Randomised, placebo-controlled Phase II proof of concept study of efficacy and safety of a novel rifamycin SV in situ gelling rectal solution administered by enema to patients with mild to moderate left-sided ulcerative colitis - CB-01-35/01

开始日期2024-06-06

申办/合作机构

COSMO TECH Co., Ltd.

NCT04026984

/ Not yet recruiting临床2期

Double Blind, Multi-center Study to Evaluate the Safety and Efficacy of 100 mg Twice Daily Rifamycin SV MMX® Added to Standard ORT Versus Placebo Plus ORT, in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

This will be a double-blind comparative study, performed in pediatric subjects (Age 6-11) traveling to developing regions with a known high incidence of traveler's diarrhea. The subjects will be suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.

开始日期2024-06-01

申办/合作机构

RedHill Biopharma Ltd.

NCT04027894

/ Not yet recruiting临床2期

Double Blind Study to Evaluate the Safety and Efficacy of 400 mg Twice Daily Rifamycin SV MMX® Added to Standard Oral Rehydration Therapy (ORT) Versus Placebo Plus ORT, in the Treatment of Traveler's Diarrhea in Children Age 12 to 17 Years

This will be a double blind comparative study, performed in pediatric subjects (Age 12-17) traveling to developing regions with a known high incidence of traveler's diarrhea. The subjects will be suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.

开始日期2024-01-01

申办/合作机构

RedHill Biopharma Ltd.

100 项与利福霉素钠相关的临床结果

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100 项与利福霉素钠相关的转化医学

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100 项与利福霉素钠相关的专利（医药）

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3,176

项与利福霉素钠相关的文献（医药）

2025-03-01·MARINE POLLUTION BULLETIN

Residual heavy metals and antibiotic pollution in abandoned breeding areas along the northeast coast of Hainan Island, China

Article

作者: Zheng, Zhangqin ; Ji, Chao ; Chen, Wei ; Zhao, Sanping ; Liu, Xiaodong ; Zhu, Yongbing ; Zhang, Haiyang ; Xing, Zhe ; Dong, Bin ; Xue, Yulu

To assess the environmental status of an abandoned aquaculture and breeding area in the northeast coast of the Hainan Island, surface and well water, sediment and surface soils were sampled and analyzed for conventional physicochemical properties, heavy metals and antibiotics. Metagenome tests were also conducted to determine the composition and diversity of the microbial community in typical habitats. Affected by the discharge of wastewater from higher-place pond aquaculture, coastal freshwater rivers have undergone significant salinization, Cl^- and Na⁺ were as high as 4.51 × 10³ and 1.42 × 10³ mg/L. The 3 hand-pumped wells surveyed were also suffered from varying degrees of salinization and heavy metal pollution, especially the threat of arsenic pollution. Compared with the local background values, significantly higher valves of Cu, Zn, As and Cd were observed in the surface soil and sediment, and the average concentrations for Cu, Zn, As and Cd are 5.71, 17.6, 15.4 and 0.09 mg/kg respectively. For As，the Nemerow index ranges from 7 to 16 and the geoaccumulation index is between 2 and 4, indicating moderate to severe pollution levels in surface soil. 14 antibiotics were detected in the soil and sediment samples, and the highest total amount was 73 μg/kg, with tetracycline being the dominant antibiotic. Sediment and forest soil showed different microbial community and the genetic diversity index of sediment was lower than that of the forest soils. For typical vegetation soil, the genetic diversity followed the order as P. elliottii × P. caribaea > Eucalyptus > C. equisetifolia. Among the soil and sediment samples, the highest abundances of antibiotic resistance genes (ARGs) were associated with elfamycin, peptide, rifamycin, and the most common antibiotic resistance mechanisms were antibiotic target alteration (54.5 %), antibiotic efflux (27.6 %) and antibiotic target replacement (12.1 %). The metal resistance genes (MRGs) for Cu, Fe, and Zn resistance were the main MRGs in the samples. This study identified the potential ecological environment risk factors in the abandoned coastal breeding areas, and suggested continuous monitoring and assessment of the residual pollutant abatement processes in the future.

2025-02-01·ENVIRONMENTAL POLLUTION

Impact of different continuous fertilizations on the antibiotic resistome associated with a subtropical triple-cropping system over one decade

Article

作者: Gu, Wen-Jie ; Lu, Yu-Sheng ; Wang, Dan ; Sun, Li-Li ; Liu, Chong ; Li, Ya-Ying ; Xie, Kai-Zhi ; Zhou, Chang-Min ; Shi, Chao-Hong ; Zheng, Jin ; Peng, Huan-Long ; Zhang, Kun

The prevalence of antibiotic resistance genes (ARGs) in agricultural soils has garnered significant attention. However, the long-term impacts of various nitroge (N)-substitution fertilization regimes on the distribution of soil ARGs and their dominant drivers in a subtropical triple-cropping system remain largely unexplored. This study employed a metagenomic approach to analyze soil ARGs, microbial communities, mobile genetic elements (MGEs), and viruses from a maize-maize-cabbage rotation field experiment with five different fertilization regimes. Soil samples were collected in 2012 and 2021. A total of 615 unique ARG subtypes were identified, with multidrug, bacitracin, and rifamycin resistance genes being the most abundant. Notably, ARG types. the continuous application of fresh chicken manure (CM) over 10 years significantly increased both the count of unique ARG subtypes and the total ARG abundance compared to other fertilization regimes, such as inorganic fertilizer and composted chicken manure. Specifically, the abundance of genes associated with antibiotic target replacement (e.g., sul1 and sul2) in the CM-treated soil rose by 8.83-fold from 2021 to 2012. Our random forest analysis revealed that the abundance of three MGEs (QacEdelta, plasmids, and IstB), two viral families (Myoviridae and Podoviridae), two bacterial phyla (Chloroflexi and Planctomycetes), and two environmental factors (pH and soil organic matter (SOM)) significantly influenced the distribution of ARGs. Furthermore, variance decomposition analysis underscored the critical roles of the three MGEs and the two viral families in the dissemination of ARGs, suggesting that horizontal gene transfer (HGT) may play a key role in ARG spread. These findings enhance our understanding of how different fertilization practices influence ARG dissemination in subtropical triple-cropping agroecosystems over the long term and provide valuable insights for optimizing fertilization management strategies.

