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）股份有限公司

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.

开始日期2023-05-18

申办/合作机构

丹诺医药（苏州）股份有限公司

ChiCTR2300070540

/ Not yet recruiting临床3期IIT

A multicenter, randomized, double-blind, bismuth quadruple positive control phase III clinical trial to evaluate the efficacy and safety of TNP-2198 combined with rabeprazol sodium and amoxicillin in the primary treatment of participants with positive helicobacter pylori infection

开始日期2023-02-28

申办/合作机构-

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转化医学

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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）

2026-01-01·LANCET INFECTIOUS DISEASES

Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial

Article

作者: Liao, Aijun ; Zheng, Pengyuan ; Zuo, Xiuli ; Li, Fangfang ; Yang, Shaoqi ; Gao, Xiang ; Zeng, Zhirong ; Chen, Lei ; Zou, Chuanxin ; Xu, Min ; Ma, Zhenkun ; Gu, Yongsong ; Song, Zhiqiang ; Lan, Cheng ; Gao, Hong ; Zheng, Jianwei ; Zhen, Yanbo ; Zeng, Xin ; Chen, Huixin ; Wang, Xuehong ; Du, Qin ; Chen, Zhengyi ; Li, Xing ; Geng, Guozhu ; Xu, Meihua ; Chen, Jing ; Zhou, Liya ; Zhang, Hong ; Xie, Jun ; Chen, Tao ; Xu, Jianguang ; Liu, Gaifang ; Wang, Weihong ; Zhang, Xiaojie ; Zhu, Yin ; Tang, Tongyu ; Wang, Hong ; Fan, Huizhen ; Wang, Qizhi ; Feng, Huang ; Liu, Chengxia ; Tan, Shiyun ; Xu, Hongzhi ; Zhang, Qing

BACKGROUND:

Rifasutenizol (TNP-2198) is a new molecular entity with a synergistic dual mechanism of action under clinical development for the treatment of Helicobacter pylori infection. We aimed to evaluate the efficacy and safety of a rifasutenizol-based triple therapy (RTT) versus bismuth plus clarithromycin-based triple therapy (BCTT) for the treatment of H pylori infection in treatment-naive patients.

METHODS:

EVEREST-HP was a phase 3, randomised, triple-dummy, double-blind, active-controlled, non-inferiority trial with adaptive design for sample size re-estimation conducted at 40 research hospitals in China. Treatment-naive patients aged 18-65 years, with a positive [¹³C]urea breath test ([¹³C]UBT), further confirmed by gastric biopsy and histological examination, were randomly assigned (1:1) to receive RTT (rifasutenizol 400 mg oral capsules, amoxicillin 1 g oral capsules, and rabeprazole 20 mg enteric-coated tables) or BCTT (bismuth potassium citrate 240 mg oral tablets, clarithromycin 500 mg oral tablets, amoxicillin 1 g oral capsules, and rabeprazole 20 mg enteric-coated tablets), all twice a day for 14 days. Randomisation was done centrally by a secure interactive web response system using block sizes of two or four and stratified by study site. RTT was compared against BCTT using a triple-dummy approach to ensure masking. The primary endpoint was H pylori eradication rate based on [¹³C]UBT 4-6 weeks after the end of treatment in the modified intention-to-treat population, which included all participants who received at least one dose of the study drugs. The eradication rates of RTT and BCTT were compared using a one-sided α value of 0·025 and a non-inferiority margin of -10%. Safety endpoints included investigator assessed treatment-emergent adverse events, the severity and relationship with study drugs, findings from physical examinations, vital signs, laboratory tests, and electrocardiogram. An interim analysis was conducted by an independent data monitoring committee after 50% (350) of patients completed the last [¹³C]UBT. The trial is registered with ClinicalTrials.gov, NCT05857163.

