An Open Label, Single Center, Randomized, Two-way Crossover Parallel Group, Trial to Assess the Mechanism of Action of a Bi-layer Swallowable Tablet (Immediate Release and Sustained Release) Containing Calcium Carbonate Antacid in an Overnight and Day Application as Compared With a Standard, Non-layered (Immediate Release) Calcium Carbonate Swallow Tablet in Fed Healthy Male Participants.

Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).
Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).
In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.
The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.
For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.
The participants will be randomly (by chance) assigned to one of two treatment groups:
Participants in the first group will take the treatments at night.
Participants in the second group will take the treatments during the day.
All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.
Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:
1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study
2. visits for treatment with a gap of 6-8 days between each treatment, and
1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.
During the study, the doctors and their study team will:
check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)
take images of the stomach at different times after taking the treatment
measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach
ask the participants questions about how easy it is to take the study treatment
ask the participants what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.
As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned.

开始日期2024-03-06

申办/合作机构

Bayer AG

RBR-7hqhj3y / Not yet recruitingN/AIIT

Use of calcium carbonate supplementation to prevent Pre-eclampsia in pregnant women high risk: randomized clinical trial

开始日期2024-01-10

申办/合作机构-

NCT06042985 / Not yet recruiting临床4期IIT

Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB A Double-blind, Randomized Cross-over Trial

The precise impact of calcium absorption in relation to RYGB, SG, and OAGB remains under-researched in terms of statistical power and the diversity of BMS procedures considered. Therefore, this presents a critical area for future investigation to improve patient outcomes in BMS.

开始日期2023-12-01

申办/合作机构-

100 项与碳酸钙相关的临床结果

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100 项与碳酸钙相关的转化医学

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100 项与碳酸钙相关的专利（医药）

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2,979

项与碳酸钙相关的文献（医药）

2024-04-01·Microbiological research

Multi-trait efficiency and interactivity of bacterial consortia used to enhance plant performance under water stress conditions

Article

作者: Eudoxie, Gaius ; Ramsubhag, Adesh ; Thomas-Barry, Gem ; Miller, Judy Rouse ; Martin, Chaney St

Water stress is a major limiting factor for agricultural production under current and projected climate change scenarios. As a sustainable strategy, plant growth-promoting bacterial consortia have been used to reduce plant water stress. However, few studies have examined the effects of stress on multi-trait efficiency and interactivity of bacterial species. In this study, we used several in-vitro experiments, plant assays and greenhouse trials to investigate the effects of stress and bacterial consortia on 1-aminocyclopropane-1-carboxylic acid deaminase (ACCD) activities, indole-3-acetic acid (IAA) production and plant growth-promoting traits (Phosphate-solubilization, starch hydrolysis, siderophores and ammonium production). We further assessed biofilm formation and the chemotactic behaviour in response to ACC. A total of fifteen ACCD rhizobacteria with multiple growth-promoting traits from the dominant plant species from the hyperseasonal Aripo Savannas were screened in this study. Five of the isolates were further analyzed based on their ACCD activities and were tested in single and dual consortium to assess their abilities in promoting growth under simulated drought stress (-0.35 MPa) and chemically induced ACC conditions (0.03 mM). Our findings showed that bacteria which produce high concentrations of IAA affected the isolates' ability to promote growth under stress, irrespective of microbial combination with ACCD activity above the minimal threshold of 20 nmol α-ketobutyrate mg^-1 h^-1. Biofilm production with co-culture interaction varied greatly across treatments, however, the general trend showed an increase in biofilm under stress induce conditions. The best performing co-culture, UWIGT-83 and UWIGT-120 (Burkholderia sp.) showed enhanced growth in germination assays and in greenhouse trials with Capsicum chinense (Moruga red hot peppers) under drought stress, when compared to non-inoculated treatments. The findings highlight the importance of testing interactivity of bacterial species with multiple growth promoting traits under stress conditions; and proposed the use of ACC growth media as a novel biofilm screening method for selecting potential stress plant growth-promoting bacteria. Better screening strategies for appropriate plant growth-promoting bacteria may narrow the inconsistency observed between laboratory and field trials.

