主要目的：与注射用艾司奥美拉唑钠（Esomeprazole，ESO）相比，对消化性溃疡引起的上消化道出血且再出血风险为高危者经内镜下治疗后给予不同剂量给药方案的H008注射液以评价降低再出血风险的初步有效性。次要目的： 1) 与注射用ESO相比，对消化性溃疡引起的上消化道出血且再出血风险为高危者经内镜下治疗后给予不同剂量给药方案的H008注射液以评价本品的初步安全性； 2) 观察不同剂量H008注射液在消化性溃疡出血人群中的药代动力学特征，进一步评估本品在患者中的群体药代动力学特征。

开始日期2024-10-16

申办/合作机构

南京柯菲平盛辉制药有限公司

[+1]

NCT06734260

/ Recruiting临床3期IIT

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection：a Multicenter, Prospective, Randomized Controlled Study

Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .

开始日期2024-09-10

申办/合作机构-

100 项与盐酸凯普拉生相关的临床结果

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100 项与盐酸凯普拉生相关的转化医学

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100 项与盐酸凯普拉生相关的专利（医药）

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项与盐酸凯普拉生相关的文献（医药）

2024-11-01·Current gastroenterology reports

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments

Review

作者: Scarpignato, Carmelo ; Hunt, Richard H

Abstract:

Purpose of the Review:

Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice.

Recent Findings:

Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs.

Summary:

Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

2024-11-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

The efficacy of keverprazan-based quadruple therapy for Helicobacter pylori eradication: A phase III, randomised, double-blind, multicentre trial

Article

作者: Qiu, Rongyuan ; Li, Xing ; Liu, Chengxia ; Su, Dongxing ; Tan, Niandi ; Li, Fangfang ; Xia, Min ; Liu, Youli ; Jiao, Zhiyong ; Zhang, Zhe ; Su, Mei ; Chen, Huixin ; Zhang, Xiaomei ; Liao, Aijun ; Xiao, Weiming ; Xiao, Yinglian ; Chen, Minhu ; Wu, Hao ; Lan, Cheng

INTRODUCTION:

Keverprazan is a novel potassium-competitive acid blocker. The advantages of keverprazan as a potent acid suppressor in Helicobacter pylori eradication have not yet been demonstrated. The aim of this study was to evaluate the efficacy of keverprazan as a component of bismuth quadruple therapy in H. pylori treatment.

METHODS:

Adult patients with H. pylori infection were enrolled and randomised to take keverprazan (KEV group)- or esomeprazole (ESO group)-quadruple therapy. The regimens contained keverprazan 20 mg or esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg and bismuth potassium citrate 240 mg and were administered twice daily for 14 days. The primary endpoint was the H. pylori eradication rate at 4 weeks after treatment.

RESULTS:

The full analysis set showed that the H. pylori eradication rates were 87.8% (252/287) and 82.52% (236/286) for the KEV and ESO groups, respectively (difference: 5.29%; 95% confidence interval [CI]: -0.55-11.18). Keverprazan was superior to esomeprazole in terms of eradication rate in the per protocol set (P=0.0382). The eradication rates for patients resistant or non-resistant to clarithromycin were both numerically higher in the KEV group than the ESO group (83.45% vs. 76.98% for clarithromycin-resistance; 92.31% vs. 88.16% for clarithromycin-non-resistance). The incidence of adverse events was similar in the KEV and ESO groups (76.31% vs. 77.62%), with most adverse events (>90%) being mild in severity. No TEAEs led to death in either group.

CONCLUSIONS:

Keverprazan 20 mg twice daily, used as a component of bismuth quadruple therapy, provided effective H. pylori eradication and was non-inferior to an esomeprazole-based regimen.

2024-01-01·Therapeutic Advances in Gastroenterology

Potassium-competitive acid blockers and proton-pump inhibitors for healing of erosive esophagitis: a systematic review and network meta-analysis

Review

作者: Gao, Zhifeng ; Liu, Yin ; Hou, XiaoHua

Background::

Proton-pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) are recommended for erosive esophagitis (EE), with good safety and tolerance. However, it is unclear which is the best treatment option for EE.