FINDINGS:

Between May 18, 2023, and Nov 10, 2023, 1267 patients were screened and 700 patients were randomly assigned to receive either RTT (n=353) or BCTT (n=347). 261 (37%) patients were men and 439 (63%) were women. 351 patients in the RTT group and 346 in the BCTT group took at least one dose of the study drugs and were included in the modified intention-to-treat group and the safety set. H pylori was successfully cultured from 579 (83%) of 697 patients. 236 (41%) of 579 patients had H pylori infection resistant to clarithromycin, 395 (68%) to metronidazole, 203 (35%) to levofloxacin, and 47 (8%) to amoxicillin. All H pylori clinical isolates were susceptible to rifasutenizol. In the modified intention-to-treat analysis, the H pylori eradication rate in the RTT group was non-inferior to that in the BCTT group (92·0% [95% CI 88·7 to 94·6; 323 of 351] vs 87·9% [83·9 to 91·1; 304 of 346]; absolute difference 4·2% [95% CI -0·3 to 8·8]). 131 (37%) of 351 patients in the RTT group and 184 (53%) of 346 in the BCTT group had treatment-emergent adverse events. Treatment-emergent adverse events occurring in more than 5% of patients in the RTT group were diarrhoea (in 24 [7%] patients), nausea (22 [6%]), and dizziness (21 [6%]), and in more than 5% of patients in the BCTT group were taste perversion (125 [36%]), nausea (21 [6%]), and diarrhoea (19 [5%]) Most of the treatment-emergent adverse events were mild or moderate in severity. No serious adverse event related to study drugs was reported.

INTERPRETATION:

As the first novel antimicrobial agent specifically developed for H pylori infection, rifasutenizol represents a promising addition to the existing options for tackling antimicrobial resistance, and RTT represents a promising first-line treatment option for H pylori infection.

FUNDING:

TenNor Therapeutics.

TRANSLATION:

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

2026-01-01·LANCET INFECTIOUS DISEASES

Rifasutenizol-based triple therapy for Helicobacter pylori infection

Article

作者: Chen, Jinnan ; Lu, Hong

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.