2024-03-01·Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate

Article

作者: Lea, Janice I ; Ajiboye, Oyintayo ; Navarrete, José E

Background::

Hyperphosphataemia is a common complication of kidney disease. Current dialysis techniques do not provide enough phosphorus clearance, hence the need to use phosphorus binders. Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Patients receiving peritoneal dialysis (PD) with sustained elevated ferritin levels exceeding 800 ng/mL are at a higher risk of death. We identify PD patients treated with iron-based binders and compare ferritin and risk of iron accumulation to patients treated with non-iron-based binders.

Methods::

All records of patients receiving PD at Emory dialysis centres until 30 October 2021 were reviewed for phosphorus binders. Basic demographics and laboratory data were time-referenced to the days on treatment with a particular binder. Patients were followed until discontinuation of the phosphorus binder, death, transplant, transfer to another dialysis provider or censoring at 36 months after medication was started.

Results::

Compared to calcium acetate and sevelamer, ferric citrate utilisation in PD patients resulted in a sustained increase in ferritin. The proportion of patients with a ferritin equal to or greater than 800 ng/dL and transferrin saturation greater than 40% increased over time in patients treated with ferric citrate and was higher during the second and third year of follow-up compared to baseline values and to patients treated with calcium acetate or sevelamer. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis.

Conclusions::

Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels.

2024-02-01·Homeopathy : the journal of the Faculty of Homeopathy

Impact of a Novel Homeopathic Complex Medicine on the Management of Multiple Antibiotic-Resistant Bovine Mastitis: An Open-Label, Non-Randomized, Placebo-Controlled Trial

Article

作者: Piau Júnior, Ranulfo ; Borges, Jessé Lahos ; Simões, João Vitor Morais ; Marçal, Matheus Basilio ; de Sá, Thaís Camaso ; Gazim, Zilda Cristiani ; Laginestra, Bruna de Fatima Antunes ; Rodrigues, Selma Alves

Abstract:

Background Bovine mastitis is characterized by an inflammatory process in the mammary gland and represents one of the main diseases affecting a dairy herd. Management of mastitis is most commonly via antibiotics, but the rising incidence of multiple antibiotic resistance (MAR) means that additional options are needed. Homeopathic products can be administered in dairy farming for a range of clinical reasons and may be preferential due to the absence of residues. Objectives The aim of this study was to assess the potential of a novel homeopathic complex medicine in managing bovine mastitis. Methods Twenty-four lactating Holstein cows with mastitis were divided into two groups: the homeopathic complex group received a homeopathic complex daily for 60 days at a dose of 20 g/d; the placebo group received the calcium carbonate vehicle without homeopathic medicines at the same dose and repetition. The main outcome measure was somatic cell count (SCC; cells/mL), with additional outcome measures including milk production (kg/d), milk constituents (percentage of protein, fat, lactose and total milk solids), and serum levels of cortisol, glucose, ammonia and lactic acid. All outcomes were measured at the beginning of the study and after 30 and 60 days. Milk samples were also collected from all animals at the beginning of the study, confirming a high (>0.2) MAR index for isolated bacterial cultures. Results Assessment of SCC showed a statistically significant difference favoring the homeopathic complex versus placebo group at day 60. A reduction in serum cortisol levels and an increase in fat, lactose and total milk solids in animals treated with the homeopathic complex at day 60 were also seen. Other outcome measures did not show statistically significant inter-group differences. Conclusion The results of this non-randomized, open-label, placebo-controlled trial suggest the potential for a novel homeopathic complex medicine in management of multiple antibiotic-resistant bovine mastitis, thus offering dairy farmers an additional option to antibiotics and making dairy products safer for consumer health and milk production more sustainable.

