A Single Center, Open Label, Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.

开始日期2024-08-26

申办/合作机构

丹诺医药（苏州）有限公司

CTR20242839 / Recruiting临床1期

在健康受试者中评价TNP-2198与咪达唑仑、克拉霉素药物相互作用的单中心、开放、I 期临床研究

主要目的——咪达唑仑组：在健康受试者中评价TNP-2198 胶囊多次口服给药对咪达唑仑口服溶液单次口服给药药代动力学（PK）参数的影响；克拉霉素组：在健康受试者中评价克拉霉素片多次口服给药对TNP-2198 胶囊多次口服给药PK 参数的影响。次要目的——咪达唑仑组：在健康受试者中评价咪达唑仑口服溶液单次口服给药或与TNP-2198 胶囊多次同时口服给药的安全耐受性；克拉霉素组：在健康受试者中评价TNP-2198 胶囊多次口服给药或与克拉霉素片多次同时口服给药的安全耐受性。

开始日期2024-08-22

申办/合作机构

丹诺医药（苏州）有限公司

NCT05857163 / Completed临床3期

Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.
Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and bismuth potassium citrate capsules combined with RSZ placebo capsules (control group) for 14 consecutive days.
13C UBT will be performed 4 6 weeks after the last dose to evaluate the eradication effect of H. pylori.

开始日期2023-05-18

申办/合作机构

丹诺医药（苏州）有限公司

100 项与瑞法舒坦唑相关的临床结果

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100 项与瑞法舒坦唑相关的专利（医药）

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项与瑞法舒坦唑相关的文献（医药）

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

BACKGROUND:

Due 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.

METHODS:

We 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.

FINDINGS:

Between 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).

INTERPRETATION:

Rifasutenizol 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.

FUNDING:

TenNor Therapeutics and National Natural Science Foundation of China.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

2022-05-01·CURRENT MEDICINAL CHEMISTRY2区 · 医学

A Comparative Insight on the Newly Emerging Rifamycins: Rifametane, Rifalazil, TNP-2092 and TNP-2198

2区 · 医学

Review

作者: Nazli, Adila ; He, Yun ; Xu, Huacheng ; Wang, Zhi-Peng ; He, David L

Abstract::

Rifamycins are considered a milestone for tuberculosis (TB) treatment because of their proficient sterilizing ability. Currently, available TB treatments are complicated and need a long duration, which ultimately leads to failure of patient compliance. Some new rifamycin derivatives, i.e., rifametane, TNP-2092 (rifamycin-quinolizinonehybrid), and TNP-2198 (rifamycin-nitromidazole hybrid) are under clinical trials, which are attempting to overcome the problems associated with TB treatment. The undertaken review is intended to compare the pharmacokinetics, pharmacodynamics and safety profiles of these rifamycins, including rifalazil, another derivative terminated in phase II trials, and already approved rifamycins. The emerging resistance of microbes is an imperative consideration associated with antibiotics. Resistance development potential of microbial strains against rifamycins and an overview of chemistry, as well as structure-activity relationship (SAR) of rifamycins, are briefly described. Moreover, issues associated with rifamycins are discussed as well. We expect that newly emerging rifamycins shall appear as potential tools for TB treatment in the near future.

2022-03-24·Journal of medicinal chemistry1区 · 医学

Design, Synthesis, and Characterization of TNP-2198, a Dual-Targeted Rifamycin-Nitroimidazole Conjugate with Potent Activity against Microaerophilic and Anaerobic Bacterial Pathogens

1区 · 医学

Article

作者: Wang, Huan ; Ma, Zhenkun ; Molodtsov, Vadim ; Ding, Charles ; He, Shijie ; Liu, Yu ; Yuan, Ying ; Zhuang, Zhijun ; Xu, Xiangyi ; Weiss, William J. ; Nguyen, Phung ; Lin, Wei ; Duncan, Leonard ; Pulse, Mark ; Lynch, Anthony Simon ; Robertson, Gregory T. ; Ebright, Richard H. ; Doyle, Timothy ; Chen, Jing