124

项与瑞法舒坦唑相关的新闻（医药）

2026-04-03

·搜狐新闻

又一药企冲刺“A+H”！底牌是什么？

来源：新康界中国创新药企的“A+H”版图上，又迎来了一位新的角逐者。2026年，医药IPO市场的暖意延续。在瑞博生物、精锋医疗等企业上市首日全线飘红之后，迈威生物悄然站上了资本市场的聚光灯下。4月2日，其港交所IPO申请正式通过聆讯，即将实现“A+H”双平台上市。2022年1月，迈威生物在科创板挂牌上市，如今即将实现港股二次上市，向一家高度国际化的创新药企稳步转型再进一步。在医药领域，像迈威生物这样已实现或正在推进A+H两地上市的医药企业还包括：恒瑞、诺诚健华、荣昌、百济、君实、康希诺等。通过A+H上市，这些企业获得了更多资本市场的支持，拓展了国际融资渠道，全球竞争力得到显著提升。但市场更为关心的是：2026年，在港股与A股排队候审的医药企业已达100+家、竞争日趋白热化的当下，迈威生物凭什么能脱颖而出？差异化布局奠定竞争壁垒强劲的产品和在研管线是迈威生物备受市场期待的原因。据业绩报告显示，迈威生物已有数款产品实现商业化，包括阿达木单抗、贝伐珠单抗、地舒单抗生物类似药，以及治疗化疗所致中性粒细胞减少症的创新药注射用阿格司亭α。2025年营业收入达到6.63亿元，同比增长了231.62%。核心增长动力来自地舒单抗的两款生物类似药：迈利舒、迈卫健，两款药品销售收入为2.06亿元，同比增长48.59%。此外，其核心在研产品9MW2821，有望成为同类最佳的Nectin-4 ADC。该产品单药治疗尿路上皮癌、联合PD-1抗体一线治疗尿路上皮癌均获得突破疗法认定，这两项适应症均处于三期临床阶段；单药治疗宫颈癌也处于三期临床阶段。这三项临床将于今年进行期中分析，并据此递交新药上市申请前会议（pre-BLA）。同时，9MW2821联合其他疗法一线治疗宫颈癌、一线治疗子宫内膜癌的二期临床将于今年完成，随后将启动联合治疗的关键三期临床；单药治疗三阴乳腺癌的三期临床也将在今年启动。不仅如此，在技术平台层面，迈威生物已建立起多个创新技术平台：定点偶联的DARfinity技术、经过优化设计的连接子IDconnect技术、基于喜树碱的新型毒素分子Mtoxin技术，以及有条件释放毒素的LysOnly技术。此外，公司还建立了新一代TCE双抗/三抗技术平台、小核酸技术平台等。从产品布局到技术搭建，迈威生物的前瞻性最终体现在差异化的明确竞争格局上。而本次港股IPO募资，迈威生物将进一步夯实资金储备，并用于核心ADC管线临床研发、产能建设、商业化推广。业内也认为，冲刺“A+H”布局，有助于迈威生物创新技术和管线的持续深度布局，加速国际化进程。港股依然是主战场迈威生物的闯关并非孤例。动脉网统计显示，截至2026年2月，在港股与A股排队候审的医药企业已达127家，创下历史新高（名单见文末）。其中，制药领域企业占比近三分之二，达83家。具体来看，127家排队企业中，港股是主战场，聚集了超百家医疗健康企业，医药大健康占港股IPO排队总数的1/3。这其中，仍有69家处于亏损状态，且多数是尚未实现产品商业化的创新药企。得益于港股“18A”政策率先开放，未盈利生物医药企业有了通往资本市场的特殊通道。同时，2025年6月科创板重启第五套上市标准，也为未盈利科技企业开辟通路。2026年对医疗企业而言充满机遇。2025年，医药IPO市场破冰回暖，全年共有37家医疗企业成功上市，数量较2024年翻番。进入2026年，这一势头有增无减——仅前两个月，国内医疗领域就有8家企业登陆资本市场，上市首日全线飘红，平均涨幅超过100%，包括瑞博生物、精锋医疗、卓正医疗、爱舍伦、爱得科技、海圣医疗、北芯生命、新桥生物。与此同时，无论是港股还是A股，监管层面均释放积极信号，上市审核效率明显提升。例如禾元生物从提交注册到获得IPO批文仅用时14天。进入2026年，这一高效审核节奏仍在延续。不过，业内人士指出，二级市场的评判标准已趋于理性和成熟。单靠研发阶段的“概念故事”难以赢得认可，企业必须展现核心“硬实力”才能获得青睐。这包括细分领域的技术领先性——如脑机接口赛道的强脑科技、博睿康；独特的商业模式；或是能解决未满足临床需求的突破性疗法，如泰诺麦博的首个国产破伤风预防药。以丹诺医药为例，这家专注细菌感染及耐药性领域的企业，核心平台为多靶点偶联分子技术，已建立7条在研管线。其中最具代表性的利福特尼唑（TNP-2198），是全球首个且唯一进入后期临床开发的、用于治疗该细菌感染的新分子实体候选药物。2024年11月，丹诺医药与远大生命科学达成独家商业化合作协议。资本市场也更青睐有确定性前景的企业：清晰的产品上市时间表、明确的商业化进展与收入提升路径、可见的扭亏为盈趋势，以及成功的海外BD或出海合作案例。例如麓鹏制药、麦科田、多宁生物等均在2025年实现扭亏为盈，成为市场追捧的对象。整体来看，2026年医疗IPO市场在数量与效率上双双升温，但资本市场的选择正愈发理性与聚焦，一场关于硬实力的竞赛，已然拉开帷幕。而迈威生物能否在这场竞赛中脱颖而出，时间将给出答案。（图片来源：动脉网）参考资料：网络公开信息，包括新闻资讯、企业官网、政府文件等。【免责声明】1.“新康界”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“新康界”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“新康界”所有信息仅供参考，不做任何商业交易及或医疗服务的根据，如自行使用“新康界”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。4.本声明未涉及的问题参见国家有关法律法规，当本声明与国家法律法规冲突时，以国家法律法规为准。返回搜狐，查看更多