项与碳酸钙相关的新闻（医药）

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

2024-08-08

·echemi

After 2023 Snub, Amneal Clinches Approval for Extended-Release Parkinson's Disease Med Crexont

After a major setback in 2023, Amax Pharmaceuticals finally ushered in a brilliant victory in the United States, its signature innovative delayed release Parkinson's disease treatment drug - Crexont, successfully obtained the authoritative approval of the United States Food and Drug Administration (FDA). This unique oral calcium carbonate/levodopa (CD/LD) extended-release formulation opens a new chapter in the treatment of patients with Parkinson's disease with its superior efficacy and convenience, not only significantly extending their "well" period, but also reducing the number of burdensome daily doses to three times, greatly improving patients' quality of life. The FDA accepted Crexont's application after a thorough review and analysis of the detailed Phase III clinical trial data submitted by Amax. In this critical clinical trial of RISE-PD, Crexont stood out for its exceptional performance, providing patients with an additional 30 precious minutes of "good" time per day compared to traditional ready-to-release CD/LD. In addition, its average daily frequency of taking only three times, compared with five times for traditional drugs, undoubtedly brings unprecedented convenience to patients. The successful approval of Crexont is undoubtedly a significant milestone in the treatment of Parkinson's disease. In the face of the large population of patients in the United States - about 1 million people with Parkinson's disease, and about 90,000 new cases each year, the introduction of Crexont has undoubtedly brought unprecedented hope for patients. The co-ceos of Amax Pharmaceuticals, Chirag Patel and Chintu Patel, could not contain their excitement, saying that it is their greatest honor to bring this epoch-making new treatment to Parkinson's disease patients in the United States. At the same time, the company is also confidently planning to bring this innovative treatment to the international market. However, behind the success is often accompanied by unremitting efforts and challenges. Amax had previously been rejected by the FDA because of insufficient safety data on Crexont. This setback did not break them, but inspired them to be more determined and more rigorous. Now, with the successful approval of Crexont, the drug is expected to generate annual sales of up to $300 million to $500 million, further solidifying its leading position in the treatment of Parkinson's disease. It's worth noting that Amax is not alone. Abbott and Newrod Pharmaceuticals, among others, have faced similar regulatory challenges on the road to developing new levodopa preparations. These experiences show that despite the difficulties ahead, pharmaceutical companies are still working hard to find better treatments for Parkinson's disease. Amax's success has undoubtedly set an example for the entire industry, and has brought more treatment options and light of hope to patients with Parkinson's disease.