2025-01-01·ACTA BIOCHIMICA ET BIOPHYSICA SINICA

Continuous carbon source supply is essential for high rifamycin productivity of <italic>Amycolatopsis mediterranei</italic> in nitrate-stimulated fermentation revealed by a metabolomic study

Article

作者: Yang, Chen ; Shao, Zhihui ; Yan, Qi ; Zhao, Guoping

Amycolatopsis mediterranei U32 is an industrial strain capable of producing therapeutically useful rifamycin SV. In early days of fermentation studies, nitrate was found to increase the yield of rifamycin along with globally, affecting both carbon and nitrogen metabolism in favor of antibiotic biosynthesis; thus, the nitrate-stimulating effect (NSE) hypothesis was proposed. Although GlnR is likely the master regulator of the pleotropic effect of NSE, the global metabolism affected by NSE has never been systematically examined. In this study, we use mass spectrometry-based metabolomics to quantitatively monitor the metabolomic responses of A. mediterranei U32 to nitrate supplementation. The concentrations of many metabolites involved in central carbon metabolism, including glucose 6-phosphate, glucose 1-phosphate, UDP-glucose, and acetyl-coenzyme A, decrease significantly after the addition of 80 mM potassium nitrate to the medium. We find that the rifamycin SV production yield could be increased by the addition of glucose during the logarithmic growth phase. Moreover, at multiple time points during glucose supplementation in the mid- and late-exponential phases, the yield of rifamycin SV further increases, reaching 354.3%. Quantitative real-time PCR assays of the key genes corresponding to the synthesis of the rifamycin SV precursor combined with data from metabolomics analysis confirm that carbon source deficiency is compensated for after glucose supplementation and that the expression of genes involved in the pathway of 3-amino-5-hydroxybenzoic acid synthesis by UDP-glucose and glutamine is significantly increased. This preliminary exploration of dynamic metabolomic profiles has the potential to increase our understanding of the NSE.

