Rifasutenizol

DUBLIN--( BUSINESS WIRE )--The "Helicobacter Pylori Infection - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Helicobacter Pylori Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Helicobacter Pylori Infection R&D. The therapies under development are focused on novel approaches to treat/improve Helicobacter Pylori Infection. Helicobacter Pylori Infection Emerging Drugs Chapters This segment of the Helicobacter Pylori Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Helicobacter Pylori Infection Emerging Drugs TNP-2198: TenNor Therapeutics (Suzhou) Limited Rifasutenizole (TNP-2198) is a new molecule entity discovered and developed by TenNor specifically for the treatment of H. pylori infection. Its multi-targeting synergistic mechanism delivers low drug resistance frequencies, maintaining excellent bactericidal activities against H. pylori strains isolated from various regions. Rifasutenizole has the potential to streamline the eradication regimes of H. pylori so as to improve the compliance and enable a seamless connection to the urea breath test (UBT), rendering the possibility of carrying out screening-eradication on large scale. TenNor is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study to evaluate the efficacy and safety of Rifasutenizole in the primary treatment of patients with H. pylori infection. SVT1C4610: Servatus Biopharmaceuticals SVT1C4610 is a live biotherapeutic type of drug. Its mechanism include Bacteria replacements, gastrointestinal microbiome modulators. Its main therapeutic area is infectious disease control. Currently, the drug is in phase I stage of its clinical trial for the treatment of H. pylori infection. Major Players in Helicobacter Pylori Infection There are approx. 5+ key companies which are developing the therapies for Helicobacter Pylori Infection. The companies which have their Helicobacter Pylori Infection drug candidates in the most advanced stage, i.e. Phase III include, TenNor Therapeutics (Suzhou) Limited. Helicobacter Pylori Infection: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Helicobacter Pylori Infection therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Helicobacter Pylori Infection drugs. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Helicobacter Pylori Infection Report Insights Helicobacter Pylori Infection Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Helicobacter Pylori Infection Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players TenNor Therapeutics (Suzhou) Limited Servatus Biopharmaceuticals TenNor Therapeutics Inc. Key Products TNP-2198 SVT-1C4610 TNP-2092 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ck4nzd About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条百济神州CDK2抑制剂启动Ⅰ期临床。百济神州细胞周期蛋白依赖性激酶2（CDK2）抑制剂BG-68501在Clinicaltrials.gov网站上注册一项美国Ⅰ期临床试验，计划入组108例晚期实体瘤患者，评估BG-68501的安全性、耐受性与初步疗效数据。CDK2对细胞周期调控至关重要，在多种癌症中经常高度激活。百济神州计划开发CDK2抑制剂与CDK4抑制剂形成补充，改善目前CDK4/6抑制剂在一些乳腺癌患者中的应用。国内药讯1.亚盛Bcr-Abl抑制剂获批国际Ⅲ期临床。亚盛医药第三代BCR-ABL抑制剂奥雷巴替尼（耐立克；HQP1351）获FDA批准开展国际Ⅲ期临床，评估用于治疗伴有或不伴有T315I突变的慢性髓细胞白血病（CML）慢性期（-CP）经治患者的有效性与安全性。该项研究预计2024年上半年启动。在Ⅰ期研究中，奥雷巴替尼在CML-CP患者中达到100%的完全血液学缓解率。去年11月，该新药上述适应症已在中国获批上市。2.武汉滨会溶瘤病毒获胶质瘤孤儿药资格。滨会生物溶瘤病毒药物BS001（OH2）注射液获FDA授予孤儿药资格，用于治疗恶性脑胶质瘤。OH2是一款重组人粒细胞-巨噬细胞集落刺激因子（GM-CSF）溶瘤II型单纯疱疹病毒产品，具有直接溶瘤、诱导局部和全身性抗肿瘤免疫应答、广谱抗肿瘤的效果。此前，该产品已获FDA授予孤儿药资格，用于治疗IIb期至IV期黑色素瘤。3.丹诺抗幽门螺杆菌新药早期研究见刊。丹诺医药多靶点偶联分子rifasutenizol（TNP-2198）在《柳叶刀–感染病学》上发表用于治疗幽门螺杆菌感染的Ⅰ/Ⅱ期临床试验结果。数据显示，rifasutenizol能剂量依赖性提高对幽门螺杆菌的根除率；rifasutenizol（400mg）与雷贝拉唑（20mg）和阿莫西林（1g）联合治疗14天后，对幽门螺杆菌根除率达到95%：rifasutenizol单药或联合用药均具有良好的耐受性，未出现严重不良事件。4.瑞吉康AAV基因疗法报渐冻症IND。上海瑞吉康自主研发的AAV基因治疗药物RJK002的临床试验申请（IND）获CDE受理，拟开发用于治疗肌萎缩侧索硬化（ALS，也称“渐冻症”）。该公司RJK系列多肽药物可在生理层面实现聚集蛋白的“溶解”，恢复这类聚集蛋白的生理功能，有望为神经退行性疾病提供新的治疗选择。去年10月，FDA已授予RJK002用于治疗ALS患者的孤儿药资格。5.腾盛博药收购乙肝新药BRII-179知识产权。腾盛博药宣布与VBI Vaccines（VBI）达成协议，以确保扩大并掌控乙肝（HBV）免疫疗法BRII-179（VBI-2601）的未来临床开发和商业供应。去年7月，腾盛博药已将BRII-179的独家许可扩展至全球市场；该疗法目前已处于Ⅱ期临床开发。根据协议，腾盛博药最初将向VBI开具250万美元的本票，这将取消乙型肝炎疫苗PreHevbri相关的特许权使用费和里程碑费用。在满足特定条件后，票据将增加至1,000万美元，以获得VBI在BRII-179的所有知识产权，BRII-179相关付款也都将被取消。国际药讯1.全球首款TIL疗法获FDA批准上市。Iovance公司肿瘤浸润淋巴细胞（TIL）疗法Amtagvi（lifileucel）获FDA加速批准上市，用于治疗晚期黑色素瘤。Lifileucel可识别并靶向多种患者特异性新抗原，以介导肿瘤细胞死亡。在II期C-144-01研究中，Lifileucel的客观缓解率（ORR）达到31.4%；有41.7%的缓解持续时间≥18个月。lifileucel是全球首款获批的TIL疗法，也是首款获批用于实体瘤的T细胞疗法。2.