Objectives::

This study aimed to evaluate the comparative efficacy of P-CABs and PPIs for healing EE patients, seeking an appropriate treatment choice in the 4- or 8-week treatment and standard or double dose.

Design::

A systematic review and network meta-analysis.

Data sources and methods::

Relevant databases were searched to collect randomized controlled trials of PPIs and P-CABs in the treatment of EE up to 31 May 2023. Studies on standard or double-dose PPIs or P-CABs which were published in English and assessed 4- or 8-week healing effects in EE were included. A network meta-analysis was performed to evaluate the efficacy of the treatments under the frequentist framework. Sensitivity and subgroup analyses of patients with different baseline EE were also conducted.

Results::

In all, 34 studies involving 25,054 patients and 9 PPIs, 6 P-CABs, or placebo treatment interventions were included. The pooled 4-week healing rate was significantly statistically lower than the pooled 8-week healing rate for most treatments. Besides, the higher healing rate of double-dose treatment than standard-dose treatment was not observed in the initial treatment of most drugs. The main analysis only included studies conducted for both patients with and without severe EE at baseline, and the proportion of severe EE included in the study was >10%, Keverprazan 20 mg qd ranked best with a surface under the cumulative ranking curve (SUCRA) value of 84.7, followed by Ilaprazole 10 mg qd with a SUCRA value of 82.0, for the healing rate at 8 weeks. Sensitivity analysis showed that the results were robust. Subgroup analysis showed that most P-CABs had higher healing rates than PPIs, particularly for patients with severe EE. And the healing rate of Keverprazan 20 mg qd at 8 weeks ranked best in the subgroup without or with severe EE at baseline.

Conclusion::

This study showed that an 8-week treatment seemed more effective than the 4-week treatment for healing EE patients. The healing effect of Keverprazan (20 mg qd) ranked best in 8-week treatment, for both severe and non-severe EE patients.

Trial registration::

The study protocol was registered with INPLASY (registration number INPLASY2023120053).

项与盐酸凯普拉生相关的新闻（医药）

2024-12-25

·复星医药

抑酸加倍，稳妥无幽 | 倍稳®医保上市一周年

2024年1月1日，倍稳®(盐酸凯普拉生片)被纳入国家医保目录。作为新一代钾离子竞争性酸阻滞剂(P-CAB)，倍稳®进入医保一年以来，以其强效抑酸，久稳达标等抑酸优势，解决临床治疗痛点，截至目前覆盖超过2000家医疗机构，惠及超过50万酸相关疾病患者。倍稳®结构更优，速效兼备，久稳达标为酸相关疾病患者带来新的治疗选择酸相关疾病是消化领域的常见病，由于其病因复杂，难治愈，易复发，严重影响患者生活质量。随着对于疾病认知的深入和药物研发的进步，近年来新型抑酸药物不断涌现，为解决临床抑酸难题带来了新的选择，新的希望。 2023年2月14日，由江苏柯菲平研制，复星医药独家商业化的倍稳®(盐酸凯普拉生片)获得国家药监局（NMPA）批准，用于治疗十二指肠溃疡（DU）和反流性食管炎（RE）。盐酸凯普拉生片是拥有中国自主知识产权的1.1类新药，突破传统抑酸药物PPI的药理局限性，引入具有专利性的片段—甲氧基丙氧基苯基官能团，改变组织分布，提高靶器官胃内分布，胃壁/血浆组织分布比例更高1 ，给药后2h起效，4h可达最大疗效2，抑酸更加持久平稳，RE8周黏膜愈合率高达95.8%3， DU6周溃疡愈合率高达94.4%4，为酸相关疾病患者带来新的治疗选择。倍稳®(盐酸凯普拉生片)全国上市会开展医学研究及学术活动推动领域规范化发展为了进一步推动酸相关疾病的规范化诊疗，复星医药携手权威专家及学术组织，积极支持和开展指南巡讲，区域沙龙等学术活动，提高临床医生诊疗能力，共计覆盖8000多名医生，同时开展多项医学研究，探究新药临床价值，公益支持首部《中国消化性溃疡诊疗现状白皮书》，填补临床学术空白，为推动领域发展贡献力量。指南巡讲及区域沙龙领航计划-《中国消化性溃疡诊疗现状白皮书》发布会倍稳Hp二联临床研究启动会支持酸相关疾病科普及公益活动提高国民健康素养为进一步提高国民健康素养，复星医药支持酸相关疾病科普及公益活动，通过健康中国行动——消化系统疾病专题系列宣传活动和《乡村医生诊疗口袋书》公开课等，为实现“健康中国2030”规划目标贡献力量。健康中国行动—消化系统疾病专题系列宣传活动《乡村医生诊疗口袋书》公开课新适应症获批开启无幽治疗新篇章 2024年11月5日，倍稳®(盐酸凯普拉生片)获批与适当的抗生素连用以根除幽门螺旋杆菌（Hp）新适应症，III期研究表明，盐酸凯普拉生片四联方案Hp根除率高达93.4%，优于PPI5。此前倍稳®是中国首款获批DU和RE双适应症的P-CAB，新适应症的获批，不但增加了倍稳®的临床适用范围，也为Hp感染人群提供新的治疗武器。复星医药将履行企业职责，搭建多种学术交流平台，助力临床研究，最大化创新产品的临床价值，惠及更多患者，为中国消化领域的发展贡献力量，让每个家庭乐享健康。参考文献： 1. 赵世峰,汪荣华.中国临床药理学与治疗学, 2018, 23(3):9. 2. Data on file. 3. T Tan ND, et al. Clin Transl Gastroenterol. 2023 Jul 1;14(7)e00602. 4. Zhou S, et al. Clin Transl Sci. 2023 Aug 2. 5. Data on file