TNP-2198, a stable conjugate of a rifamycin pharmacophore and a nitroimidazole pharmacophore, has been designed, synthesized, and evaluated as a novel dual-targeted antibacterial agent for the treatment of microaerophilic and anaerobic bacterial infections. TNP-2198 exhibits greater activity than a 1:1 molar mixture of the parent drugs and exhibits activity against strains resistant to both rifamycins and nitroimidazoles. A crystal structure of TNP-2198 bound to a Mycobacterium tuberculosis RNA polymerase transcription initiation complex reveals that the rifamycin portion of TNP-2198 binds to the rifamycin binding site on RNAP and the nitroimidazole portion of TNP-2198 interacts directly with the DNA template-strand in the RNAP active-center cleft, forming a hydrogen bond with a base of the DNA template strand. TNP-2198 is currently in Phase 2 clinical development for the treatment of Helicobacter pylori infection, Clostridioides difficile infection, and bacterial vaginosis.

项与瑞法舒坦唑相关的新闻（医药）

2024-03-03

·药明康德

前沿 | 约7亿中国人感染！《柳叶刀》子刊：新药根除幽门螺杆菌超90%！

▎药明康德内容团队编辑幽门螺杆菌感染影响着全球近50%的人群，是导致慢性胃炎、消化性溃疡、胃癌等疾病的重要原因。据统计，中国人群当前感染率在50%-56%（约7亿人被感染），是影响公共健康的因素之一。根除幽门螺杆菌可降低胃癌发生风险，已被推荐为胃癌一级预防策略。根除幽门螺杆菌有多种方案，但普遍面临着不同程度的耐药挑战。过去30多年来的一线策略是质子泵抑制剂、阿莫西林和克拉霉素（PPI-AC）的三联疗法，但近年来幽门螺杆菌对克拉霉素耐药性有所增加，标准PPI-AC三联疗法根除率有所下降，在部分国家和地区甚至下降到80%以下。含铋四联疗法（铋剂、一种质子泵抑制剂和两种抗菌药，BQT）被推荐作为原发性克拉霉素耐药率较高地区的一线治疗策略，但BQT也存在给药复杂、不良反应高等问题。此外，其他被推荐用于根除幽门螺杆菌的抗生素，如甲硝唑、左氧氟沙星等被广泛用于治疗其他感染性疾病，幽门螺杆菌对部分抗生素的耐药性也开始增加。近日，The Lancet Infectious Diseases发表一项研究，表明创新口服药物rifasutenizol（TNP-2198）单药治疗或联合治疗策略在健康受试者和幽门螺杆菌感染者中普遍耐受性良好。Rifasutenizol、雷贝拉唑、阿莫西林的三联治疗方案表现出良好的疗效，或可作为根除幽门螺杆菌的新方案。图片来源：The Lancet Infectious Diseases该研究在健康受试者（年龄18-55岁，78例）和无症状的幽门螺杆菌感染者（年龄18-65岁，168例）中开展了4项rifasutenizol相关随机对照试验。试验1-3主要研究终点为rifasutenizol的耐受性、安全性和药物代谢动力学，试验4主要研究终点为幽门螺杆菌根除率。具体如下：试验1-健康人群队列，rifasutenizol单剂量递增vs安慰剂：在7个健康受试者队列（每个队列10例）中进行的双盲、随机、安慰剂对照、单次剂量递增1期试验，研究人员将每个队列的受试者以4：1的比例随机分配，接受50 mg、100 mg、200 mg、400 mg、600 mg、800 mg或1000 mg的rifasutenizol或安慰剂。试验2-无症状的幽门螺杆菌感染队列，rifasutenizol多剂量递增vs安慰剂：在3个无症状的幽门螺杆菌感染队列（每个队列16例）开展的双盲、随机、安慰剂对照、多次剂量递增1期研究，研究人员以3：1的比例将每个队列受试者随机分配，接受200 mg、400 mg、600 mg的rifasutenizol或安慰剂，每日2次，持续14天。