112

项与利福霉素钠相关的新闻（医药）

2025-01-24

·摩熵医药

三大重磅小分子药专利到期，BI、BMS巨头面临挑战，百亿市场迎变局！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。随着全球医药市场的快速发展，专利到期成为仿制药企业抢占市场份额的关键契机。本文聚焦三款即将专利到期的重磅小分子药品——TRADJENTA®（欧唐宁）、XIFAXAN®（昔服申）和SPRYCEL®（施达赛），分别从药物简介、临床应用、市场表现、专利情况以及仿制药相关动态等方面进行详细梳理，分析其国内仿制药研发格局和专利挑战现状。一、 TRADJENTA®（欧唐宁）：2型糖尿病治疗的明星药物 1.TRADJENTA®药物简介及重要交易事件 TRADJENTA®（欧唐宁，通用名利格列汀片）由BoehringerIngelheim（勃林格殷格翰，BI）研发，于2011年5月在美国首次获批上市，用于治疗2型糖尿病。2013年3月26日，原研在中国获批进口，进入中国市场。利格列汀是DPP-4抑制剂，DPP-4是一种降解肠促胰岛素激素胰高血糖素样肽1(GLP-1)和葡萄糖依赖性促胰岛素多肽(GIP)的酶。因此，利格列汀会增加活性肠促胰岛素激素的浓度，以葡萄糖依赖性方式刺激胰岛素的释放，并降低循环中的胰高血糖素水平。自获批以来，BI与礼来、Yuhan、LupinLtd等多家公司达成合作，在全球范围内推广该药物。 2011年1月，BI与礼来达成协议在全球合作开发包括利格列汀在内的多个糖尿病治疗药物。2011年12月，Yuhan获得了与原研公司共同在韩国经营利格列汀片的权益。2015年10月，BI与LupinLtd达成合作在印度共同推广利格列汀。 2.利格列汀片：用于肝肾功能不全患者无需调整剂量，全球销售额近30亿美元根据《中国成人2型糖尿病口服降糖药联合治疗专家共识》治疗推荐意见，利格列汀是唯一可全程用于肝、肾功能不全患者且无需调整剂量的DPP-4抑制剂。利格列汀片为每日一剂的口服DPP-4抑制剂，且无需调整剂量，集有效、安全、方便为一体，上市后迅速在临床广泛使用，2019年全球销售额已达26.84亿美元，此后两年保持缓慢增长，2022年有小幅度下跌，2023年回升且超过下降前水平，增至29.23亿美元。数据来源：摩熵医药销售数据库 3.利格列汀片原研专利情况及挑战历程利格列汀片原研产品在中美的核心专利信息受到关注，东阳光等国内企业对其化合物及制剂专利提起了无效挑战。利格列汀片原研中美核心专利信息一览东阳光从2022年4月开始就已经开始对利格列汀片化合物专利提起了无效挑战，但未能在专利届满到期前挑战成功（届满到期日为2023年8月18日）。2018年8月28日，何明月对利格列汀片制剂专利分案提出无效请求，最终该专利宣告全部无效。利格列汀片原研中国核心专利无效挑战历程 2022年6月30日，石药欧意请求无效利格列汀片制剂专利母案获得成功，2023年3月17日该专利宣告全部无效，两项制剂专利原本预计2027年4月30日到期。 4.2023年8月利格列汀片原研核心专利全部失效，国内仿制药市场解冻截止2024年9月20日，国内共7家企业仿制药获批上市，其中广东东阳光为国内首仿。2020年7月8日广东东阳光仿制的利格列汀片获批上市后便开始着手挂网销售，2021年11月5日，勃林格殷格瀚就广东东阳光这一行为提出侵权诉讼，该案件被国家知识产权局列入重大专利侵权纠纷。 2022年8月5日，国家知识产权局发布了行政裁决结果，责令广东东阳光立即撤网停止销售。东阳光曾尝试无效利格列汀片化合物专利未成功，直到2023年8月利格列汀片国内核心专利到期，广东东阳光才获准恢复挂网销售资格，国内其他获批的仿制药企也陆续进入市场。 5.竞争格局：随着仿制药涌入，利格列汀片国内市场将重新洗牌利格列汀可谓名副其实的“明星降糖药”，近年国内市场以亿元为单位增长，2023年全年市场销售额超15亿元。首仿企业广东东阳光在2022年遭受侵权撤网风波的情况下仍斩获了7684.74万元的市场销售额，2023年下半年广东东阳光重新恢复挂网资格开始回到市场中，并在年末总共获得了超5000万元的销售额。数据来源：摩熵医药销售数据库随着原研专利全部到期失效，将有更多仿制药涌入市场。截至2024年9月，除获批上市的7家外，还有6家正在申报上市（1家已完成审评），5家在开展BE试验（1家试验已完成），仿制药市场竞争俨然一幅激烈景象，进入集采之后利格列汀片国内市场格局将重新洗牌，未来市场主位花落谁家，可拭目以待。二、 XIFAXAN®（昔服申）：肠道感染与肝性脑病治疗的新选择 1.XIFAXAN®药物简介及重要交易事件 XIFAXAN®（昔服申，通用名利福昔明片）由Alfa Wassermann SpA（阿尔法韦士曼制药）研发，于1988年10月在意大利首次获批上市，适用于肠道感染、肝性脑病、肠易激综合征、憩室病等多种病症。利福昔明是利福霉素类抗菌药物，能与细菌的DNA依赖性RNA多聚酶β亚基发生不可逆结合而抑制细菌RNA合成，最终抑制细菌蛋白质的合成。利福昔明具有广泛的抗菌谱，对多数革兰阳性菌和革兰阴性菌，包括需氧菌和厌氧菌具有杀菌作用。利福昔明有5种不同的晶型（α、β、γ、δ和ε），不同晶型间的药理存在显著差异，α晶型利福昔明在胃肠道中几乎不被吸收。由于胃肠道的吸收非常低，多晶型α的利福昔明局部作用于肠腔，对侵入性致病菌无临床疗效。图片来源：摩熵咨询《专利即将到期五大重磅小分子药品，国内仿制药“战况”几何》 2.利福昔明临床优势：治疗肠道感染和肝性脑病获得国家权威指南认可 α晶型利福昔明口服后吸收率很低，在肠道内易形成较高的药物浓度并发挥抗菌活性，因此，对肠道感染相关疾病疗效确切。同时，其可能通过改善肠道菌群紊乱，减轻炎症反应，调节肠道免疫等机制，在一些慢性肠道炎症和肠功能紊乱的治疗中发挥作用，且对正常菌群影响较小、安全性好。此外，利福昔明还可能通过调节肠道菌群改善内毒素血症，进而影响肠-肝轴的作用防治肝性脑病。此外还有研究发现，其对肝硬化其他并发症的防治和延长慢性肝病患者生存期均有积极作用，显示出广阔的应用前景。 3.利福昔明片：口服不吸收广谱抗生素，疗效确切，耐受性好，前景广阔利福昔明片是一款经典肠道抗感染药物，活性成分为α晶型利福昔明，主要用于肠道感染和高氨血症(肝性脑病)的辅助治疗，已在全球多个国家上市使用多年，积累了庞大的市场基础，近年销售额仍在稳健上升，2023年全球销售额约23.86亿美元。数据来源：摩熵医药销售数据库摩熵医药全球药物研发数据库显示，利福昔明治疗克罗恩病、假性肠梗阻、镰状细胞性贫血等多种疾病的研究已进入临床阶段，目前克罗恩病在欧洲已进入III期临床，假性肠梗阻和镰状细胞性贫血分别在日本和美国开展II期临床研究。 4.利福昔明片原研专利情况利福昔明片的活性成分为利福昔明α晶型，原研α晶型在中国的专利权将于2024年11月4日到期。除α晶型外，原研还布局了β、γ、δ和ε晶型的专利，其中β和γ晶型专利将与α晶型一同到期，δ和ε晶型专利将于2025年7月20日到期。但原研并未在中国上市药品专利信息登记平台登记相关专利信息。利福昔明片原研中美核心专利信息一览原研曾计划在国内布局肠易激综合征和肝性脑病用途专利，但均以被国家知识产权局驳回失效告终。 5.仿制药市场：核心晶型专利届满日在即，但临床难度令仿制药企望而却步事实上，国内已有利福昔明仿制药上市并应用多年，但都是未通过一致性评价的老批文，获批剂型包括片剂、干混悬剂、胶囊剂。据摩熵医药销售数据库显示，近年胶囊剂已退出市场，目前主要应用剂型为片剂，干混悬剂在市场中也还占有一席之地。国内利福昔明制剂市场向好，5年市场增速为26.13%，2023年市场增量更是超2000万元，销售额达7035.51万元，其中有6459.38万元来自利福昔明片。目前国内利福昔明片市场几乎全部落入原研囊中，仿制药市场占比不到1%。作为一款经典肠道抗感染药物，同时又因其药理作用特点而具有广阔市场前景，利福昔明在国内布局的核心专利将于不久后的2024年11月4日到期失效，然而至今仍无任何一家国内仿制药企跟进仿制的消息，已获得老批文的企业也没有进一步开展一致性评价，推测跟利福昔明特殊的药理作用（几乎不吸收，局部作用）导致其临床研究难度大、成本高有关。摩熵咨询研发建议：两种选择：（1）四项以药代动力学为终点的生物等效性研究和体外生物等效性研究（比较溶出度）；（2）四项以药代动力学为终点的生物等效性研究和体外生物等效性研究（比较溶出度）和两项临床终点生物等效性研究。三、 SPRYCEL®（施达赛）：白血病治疗领域的经典药物 1.SPRYCEL®药物简介及重要交易事件 SPRYCEL®（施达赛，通用名达沙替尼片）由Bristol-Myers Squibb Co（百时美施贵宝，BMS）研发，于2006年6月在美国首次获批上市，用于治疗对甲磺酸伊马替尼耐药或不耐受的费城染色体阳性慢性粒细胞白血病以及费城染色体阳性急性淋巴细胞白血病。2011年9月7日，原研在中国获批进口，仅用于治疗对甲磺酸伊马替尼耐药或不耐受的费城染色体阳性慢性粒细胞白血病成年患者。达沙替尼属于蛋白激酶抑制剂，可抑制BCR-ABL激酶和SRC家族激酶以及许多其它选择性的致癌激酶，包括c-KIT、ephrin（EPH）受体激酶和PDGFβ受体。达沙替尼是一种强效的、次纳摩尔（subnanomolar）的BCR-ABL激酶抑制剂，其在0.6-0.8nM的浓度下具有较强的活性。它与BCR-ABL酶的无活性及有活性构型均可结合。体外研究中，达沙替尼在表达各种伊马替尼敏感和耐药疾病的白血病细胞系中具有活性。此外，达沙替尼可在次纳摩尔浓度下抑制SRC家族激酶。 2009年4月，BMS与Otsuka达成合作共同开发和商业化包括达沙替尼在内的血液肿瘤药物。2011年1月Otsuka同意与BMS联合在日本推广达沙替尼片。2015年2月Otsuka终止了在日本联合推广的达沙替尼片协议，BMS独自接手了日本市场的推广业务，这一变动不影响双方公司在达沙替尼片上的其他合作事宜。 2.达沙替尼片临床表现：国内外权威指南均支持其治疗白血病临床地位 3.市场表现：第二代酪氨酸激酶抑制剂，达沙替尼片全球销售额超20亿美元达沙替尼片为第二代酪氨酸激酶抑制剂，上市后临床应用广泛，可用慢性髓性白血病于一线和二线治疗。2019年全球市场已超20亿美元，此后三年缓慢增长，2022年达24.93亿美元，2023年有小幅下降，降至24.08亿美元。达沙替尼片已获批的适应症为甲磺酸伊马替尼耐药或不耐受的费城染色体阳性慢性粒细胞白血病（又称慢性髓性白血病）和费城染色体阳性急性淋巴细胞白血病，但在中国仅用于治疗慢性髓性白血病，急性淋巴细胞白血病还停留在II期临床阶段。近年来欧美地区对达沙替尼片在其他肿瘤治疗的潜力展开了研究，其中转移性非小细胞肺癌、转移性乳腺癌、三阴乳腺癌、胶质母细胞瘤方面的研究已进入II期临床。 4.专利情况：达沙替尼晶型专利壁垒遭石药欧意攻破，至此原研国内专利全部无效原研公司未在中国上市药品专利信息登记平台登记达沙替尼片相关专利信息。2020年12月，石药欧意以不符合专利法为由对原研晶型专利提出无效请求，2021年5月国家知识产权局宣告专利全部无效。 5.仿制药研发格局：正大天晴抢占先机，稳居国内达沙替尼片市场主位多年截止2024年9月20日，达沙替尼片国内目前已有5家仿制药企业获批上市，其中正大天晴药业为首仿企业，但比较特殊的是正大天晴首次获批是在2013年9月，未经过一致性评价，直到2021年5月才通过一致性评价正式成为过评品种。此外，北京双鹭药业已完成达沙替尼片的BE试验，预计很快将申报上市。据悉，正大天晴仿制的达沙替尼片所使用的活性成分为不带水的晶型，而非原研的一水合物晶型，因此不存在专利侵权问题，上市后便开始推广销售，原研公司也未对这一行为提起侵权诉讼。因正大天晴仿制药价格的优势，很快取代原研抢占了国内市场大头，近5年其市场份额更是稳定保持在80%以上，2023年销售额超3亿元。2021年正大天晴达沙替尼片成功通过一致性评价，进一步稳定了其市场地位。数据来源：摩熵医药数据库随着原研专利失效，包括石药欧意在内的多家仿制药企纷纷布局，未来市场竞争将更加激烈。 END 本文为原创文章，转载请留言获取授权专利即将到期五大重磅小分子药品下期内容预告一、5款重磅小分子药品专利到期全解析：专利攻防策略、专利制度意义和影响近期将持续更新，敬请期待近期热门资源获取【摩熵咨询】以终为始，数据助力高质量立项-20240527 【摩熵咨询】市场洞察，精准决策，医疗大数据赋能药企市场准入-2024.5.23 【摩熵咨询】CGT产业现状与未来趋势蓝皮书-20240530 【摩熵咨询】2024年十大重磅小分子药物-20240530 【摩熵咨询】-吸入制剂壁垒高玩家少，国产替代空间广阔-20240604 【摩熵咨询】中药行业现状与未来趋势白皮书-2024.7.8 【摩熵咨询】2023年医药企业综合实力排行榜-20240723 【摩熵咨询】跨越国界，引领创新：中国药企出海的布局实践-202408 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 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专利到期上市批准

