A Single-centre Randomised Controlled Study of 4-week Zuojin Pills in Combination With Sodium Rabeprazole Enteric-coated Tablets or Mosapride Citrate for the Treatment of Functional Dyspepsia Combined With Depression

To evaluate the symptom improvement of Zuojinwan combined with rabeprazole or Zuojinwan combined with a mosapride regimen in patients with functional dyspepsia combined with depression (liver-stomach depression-heat type) using rabeprazole or mosapride regimen as a control, and to compare the patients' adherence to the medication and the adverse effects between the two groups.

开始日期2024-06-30

申办/合作机构

南京医科大学第一附属医院

NCT06417229 / Recruiting临床1期

A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.

开始日期2024-05-28

申办/合作机构

Celgene Corp.

NCT06264440 / Completed临床1期

A Phase 1, Open-Label, Crossover Study to Assess the Potential for Gastric pH-Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants

The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.

开始日期2024-02-12

申办/合作机构

Biogen, Inc.

100 项与雷贝拉唑钠相关的临床结果

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100 项与雷贝拉唑钠相关的转化医学

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100 项与雷贝拉唑钠相关的专利（医药）

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145

项与雷贝拉唑钠相关的文献（医药）

2024-10-01·International Journal of Toxicology

13-Week Repeated Oral Toxicity and Toxicokinetic Studies of Rabeprazole Sodium and Sodium Bicarbonate Combination in Dogs

Article

作者: Hwang, Eui-Kyung ; Nam, Kyu-Yeol ; Kim, Young-Min ; Roh, Jae Seok ; Jeon, Tae-Won ; Jung, Won Tae

The subchronic toxicity and toxicokinetics of a combination of rabeprazole sodium and sodium bicarbonate were investigated in dogs by daily oral administration for 13 consecutive weeks with a 4-week recovery period. The dose groups consisted of control (vehicles), (5 + 200), (10 + 400), and (20 + 800) mg/kg of rabeprazole sodium + sodium bicarbonate, 20 mg/kg of rabeprazole sodium only, and 800 mg/kg of sodium bicarbonate only. Esophageal ulceration accompanied by inflammation was observed in only one animal in the male (20 + 800) mg/kg rabeprazole sodium + sodium bicarbonate group. However, the severity of the ulceration was moderate, and the site of occurrence was focally extensive; thus, it was assumed to be a treatment-related effect of rabeprazole sodium + sodium bicarbonate. In the toxicokinetics component of this study, systemic exposure to rabeprazole sodium (AUClast and Cmax at Day 91) was greater in males than females, suggesting sex differences. AUClast and Cmax at Day 91 were increased compared to those on Day 1 in a dose-dependent manner. A delayed Tmax and no drug accumulation were observed after repeated dosage. In conclusion, we suggest under the conditions of this study that the no-observed-adverse-effect level (NOAEL) of the combination of rabeprazole sodium + sodium bicarbonate in male and female dogs is (10 + 400) and (20 + 800) mg/kg, respectively.

2024-06-01·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Protective effect of Albizia chinensis saponin on ethanol-induced gastric mucosal injury in rats focus on mucus and mucosal barriers].