2026-03-28

·阿懒解读

(附标的合集)题材：幽门螺旋杆菌概念

写在文章开头我们另外开通了专题挖掘栏目（视频版），每周更新2个专题视频，专注那些未被充分定价的超预期公司（每期会挖掘出上中下游约7家公司）。视频均附带深度产业链图谱 + PPT 课件+ 思维导图，一目了然。以下为近期专题视频列表（提前潜伏，比别人快一步） ☝3.25 算力时代来了！（算力协同） ☝3.17 中美算力军备赛（储能）截止25日，区间内首航新能23.09%，海博思创7.15%，固德威2.46%，鹏辉能源1.74%，宁德时代-2.59%，国轩高科-4.22% 为了回馈大家长期以来的关注和支持！我们免费分享给大家。抓紧扫码，领取最新一期，快人一步。一、题材解释幽门螺旋杆菌是定植于人类胃部的致病菌，感染率超50%，可引发慢性胃炎、消化性溃疡、胃癌等疾病，被世界卫生组织列为Ⅰ类致癌物。当前临床以抗生素四联疗法为主，但面临耐药性加剧（如克拉霉素耐药率超30%）、根除率下降（传统方案成功率约70-80%）、肠道菌群紊乱等痛点。诊疗需求覆盖检测、药物治疗、预防三大环节，涉及体外诊断、创新抗生素、疫苗、功能性食品等细分赛道。二、最新事件新型疗法突破：丹诺医药的利福特尼唑（TNP-2198）作为全球首个针对Hp的创新型抗菌药，III期临床结果发表于《柳叶刀•感染病学》，预计通过与远大生命科学合作实现商业化。丽珠医药P-CAB抑酸剂JP-1366片反流性食管炎适应症上市申请受理，幽门螺杆菌根除适应症申报IND，注射剂进入II期临床。检测技术革新：芯超生物全球首个幽门螺杆菌抗体口腔黏膜渗出液检测试剂盒获批，实现无创采样与高精度检测，推动“主动健康管理”模式。广中医与诺奖得主巴里·马歇尔团队合作，探索中西医结合的耐药机制研究与精准诊疗方案。跨界创新尝试：扬州学生团队开发基于基因工程的“可食用抗体”产品，利用益生菌载体实现靶向中和Hp，突破传统抗体药物注射限制。监管与市场动态：国家药监局严控“抗幽门螺杆菌”牙膏虚假宣传，17款违规产品被查处。三、核心公司梳理一、检测诊断（上游筛查）万孚生物：幽门螺杆菌胶体金检测试剂龙头，覆盖家庭自测与终端渠道，产品便捷易用。东诚药业：核药龙头，尿素 ¹⁴C 胶囊用于无创呼气检测，临床筛查应用广泛。安图生物：提供幽门螺杆菌抗体检测试剂盒，适配临床实验室批量筛查需求。二、治疗药物（中游核心）罗欣药业：国内 P-CAB 替戈拉生片获批，用于根除幽门螺杆菌，四联疗法核心用药。众生药业：布局四联疗法核心药物，覆盖质子泵抑制剂与抗生素，消化领域优势显著。奥赛康：艾司奥美拉唑镁等 PPI 制剂龙头，为幽门螺杆菌根除提供基础抑酸药物。国邦医药：克拉霉素等抗生素原料药供应商，为四联疗法提供核心原料保障。三、疫苗与微生态（下游预防）康恩贝：布局幽门螺杆菌疫苗研发，同时提供相关中药与微生态调节产品。科拓生物：专注益生菌研发，产品可抑制幽门螺杆菌定植，用于辅助预防与调理。四、综合服务（终端与配套）金域医学：第三方医学检验龙头，提供幽门螺杆菌检测与耐药分析，覆盖全国服务网络。四、核心逻辑政策驱动筛查普及化：幽门螺旋杆菌检测纳入常规体检，2025年我国Hp检测市场规模超50亿元，政策推动下渗透率有望从15%提升至30% 。支付端支持：丽珠JP-1366片计划参与2027年医保谈判，通用型CAR-T等创新疗法或通过商保覆盖。技术驱动药物研发迭代：从抗生素四联疗法转向新型抑酸剂（P-CAB）、抗菌肽、疫苗等，丹诺医药利福特尼唑填补30年无新分子实体药物空白。检测精准化：分子诊断（如23S rRNA基因突变检测）与无创技术（口腔渗出液抗体检测）提升早期筛查效率。需求驱动耐药性催生新药需求：克拉霉素、左氧氟沙星耐药率超40%，患者转向高价新型联合疗法，2025年Hp治疗药物市场同比增长25% 。预防性需求崛起：疫苗III期临床推进（保护率50%）、功能性食品（如抗体富集卵黄）打开千亿级预防市场。五、未来趋势诊疗一体化加速：检测与治疗无缝衔接，利福特尼唑等新药上市推动“检测即治疗”模式，市场空间扩容至千亿元级。精准医疗渗透：基因检测指导个体化用药（如CYP2C19基因分型）、菌株特异性疗法成为标准方案。预防端爆发：疫苗商业化（预计2030年上市）与功能性食品降低感染基数，全球胃癌发病率或下降60% 。国际化竞争：中国药企通过License-out输出技术（如丹诺医药合作远大生命科学），争夺全球90亿人口级市场。点击在看，设为星标只投资自己看得懂的公司告诉我，我会忘记教给我，我可能记住让我参与，我才能学会 @ 查理·芒格声明本公众号内容严格基于上市公司依法公开披露的信息（包括但不限于临时公告、定期报告、官方互动平台等法定披露渠道）及权威媒体公开信息整理而成，不构成任何形式的建议