2025-01-21

·PRNewswire

RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published

Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists Additionally, new data describing the foundations for Talicia's recent FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, has been published in the Journal of Clinical Pharmacology The published data describe the use of physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence of the TID regimen to the previous every 8-hour (Q8H) dosing regimen H. pylori infection affects approximately 35% of the U.S. adult population and is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the coverage of Talicia by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without the requirement for prior therapeutic steps or authorizations, for both treatment-naïve and treatment-experienced patients, effective as of January 1, 2025. "There is broad recognition of the clinical efficacy of Talicia and the recently updated American College of Gastroenterology (ACG) Clinical Guideline, listing Talicia as a first-line treatment option. Talicia is the only FDA-approved low-dose rifabutin-based therapy for the eradication of H. pylori, and continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists1," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "We are pleased that coverage in the Medicare arena is growing as the Part D payers recognize the importance of treating H. pylori with the right therapy the first time and look forward to expanding coverage in Medicare." The Company also announced the publication of new data in The Journal of Clinical Pharmacology2. The published data describe the foundations for Talicia's recently FDA-approved label change to a more convenient three-times daily (TID) with food (at least 4 hours apart, e.g., breakfast, lunch, and dinner) dosing routine, further simplifying the patient experience and supporting increased patient adherence. The result of a successful collaboration with Certara, the published study utilized Certara's Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence in plasma and within the stomach for all three of Talicia's components, regardless of dosing TID or Q8H. These data support the provision of a more patient-friendly Talicia regimen and further demonstrate RedHill's ongoing commitment to enhanced patient experience and outcomes. "Treating H. pylori infection is challenging and often requires patients to take multiple different pills multiple times a day. Simplified dosing regimens improve patient adherence. In the treatment of H. pylori infection, adherence to dosing is critical for optimizing patient outcomes, while also mitigating against the development of bacterial resistance. Therefore, it is important to use an effective therapy that is most likely to eradicate H. pylori infection at the first attempt," said Colin W. Howden, MD, Professor Emeritus, University of Tennessee College of Medicine, and co-author of the paper. "These important data, and the retention of Talicia's pharmacokinetic profile across dosing regimens, support the change to a more simplified TID dosing schedule. Talicia's efficacy, tolerability, and resistance profile, along with its convenient all-in-one formulation and TID dosing, further support its inclusion as an empirically prescribed first-line option in the 2024 ACG Clinical Guideline on the treatment of H. pylori infection3." About H. pylori H. pylori is a bacterial infection that affects approximately 35%4 of the U.S. population, with an estimated two million patients treated annually3. Worldwide, around 66% of the population has H. pylori infection5, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies10. About Talicia® Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. More specifically, the high rates of H. pylori resistance to clarithromycin have led to significant increases in treatment failures with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent11 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm12. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Patients should check coverage details with their health plan. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at . About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults13. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. All information contained herein is the sole responsibility of RedHill Biopharma Ltd. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Commercial 1 IQVIA XPO Data on file 2 Vakil N, Howden CW, Shah SC, Chen KF, Offman E, Almenoff JS, Sheldon KL. Physiologically Based Pharmacokinetic Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025 Jan 2. doi: 10.1002/jcph.6178. Epub ahead of print. PMID: 39745109. 3 Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH, FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI: 10.14309/ajg.0000000000002968 4 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 5 6 Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 7 NIH – Helicobacter pylori and Cancer, September 2013. 8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 10 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. 11 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. 12 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). 13 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期临床结果上市批准