Article

作者: Zhang, Jian-Jun ; Jia, Xiao-Yu

This study aims to explore the protective effect of Albizia chinensis saponin on ethanol-induced acute gastric ulcer in rats and elucidate its mechanisms. SD rats were deprived of water for 24 hours before the experiment. The control group and model group were administered water by gavage, and the positive drug group received rabeprazole sodium solution(40 mg·kg~(-1)) by gavage. The experimental groups were given different doses of Albizia chinensis saponin solution(3, 10, and 30 mg·kg~(-1)). After 30 minutes, the control group received 1.5 mL of water by gavage, while the other groups were administered an equal volume of 95% ethanol for modeling. After six hours, the rats were killed by cervical dislocation, and the stomachs were collected. The ulcer area was measured, and the ulcer index was calculated. Hematoxylin-eosin(HE) staining was performed to assess histopathological changes in gastric tissue. Periodic acid-Schiff(PAS) staining was used to evaluate the distribution of gastric mucosal surface mucus. Enzyme-linked immunosorbent assay(ELISA) was employed to measure the levels of phospholipids and aminohexose in the gastric mucosa. Western blot was performed to determine the expression levels of the bicarbonate transporter, matrix metalloproteinase, and tight junction-associated proteins in gastric tissue. Immunohistochemistry(IHC) staining was conducted to quantify the number of positive cells for secreted mucin and tight junction-associated proteins. The results showed that the gastric tissue surface of rats in the control group was smooth without ulceration, and the gastric ulcer index of rats in the model group was 35±11. Albizia chinensis saponin at doses of 3, 10, and 30 mg·kg~(-1) resulted in inhibition rates of gastric ulcer of 46%(P<0.01), 85%(P<0.001), and 100%(P<0.001), respectively. Severe disruption of gastric mucosal structure and absence of the mucus layer were observed in the model group. Compared with the model group, the Albizia chinensis saponin group showed intact gastric mucosal surface mucus layer, significantly increased levels of phospholipids and aminohexose in the mucus, increased number of MUC5AC positive cells, and upregulated expression levels of the bicarbonate transporter SLC26A3 and CFTR. It also showed decreased phosphorylation of JNK and c-Jun, reduced expression levels of MMP-8, elevated expression of TIMP-1, and increased expression levels of Occludin and ZO-1. In conclusion, Albizia chinensis saponin enhances the function of the mucus-bicarbonate barrier by upregulating the content of MUC5AC, phospholipids, and aminohexose and increasing the expression levels of the bicarbonate transporter SLC26A3 and CFTR. Moreover, Albizia chinensis saponin exerts its protective effects on gastric ulcers by inhibiting the JNK signaling pathway to prevent excessive activation of MMP-8, thereby reducing the degradation of Occludin and ZO-1 and enhancing the mucosal barrier function. In summary, Albizia chinensis saponin exerts its anti-gastric ulcer effects by simultaneously enhancing the mucus barrier and the mucosal barrier.

2024-06-01·The Lancet Infectious Diseases

Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials

Article

作者: Lou, Jinfeng ; Wang, Jing ; Ma, Zhenkun ; Wang, Meng ; Geng, Guozhu ; Liu, Yusi ; Chen, Hong ; Gao, Lei ; Li, Xiaojiao ; Chen, Jing ; Zhang, Hong ; Wu, Min ; Ding, Yanhua ; Liu, Jingrui

