奈德乳膏销售额超过6亿元，同比增长13.91%；2024年上半年其销售额超过3亿元，同比增长0.29%。中国三大终端六大市场地奈德乳膏销售情况（单位：万元）来源：米内网格局数据库此前国内已有4家企业华邦制药、人福医药、华邦胜凯制药、福元药业获得了地奈德乳膏的生产批文，海思科为该产品国产第5家。本次地奈德乳膏获批上市，将进一步丰富公司产品线，有助于提升公司产品的市场竞争力。目前，海思科已有3款软膏剂产品夫西地酸钠软膏、利丙双卡因乳膏、地奈德乳膏获批上市。 10月29日，海思科公布2024年第三季度业绩，公司前三季度实现营业收入27.51亿元，同比增长15.41%；归母净利润3.82亿元，同比增长90.20%；扣非净利润2.15亿元，同比增长44.55%。2024年前三季度公司研发费用3.78亿元，同比增长10.61%。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

财报上市批准

2024-08-26

·CPHI制药在线

会议报名 | 东南亚医药市场开拓机遇与挑战主题会议

✦ ✦ ✦ 随着中国经济的快速增长和科技实力的提升，国内新药研发蓬勃发展，为出海打下良好基础。一直以来，中国医药、原料药出口贸易在东南亚市场占有举足轻重的份额。其中，印度尼西亚、泰国、越南、菲律宾和马来西亚五个国家占据了东南亚医药市场的90%以上。未来这些国家将会成为国内企业转战的重要市场，包括投资建厂等深度合作开发。为助力中国药企加速布局东南亚医药市场，9月11日，东南亚医药市场开拓机遇与挑战主题会议将于CPHI & PMEC 制药工业展（深圳）展会期间在深圳会展中心（福田）举办。会议将从当下市场的最新国际形势出发，结合案例与报告，与上下游企业共同探讨东南亚市场的发展机遇。 ✦ ✦ ✦ 东南亚医药市场开拓机遇与挑战主题会议会议时间 9月11日会议地点深圳会展中心（福田）论坛区A（展位：9A56）主办单位上海博华国际展览有限公司承办单位北京东方比特科技有限公司协办单位 E药经理人扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份 SHENZHEN 会议议程 09:30 主持人致辞 09:40-10:20 东南亚国家医药国际贸易报告嘉宾介绍吴惠芳北京东方比特（健康网）总经理兼首席研究员，北京玉德未来控股有限公司副总裁吴女士在军事医学科学院药物分析专业获理学硕士学位，1980年起从事药学相关工作，2000年前在部队医疗、科研机构从事临床药学、科研管理等工作，技术职务副主任药师。2000年退役后从事医药信息研究工作，专注于医药行业研究、市场研究、产业链结构研究等领域。在医药原料药、医药商品进出口、医药产业数据等信息方面有发布了大量文献资料和报告发表。为国内外企业、政府和科研机构提供咨询服务。连续多年为“中国化学制药工业协会”所著《医药发展蓝皮书》、《中国医药手册》作者之一；是《中国医药报》、《医药经济报》的特约撰稿人，在国内重要医药报刊发表大量文章。多次被邀请在中国医药行业大型会议和展览上做有关中国医药市场专题演讲。她的演讲以实际数据和案例阐明问题、总结变化规律，在中国制药企业中广为流传，受到医药界的好评。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:20-10:50 中国制药企业出海东南亚国家的案例分享嘉宾介绍王亚锋上海医药国际业务事业部东南亚区域负责人、上药泰国总经理中国药科大学本科，中欧国际工商学院Global EMBA。从事医药国际营销工作十余年，深厚的医药行业知识和专业能力。拥有丰富的海外子公司运营和营销团队管理经验。深度参与海外工厂立项，写字楼，仓库等绿地项目建设。海外常驻包括非洲加纳，尼日利亚，乌干达，科特迪瓦，东南亚泰国，菲律宾等多个国家。熟悉多个市场药政法规以及行业准入要求。多次在海外国家从零开始设立全资公司、合资公司，组建销售团队，实现业绩从零突破，运作药品进入国家用药指南和国家医保。所在团队曾实现单品种中国制剂出口第一。历任复星医药集团桂林南药国际商务代表，销售经理，海外国家经理，大区经理等，现任上海医药国际业务事业部东南亚区域负责人，上药泰国总经理。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:50-11:20 印度尼西亚制药业的机遇和市场开拓实践嘉宾介绍张君丽成都市一诺医药化工有限公司总经理采购总监公司团队深耕印尼市场十年，专注医药API等产品出口；聘请多名印尼本地员工，长期穿梭在印尼各个制剂工厂，拜访客户，与当地前十大药企均有超级深度的合作与链接！ 