伊立替康脂质体获批联合治疗胰腺腺癌。FDA批准益普生拓扑异构酶抑制剂伊立替康脂质体注射剂（Onivyde）补充新药申请，联合NALIRIFOX化疗方案（包含5-氟尿嘧啶/亚叶酸钙、奥沙利铂）一线治疗成人转移性胰腺腺癌（mPDAC）。在Ⅲ期临床（NAPOLI 3）中，中位随访为16.1个月时，Onivyde组合方案较活性对照组提高患者的总生存期（mOS：11.1个月vs9.2个月）和无进展生存期（mPFS：7.4个月vs5.6个月）。3.渤健Nrf2激动剂在欧盟获批上市。渤健Nrf2激动剂Skyclarys（Omaveloxolone）获欧盟委员会（EC）批准上市，成为首款针对弗里德赖希共济失调症（FA）患者的治疗药物。在II期MOXIe临床中，omaveloxolone治疗48周时患者mFARS（用于评估FA进展的神经系统评定量表）评分较安慰剂组显著降低（安慰剂校正差异为-2.41分，p=0.0138）。2023年7月，渤健以交易总额约为73亿美元收购Reata公司并获得这款罕见病治疗方法。4.FDA批准首个冻疮治疗药物。Eicos Sciences所开发的血管扩张剂Aurlumyn（iloprost）注射液获FDA批准新适应症，用于治疗成人严重冻伤（frostbite），以降低患者手指或脚趾截肢的风险。在临床试验中，iloprost联合阿司匹林和标准护理治疗7天后，需要截肢的患者比例为0%，而其他治疗方案需要截肢的患者比例分别为19%和60%。此前，Aurlumyn已被批准用于治疗肺动脉高压。5.SORD缺陷疗法Ⅲ期临床成功。Applied公司高脑渗透性醛糖还原酶抑制剂goorestat治疗山梨醇脱氢酶（SORD）缺乏症的Ⅲ期临床INSPIRE达到主要终点和关键次要终点。与安慰剂相比，govorestat治疗12个月时持续降低患者的山梨醇水平（p<0.001）；患者的山梨醇水平与CMT-FOM复合临床终点（10米步行跑测试、4次爬楼梯、坐站测试、6分钟步行测试和背屈）之间显示出统计学显著相关性（p=0.05）；药物总体耐受性良好。6.BMS新一代TKI获FDA优先审评资格。百时美施贵宝新一代酪氨酸激酶抑制剂（TKI）Augtyro（repotrectinib）的补充新药申请（sNDA）获FDA受理，用于治疗≥12岁、神经营养性酪氨酸受体激酶（NTRK）基因融合阳性的局部晚期或转移性实体瘤患者。FDA同时授予其优先审评资格，PDUFA日期为今年6月15日。repotrectinib能够同时靶向抑制ROS1和NTRK。去年11月，该新药已获FDA批准用于治疗局部晚期或转移性ROS1阳性非小细胞肺癌（NSCLC）成人患者。7.吉利德购进肝病突破性PPARδ激动剂。吉利德宣布以总金额达43亿美元收购CymaBay公司，并获得该公司拟开发用于治疗原发性胆汁性胆管炎（PBC）的突破性疗法--过氧化物酶体增殖物活化受体（PPARδ）激动剂seladelpar。目前，FDA已受理Seladelpar的上市申请，并授予优先审评资格，PDUFA日期为今年8月14日。在Ⅲ期试验RESPONSE中，与安慰剂相比，seladelpar治疗达到血清碱性磷酸酶和胆红素相关的主要复合终点的患者比例显著更高（61.7%vs20.0%）。医药热点1.俄罗斯癌症疫苗即将面世。近日，俄罗斯总统普京宣布，俄罗斯科学家在癌症疫苗研发方面取得了重要进展，已接近成功研制出一种新型癌症疫苗。这种疫苗属于新一代免疫调节药物，能针对不同类型的癌症进行治疗。这意味着，患者在接受治疗时将更有针对性，能减少不必要的痛苦和风险。同时，每个患者都能根据自身情况和癌症类型，制定最适合的治疗方案。2.云南省儿童医院揭牌成立。近日，“云南省儿童医院”揭牌仪式在昆明市儿童医院举行，标志着云南省构建整合型儿童健康服务体系迈出关键步伐，将进一步建强儿科高地，辐射带动儿童医疗保健服务不断提质增效。昆明市儿童医院是该省唯一集急救、医疗、教学、科研、康复、保健、预防为一体的大型儿童综合性专科医院，承担儿童医学中心、儿童重大疾病研究重点实验室、儿童健康与疾病临床研究中心、儿科疾病临床医学中心、儿科研究所、新生儿疾病研究中心等重要职责。评审动态  1. CDE新药受理情况（02月09日) 2. FDA新药获批情况（北美02月18日）股市资讯上个交易日 A 股医药板块 +1.43%涨幅前三     跌幅前三热景生物+20.01%  大唐药业-11.92%浩 欧 博 +19.96%  生 物 谷 -7.69%仁度生物+19.87%  我武生物-4.43%【诺禾致源】拟以集中竞价交易方式回购8,000万元-16,000万元股份，用于员工持股计划或股权激励，回购价格不超过28.53元/股。【东方生物】拟以集中竞价交易方式回购5,000-10,000万元股份，用于员工持股计划或股权激励，回购价格不超过39.33元/股。【香雪制药】子公司香雪生命科学TAEST16001注射液申报临床试验获得受理。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。