BACKGROUNDDue to the rapid development of antimicrobial resistance, the efficacy of most Helicobacter pylori eradication therapies have progressively decreased to an unacceptable level. Rifasutenizol (TNP-2198) is a new molecular entity with a synergistic dual mechanism of action currently under clinical development for the treatment of microaerophilic and anaerobic bacterial infections. We aimed to evaluate the safety, pharmacokinetics, and efficacy of rifasutenizol in healthy Chinese participants and patients with H pylori.METHODSWe conducted four clinical trials of rifasutenizol capsules in healthy participants (aged 18-55 years) and patients with asymptomatic H pylori infection (aged 18-65 years) in a clinical trial centre in Jilin province, China. Trial 1 was a phase 1, double-blind, randomised, placebo-controlled, single ascending dose study, in which participants were enrolled into one of seven rifasutenizol dose groups (50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, or 1000 mg) and were randomly assigned in a 4:1 ratio to study drug or placebo. Trial 2 was a phase 1, double-blind, randomised, placebo-controlled, multiple ascending dose study, in which patients were enrolled into one of three rifasutenizol dose groups (200 mg, 400 mg, or 600 mg) and were randomly assigned in a 3:1 ratio to study drug or placebo. Trial 3 was a phase 2a, open-label, randomised, multiple-dose, dose-finding study in which patients enrolled into one of four cohorts were randomly assigned in a 1:1:1:1 ratio to a rifasutenizol dual or triple regimen. Trial 4 was a phase 2b, open-label, randomised, multiple-dose, regimen exploration study, in which patients enrolled into one of five cohorts were randomly assigned in a 2:2:1:1:2 ratio to a rifasutenizol dual therapy, triple therapy, or a control cohort. Block randomisation (block size 4 or 8) was used in all four trials. The key primary endpoints for trials 1, 2, and 3 were the tolerability, safety, and pharmacokinetics of rifasutenizol. For trial 4, the primary endpoint was the eradication rate of H pylori. These four trials were registered at ClinicalTrials.gov (NCT06081699, NCT06081712, NCT06076681, and NCT06076694) and chinadrugtrials.org.cn (CTR20190734, CTR20192553, CTR20212050, and CTR20220625) and are completed.FINDINGSBetween May 9, 2019, and Sept 14, 2022, 78 healthy participants (trial 1: n=10 per cohort in a 4:1 rifasutenizol:placebo ratio; and an additional eight for the food-effect cohort) and 168 patients with asymptomatic H pylori infection (trial 2: n=16 per cohort in a 3:1 rifasutenizol:placebo ratio; trial 3: n=10 per cohort; trial 4: n=10 or n=20 per cohort) were enrolled in the four clinical trials. Single doses of rifasutenizol (50-1000 mg) and multiple doses of rifasutenizol (200 mg to 600 mg, twice a day), either as monotherapy or co-administered with rabeprazole and amoxicillin, showed favourable safety and tolerability profiles. Most adverse events were mild, and no serious adverse events were reported. Rifasutenizol demonstrated a linear pharmacokinetic profile over the dose range of 50-800 mg, and there were no apparent pharmacokinetic interactions between rifasutenizol and the co-administrated drugs. Food intake slightly elevated the area under the plasma concentration-time curve (AUC) of rifasutenizol, and the geometric mean of AUC from time 0 to the last timepoint with a quantifiable concentration (AUC_0-t) and AUC from time 0 to infinity (AUC_0-∞) in the fed state were 1·334 and 1·396 times of those in the fasted state, respectively. There was mild accumulation after continuous administration of rifasutenizol, and the R_ac(AUC) of rifasutenizol 400 mg in the dual and triple regiments in trial 3 were 1·37 and 1·49, respectively. In trial 3, the eradication rates of H pylori with 200 mg, 400 mg, or 600 mg of rifasutenizol in combination with rabeprazole, twice a day for 14 days, were 0% (95% CI 0-31), 30% (7-65), and 40% (12-74), respectively, identifying rifasutenizol 400 mg as the effective dose. In trial 4, H pylori eradication rates with the triple regimen in cohort A (400 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) twice a day for 14 days was 95% (95% CI 74-100), and triple therapy (600 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) three times a day for 7 days was 100% (69-100).INTERPRETATIONRifasutenizol monotherapy and combination therapy was generally safe and well tolerated in healthy participants and patients with H pylori infection. A triple regimen of 400 mg rifasutenizol capsules, 20 mg rabeprazole sodium enteric-coated tablets, and 1 g amoxicillin capsules twice a day for 14 days showed promising efficacy as a new treatment regimen for H pylori infection.FUNDINGTenNor Therapeutics and National Natural Science Foundation of China.TRANSLATIONFor the Chinese translation of the abstract see Supplementary Materials section.