11:20-11:45 印尼清真医药产品市场情况更新嘉宾介绍 Dr. Ir. Muslich, M.Si Halal Partnership and Audit Services Director, LPPOM 获得IPB大学学士(S1)、研究生(S2)和博士(S3)学位;此前曾在多家私营公司工作(1991年至1993年)，PT TELKOM WITEL IX Jayapura农业和农用工业发展中心经理(1993年至1994年)，LPPOM MUI清真保证体系负责人(2010年至2015年)，QA和LPPOM MUI标准负责人(2015年至2019年)，LPPOM MUI高级顾问(2020年)，MUI清真认证要求开发团队负责人(2010年至2011年);现为IPB大学农业技术学院农业工业工程系讲师(自1994年起)，清真审核员(自1995年起)，清真管理体系标准制定技术委员会(SNI 99 001)成员，清真家禽屠宰场(SNI 99 002)，家庭切清真反刍(SNI 99 003)，清真食品(SNI 99 004)国家标准化机构(自2015年起)，SKKNI主管能力测试设备开发团队负责人Halal & SKKNI清真审核员(自2017年起)，国家认证机构能力评估员职业(BNSP)(自2015年起)，食品安全能力评估员，机构专业认证(LSP)食品质量保证与安全(JMKP)(自2015年起);于2020-2022年被任命为LPPOM MUI清真合作与审计服务总监。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 11:20-12:00 圆桌讨论：寻找东南亚市场的机会讨论嘉宾深圳市远邦医药有限公司湖南尔康制药股份有限公司成都倍特药业有限公司广州康臣药业有限公司 ...... 扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份把握东南亚市场发展机遇加速融入全球制药供应链随着东南亚医药市场的发展潜能进一步释放，中国医药企业将迎来更多发展机遇。作为中国药企链接国际市场的重要纽带，CPHI & PMEC 制药工业展（深圳）将携手400余家优质展商，共同探索企业在东南亚乃至全球市场的发展路径。下面就请跟随小编的步伐，一起走近本期的优选展商吧！浙江瑞邦药业股份有限公司展位：9F08 浙江瑞邦药业股份有限公司成立于1956年，具有60多年生产医药原料药和食品添加剂的生产经验。公司以药品生产质量管理规范（GMP) 标准组织生产和销售。本公司的产品获得了美国FDA，欧洲CEP和中国GMP的认证。主要产品有葡萄糖酸盐系列，莫匹罗星，莫匹罗星钙，环孢菌素，夫西地酸等。浙江瑞邦药业股份有限公司在国内外都享有良好的声誉。产品远销美国，欧洲，日本，印度及其他南美和东南亚地区。主推产品环孢菌素、莫匹罗星、莫匹罗星钙、葡萄糖酸钙、葡萄糖酸锌、葡萄糖酸钾、葡萄糖酸镁、葡萄糖酸亚铁、葡萄糖酸铜、葡萄糖酸锰、葡萄糖酸钠、多粘菌素B、夫西地酸、夫西地酸钠、米尔贝肟、葡萄糖酸内酯、非达霉素、甘草次酸、原儿茶酸。 ☝🏿☝🏿上下滑动查看完整展商介绍河北华晨药业集团有限公司展位：9D46 河北华晨药业集团有限公司，始建于1991年，坐落于黄骅经济开发区。是一家集研发、生产、销售药用包装材料、原料药、制剂、医疗器械，开展国内外贸易为一体的医药企业。集团公司现下设河北华晨药业有限公司、黄骅华宾生物科技有限公司、河北华迪药业有限公司、华晨吉海（北京）药物研究院。目前华晨药业拥有通过GMP认证的药用氯化钠、碳酸氢钠、氯化钾及新增制剂包括片剂、硬胶囊制剂、颗粒剂、散剂、软膏剂、凝胶贴膏剂、口服液等数十种，同时生产药用PE袋、膜、包装桶、瓶等药用包装材料等。主推产品氯化钠、碳酸氢钠、氯化钾、氯化钙、氯化铵、依地酸二钠、重酒石酸胆碱、富马酸（辅料、富马酸亚铁、醋酸钙、醋酸钠、硫酸镁、碘化钾、氯化镁、富马酸亚铁、葡萄糖酸锌、葡萄糖二酸钙、双乙酸钠、树脂再生剂、碳酸镧、硫酸钾、利多卡因、氟比洛芬、氯化镁、麝香草粉、盐酸利多卡因、葡萄糖酸钙、洛索洛芬钠、磷酸奥司他韦、无水硫酸钠、氨苯蝶啶、托匹司特、硫酸亚铁、西甲硅油、硫酸双肼屈嗪、甘羟鋁、葡萄糖酸亚铁、叔丁醇镁、异丙醇镁、二甲硅油、碳酸钙、亚硫酸镁（六水）、硫酸钾、乳酸钙、乳酸钠、乳果糖、丙胺卡因、喷托维林、丁卡因、双氯芬酸依泊胺、克立硼罗、阿达帕林、盐酸异丙嗪、高岭土、克罗米通、盐酸异丙嗪、氨苯蝶啶、叔丁醇镁、异丙醇镁、亚硫酸镁知名。 ☝🏿☝🏿上下滑动查看完整展商介绍山西阳和药业有限公司展位号：9A13 山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。主推产品乙酰半胱氨酸、间苯三酚、聚乙烯醇、间苯三酚三甲醚。 ☝🏿☝🏿上下滑动查看完整展商介绍浙江荣耀生物科技股份有限公司展位：9C51 浙江荣耀生物科技股份有限公司创立于1999年，位于台州湾经济技术开发区，是一家集研发、生产、销售于一体的创新型医药企业，是国家高新技术企业、浙江省专精特新中小企业、浙江省科技型中小企业。业务涵盖医药原料药及中间体、兽药原料药及中间体、CDMO等。