上市批准核酸药物

2024-12-16

·复星医药

国内首个自主研发P-CAB药物凯普拉生用于反流性食管炎患者真实世界研究全国启动会成功召开

近日，由中国医药教育协会主办，上海交通大学医学院附属仁济医院牵头的“星前研——前研进展与临床实践研讨会”在上海成功举办。本次会议聚焦于国内首个自主研发的钾离子竞争性酸阻断剂（P-CAB）凯普拉生在反流性食管炎（RE）治疗中的临床研究，旨在评估其在真实世界临床实践中的安全性和有效性。会议由项目牵头PI房静远教授担任主席，汇聚了来自全国各地消化领域20余位专家，共同探讨凯普拉生在RE治疗中的研究进展。会议内容涵盖了项目介绍、研究方案讨论、项目管理时间线等多个环节。会议伊始由房静远教授首先致开场辞，阐述了开展创新药在真实世界中安全性和有效性的研究具有重要意义。随后，复星全球合伙人、复星医药国内营销平台CEO袁春袁春先生发表了致辞，他期待在消化领域专家的支持下，通过积累中国人群的真实世界数据，推动消化领域临床实践的高质量发展。在学术交流环节时，上海交通大学医学院附属仁济医院陈萦晅教授详细介绍了凯普拉生用于RE患者单臂、多中心、真实世界研究的方案。陈萦晅教授概述了研究背景，从1960年代至今，PPI和P-CAB已成为临床上常用的抑酸药物1。特别是P-CAB，因其在RE患者中展现出的抑酸持续时间和黏膜愈合率更高，被国内外指南共识推荐为RE初始治疗的一线优选抑酸药2,3。特别是凯普拉生已经获批RE/DU/Hp根除适应证，且其吸收不受饮食影响，具有快速强效、持久稳定等抑酸优势4-6。陈教授还分享了既往RE研究中凯普拉生用于RE的研究结果:凯普拉生治疗8周的RE黏膜愈合率高达95.8%7，在1项荟萃分析中，与其它PPI和P-CAB相比，凯普拉生表现出更高黏膜愈合率累积排名曲线下面积（SUCRA）8。此外陈萦晅教授详细介绍了研究设计、研究人群、研究流程等方面内容，并就试验中可能遇到的问题进行了回复。复星医药国内营销平台医学部副总经理宋琦介绍了作为中国首个自主研发的P-CAB的凯普拉生，其研发历程、项目管理时间线以及真实世界研究的质量控制和中心进度。在会议讨论环节中，专家们就入排标准、合并用药、安全性以及患者获益与风险等方面进行了深入交流。专家们一致认为，对于合并用药的记录应详尽，以便分析药物间的相互作用及对疗效的影响。同时，对于特殊人群，应在医生评估风险和获益后决定是否入组。安全性问题作为研究的核心，专家们强调了对不良事件的监测和记录的重要性。会议尾声会议在热烈的讨论和积极的交流中圆满结束，与会专家对凯普拉生在RE治疗中的潜力高度期待，并对全国多中心真实世界研究的顺利实施充满信心。此次全国启动会的成功举办，标志着凯普拉生临床研究正式拉开序幕，为RE患者带来了更多样化的治疗选择。参考文献 1. Pharmaceutics. 2022;14(10):2043. Published 2022 Sep 25. 2. 中华医学会消化病学分会. 中华消化杂志,2020,40(10):649-663. 3. J Gastroenterol. 2022;57(4):267-285. 4. Clin Transl Sci. 2023 Oct;16(10):1911-1922. 5. Eur J Pharm Sci. 2023 Nov 1;190:106578. 6. 国家药品监督管理局. 2024年11月05日药品批准证明文件送达信息.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241105145400132.html 7. Aliment Pharmacol Ther. 2022;55(12):1524-1533. 8. Therapeutic advances in gastroenterology vol. 17 17562848241251567. 19 Jun. 2024,