235

项与雷贝拉唑钠相关的新闻（医药）

2024-10-29

·米内网

第十批集采10个品种迎战！千亿市场3连跌，扬子江、齐鲁蓄势，6个超10亿品种承压

精彩内容近日，第十批集采正式启动报量，拟纳入的62个品种涵盖10个治疗大类，其中10个为消化系统及代谢药物，扬子江、科伦、倍特等均有多个产品涉及。近年来消化系统及代谢化药市场跌跌不休，TOP20产品持续洗牌。目前190个消化系统及代谢药物已有企业过评，齐鲁领跑过评榜。千亿市场跌跌不休！AZ、扬子江、齐鲁亮了米内网数据显示，近年来中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端消化系统及代谢化药（不含生物药，下同）市场规模均超过1200亿元。但受集采等因素影响，2022年以来其销售额呈逐年下滑态势。近年来中国公立医疗机构终端消化系统及代谢化药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局消化系统及代谢化药涵盖14个治疗亚类，其中糖尿病用药为最畅销品类，近年来市场份额持续提升，2024上半年超过22%；治疗与胃酸分泌相关疾病的药物紧接在后，但销售额持续下滑，市场份额由2017年的超30%减少至2024上半年的21%。从集采属性看，非集采品种为消化系统及代谢化药销售“主力”，已集采品种的销售额逐年下滑，销售占比由2019年的超45%下滑至2024上半年的约22%；从医保属性看，医保品种占主导地位，近年来销售占比均超过85%。在TOP20集团中，阿斯利康、正大制药、默沙东、健康元药业、华润医药依次位列前五；与2023年同期相比，2024上半年阿斯利康、扬子江药业、齐鲁制药、勃林格殷格翰、北京协和药厂等企业的销售额增速均超过10%。 2024H1中国公立医疗机构终端消化系统及代谢化药TOP5集团来源：米内网中国公立医疗机构药品终端竞争格局 TOP20产品洗牌！“药王”7连涨 2024上半年消化系统及代谢化药TOP20产品中，达格列净片蝉联榜首，该产品自上市以来持续放量，至今销售额已实现“7连涨”；异甘草酸镁注射液、盐酸雷尼替丁注射液分别位列第二、第三，其中异甘草酸镁注射液为国产新药，盐酸雷尼替丁注射液目前暂无企业过评且无企业布局一致性评价，这2个品种短时间内不会被纳入国采。 2024H1中国公立医疗机构终端消化系统及代谢化药TOP20产品来源：米内网中国公立医疗机构药品终端竞争格局与2023年同期相比，达格列净片、依帕司他片、碳酸钙D3片(Ⅰ)、利格列汀片、双环醇片5个品种逆势大涨超10%，其中达格列净片、依帕司他片、利格列汀片均为糖尿病用药，且近年来销售额均保持两位数的正增长，而双环醇片目前仅1家企业在销。近年来中国公立医疗机构终端达格列净片、依帕司他片、利格列汀片销售额增速来源：米内网中国公立医疗机构药品终端竞争格局 7个品种跌幅超过10%，其中雷贝拉唑钠肠溶胶囊、雷贝拉唑钠肠溶片为第九批集采品种。在国家开展的八批九轮化药集采中，消化系统及代谢化药分别有1个、4个、8个、9个、11个、6个、3个、7个品种被纳入其中，合计49个品种（不含落标品种）。部分临床畅销的存量品种在集采执行后销售额“大跳水”，如第二批集采品种阿卡波糖口服常释剂型，其销售峰值超过95亿元，2024上半年销售额不足9亿元；第四批集采品种泮托拉唑注射剂，其销售峰值超过87亿元，2024上半年销售额不足3亿元；第五批集采品种兰索拉唑注射剂，其销售峰值超过51亿元，2024上半年销售额不足1亿元等。 10个品种拟纳入第十批集采！6个超10亿品种承压米内网数据显示，截至10月25日，190个消化系统及代谢化药有企业过评或视同过评。33个品种火热，过评企业数达10家及以上，其中有3个达40家以上，分别为盐酸二甲双胍片（47家）、盐酸二甲双胍缓释片（46家）、注射用奥美拉唑钠（41家）。从企业过评情况看，17家药企（以集团计）已过评的消化系统及代谢化药品种数达10个及以上，其中齐鲁制药、华润医药、扬子江药业、远大健康、正大制药均超过20个。近日，第十批集采正式启动报量，10个消化系统及代谢化药在列，包括4个糖尿病用药、1个矿物质补充剂、1个胃肠解痉药/抗胆碱药/胃动力药、1个治疗便秘的药物、1个治疗与胃酸分泌相关疾病的药物、1个维生素类及1个止吐药/止恶心药。拟纳入第十批集采的消化系统及代谢化药注：销售额低于1亿元用*代表来源：米内网综合数据库 10个品种2023年在中国公立医疗机构终端的销售额合计超过100亿元，其中西格列汀口服常释剂型超20亿元，依帕司他口服常释剂型、利格列汀口服常释剂型、间苯三酚注射剂、复方聚乙二醇电解质散、注射用盐酸罗沙替丁醋酸酯均超10亿元。从竞争情况看，氯化钾颗粒剂、西格列汀口服常释剂型、西格列汀二甲双胍口服常释剂型、间苯三酚注射剂、复方聚乙二醇电解质散、注射用盐酸罗沙替丁醋酸酯6个品种竞争激烈，符合申报资格企业数达10家及以上，其中西格列汀口服常释剂型、间苯三酚注射剂均达30家及以上。从过评企业看，扬子江药业以6个过评品种领跑，倍特药业、复星医药、科伦药业、齐鲁制药以4个过评品种并列第二，广东东阳光药业、华海药业、华润医药、江苏德源药业、天宇股份均有3个过评品种在列，辰欣药业、人福医药、石家庄四药、石药集团、四环医药等10余家企业均有2个过评品种在列。资料来源：米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至10月25日，如有疏漏，欢迎指正！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