主推产品二硝托胺148-01-6、甲砜霉素15318-45-3、氟苯尼考73231-34-2、非班太尔58306-30-2、芬苯达唑43210-67-9、莫昔克丁113507-06-5、赛拉菌素220119-17-5、氟雷拉纳864731-61-3、奥拉替尼1208319-26-9、2-氨基-N-(2、2、2-三氟乙基)乙酰胺盐酸盐1171331-39-7、三氯苯达唑68786-66-3、癸氧喹酯18507-89-6、尼卡巴嗪330-95-0、3′、5′-二氯-2、2、2-三氟苯乙酮130336-16-2、4-氯吡咯并嘧啶3680-69-1、反式-N-甲基-[4-(甲氨基)环己基]甲磺酰胺1809995-95-6、依帕司他82159-09-9、盐酸氨溴索23828-92-4、盐酸金刚乙胺1501-84-4、盐酸溴己新611-75-6、西司他丁82009-34-5、3-甲基-6-硝基-1H-吲唑6494-19-5、2-[4-(2-吡啶基)苄基]-肼羧酸叔丁酯198904-85-7、2-氨基-1-(2、5-二甲氧基苯基)乙醇3600-87-1、3-(三氟甲基)-5、6、7、8-四氢-[1、2、4]三唑并[4、3-a]吡嗪盐酸盐762240-92-6、(3S、4R)-4-(4-氟苯基)-1-甲基-3-哌啶甲醇105812-81-5、1-(4-氨基苯基)环戊甲腈115279-73-7、3-氨基-1-金刚烷醇702-82-9、1-金刚烷甲酸828-51-3、2-金刚烷酮700-58-3、1-金刚烷胺768-94-5、1-金刚烷甲醇770-71-8、2-金刚烷醇700-57-2、1-金刚烷醇768-95-6。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏宇田医药有限公司展位：9E31 江苏宇田医药有限公司是一家从事现代医药研发、生产、销售为一体的新型特色API及CDMO制药企业，致力于为国内各大制药企业提供高质量的原料药与中间体，公司产品同时远销欧洲、日韩、印度等数十个国家，为国家重点高新技术企业、市科技小巨人企业、中华药港新医药产业基地骨干企业之一。宇田医药始终把科研开发作为企业可持续发展的支撑力量，是国内科研投入较多的药企之一，公司以连云港研发中心为科研载体，配合杭州科巢生物科技、连云港万科生物科技、黑龙江迪诺医药，自主创新能力不断增强。形成了“以一带三”的良性格局。宇田医药在江苏连云港、黑龙江佳木斯建有两个生产基地，获得国家高新技术企业、省级工程技术研究中心、江苏省瞪羚企业、江苏省科技型中小企业、安全标准化二级企业、省两化融合示范试点企业，同时也获得了原料药品种的GMP和注册现场核查的二合一认证，先后承担省/市级成果转换等多个省/市级科技项目；获得授权专利与商标数十项；通过ISO9000、ISO14000认证。这些荣誉的取得标志着企业药品生产质量和管理水平走在了全国医药行业前列。主推产品原料药：碘克沙醇、碘海醇、阿托伐他汀钙、瑞舒伐他汀钙、盐酸伊伐布雷定、利奈唑胺、西洛多辛、盐酸厄洛替尼、盐酸莫西沙星及各中间体。中间体：造影剂系列中间体、多尼培南侧链、比阿培南侧链、1,4-丁二磺酸。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏同禾药业有限公司展位：9D26 江苏同禾药业有限公司是江苏万兴创业投资有限公司的全资子公司，是一家集制剂药、原料药和保健食品的研发、生产、销售为一体的国家高新技术企业。连续8年，跻身于常熟市百强企业前50 名。公司拥有原料药、片剂、胶囊剂和颗粒剂的GMP证书。硫辛酸、6.8-二氯辛酸乙酯、右旋硫辛酸钠、环丙贝特、10-甲氧基亚氨基芪等多个产品被评为江苏省高新技术产品；硫辛酸、盐酸二甲双胍等取得了原料药品批件，厄多司坦片、氨酚伪麻分散片和新雪胶囊等取得药品注册批件和新药证书；硫辛酸片和胶囊即将取得新药证书，另有10多个新药正在SFDA审批中。调节血糖和控制并发症的保健食品唐苹片正在全国热销中。主推产品硫辛酸系列、右旋硫辛酸、右旋硫辛酸钠盐、右旋硫辛酸氨基丁三醇盐。 ☝🏿☝🏿上下滑动查看完整展商介绍 CPHI & PMEC 制药工业展（深圳）致力于打造国际化制药产业生态圈，汇集产业链上下游实力企业，以技术驱动产业提升，助推更多中国药企扬帆“出海”，聚势共赢！扫描二维码 0元领票 8月30日前完成预登记现场可领取电子会刊一份金秋九月·不见不散！联系我们参观咨询林女士电话：021-33392105 邮箱：ashley.lin@imsinoexpo.com 张女士电话：010-58036315 邮箱：zhangyuanyuan@cccmhpie.org.cn 参展咨询茅女士电话：021-33392250 邮箱：chris.mao@imsinoexpo.com 吴女士电话：010-58036296 邮箱：wuyushuang@cccmhpie.org.cn 👇点击“阅读原文”，免费领取展会参观门票！！