2024-12-29

·药筛

艾曲泊帕乙醇胺干混悬剂首仿，维生素B6注射液首家过评 | 仿制药周报（12.23-12.29）

统计每周仿制药一致性评价申报、上市申请（12.23-12.29） 1、仿制药上市申请获批药品名称企业名称类型受理号阿奇霉素干混悬剂海南斯达制药有限公司;海南赛立克药业有限公司4CYHS2301549艾曲泊帕乙醇胺干混悬剂山东则正医药技术有限公司;湖南九典制药股份有限公司3CYHS2303319贝前列素钠片江苏和晨药业有限公司4CYHS2302529玻璃酸钠滴眼液广东汉丰百盛医药有限公司;珠海亿胜生物制药有限公司4CYHS2302162布美他尼注射液新乡市常乐制药有限责任公司3CYHS2302028碘美普尔注射液成都倍特药业股份有限公司4CYHS2300806碘美普尔注射液重庆圣华曦药业股份有限公司4CYHS2300398二甲双胍恩格列净片(Ⅴ)浙江诺得药业有限公司4CYHS2302084二甲双胍恩格列净片(Ⅵ)浙江诺得药业有限公司4CYHS2301714二甲双胍恩格列净片(Ⅵ)杭州朱养心药业有限公司4CYHS2301799枸橼酸西地那非口崩片金鸿药业股份有限公司4CYHS2300933聚乙二醇钠钾散山东新华鲁抗医药有限公司;山东鲁抗医药集团赛特有限责任公司4CYHS2201777利丙双卡因乳膏海南海灵化学制药有限公司4CYHS2300688硫酸镁钠钾口服用浓溶液南京海鲸药业股份有限公司4CYHS2301975硫酸镁钠钾口服用浓溶液维生原（厦门）生物科技有限公司;江苏万高药业股份有限公司4CYHS2301214罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2301616罗沙司他胶囊江西山香药业有限公司4CYHS2301375罗沙司他胶囊江西山香药业有限公司4CYHS2301376罗沙司他胶囊南京正大天晴制药有限公司4CYHS2301366罗沙司他胶囊南京正大天晴制药有限公司4CYHS2301367乳果糖口服溶液青岛黄海制药有限责任公司4CYHS2302134乳果糖口服溶液青岛黄海制药有限责任公司4CYHS2302135乳果糖口服溶液保定爱晖药业有限公司4CYHS2301666他达拉非片湖南威特制药股份有限公司4CYHS2302456他达拉非片广东九明制药有限公司4CYHS2302381吸入用复方异丙托溴铵溶液南京力成药业有限公司4CYHS2302748西甲硅油乳剂维生原（厦门）生物科技有限公司;江苏万高药业股份有限公司4CYHS2302283盐酸奥洛他定滴眼液石家庄格瑞药业有限公司4CYHS2302351盐酸奥洛他定滴眼液石家庄格瑞药业有限公司4CYHS2302350盐酸布比卡因注射液江西和盈药业有限公司;江西银涛药业股份有限公司3CYHS2301026盐酸利多卡因局部溶液浙江赛默制药有限公司3CYHS2400324盐酸普萘洛尔片合肥国药诺和药业有限公司;华益药业科技(安徽)有限公司3CYHS2400861依托咪酯中/长链脂肪乳注射液燃点（南京）生物医药科技有限公司;江苏康禾生物制药有限公司4CYHS2302459依折麦布片山东新时代药业有限公司4CYHS2300782注射用甲磺酸齐拉西酮南京正大天晴制药有限公司4CYHS2302315注射用磷酸特地唑胺四川美大康佳乐药业有限公司;峨眉山通惠制药有限公司4CYHS2302155左氧氟沙星滴眼液湖北远大天天明制药有限公司4CYHS2301688 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿莫西林胶囊国药集团汕头金石制药有限公司CYHB2450017阿莫西林克拉维酸钾干混悬剂国药集团威奇达药业有限公司CYHB2350931醋酸泼尼松片浙江仙琚制药股份有限公司CYHB2150103对乙酰氨基酚片石家庄四药有限公司CYHB2450177对乙酰氨基酚片石家庄四药有限公司CYHB2450176法莫替丁注射液华润双鹤利民药业（济南）有限公司CYHB2350536呋塞米注射液石家庄四药有限公司CYHB2450147复方电解质注射液成都国为生物医药有限公司;四川科伦药业股份有限公司CYHB2350782复方氯化钠注射液广东科伦药业有限公司CYHB1950827甘露醇注射液河南科伦药业有限公司CYHB2050048格列美脲片悦康药业集团股份有限公司CYHB2450084格列齐特缓释片山东司邦得制药有限公司CYHB2450198喷他佐辛注射液华润双鹤药业股份有限公司CYHB2350459碳酸氢钠注射液辽宁民康制药有限公司;湖南科伦制药有限公司CYHB2350797维生素B6注射液湖北科伦药业有限公司CYHB2350932盐酸氨基葡萄糖胶囊北京康必得药业有限公司CYHB1950937盐酸氨溴索片黑龙江澳利达奈德制药有限公司CYHB2350642盐酸苯海拉明片安徽博诺美科生物医药有限公司;上海华源安徽锦辉制药有限公司CYHB2450078盐酸纳美芬注射液辽宁海思科制药有限公司CYHB2450045注射用厄他培南钠石药集团欧意药业有限公司CYHB2450089注射用磷霉素钠厦门宝瑞药业有限公司;国药集团国瑞药业有限公司CYHB2350981注射用磷霉素钠厦门宝瑞药业有限公司;国药集团国瑞药业有限公司CYHB2350982注射用磷霉素钠厦门宝瑞药业有限公司;国药集团国瑞药业有限公司CYHB2350983注射用头孢哌酮钠舒巴坦钠安徽威尔曼制药有限公司CYHB2350857 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称类型受理号阿戈美拉汀片江苏和晨药业有限公司;昆山龙灯瑞迪制药有限公司4CYHS2404488阿立哌唑口崩片哈尔滨三联药业股份有限公司3CYHS2404560阿立哌唑口崩片哈尔滨三联药业股份有限公司3CYHS2404559阿莫西林克拉维酸钾干混悬剂山东益康药业股份有限公司4CYHS2404590阿瑞匹坦注射液山东齐都药业有限公司3CYHS2404598艾曲泊帕乙醇胺干混悬剂广州市联瑞制药有限公司3CYHS2404528艾托格列净片山东朗诺制药有限公司4CYHS2404557氨茶碱注射液湖南赛隆药业（长沙）有限公司3CYHS2404595氨茶碱注射液湖南赛隆药业（长沙）有限公司3CYHS2404594氨磺必利口服溶液浙江浙北药业有限公司3CYHS2404541氨溴特罗口服溶液湖南九典制药股份有限公司3CYHS2404519氨溴特罗口服溶液南昌立健药业有限公司3CYHS2404538氨溴特罗口服溶液山东简道制药有限公司3CYHS2404517倍他米松磷酸钠注射液成都天台山制药股份有限公司3CYHS2404555苯磺酸美洛加巴林片成都苑东生物制药股份有限公司4CYHS2404569苯磺酸美洛加巴林片成都苑东生物制药股份有限公司4CYHS2404570苯磺酸美洛加巴林片成都苑东生物制药股份有限公司4CYHS2404571苯磺酸左氨氯地平片济南高华制药有限公司4CYHS2404475苯磺酸左氨氯地平片济南高华制药有限公司4CYHS2