申请上市

2024-12-12

·复星医药

盐酸凯普拉生片用于幽门螺旋杆菌根除的多中心临床研究在深圳启动

近日，“凯普拉生二联、四联疗法根除幽门螺杆菌（Hp）的疗效和安全性：一项多中心、开放标签、随机对照研究”全国启动会在南方•深圳消化论坛暨第八届南方-仁济幽门螺杆菌与胃肠微生态论坛期间顺利举行。本次会议旨在探讨探索不同疗程（10天、14天）的凯普拉生二联疗法对比标准四联疗法根除Hp的有效性和安全性的影响，同时进一步验证创新结构的凯普拉生在临床使用中的安全有效性，进而为患者带来更加安心、有效、且性价比高的治疗方案。该研究是一项前瞻性、多中心、随机对照的临床研究，由南方医科大学深圳医院作为牵头单位，以中华医学会消化病学分会幽门螺杆菌学组专家为主要参与者的全国23家分中心组成了强大的研究团队。启动会由中华医学会消化病学分会幽门螺杆菌学组组长、南方医科大学深圳医院副院长陈烨教授担任大会主席，阐述了临床研究项目对于科研机构乃至卫生事业发展的重要意义，更寄托了对医学研究无限未来的美好憧憬。会议伊始由中山大学附属第一医院曾志荣教授进行了“强效抑酸，无幽之选——幽门螺杆菌根除治疗抑酸新选择”主题讲课，详细介绍了中国幽门螺杆菌流行病学现状及Hp根除治疗领域的未满足需求，并详细解读了凯普拉生在Hp根除治疗方面的临床应用价值。随后，南方医科大学深圳医院陆冰云医生做了“凯普拉生二联、四联疗法根除幽门螺杆菌（Hp）的疗效和安全性：一项多中心、开放标签、随机对照研究”的情况介绍，详细讲述了项目的研究背景、设计方案、预期目标以及关键试验流程，特别是对患者的受益与风险评估进行了深入的分析。同时强调该项目在幽门螺杆菌根除治疗领域的研究意义，展示如何通过优化的治疗方案提高患者的用药依从性并改善Hp根除率。在汇报结束后，陈烨教授与上海交通大学医学院附属仁济医院陆红教授共同主持讨论环节，各分中心的专家们就项目在实际落地过程中的潜在问题和挑战展开了热烈讨论，结合各自中心的实际情况，积极为项目的顺利推进提出建设性意见。会议尾声陈烨教授特别强调，所有研究人员必须保持科学、严谨的态度，严格按照研究方案执行，确保数据收集的完整性和规范性。同时，鼓励各分中心的研究者们在日常临床工作中保持思考与创新意识，积极开展团队合作，将科研成果应用于临床，提升整体诊疗水平。凯普拉生幽门螺杆菌根除全国多中心研究的顺利启动，是凯普拉生幽门螺杆菌根除适应证获批后的又一重要研究。通过多中心协作和专家们的共同努力，期待项目在未来取得突破性进展，推动盐酸凯普拉生在幽门螺杆菌根除领域的广泛应用。