高管变更

2023-02-06

·GlobeNewswire-Health Care

Aceragen Announces Recommendation of Data Monitoring Committee in Terra Study

DURHAM, N.C. and EXTON, Pa., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Aceragen, Inc. (Nasdaq: ACGN) a clinical-stage biopharmaceutical company committed to transforming the care of people living with rare pulmonary and rheumatic diseases, today announced the recommendation of its independent Data Monitoring Committee (DMC) in regard to the on-going TERRA Phase 2 study of ACG-701 in patients with melioidosis. The DMC is responsible for providing oversight of safety and efficacy for this study and has recommended the TERRA study continue without modification. The DMC review was a planned meeting held in order to monitor the safety of the seriously ill subjects participating in the TERRA study. “This safety review represents an important milestone for ACG-701, as it allows the TERRA study to continue to evaluate ACG-701 in these hospitalized melioidosis patients. We are very pleased that the DMC recommended that the trial continue. We look forward to delivering the data from the study later this year,” stated Carl Kraus, M.D., Aceragen’s Chief Medical Officer. ACG-701 for MelioidosisAceragen has executed an ~$50 million development partnership with the Department of Defense’s Defense Threat Reduction Agency (“DTRA”) to investigate ACG-701 as a potential medical countermeasure for melioidosis, a life-threatening infection caused by the B. pseudomallei pathogen. This program is centered around a Phase 2 trial, the TERRA study (NCT05105035), which is a randomized double-blind, placebo-controlled trial conducted in hospitalized melioidosis patients. TERRA was initiated in May 2022 and continues to actively enroll patients with a data read-out expected in the fourth quarter of 2023. About Aceragen, Inc. Aceragen is a clinical-stage biopharmaceutical company committed to transforming the care of people living with rare pulmonary and rheumatic diseases. Our lead product candidate, ACG-701, is an oral, loading dose formulation of sodium fusidate that is in development for the treatment of melioidosis and acute pulmonary exacerbations associated with cystic fibrosis. ACG-701 has received Fast Track Designation, Orphan Drug Designation, and Qualified Infectious Disease Product (QIDP) from the FDA in acute exacerbations with cystic fibrosis. Aceragen is also developing ACG-801, recombinant human acid ceramidase, as an enzyme replacement therapy for an untreated lysosomal storage disorder called Farber disease. To learn more about us and our programs, please visit Aceragen.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including, without limitation, statements regarding the Company's new development opportunities, clinical trials and studies, product designation and/or status, financial position, funding for continued operations, cash reserves, projected costs, prospects, clinical trials, plans, expectations, strategies, projections and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," “schedule,” and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on our current expectations and projections about future events and various assumptions. We cannot guarantee that we will achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond our control, and which may cause our actual results, performance, or achievements to differ materially from future results, performance, or achievements expressed or implied by such forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by its forward-looking statements including, without limitation: whether we will be able to successfully integrate the acquired operations; whether our cash resources will be sufficient to fund continuing operations; and newly acquired operations; whether our products will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether our products receive approval, they will be successfully distributed and marketed; and whether our collaborations will be successful. All forward-looking statements included in this press release are made as of the date hereof and are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and otherwise in the Company’s subsequent filings and reports filed with Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required by law. Please direct questions to: John KirbyChief Financial OfficerAceragen, Inc.