404474苯溴马隆片北京福元医药股份有限公司3CYHS2404558吡仑帕奈口服混悬液南京海纳制药有限公司4CYHS2404484波生坦分散片江苏天士力帝益药业有限公司4CYHS2404493布美他尼注射液中山万汉制药有限公司3CYHS2404577布美他尼注射液中山万汉制药有限公司3CYHS2404578布美他尼注射液河南群益医药科技开发有限公司;信合援生制药股份有限公司3CYHS2404492布瑞哌唑口崩片河北龙海药业有限公司3CYHS2404510布瑞哌唑口崩片河北龙海药业有限公司3CYHS2404509达格列净二甲双胍缓释片（Ⅰ）江苏万高药业股份有限公司4CYHS2404592达格列净二甲双胍缓释片（Ⅰ）新乡市常乐制药有限责任公司4CYHS2404561达格列净二甲双胍缓释片（Ⅱ）新乡市常乐制药有限责任公司4CYHS2404562达格列净二甲双胍缓释片（Ⅲ）新乡市常乐制药有限责任公司4CYHS2404563达格列净二甲双胍缓释片（Ⅲ）江苏万高药业股份有限公司4CYHS2404591达格列净片上海衡山药业有限公司4CYHS2404506蛋白琥珀酸铁口服溶液山东则正医药技术有限公司;华益泰康药业股份有限公司4CYHS2404465地夸磷索钠滴眼液江苏福邦药业有限公司4CYHS2404467地夸磷索钠滴眼液福建华耀医药科技有限公司;杭州民生药业股份有限公司4CYHS2404489地氯雷他定口服溶液浙江华润三九众益制药有限公司;天大药业（珠海）有限公司3CYHS2404549地屈孕酮片北京金城泰尔制药有限公司;浙江赛默制药有限公司4CYHS2404601低钙腹膜透析液(乳酸盐-G1.5%)广东科泓药业有限公司4CYHS2404583对乙酰氨基酚片重庆药友制药有限责任公司3CYHS2404564对乙酰氨基酚维生素C泡腾片江苏和晨药业有限公司3CYHS2404600多巴丝肼片河北龙海药业有限公司4CYHS2404523二羟丙茶碱注射液江西科为制药有限公司;亚邦医药股份有限公司3CYHS2404553二十碳五烯酸乙酯软胶囊博瑞制药（苏州）有限公司4CYHS2404522非那雄胺片江苏知原药业股份有限公司4CYHS2404532非那雄胺片江苏知原药业股份有限公司4CYHS2404531非奈利酮片湖南慧泽生物医药科技有限公司;湖南九典制药股份有限公司4CYHS2404544氟比洛芬凝胶贴膏江苏万高药业股份有限公司4CYHS2404573复方电解质注射液(Ⅴ)湖南科伦制药有限公司3CYHS2404500复方磺胺甲噁唑注射液苏州伏生医药科技有限公司;寿光富康制药有限公司3CYHS2404534富马酸伏诺拉生片中曦（福建）药业有限公司;江苏万高药业股份有限公司4CYHS2404582富马酸伏诺拉生片中曦（福建）药业有限公司;江苏万高药业股份有限公司4CYHS2404581富马酸伏诺拉生片浙江九洲生物医药有限公司;浙江四维医药科技有限公司4CYHS2404477富马酸伏诺拉生片浙江九洲生物医药有限公司;浙江四维医药科技有限公司4CYHS2404476富马酸酮替芬滴眼液浙江恒研医药科技有限公司;浙江赛默制药有限公司3CYHS2404546富马酸依美斯汀滴眼液南京海纳制药有限公司4CYHS2404471枸橼酸托瑞米芬片上海安必生制药技术有限公司;吉林四环制药有限公司4CYHS2404547甲磺酸沙芬酰胺片齐鲁制药有限公司4CYHS2404586甲磺酸沙芬酰胺片杭州和康药业有限公司4CYHS2404580甲磺酸沙芬酰胺片杭州和康药业有限公司4CYHS2404579甲磺酸沙芬酰胺片齐鲁制药有限公司4CYHS2404587甲磺酸沙芬酰胺片华润赛科药业有限责任公司4CYHS2404527甲氧氯普胺片石家庄四药有限公司3CYHS2404607甲氧氯普胺片浙江百代医药科技有限公司;浙江赛默制药有限公司3CYHS2404551甲氧氯普胺片浙江百代医药科技有限公司;浙江赛默制药有限公司3CYHS2404552精氨酸布洛芬颗粒赫力昂（苏州）制药有限公司4CYHS2404482聚乙二醇4000散(儿童型)重庆赛诺生物药业股份有限公司3CYHS2404521卡铂注射液云南植物药业有限公司4CYHS2404545卡格列净片江西同和药业股份有限公司;江苏联环药业股份有限公司4CYHS2404536卡格列净片江西同和药业股份有限公司;江苏联环药业股份有限公司4CYHS2404535拉西地平片湖南普道医药技术有限公司;湖南九典制药股份有限公司4CYHS2404593利丙双卡因乳膏常州康普药业有限公司4CYHS2404485利丙双卡因乳膏常州康普药业有限公司4CYHS2404483利丙双卡因乳膏常州康普药业有限公司4CYHS2404481利福霉素钠注射液广东星昊药业有限公司3CYHS2404498利福霉素钠注射液广东星昊药业有限公司3CYHS2404499硫代硫酸钠注射液成都药宜立康医药科技有限公司;中玉制药（海口）有限公司3CYHS2404589硫代硫酸钠注射液长春澜江医药科技有限公司;成都硕德药业有限公司3CYHS2404508硫酸阿托品注射液烟台万润药业有限公司;烟台鲁银药业有限公司3CYHS2404615铝碳酸镁混悬液湖南普道医药技术有限公司;湖南九典制药股份有限公司3CYHS2404466氯化琥珀胆碱注射液成都欣捷高新技术开发股份有限公司;四川美大康佳乐药业有限公司3CYHS2404503氯化琥珀胆碱注射液成都欣捷高新技术开发股份有限公司;四川美大康佳乐药业有限公司3CYHS2404502氯化钾注射液河南普瑞药业有限公司3CYHS2404516氯化钾注射液河南普瑞药业有限公司3CYHS2404518氯硝西泮注射液国药集团工业有限公司廊坊分公司3CYHS2404609罗沙司他胶囊天方药业有限公司4CYHS2404504罗沙司他胶囊天方药业有限公司4CYHS2404505罗沙司他胶囊浙江百代医药科技有限公司;浙江赛默制药有限公司4CYHS2404480罗沙司他胶囊浙江百代医药科技有限公司;浙江赛默制药有限公司4CYHS2404479洛索洛芬钠口服溶液北京民康百草医药科技有限公司;山西同达药业有限公司3CYHS2404511马来酸曲美布汀片浙江昂利康制药股份有限公司;浙江赛默制药有限公司3CYHS2404602马来酸曲美布汀片浙江昂利康制药股份有限公司;浙江赛默制药有限公司3CYHS2404603吗啉硝唑氯化钠注射液广州大光制药有限公司;山东华鲁制药有限公司4CYHS2404608美沙拉秦肠溶片牡丹江恒远药业股份有限公司;浙江赛默制药有限公司4CYHS2404574美沙拉秦灌肠液杭州和泽坤元药业有限公司;浙江鼎泰药业股份有限公司4CYHS2404554米诺地尔搽剂广东恒健制药有限公司3CYHS2404576米诺地尔搽剂沈阳三生制药有限责任公司;浙江三生蔓迪药业有限公司3CYHS2404469米诺地尔搽剂沈阳三生制药有限责任公司;浙江三生蔓迪药业有限公司3CYHS2404470钠钾镁钙注射液中国大冢制药有限公司3CYHS2404568尼莫地平注射液南京卡文迪许生物工程技术有限公司;远大医药（中国）有限公司4CYHS