一致性评价带量采购

2024-10-18

·赛柏蓝

第十批国采，规模、品种、涉及企业

特约作者 | 张自然博士责任编辑 | 郑瑶关注赛柏蓝，进入主页发消息界面发送【第十批报量】获取第十批报量文件全文word获取，一切以最终官方消息为准第十批国采已开始报量。注：除特别注明外，本文中的市场规模（或销售额）均指于国采前一年在全国公立医疗机构的销售额，且单位都是亿元。 01 规模一、市场规模与前九批国采相比，第十批国采虽然涉及的品种数（62个）最多，但市场规模却很小，仅排在第7位。第十批国采涉及市场规模550亿元，比第五批的866亿元少了1/3还多，比第七批和第一批的700多亿元也少了1/5～1/4。与第三、第四批的市场规模相近，只比第九批（263亿元）、第二批和第六批（胰岛素专项）的多。除整体市场规模外，再对各批国采单个品种的平均销售额作一比较。第十批国采的62个品种涉及550亿元的市场，单个品种平均销售额只有8.87亿元，位居前十批国采倒数第2位，仅比第九批的6亿元高，与第三批的10亿元、第二批的11亿元接近，只有第一批国采单品平均销售额（30亿元）的不到1/3。企业一般先对大品种做一致性评价，并参与国采。历经八批国采，到第九批时，剩下的大都是小品种了。 02 大品种品种越大，“水分”含量也就越高，也当然成为集采的目标。在第十批国采涉及的62个品种中，年销售额超过10亿元的有20多个，过10亿品种数位居前十批国采（化药）第六位，仅比第九批（6个）、第二批（9个）和第一批（18个）的多，小于第三、四批的22个，比第五批的29个少了近1/3。第十批过10亿的品种数量还不算太少，是因距离第九批时间间隔太长，积累的过评品种数量超多所致，第十批距离去年11月6日开标的第九批过去了已近1年时间，较前九批各批间6.7个月的时间间隔延长了近一倍，如同样与第九批间隔6.7个月（2024年5月中旬）的话，则第十批过10亿品种也不会有这么多。就大品种数占本批国采品种总数的比重而言，第十批排名也很靠后，位居前十批国采（化药）倒数第3位。第十批国采过10亿品种20个，占第十批国采品种总数62个的32%，只比第九批（14%）和第二批（28%）的高。第一批国采大品种占比最高，高达72%，在中选的25个品种中，过10亿的就有18个，其次是第八批，占了56%。除数量少外，自第九批开始，大品种的销售额更相形见绌，第十批最大的也就30亿元（盐酸多柔比星脂质体注射液在样本医院的销售额）、第九批最大的也就36亿元（雷贝拉唑口服常释剂型）。而往批国采中大品种的销售额则大的多，如第八批还有83亿元的哌拉西林他唑巴坦注射剂、69亿元的头孢哌酮舒巴坦注射剂，更不用说首批国采时还有过百亿的大品种了，如氯吡格雷口服常释剂型115亿元、阿托伐他汀口服常释剂型99亿元。 03 企业第十批国采，涉及品种数最多的是齐鲁，共涉及22个品种，齐鲁也是前九批国采中选品种数最多的企业，前九批共中选了63个品种。第二是科伦，第十批涉及19个品种，科伦前九批中选品种数排名也很靠前，与扬子江并列第3位，共有50个品种中选。倍特和复星并列第3，第十批都涉及18个品种，倍特和复星前九批中选品种数分别位居第4、第8位，分别中选了34个和28个。扬子江和石家庄四药并列第4，第十批都涉及17个品种，前九批中选品种数分别位居第3、第15位，分别中选了50个和13个品种。石药集团位居第5位，第十批涉及15个品种，前九批国采中选品种数排名第5，合计中选了33个品种。正大制药位居第10，第十批共涉及10个品种，其上市公司中国生物制药前九批中选品种数排名高居第2位，仅次于齐鲁，共有55个品种中选。第十批涉及品种数较多的企业，大多也在前九批国采中斩获较多，这些企业将挑起我国仿制药的大梁。附：第十批集采拟纳入品种竞争格局注：一切信息以官方发布为准！符合申报资格企业数以集团计（含上市许可持有人）；来源：米内网综合数据库 END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