试验3-无症状的幽门螺杆菌感染队列，剂量探索和概念验证：在4个无症状的幽门螺杆菌感染队列（每个队列10例）开展的开放标签、随机、多次给药、剂量探索2a期试验，研究人员将受试者以1：1：1：1的比例随机分配接受下列方案之一：试验4-无症状的幽门螺杆菌感染队，幽门螺杆菌根除方案探索和方案确认：在4个无症状的幽门螺杆菌感染队列中开展的开放标签、随机、多次给药、剂量探索2b期试验，研究人员将受试者（80例）以2：2：1：1：2的比例随机分配接受下列方案之一：Rifasutenizol具有良好的安全性和耐受性研究结果显示，无论是rifasutenizol单剂量（50-1000 mg）或多剂量（200-600 mg，2次/日），还是rifasutenizol与雷贝拉唑和阿莫西林联合用药，在4项试验中均显示出良好的安全性和耐受性。未报告有死亡或严重不良事件（SAE）。文章表示，rifasutenizol双联疗法（试验3）的药物相关不良事件略多于200 mg和400 mg的rifasutenizol单药治疗（试验2），但略少于600 mg的rifasutenizol单药治疗，而400 mg的rifasutenizol双联和三联方案的药物不良事件发生率类似，这意味着rifasutenizol、雷贝拉唑和阿莫西林联合用药无特有的安全性问题。双联或三联治疗中常见的不良事件，如血清肌酐升高，都是轻度、一过性的，无需临床干预即可恢复正常。Rifasutenizol在50-800 mg剂量范围内表现出线性药代动力学特征，与其他联合用药的药物之间无明显的药代动力学相互作用。进食可使rifasutenizol的血药浓度-时间曲线下面积略微升高。Rifasutenizol三联方案根除率均超过80%在试验3中，双联方案（不同剂量rifasutenizol+雷贝拉唑）和三联方案（rifasutenizol+雷贝拉唑+阿莫西林）给药中，双联方案治疗后4-6周对幽门螺杆菌根除率存在剂量依赖性影响。幽门螺杆菌根除率随着rifasutenizol给药剂量的增加而增加，其中200 mg、400 mg和600 mg的rifasutenizol根除率分别为0%、30%和40%，确认rifasutenizol的有效剂量为400 mg。400 mg的rifasutenizol三联方案治疗4-6周后，幽门螺杆菌根除率为80%。在试验4中，方案4（三联方案）7天内幽门螺杆菌根除率为100%；治疗14天后，方案1和方案2的三联方案根除率分别为95%和89%，表明rifasutenizol三联方案可有效根除幽门螺杆菌。文章表示，试验2中，rifasutenizol单药治疗未表现出根除幽门螺杆菌的作用，提示质子泵抑制剂的联合使用在根治幽门螺杆菌方面具有重要作用。质子泵抑制剂可抑制胃酸分泌并增加胃内pH值，从而提高抗幽门螺杆菌的药物疗效，从本次研究结果来看，rifasutenizol联合质子泵抑制剂雷贝拉唑后，可达到0%-40%的剂量依赖性幽门螺杆菌根除率。试验4的方案3显示了这种双联干预策略的最佳治疗效果，达到了50%的根除率。小结总之，rifasutenizol在健康受试者中单次给药（50-1000 mg）和在幽门螺杆菌感染者中多次给药（200-600 mg，每次2次），均显示出可接受的安全性、耐受性和药物代谢动力学特征。在幽门螺杆菌感染者中，rifasutenizol、雷贝拉唑和阿莫西林联合用药安全且耐受性良好，未观察到药物相互作用。Rifasutenizol三联方案在幽门螺杆菌患者中的根除率均超过80%，这些结果均支持进一步开展rifasutenizol治疗幽门螺杆菌感染的研究。点击文末“阅读原文/Read more”，即可访问The Lancet Infectious Diseases官网阅读完整论文。相关阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Li X, Liu Y, Wang M, et al. 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. Lancet Infect Dis. 2024 Feb 12:S1473-3099(24)00003-3. doi: 10.1016/S1473-3099(24)00003-3. Epub ahead of print. PMID: 38359854.免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

微生物疗法临床结果

2024-02-27

·Business Wire

Helicobacter Pylori Infection Pipeline Insight Report 2024: Insights About 5+ Companies and 5+ Pipeline Drugs Featuring TenNor Therapeutics, Servatus Biopharmaceuticals, and TenNor Therapeutics - ResearchAndMarkets.com

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.