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KEGG	Wiki	ATC	Drug Bank
-	-	D09AA02 S01AA13 J01XC01	-

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适应症	国家/地区	公司	日期
细菌感染	加拿大	Leo Pharma, Inc.	1984-01-01
继发感染	日本	Alfresa Pharma Corp.	1972-04-22

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适应症	最高研发状态	国家/地区	公司	日期
骨和关节感染	临床3期	美国	Arrevus, Inc.初创企业	2015-12-01
葡萄球菌感染	临床3期	美国	Arrevus, Inc.初创企业	2015-12-01
皮肤和皮肤结构感染	临床3期	美国	Arrevus, Inc.初创企业	2015-11-01
皮肤和皮肤结构感染	临床3期	波多黎各	Arrevus, Inc.初创企业	2015-11-01
肺囊性纤维化	临床2期	美国	Aceragen, Inc.	2023-02-10
类鼻疽	临床2期	泰国	Arrevus, Inc.初创企业	2022-06-14
假体关节感染	临床2期	美国	Arrevus, Inc.初创企业	2012-12-01
细菌性皮肤疾病	临床2期	美国	Arrevus, Inc.初创企业	2009-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02569541 (CTgov)	临床2/3期	骨和关节感染 \| 葡萄球菌感染	30	sodium fusidate	鹽鏇蓋膚餘積襯衊廠壓(淵積醖襯鑰廠夢鹹繭遞) = 鑰鑰鏇積夢餘選襯糧憲廠製積築鹽製壓廠構鬱 (積鹽製鑰壓製簾餘醖餘, 壓鬱鑰繭遞襯選艱範鏇 ~ 淵淵鹽顧蓋襯蓋憲鬱淵) 更多	-	2020-01-30
NCT02570490 (GlobeNewswire) 人工标引	临床3期	皮肤和皮肤结构感染	716	Fusidic acid	鹽築鹹壓製夢齋製構積(糧獵窪壓窪憲鑰範遞襯) = 遞築繭襯襯壓膚壓範壓鏇簾壓製衊簾鑰襯築廠 (觸積構獵築繭夢蓋夢獵 ) 更多	非劣	2017-02-24
				linezolid	鹽築鹹壓製夢齋製構積(糧獵窪壓窪憲鑰範遞襯) = 構糧遞製遞淵醖觸顧構鏇簾壓製衊簾鑰襯築廠 (觸積構獵築繭夢蓋夢獵 ) 更多
NCT00986856 (CTgov)	临床4期	脓疱疮	58	Fucidin® cream (Fucidin® Cream)	願顧選觸齋製顧襯願鑰(淵淵壓憲窪襯簾蓋壓鬱): Odds Ratio (OR) = 13.2 (95% CI, 1.4 ~ 120.4), P-Value = <0.01 更多	-	2010-09-29
				Fucidin® cream (Fucidin® Cream Vehicle)