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适应症	国家/地区	公司	日期
幽门螺杆菌感染	中国	江苏柯菲平医药股份有限公司	2024-10-29
十二指肠溃疡	中国	江苏柯菲平医药股份有限公司	2023-02-14
反流性食管炎	中国	江苏柯菲平医药股份有限公司	2023-02-14

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适应症	最高研发状态	国家/地区	公司	日期
消化性溃疡出血	临床2期	中国	江苏柯菲平医药股份有限公司	2024-10-16
消化性溃疡出血	临床2期	中国	南京柯菲平盛辉制药有限公司	2024-10-16
糜烂性食管炎	临床1期	美国	江苏柯菲平医药股份有限公司	2021-06-24
早期胃癌	临床1期	中国	南京柯菲平盛辉制药有限公司	2018-09-03
早期胃癌	临床1期	中国	江苏柯菲平医药股份有限公司	2018-09-03
幽门螺杆菌相关性胃炎	临床1期	中国	南京柯菲平盛辉制药有限公司	2018-09-03
幽门螺杆菌相关性胃炎	临床1期	中国	江苏柯菲平医药股份有限公司	2018-09-03
胃MALT淋巴瘤	临床1期	中国	南京柯菲平盛辉制药有限公司	2018-09-03
胃MALT淋巴瘤	临床1期	中国	江苏柯菲平医药股份有限公司	2018-09-03
免疫性血小板减少症	临床1期	中国	江苏柯菲平医药股份有限公司	2018-09-03

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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


Pubmed 人工标引	临床3期	十二指肠溃疡	360	Keverprazan 20 mg	選鹽願願廠憲願鏇獵願(製網夢積構襯選獵艱顧) = 鹹顧鹽廠蓋鑰醖蓋積網網鏇餘憲壓衊遞窪襯遞 (鑰鑰餘選膚顧鏇壓廠齋 ) 更多	非劣	2023-07-01
				Lansoprazole 30 mg	選鹽願願廠憲願鏇獵願(製網夢積構襯選獵艱顧) = 製廠鏇鑰觸願鑰顧鬱願網鏇餘憲壓衊遞窪襯遞 (鑰鑰餘選膚顧鏇壓廠齋 ) 更多
Pubmed 人工标引	临床3期	糜烂性食管炎	238	Keverprazan 20 mg	糧襯壓觸醖醖壓蓋鑰窪(鬱鏇遞鑰顧繭衊夢鬱簾) = 醖夢醖糧遞糧壓選糧壓鬱襯餘鏇艱蓋築簾衊獵 (壓廠願壓鬱壓餘壓選壓 ) 更多	非劣	2022-05-03
				Lansoprazole 30 mg	糧襯壓觸醖醖壓蓋鑰窪(鬱鏇遞鑰顧繭衊夢鬱簾) = 夢窪選鏇鬱廠構鏇衊鹽鬱襯餘鏇艱蓋築簾衊獵 (壓廠願壓鬱壓餘壓選壓 ) 更多
CTR20191638 (H008, UEGW)	临床2期	十二指肠溃疡一线	-	H008 20mg	齋築繭鹹構網襯網構襯(膚願獵願壓繭繭淵夢膚) = 窪艱窪範憲餘壓夢選觸襯膚鑰築壓積鏇廠遞顧 (糧簾鏇糧衊夢範糧艱選 ) 更多	积极	2021-10-02
				H008 30mg	齋築繭鹹構網襯網構襯(膚願獵願壓繭繭淵夢膚) = 衊衊願艱齋餘積糧鑰鹹襯膚鑰築壓積鏇廠遞顧 (糧簾鏇糧衊夢範糧艱選 ) 更多