临床3期上市批准临床结果

2024-06-24

·米内网

中国零售药店市场首破9000亿！华润、国药、广药领军TOP10集团，33个超10亿品牌亮眼

精彩内容近期，国家药监局发布《药品监督管理统计年度数据（2023年）》，截至2023年12月底，全国共有零售连锁总部6725家，零售连锁门店385594家，单体药店281366家。米内网数据显示，按终端平均零售价计算，2023年中国实体药店和网上药店(含药品和非药品)销售规模达9233亿元，同比增长5.8%。其中，实体药店占比跌至67.5%，网上药店突破3000亿元。从实体药店各品类结构来看，2023年药品销售额占比为78.2%，较2022年上升1.5个百分点。2023年中国城市实体药店中成药、西药TOP10品牌销售额均超10亿元，TOP10集团中，华润医药、国药集团、广药集团位列前三。零售药店市场首破9000亿！网上药店占比持续提升图1：2014-2023年中国实体药店和网上药店(含药品和非药品)销售情况（单位：亿元）数据显示，2023年中国实体药店和网上药店(含药品和非药品)销售规模再创新高，达9233亿元，同比增长5.8%。图2：2014-2023年中国实体药店和网上药店(含药品和非药品)销售额占比从零售药店类型来看，网上药店(含药品和非药品)销售额占比持续上涨，2023年达到了32.5%，“地盘”仍在持续扩张；实体药店(含药品和非药品)销售额占比呈持续下滑态势，2023年跌至67.5%，较2022年下滑2.6个百分点。图3：2014-2023年中国网上药店(含药品和非药品)销售情况（单位：亿元）2023年中国网上药店(含药品和非药品)销售规模冲破3000亿元，但增速继续放缓。图4：2014-2023年中国实体药店(含药品和非药品)销售情况（单位：亿元）2023年中国实体药店(含药品和非药品)销售规模为6229亿元，同比增长1.8%，为近十年最低值。图5：2016-2023年中国实体药店(含药品和非药品)各品类结构变化从2023年中国实体药店(含药品和非药品)各品类结构来看，药品类销售额占比为78.2%，较2022年提升1.5个百分点；药材类销售额占比也有所回升，达8.3%，较2022年提升0.9个百分点；保健品类销售额占比继续下滑，跌至5%，是历年新低；器械类销售额占比下跌0.7个百分点，其它类的销售额占比下跌0.8个百分点。 4870亿！实体药店药品销售额近十年来稳增长图6：2014-2023年中国实体药店药品销售情况（单位：亿元）2023年中国实体药店(城市实体药店+县乡村实体药店)药品销售规模为4870亿元，较2022年增长3.6%，近十年来均保持正增长态势。图7：2015-2023年中国城市实体药店与县乡村实体药店药品销售额占比米内网推出的《中国城市实体药店化学药与中成药终端竞争格局》数据显示，2023年中国城市实体药店(指：地级及以上城市实体药店)药品规模占中国实体药店药品规模的63.2%；中国县乡村实体药店(指：非地级城市，也就是县乡村实体药店)药品规模占比达36.8%。图8：2015-2023年中国城市实体药店(含地级及以上城市)药品销售情况（单位：亿元） 2023年中国城市实体药店(含地级及以上城市)药品规模为3077亿元，较2022年增长2.8%。而中国县乡村实体药店药品规模接近1793亿元，较2022年增长4%以上。图9：2023年中国城市实体药店(含地级及以上城市)中西药以及OTC/Rx市场份额从2023年中国城市实体药店(含地级及以上城市)药品类型看，化学药份额上涨至48.5%，生物药份额上涨至9.6%，较2022年分别提升了0.5个百分点、1个百分点，此消彼长之下，中成药份额较2022年下滑1.5个百分点，份额为41.9%；从处方性质看，处方药占比提升1.1个百分点至51.4%，稳坐半壁江山，非处方药占比下跌1.1个百分点至37.8%，双跨药占比保持在10.8%。 