2404613培哚普利氨氯地平片(Ⅲ)安徽佳和药业有限公司4CYHS2404520匹维溴铵片广东稳健药业有限公司;华益药业科技（安徽）有限公司4CYHS2404584普瑞巴林口服溶液岳阳新华达制药有限公司3CYHS2404462屈螺酮炔雌醇片(Ⅱ)昆明南疆制药有限公司;武汉九珑人福药业有限责任公司4CYHS2404537乳果糖口服溶液山东泽宇生物有限公司;莱阳市江波制药有限责任公司4CYHS2404565乳果糖口服溶液山东泽宇生物有限公司;莱阳市江波制药有限责任公司4CYHS2404566乳果糖口服溶液翎耀生物科技（上海）有限公司;安徽新世纪药业有限公司4CYHS2404543乳果糖口服溶液翎耀生物科技（上海）有限公司;安徽新世纪药业有限公司4CYHS2404542乳果糖口服溶液江苏联环药业股份有限公司4CYHS2404495乳果糖口服溶液江苏联环药业股份有限公司4CYHS2404494噻托溴铵/奥达特罗吸入喷雾剂艾特美（苏州）医药科技有限公司;博瑞制药（苏州）有限公司4CYHS2404540沙库巴曲缬沙坦钠片国药集团致君（深圳）坪山制药有限公司4CYHS2404464双氯芬酸二乙胺乳胶剂苏州高迈药业有限公司;药源生物科技（启东）有限公司4CYHS2404507他克莫司软膏海南海神同洲制药有限公司4CYHS2404524他克莫司软膏海南海神同洲制药有限公司4CYHS2404525头孢克洛缓释片(Ⅱ)广州白云山医药集团股份有限公司白云山制药总厂;金鸿药业股份有限公司4CYHS2404597托吡酯口服溶液杭州和康药业有限公司;华益药业科技（安徽）有限公司3CYHS2404585维生素B12滴眼液石家庄格瑞药业有限公司4CYHS2404490维生素B12滴眼液石家庄格瑞药业有限公司4CYHS2404491维生素B6注射液广东君康药业有限公司;珠海润都制药股份有限公司3CYHS2404604维生素B6注射液江苏九旭药业有限公司3CYHS2404599维生素B6注射液湖北广济药业股份有限公司;朗天药业（湖北）有限公司3CYHS2404486维生素K1注射液烟台鲁银药业有限公司3CYHS2404497维生素K1注射液烟台鲁银药业有限公司3CYHS2404496维生素K滴剂江苏万高药业股份有限公司3CYHS2404515乌帕替尼缓释片江苏飞马药业有限公司4CYHS2404539西咪替丁注射液江西科为制药有限公司;亚邦医药股份有限公司3CYHS2404605西咪替丁注射液石家庄四药有限公司3CYHS2404606西咪替丁注射液泽田（山东）药业有限公司;山东齐都药业有限公司3CYHS2404501硝酸甘油舌下片汇科德晟（广东）医学技术有限公司;四川宏明博思药业有限公司4CYHS2404468盐酸倍他司汀片上海理想制药有限公司3CYHS2404514盐酸苯海拉明注射液苏州朗科生物技术股份有限公司;南京臣功制药股份有限公司3CYHS2404513盐酸苯海拉明注射液苏州朗科生物技术股份有限公司;南京臣功制药股份有限公司3CYHS2404512盐酸多沙普仑注射液湖北简诚博泰医药有限公司;湖北津药药业股份有限公司3CYHS2404611盐酸多沙普仑注射液江苏九旭药业有限公司3CYHS2404612盐酸非索非那定口服混悬液南京海纳制药有限公司3CYHS2404550盐酸莫西沙星氯化钠注射液四川太平洋药业有限责任公司4CYHS2404567盐酸莫西沙星片郑州韩都药业集团有限公司4CYHS2404526盐酸普罗帕酮注射液河北桥洲医药科技有限公司;新乡市常乐制药有限责任公司3CYHS2404572盐酸缬更昔洛韦片Bluepharma Genéricos - Comércio de Medicamentos, S.A.5.2JYHS2400066盐酸溴己新片白云山东泰商丘药业有限公司3CYHS2404529盐酸左西替利嗪口服溶液亚宝药业四川制药有限公司3CYHS2404473盐酸左西替利嗪口服溶液亚宝药业四川制药有限公司3CYHS2404472伊布替尼胶囊北京双鹭药业股份有限公司4CYHS2404588伊布替尼片湖南科伦制药有限公司3CYHS2404530依达拉奉右莰醇注射用浓溶液南京优科制药有限公司4CYHS2404548依折麦布片江西施美药业股份有限公司4CYHS2404533乙酰半胱氨酸口服溶液舒美奇成都生物科技有限公司;成都硕德药业有限公司3CYHS2404478重酒石酸间羟胺注射液河南群益医药科技开发有限公司;信合援生制药股份有限公司3CYHS2404463重酒石酸去甲肾上腺素注射液山西振东泰盛制药有限公司3CYHS2404614注射用硫酸艾沙康唑华润双鹤药业股份有限公司4CYHS2404575注射用特利加压素天津红日药业股份有限公司;哈尔滨三联药业股份有限公司4CYHS2404610注射用盐酸罗沙替丁醋酸酯山东新华鲁抗医药有限公司;山东裕欣药业有限公司3CYHS2404487注射用唑来膦酸浓溶液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2404596左炔诺孕酮片乐福思健康产业股份公司4CYHS2404556 4、新增一致性评价补充申报药品名称企业名称受理号阿仑膦酸钠片海南全星制药有限公司CYHB2450638阿昔莫司胶囊地奥集团成都药业股份有限公司CYHB2450626碘海醇注射液福安药业集团宁波天衡制药有限公司CYHB2450640对乙酰氨基酚片吉林省尚城药业有限公司;吉林省罗邦药业有限公司CYHB2450643己酮可可碱注射液江苏康缘药业股份有限公司CYHB2450622硫酸阿托品注射液信合援生制药股份有限公司CYHB2450636诺氟沙星片万邦德制药集团有限公司CYHB2450642碳酸氢钠注射液湖南康源制药有限公司CYHB2450639维生素B6注射液山东方明药业集团股份有限公司CYHB2450623西咪替丁片万邦德制药集团有限公司CYHB2450628盐酸氨溴索片国药集团汕头金石制药有限公司CYHB2450627盐酸伐昔洛韦片丽珠集团丽珠制药厂CYHB2450641盐酸林可霉素注射液国药集团容生制药有限公司CYHB2450624盐酸林可霉素注射液华中药业股份有限公司CYHB2450625盐酸溴己新片山西立业制药有限公司CYHB2450635注射用阿莫西林钠克拉维酸钾中山市力恩普制药有限公司;国药集团威奇达药业有限公司CYHB2450634注射用阿莫西林钠克拉维酸钾中山市力恩普制药有限公司;国药集团威奇达药业有限公司CYHB2450632注射用阿莫西林钠克拉维酸钾中山市力恩普制药有限公司;国药集团威奇达药业有限公司CYHB2450633注射用氨苄西林钠海南海灵化学制药有限公司CYHB2450629注射用氨苄西林钠海南海灵化学制药有限公司CYHB2450631注射用氨苄西林钠海南海灵化学制药有限公司CYHB2450630注射用甲磺酸加贝酯常州四药制药有限公司CYHB2450621注射用胸腺法新天津红日药业股份有限公司;哈尔滨三联药业股份有限公司CYHB2450637 数据来源：摩熵医药用摩熵药筛小程序，随时随地查周报