带量采购一致性评价

2024-10-16

·赛柏蓝

第十批国采，全方位分析

特约作者 | 张自然博士编辑 | yuki 第十批国采报量文件流出，从流传文件看，第十批国采共263个规格，涉及62个品种。关注赛柏蓝，进入主页发消息界面发送【第十批报量】获取第十批报量文件全文word获取，一切以最终官方消息为准 01 入围门槛最高第十批国采入围门槛是7家（7+0格局），创历史之最，比第八～九批的5家还多出2家，比第七批的4家多出3家，比4+7扩围～第六批的3家多出4家。因第十批国采间隔的时间最长，距去年11月6日开标的第九批国采已近一年时间，较前九批国采6、7个月的平均间隔延后了近一倍时间，积累的过评品种数也最多。第十批的竞争激烈程度可见一般。 02 注射剂最多自注射剂在第五批国首次集中亮相开始，此后每批国采注射剂都占主导。第十批更是创下了历史之最，在62个品种中，注射剂多达35个，占了一半以上（56%），占比也仅次于第八批的68%。此前，注射剂品种数最少的是第二批，只有一个注射剂（注射用紫杉醇（白蛋白结合型））。 03 大品种已少见在第十批国采的62个品种中，2023年样本医院销售额最大的是盐酸多柔比星脂质体注射液，2023年在样本医院卖了30亿元，也是第十批国采唯一过30亿元的大品种，共有8家企业符合条件。其余都不超过25亿元。如拉氧头孢注射剂（25亿元，9家）、哌拉西林注射剂（23亿元，15家）、复方a-酮酸口服常释剂型（22亿元，8家）、去甲肾上腺素注射剂（21亿元，10家）、阿司匹林口服常释剂型（21亿元，14家），且大部分都是注射剂。往批国采动辄50亿、80亿、甚至上百亿元大品种的情景已不再现。实际上，到第九批国采已很少有大品种了，第九批国采除雷贝拉唑胶囊（38亿元）和丙泊酚注射液（36亿元）（均为2022年全国公立医疗机构销售额）外，其他都不足20亿元。第十批国采销售额在15～20亿元的有3家，即西格列汀口服常释剂型（17亿元）、间羟胺注射剂（16.5亿元）、间苯三酚注射剂（15亿元），其中西格列汀口服常释剂型、间苯三酚注射剂也是竞争最激烈的，分别有31家、29家企业符合条件。在销售额Top20品种中，注射剂就有11个，占了一半以上。 04 竞争最激烈第十批国采符合条件企业数最多的品种是西格列汀口服常释剂型，共有31家（2023年样本医院销售额17医亿元，已创历史之最，往批国采竞争企业数最多的只有第三批的二甲双胍口服常释剂型（30家），20家以上的连一个也没有，大部分在13家以下。除西格列汀外，第十批国采20家以上的品种还有很多，如帕拉米韦注射液（29家，15亿元）、舒更葡糖钠注射液（22家，6亿元）、艾司洛尔注射剂（20家，10亿元）。在竞争企业数量Top20品种中，注射剂就有12个，占了60%。尽管第十批国采的正式文件尚未公布，但第十批国采大品种最少、竞争最激烈的事实不会变。附：第十批国采报量品种清单（供参考，最终以官方消息为准） END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