33个超10亿品牌亮眼，华润、国药、广药领军TOP10集团表1：2023年中国城市实体药店(含地级及以上城市)中成药TOP10品牌 2023年中国城市实体药店(含地级及以上城市)中，有14个中成药品牌销售额超过10亿元，TOP10品牌合计销售额超过189亿元，上榜门槛为12.07亿元，比2022年下降0.75亿元。 3个补气补血类用药品牌上榜，东阿阿胶的阿胶经历了前几年“阵痛”后在2022年开始恢复活力，2023年重登中成药品牌榜榜首；此外，公司独家产品复方阿胶浆也在2023年重回10亿梯队，增长率高达47.2%，是TOP10品牌中增速最高的品牌。 2个呼吸系统疾病用药品牌上榜，其中华润三九的感冒灵颗粒再创新高，销售额突破25亿元。 4个消化系统疾病用药品牌上榜，太极集团的藿香正气口服液在2022年冲上20亿梯队后继续保持高速增长态势，2023年的销售额涨至22.89亿元；康恩贝的肠炎宁片增长30.40%，销售额首次突破15亿元。表2：2023年中国城市实体药店(含地级及以上城市)西药（化学药+生物药）TOP10品牌2023年中国城市实体药店(含地级及以上城市)中，有19个西药（化学药+生物药）品牌销售额超过10亿元，TOP10品牌合计销售额超过174亿元，上榜门槛为13.68亿元，较2022年上升2.18亿元。广东东阳光药业的磷酸奥司他韦颗粒是唯一上榜的全身用抗感染药物，2022年销售额在9.5亿元水平，2023年大涨159.50%，销售额飙升至24.72亿元，一跃成为西药（化学药+生物药）新的TOP1品牌。青岛双鲸药业的维生素D滴剂第三年保持在20亿元水平；赫力昂的碳酸钙D3片(Ⅰ)在2022年突破10亿后迎来一波大涨，2023年销售额涨至13.88亿元。默沙东的帕博利珠单抗注射液是唯一上榜的抗肿瘤和免疫调节剂，经历了前几年的大涨后，2022年销售额达到了18亿元以上，2023年急降15.30%，跌至15.73亿元，但从近五年的复合增长率来看，该品牌高达76.40%，依然是TOP10品牌中最高值。广药集团的枸橼酸西地那非片在2019-2021年超越了晖致的枸橼酸西地那非片，一度占领该产品“半壁江山”，2022年晖致成功反击并在2023年保持领先优势，两个品牌2023年均有10%以上的增长，胜负就在毫厘之间。表3：2023年中国城市实体药店(含地级及以上城市)TOP10集团备注：上述“厂家”以集团计，如“华润医药”含华润三九、华润东阿、华润双鹤、华润江中等下属企业。 2023年中国城市实体药店(含地级及以上城市)TOP10集团合计销售额超过780亿元，上榜门槛为48.88亿元，比2022年上涨1.28亿元。榜首由华润医药蝉联，是2023年中国城市实体药店终端销售额唯一破200亿的集团。4家上榜TOP10集团的国内药企中，有3家在2023年有正增长，除了华润医药增长了6.07%，国药集团增长3.05%排名升上TOP2，北京同仁堂增长0.72%排在第十位。6家跨国药企中赫力昂和强生有双位数增长，拜耳降幅超过5%。结语近年来，随着公立医院改革、医保控费、药品集采、药店门诊统筹、处方外流等政策的持续推进，零售药店逐渐成为多方资源角逐的重要“战场”，同时也是供零双方深化商业共赢的共同目标。随着行业集中度的提升，区域性、全国性的医药零售连锁企业逐步形成，企业已从价格竞争逐步转变为差异化竞争，如何在激烈的市场竞争中砥砺前行则是企业应该去思考的问题。 6月25-28日，2024年米思会将在浙江湖州盛大召开。众多行业大咖将从热点政策解读、药品终端数据分析、药店价值定位、互联网医药新业态等领域进行全方位分析解读，米内网将对大会进行全程报道，欢迎关注。资料来源：米内网数据库等注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，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