一致性评价上市批准

100 项与利福霉素钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08480	利福霉素钠	D06AX15 J04AB03 S02AA12	DB11753

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
旅行者腹泻	美国	COSMO TECH Co., Ltd.	2018-11-16
旅行者腹泻	美国	Redhill Biopharma, Inc.	2018-11-16
痢疾	芬兰	Dr. Falk Pharma GmbH	2018-11-04
肺结核	英国	Sandoz GmbH	2000-02-01
革兰氏阳性细菌感染	中国	成都第一制药有限公司	-

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
腹泻型肠易激综合征	临床2期	比利时	Cosmo Technologies Ltd.	2017-12-18
腹泻型肠易激综合征	临床2期	德国	Cosmo Technologies Ltd.	2017-12-18
腹泻型肠易激综合征	临床2期	意大利	Cosmo Technologies Ltd.	2017-12-18
腹泻型肠易激综合征	临床2期	西班牙	Cosmo Technologies Ltd.	2017-12-18
憩室炎	临床2期	德国	Dr. Falk Pharma GmbH	2013-08-01
盲袢综合征	临床2期	美国	Cosmo Pharmaceuticals NV	-
梭菌感染	临床2期	墨西哥	Cosmo Pharmaceuticals NV	-
梭菌感染	临床2期	南非	Cosmo Pharmaceuticals NV	-
梭菌感染	临床2期	土耳其	Cosmo Pharmaceuticals NV	-
溃疡性结肠炎	临床2期	-	Cosmo Pharmaceuticals NV	-

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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


NCT02969252 (Pubmed \| Antibiotics (Basel)) 人工标引	临床1期	-	18	Rifamycin SV	鑰膚鏇衊獵觸範顧蓋襯(簾壓願艱構齋艱齋憲膚) = including diarrhea-predominant irritable bowel syndrome, hepatic encephalopathy 鹹網醖選築蓋窪鹹獵選 (壓鹹廠網壓構鏇獵壓夢 )	积极	2021-02-06
UEGW2019	N/A	-	-	Rifamycin SV-MMX 400mg BID	觸齋餘鹹築夢壓餘齋憲(遞遞製鑰蓋餘膚鏇憲廠) = 壓醖壓衊獵鑰壓壓艱鑰製繭憲壓廠憲構積築淵 (餘鏇顧構淵淵顧鬱積齋 )	-	2019-10-21
				Rifamycin SV-MMX 600mg TID	觸齋餘鹹築夢壓餘齋憲(遞遞製鑰蓋餘膚鏇憲廠) = 鹹糧衊築廠顧鹽淵衊壓製繭憲壓廠憲構積築淵 (餘鏇顧構淵淵顧鬱積齋 )
NCT01208922 (ERASE, CTgov)	临床3期	痢疾 \| 旅行者腹泻	835	Rifamycin SV-MMX® (Group A)	構淵繭衊蓋膚鑰蓋構襯(壓築鏇築網憲網獵積鹽) = 淵襯鹽構遞製襯製範膚簾遞築鬱鏇選衊鹽艱獵 (醖觸鑰網網衊艱憲淵醖, 醖獵襯糧糧顧淵蓋選選 ~ 鹹獵鏇簾製觸繭醖夢積) 更多	-	2019-02-27
				Ciprofloxacin (Group B)	構淵繭衊蓋膚鑰蓋構襯(壓築鏇築網憲網獵積鹽) = 積積餘選廠憲繭醖鑰夢簾遞築鬱鏇選衊鹽艱獵 (醖觸鑰網網衊艱憲淵醖, 鏇窪鑰鏇選膚襯蓋鑰簾 ~ 壓網鹹願憲艱憲鑰鏇壓) 更多
NCT03447821 (CTgov)	临床2期	痢疾	40	400 mg Rifamycin SV dosage (400 mg Rifamycin SV Dosage)	齋網餘顧範壓顧構鏇鏇(醖夢觸鹹衊觸鬱鑰繭鹽) = 艱衊淵艱構鑰顧餘鏇衊鬱廠鑰繭壓鏇餘壓鹹鏇 (鹽構簾衊獵膚襯顧網鹽, 選選選壓窪醖顧積壓觸 ~ 鹹窪淵窪窪夢膚齋壓範) 更多	-	2018-10-09
				800 mg Rifamycin SV dosage (800 mg Rifamycin SV Dosage)	齋網餘顧範壓顧構鏇鏇(醖夢觸鹹衊觸鬱鑰繭鹽) = 簾蓋餘醖齋憲膚鑰膚鑰鬱廠鑰繭壓鏇餘壓鹹鏇 (鹽構簾衊獵膚襯顧網鹽, 餘夢齋遞鏇憲醖顧繭簾 ~ 遞鑰簾鑰壓糧廠鹽醖鏇) 更多
NCT01142089 (CTgov)	临床3期	旅行者腹泻	264	Placebo (Placebo)	範鏇餘築淵遞積夢簾醖(餘壓鹽襯夢獵鑰願鹽鏇) = 構淵範獵窪遞鹹衊鏇築願積壓製鬱蓋觸鏇顧鬱 (醖選蓋選觸壓憲鑰網糧, 鬱膚顧製襯積醖範鬱網 ~ 繭簾築蓋壓壓遞鏇廠齋) 更多	-	2018-04-10
				Rifamycin SV MMX (Rifamycin SV MMX)	範鏇餘築淵遞積夢簾醖(餘壓鹽襯夢獵鑰願鹽鏇) = 糧淵醖壓窪襯遞膚憲淵願積壓製鬱蓋觸鏇顧鬱 (醖選蓋選觸壓憲鑰網糧, 獵淵壓構鏇範蓋膚餘積 ~ 艱積艱鏇觸餘遞鏇憲膚) 更多