带量采购

100 项与雷贝拉唑钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00724	雷贝拉唑钠	A02BC04	DBSALT000552

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
糜烂性胃食管反流病	美国	CHARTWELL RX SCIENCES LLC	2013-11-08
幽门螺杆菌感染	美国	CHARTWELL RX SCIENCES LLC	2013-11-08
螺杆菌感染	韩国	Genuone Sciences, Inc.	2000-02-21
胃溃疡	韩国	Genuone Sciences, Inc.	2000-02-21
十二指肠溃疡	美国	Waylis Therapeutics LLC	1999-08-19
胃食管反流	美国	Waylis Therapeutics LLC	1999-08-19
Zollinger-Ellison综合征	美国	Waylis Therapeutics LLC	1999-08-19

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
十二指肠溃疡	临床前	美国	Aytu Biopharma, Inc.	2013-03-26
Zollinger-Ellison综合征	临床前	美国	Aytu Biopharma, Inc.	2013-03-26
非糜烂性胃食管反流病	临床前	日本	Eisai Co., Ltd.	2004-09-01
非糜烂性反流病	临床前	日本	Eisai Co., Ltd.	2004-09-01
胃食管反流	药物发现	美国	Aytu Biopharma, Inc.	2013-03-26

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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


NCT05918822 (CTgov)	临床1期	-	32	Maribavir Pediatric Powder-for-oral Suspension Formulation+rabeprazole	鏇膚窪獵鹽製構鬱憲範(鑰壓窪鬱餘鬱顧繭製積) = 醖選觸膚鏇廠鑰艱衊鏇壓範壓遞範餘獵鹽憲範 (鑰遞鏇觸淵觸廠窪遞鑰, 選鏇獵顧範範廠鏇獵觸 ~ 構遞鏇窪築構鹹獵壓獵) 更多	-	2024-09-26
NCT06076694 (CTgov)	临床2期	幽门螺杆菌感染	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	壓鏇繭糧淵糧鹹鹹壓簾(衊簾襯繭積壓鹹蓋艱遞) = 壓衊壓鹽網襯構淵夢遞襯壓齋襯襯鹹繭糧簾鹽 (構衊製艱製壓鑰鹹衊鏇, 廠繭糧襯憲鹹觸壓鑰齋 ~ 鹹糧製願鏇糧夢艱網構) 更多	-	2023-12-12
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	壓鏇繭糧淵糧鹹鹹壓簾(衊簾襯繭積壓鹹蓋艱遞) = 遞糧衊觸蓋蓋醖憲糧顧襯壓齋襯襯鹹繭糧簾鹽 (構衊製艱製壓鑰鹹衊鏇, 糧夢鑰衊製窪築窪簾獵 ~ 積選遞鬱鏇獵鹹積鏇遞) 更多
NCT06076681 (CTgov)	临床1/2期	幽门螺杆菌感染	40	TNP-2198+Rabeprazole Sodium (Group A)	獵艱憲製願糧衊範糧網(鏇製襯選鬱壓窪糧夢構) = 淵範獵鹹衊築鬱選鬱築遞鹹網壓鹽鹹選願選構 (夢選夢積醖襯簾艱觸窪, 艱鬱糧襯鹹衊繭艱蓋蓋 ~ 淵鹽窪鏇願遞繭襯構獵) 更多	-	2023-11-22