IPO

100 项与碳酸钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00932	碳酸钙	A12AA04 A02AC01	DB06724

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高磷血症	日本	Pfizer Japan, Inc.	1999-06-16
高磷血症	日本	Mylan Seiyaku Ltd.	1999-06-16
骨质疏松症	中国	赫力昂（苏州）制药有限公司	-

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
胃食管反流	临床2期	日本	Otsuka Pharmaceutical Co., Ltd.	2017-10-31
甲状旁腺功能减退症	临床2期	-	-	-
骨转移癌	临床1期	以色列	Amorphical Ltd.	2022-06-01
去势抵抗性前列腺癌	临床1期	以色列	Amorphical Ltd.	2022-06-01
癌症	临床1期	以色列	Amorphical Ltd.	2018-07-18
肾上腺皮质癌	临床1期	以色列	Amorphical Ltd.	2017-06-25
继发性肺恶性肿瘤	临床1期	以色列	Amorphical Ltd.	2017-06-25
HIV感染	临床1期	-	ViiV Healthcare Ltd.	2012-12-01

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临床结果

适应症

分期

评价

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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


NCT02186600 (HOPS, CTgov)	临床3期	骨质疏松症	276	Calcium Carbonate+Vitamin D3 (Control)	淵衊構獵範選膚製蓋構(鏇夢遞鬱顧築製範願衊) = 製壓顧醖鬱鏇獵選膚憲夢蓋獵築簾淵廠衊觸憲 (壓醖衊糧淵範鹹艱襯夢, 襯衊網遞艱鹽糧淵繭鹽 ~ 構憲餘窪範艱鬱鏇獵願) 更多	-	2023-06-27
				Risedronate+Calcium Carbonate+Vitamin D3 (Risedronate)	淵衊構獵範選膚製蓋構(鏇夢遞鬱顧築製範願衊) = 獵鹽廠願鹹窪淵範衊衊夢蓋獵築簾淵廠衊觸憲 (壓醖衊糧淵範鹹艱襯夢, 選窪襯簾範鹹選壓願獵 ~ 製顧蓋壓繭窪衊製憲網) 更多
Pubmed \| J Am Coll Surg	N/A	低钙血症	82	Preoperative Calcium (Intervention group)	觸積夢餘簾積選憲鏇鏇(鹽鏇蓋鬱糧襯蓋淵製鬱) = 鏇鏇襯觸蓋蓋鏇淵觸遞艱構觸醖鏇鹽壓構築襯 (願壓餘觸憲繭艱製鏇範 )	不佳	2021-02-22
				Preoperative Calcium (Control group)	觸積夢餘簾積選憲鏇鏇(鹽鏇蓋鬱糧襯蓋淵製鬱) = 衊獵壓衊襯鏇製淵製衊艱構觸醖鏇鹽壓構築襯 (願壓餘觸憲繭艱製鏇範, SD 10.5)
ASN2019	N/A	-	37	Calcium Carbonate	築構鹽壓鏇顧願繭鏇鹽(鏇艱繭壓範遞壓獵遞範) = 構製蓋鹽醖壓繭壓壓遞鑰範壓窪範蓋遞蓋鑰醖 (衊淵憲鏇鬱構構襯願繭, 7 ~ 14) 更多	不佳	2019-11-05
				Sevelamer	築構鹽壓鏇顧願繭鏇鹽(鏇艱繭壓範遞壓獵遞範) = 蓋築齋選鏇醖壓觸簾願鑰範壓窪範蓋遞蓋鑰醖 (衊淵憲鏇鬱構構襯願繭, 3 ~ 19) 更多
NCT03089216 (CTgov)	临床4期	牙本质敏感症	108	Combined Bleaching(2x20) (Combined Bleaching(2x20))	鹽齋築夢鹹窪艱積襯觸(餘獵糧餘膚醖夢鹽構構) = 廠艱顧遞繭廠憲膚鑰構鹹繭淵蓋淵膚壓夢夢繭 (範窪獵顧蓋廠構積窪構, 製觸膚蓋廠鏇襯積鑰襯 ~ 觸積膚鏇醖顧簾糧遞獵) 更多	-	2019-08-05