临床3期临床1期临床2期基因疗法

2024-02-17

·药研发

【药研发0218】百济神州CDK2抑制剂启动Ⅰ期临床 | 丹诺抗幽门螺杆菌新药早期研究见刊...

「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。

孤儿药临床3期临床1期临床2期并购

100 项与瑞法舒坦唑相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
厌氧菌感染	临床3期	中国	丹诺医药（苏州）有限公司	2023-05-06
细菌性阴道炎	临床3期	中国	丹诺医药（苏州）有限公司	2023-05-06
艰难梭菌腹泻	临床3期	中国	丹诺医药（苏州）有限公司	2023-05-06
消化道感染	临床3期	中国	丹诺医药（苏州）有限公司	2023-05-06
幽门螺杆菌感染	临床3期	中国	丹诺医药（苏州）有限公司	2023-05-06
艰难梭菌感染	临床前	美国	Jones Microbiology Institute, Inc.	2022-02-17
艰难梭菌感染	临床前	中国	丹诺医药（苏州）有限公司	2022-02-17

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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


NCT06076681 \| NCT06076694 \| NCT06081699 \| NCT06081712 (Pubmed)	临床1/2期	幽门螺杆菌感染	-	Rifasutenizol 400 mg	構範積顧範齋網繭餘遞(築鬱窪窪製壓製繭夢餘) = 繭鹽鏇簾顧夢製網築網積廠糧網壓窪壓壓積壓 (鑰築蓋獵獵廠繭網衊範, 7 ~ 65)	-	2024-02-01
				Rifasutenizol 600 mg	構範積顧範齋網繭餘遞(築鬱窪窪製壓製繭夢餘) = 鬱醖願糧觸繭顧選觸廠積廠糧網壓窪壓壓積壓 (鑰築蓋獵獵廠繭網衊範, 12 ~ 74)
NCT06076694 (CTgov)	临床2期	幽门螺杆菌感染	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	構膚築願遞醖鬱壓顧願(鹹選願襯獵廠淵餘齋選) = 淵餘壓淵選廠齋膚獵觸蓋築廠築觸齋壓淵夢觸 (構淵網夢觸鑰選膚糧餘, 構網夢顧獵鬱夢簾積鬱 ~ 窪遞醖遞構鑰鏇鑰觸齋) 更多	-	2023-12-12
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	構膚築願遞醖鬱壓顧願(鹹選願襯獵廠淵餘齋選) = 繭糧鏇繭觸鹹夢衊獵鬱蓋築廠築觸齋壓淵夢觸 (構淵網夢觸鑰選膚糧餘, 廠顧蓋蓋顧衊鏇餘築網 ~ 廠製廠窪廠觸糧範鑰遞) 更多
NCT06076681 (CTgov)	临床1/2期	幽门螺杆菌感染	40	TNP-2198+Rabeprazole Sodium (Group A)	遞艱鹽鏇鏇網衊憲築齋(選憲夢壓廠鬱膚鏇糧醖) = 壓選築願糧鏇廠餘餘襯衊淵鏇構糧願範鏇觸餘 (鹹廠襯鏇醖鑰構齋簾鏇, 願觸膚鏇淵夢夢蓋遞遞 ~ 積鏇糧糧襯衊糧製衊齋) 更多	-	2023-11-22
				TNP-2198+Rabeprazole Sodium (Group B)	遞艱鹽鏇鏇網衊憲築齋(選憲夢壓廠鬱膚鏇糧醖) = 願網獵鬱鏇網築遞簾觸衊淵鏇構糧願範鏇觸餘 (鹹廠襯鏇醖鑰構齋簾鏇, 鏇範範淵觸鏇鬱網鏇鏇 ~ 製膚齋鹽積獵壓獵鑰觸) 更多