				TNP-2198+Rabeprazole Sodium (Group B)	獵艱憲製願糧衊範糧網(鏇製襯選鬱壓窪糧夢構) = 鏇簾構艱齋齋鹹膚糧鏇遞鹹網壓鹽鹹選願選構 (夢選夢積醖襯簾艱觸窪, 醖憲餘網糧淵鏇壓鑰積 ~ 廠網襯構夢衊構廠構襯) 更多
NCT02605395 (CTgov)	临床4期	胃肠道疾病	70	Idiazole (Idiazole 20 mg)	積獵醖鬱鹽築製鹹觸遞(範鏇壓淵醖鹽獵窪鏇鹹) = 壓艱製範壓淵鹽範選鹹願夢範觸鹽壓窪蓋觸糧 (鏇繭餘齋製遞艱窪顧餘, 鹽繭齋夢築簾衊網獵蓋 ~ 製憲鹽繭顧糧築鑰鬱膚) 更多	-	2018-10-01
				Pariet (Pariet 20 mg)	積獵醖鬱鹽築製鹹觸遞(範鏇壓淵醖鹽獵窪鏇鹹) = 襯夢鬱淵襯願築築鏇齋願夢範觸鹽壓窪蓋觸糧 (鏇繭餘齋製遞艱窪顧餘, 積鹹網廠範餘夢觸鏇憲 ~ 簾蓋鹹蓋網簾範遞壓鹹) 更多
NCT01202071 (CTgov)	临床2期	-	24	Rabeprazole Sodium (Rabeprazole Sodium 5 mg Tablet)	構廠觸膚糧鹹膚鏇廠鏇(顧艱廠鏇窪鑰築艱獵觸) = 鹽鹹蓋糧齋夢鹹壓蓋觸鬱鹽獵簾鬱鏇餘蓋餘齋 (觸衊範糧鏇膚鏇齋願壓, 鑰繭網願壓積遞壓鹹糧 ~ 簾壓齋簾膚鏇襯鬱獵繭) 更多	-	2012-11-27
				Rabeprazole Sodium (Rabeprazole Sodium 10 mg Tablet)	構廠觸膚糧鹹膚鏇廠鏇(顧艱廠鏇窪鑰築艱獵觸) = 願醖顧鹹積繭觸網製膚鬱鹽獵簾鬱鏇餘蓋餘齋 (觸衊範糧鏇膚鏇齋願壓, 築蓋齋壓鹹淵膚廠襯積 ~ 積築襯憲繭繭鹹鹽鏇網) 更多
NCT00770913 (CTgov)	临床2/3期	反流性食管炎	337	E3810 (E3810 20 mg Once Daily)	襯選觸廠鬱淵憲窪願範(鏇餘構鑰襯築網製構襯) = 鹽艱壓窪蓋齋觸糧範觸顧齋蓋範鑰齋餘襯簾蓋 (鬱簾壓鹹選糧範遞糧衊, 繭繭膚範遞鏇餘衊淵積 ~ 鏇衊積願壓憲積壓壓艱) 更多	-	2012-04-13
				E3810 (E3810 10 mg Twice Daily)	襯選觸廠鬱淵憲窪願範(鏇餘構鑰襯築網製構襯) = 顧膚鏇膚鏇齋遞鹽齋淵顧齋蓋範鑰齋餘襯簾蓋 (鬱簾壓鹹選糧範遞糧衊, 選餘鑰鑰繭積獵窪積選 ~ 餘襯遞夢繭鏇壓獵淵膚) 更多
IAS2008	N/A	-	93	Ritonavir 100 mg film-coated tablet	鬱鑰淵齋構鏇膚築選齋(壓膚鹹糧選鏇衊淵遞襯) = 範選鏇壓鏇憲鏇膚獵顧簾顧膚鏇艱選齋淵鬱遞 (簾齋觸憲衊製網餘繭構 ) 更多	-	2008-01-01
				Ritonavir 100 mg soft gelatin capsule	鬱鑰淵齋構鏇膚築選齋(壓膚鹹糧選鏇衊淵遞襯) = 廠鬱憲衊製餘餘顧製壓簾顧膚鏇艱選齋淵鬱遞 (簾齋觸憲衊製網餘繭構 ) 更多
IAS2003	N/A	HIV感染	-	Reverset 0 mg	(範衊築廠積選製衊築廠) = 鹹選築憲範範簾簾鑰簾製鏇鹹積壓顧憲鹽繭憲 (窪積窪窪選鹽積繭顧鹽, 0.2) 更多	-	2003-01-01
				Reverset 50 mg (enteric-coated tablets)	(範衊築廠積選製衊築廠) = 築鬱顧網鬱製網簾鬱觸製鏇鹹積壓顧憲鹽繭憲 (窪積窪窪選鹽積繭顧鹽, 1.6)