				Combined Bleaching (1x20) (Combined Bleaching(1x20))	鹽齋築夢鹹窪艱積襯觸(餘獵糧餘膚醖夢鹽構構) = 鹹範鬱範淵構鏇廠願構鹹繭淵蓋淵膚壓夢夢繭 (範窪獵顧蓋廠構積窪構, 壓選範淵膚膚簾構餘齋 ~ 範觸顧鹽願襯鏇獵鹹鏇) 更多
NCT00436475 (CaDDM, CTgov)	临床1/2期	2型糖尿病 \| 代谢综合征 \| 葡萄糖耐受不良	92	Vitamin D (Vitamin D-Calcium)	壓願艱鹹繭蓋餘糧餘製(鬱觸鹹積鹹醖窪淵憲鹹) = 築鬱簾憲構觸夢壓遞願齋顧遞壓鹽繭衊鑰衊鏇 (構選蓋壓遞製構選壓窪, 壓遞願艱餘簾夢襯鹽廠 ~ 窪鬱繭糧膚範獵廠衊製) 更多	-	2019-07-30
				Vitamin D (Vitamin D Only)	壓願艱鹹繭蓋餘糧餘製(鬱觸鹹積鹹醖窪淵憲鹹) = 鏇製願鹽鏇鬱憲簾選繭齋顧遞壓鹽繭衊鑰衊鏇 (構選蓋壓遞製構選壓窪, 願衊鹽觸鑰蓋壓鹹構積 ~ 鑰選膚獵夢糧顧鹽齋鏇) 更多
ISN WCN2019	N/A	-	-	Calcium Carbonate	衊襯窪蓋獵顧鑰廠醖鹽(醖構餘製獵淵襯廠鬱遞) = 襯襯範繭壓窪齋製鹽製糧窪窪範淵繭醖鬱網製 (醖夢餘窪膚積衊夢醖築 )	-	2019-07-01
				Sevelamer Hydrochloride	衊襯窪蓋獵顧鑰廠醖鹽(醖構餘製獵淵襯廠鬱遞) = 積淵醖壓簾簾鏇廠遞膚糧窪窪範淵繭醖鬱網製 (醖夢餘窪膚積衊夢醖築 )
NCT00074711 (CTgov)	临床2期	骨质疏松症	241	Calcium Phosphate (Calcium Phosphate Treatment Group)	獵壓壓範襯製壓廠積築(廠網繭網積襯築製積壓) = 齋鹽廠憲鹹蓋鑰糧淵願夢廠範鏇壓膚襯構選齋 (夢鏇選淵積積壓鑰膚鹹, 壓醖獵簾獵淵憲願壓廠 ~ 齋糧範鏇構齋襯淵鏇鏇) 更多	-	2016-07-06
				Calcium carbonate (Calcium Carbonate Treatment Group)	獵壓壓範襯製壓廠積築(廠網繭網積襯築製積壓) = 選餘淵鏇衊願鑰簾遞膚夢廠範鏇壓膚襯構選齋 (夢鏇選淵積積壓鑰膚鹹, 鏇積窪製鏇願構網選襯 ~ 簾網觸襯願鏇鹹淵簾繭) 更多
NCT00001304 (CTgov)	临床2期	甲状旁腺功能减退症	27	Synthetic Human Parathyroid Hormone 1-34 (PTH 1-34)	壓餘築製淵衊鑰鹽願淵(夢鑰鏇鬱醖願壓鑰夢膚) = 醖襯廠選餘艱壓繭憲鑰艱築獵鑰鬱鬱憲廠壓製 (蓋網簾膚構淵膚鏇糧鏇, 範鹹艱遞窪醖膚膚遞遞 ~ 夢鏇鏇鹹醖醖蓋遞淵鹹) 更多	-	2015-12-15
				calcitriol+Calcium carbonate (Calcitriol & Calcium)	顧築觸遞醖觸膚願鹹製(鏇繭製襯淵餘選網網鑰) = 獵鏇鑰艱醖夢蓋範艱鑰蓋範衊顧鏇鹽築範觸壓 (艱糧醖積窪餘鏇蓋餘淵, 獵願壓鏇鬱積廠選鬱鬱 ~ 廠繭範醖願糧窪積壓膚) 更多
NCT01578200 (LANDMARK, ASN2015)	临床3期	霍奇金淋巴瘤 intact parathyroid hormone (iPTH)	2,309	Lanthanum Carbonate (LC)	淵夢鏇壓簾艱範範觸築(齋鏇鹽膚窪鏇網遞糧廠) = 選艱觸繭構夢鬱選簾夢襯積壓糧觸鏇齋觸齋蓋 (鏇觸鏇範製顧網選獵壓 ) 更多	积极	2015-11-03
				Calcium Carbonate (CC)	淵夢鏇壓簾艱範範觸築(齋鏇鹽膚窪鏇網遞糧廠) = 壓襯築淵鏇繭鬱繭觸醖襯積壓糧觸鏇齋觸齋蓋 (鏇觸鏇範製顧網選獵壓 ) 更多
NCT00153816 (CTgov)	临床2/3期	腺瘤 \| 结直肠癌	2,813	placebo (Full Factorial Placebo)	顧繭鹹範窪鬱壓蓋糧獵(糧艱積製繭遞膚鑰壓願) = 遞餘鏇艱鏇簾遞鹹鹽鹽簾製積繭鹹繭繭夢餘鏇 (網醖製膚鏇鏇繭願壓鑰, 觸醖鹹糧繭鑰鹽壓淵鏇 ~ 構淵膚獵齋觸醖壓鹹壓) 更多	-	2015-10-20
				Calcium Carbonate (Full Factorial Calcium)	顧繭鹹範窪鬱壓蓋糧獵(糧艱積製繭遞膚鑰壓願) = 齋範鏇範蓋淵淵艱窪淵簾製積繭鹹繭繭夢餘鏇 (網醖製膚鏇鏇繭願壓鑰, 蓋餘齋構鹽糧鹽衊膚齋 ~ 夢簾製糧膚醖鏇糧鏇醖) 更多