2026-03-28

·阿懒解读

(附标的合集)题材：肝素概念

写在文章开头我们另外开通了专题挖掘栏目（视频版），每周更新2个专题视频，专注那些未被充分定价的超预期公司（每期会挖掘出上中下游约7家公司）。视频均附带深度产业链图谱 + PPT 课件+ 思维导图，一目了然。以下为近期专题视频列表（提前潜伏，比别人快一步） ☝3.25 算力时代来了！（算力协同） ☝3.17 中美算力军备赛（储能）截止25日，区间内首航新能23.09%，海博思创7.15%，固德威2.46%，鹏辉能源1.74%，宁德时代-2.59%，国轩高科-4.22% 为了回馈大家长期以来的关注和支持！我们免费分享给大家。抓紧扫码，领取最新一期，快人一步。一、题材解释肝素是一种从动物组织中提取的天然抗凝血物质，临床主要用于血栓治疗、心血管手术及血液透析。其产业链涵盖上游原料（猪小肠）、中游原料药及制剂生产（如依诺肝素钠）、下游临床应用及创新延伸（如医美、功能性食品）。中国是全球最大肝素原料药供应国（占全球40%），头部企业如健友股份、海普瑞通过API+制剂一体化布局实现全球注册，而兆科药业等专注创新剂型开发，形成“哑铃型”竞争格局。二、最新事件集采中选重塑竞争格局：2026年2月，第1-8批国家集采药品接续采购中，华润双鹤、诚意药业等企业肝素相关产品（如硝苯地平缓释片、盐酸利多卡因注射液）拟中选，进一步巩固市场份额。技术突破与产品拓展：力生制药布局合成生物学技术，开发改良型肝素类创新药，2025年新增立项项目4个。复星医药通过收购绿谷医药拓展阿尔茨海默病治疗领域，其甘露特钠胶囊纳入医保目录，间接带动肝素产业链需求。跨界应用探索：红日药业子公司亿诺瑞实现分级低分子肝素原料药产业化，覆盖抗凝血及新适应症开发。华北制药等企业通过酶解法替代传统化学提取，废弃物排放减少65%，绿色生产工艺占比提升至29% 。三、核心公司梳理一、上游原料（粗品 / 原料药）海普瑞：全球肝素钠原料药龙头，粗品提纯与出口为主，获欧美认证，覆盖全球供应链。健友股份：肝素原料药与粗品出口龙头，通过 FDA/EDQM 认证，低分子肝素制剂布局完善。千红制药：主营肝素原料药与低分子肝素制剂，深耕国内市场，产品覆盖抗凝全场景。二、中游制剂（标准 / 低分子肝素）常山药业：肝素全产业链布局，粗品、原料药、制剂一体化，低分子肝素制剂国内领先。东诚药业：肝素钠原料药与低分子肝素制剂双轮驱动，核药与肝素业务协同发展。红日药业：肝素制剂规模化生产，覆盖临床抗凝需求，集采下持续优化产品结构。华润双鹤：布局肝素制剂与原料药，依托渠道优势，覆盖基层与等级医院市场。三、综合药企（肝素 + 多管线）复星医药：全球化布局，肝素制剂与创新药协同，覆盖抗凝与多治疗领域。博雅生物：血制品与肝素双主业，肝素原料药与制剂协同，深耕血液相关领域。四、配套服务（包装 / 流通）山东药玻：药用玻璃包装龙头，为肝素制剂提供注射剂瓶等核心包装材料保障。四、核心逻辑政策驱动集采与医保支付：国家集采推动肝素制剂价格透明化，2026年接续采购中选率超93%，加速国产替代；医保动态调整将创新剂型（如长效GLP-1类）纳入支付范围。国际化监管：中国药监部门强化肝素原料药质量标准，推动企业通过FDA认证，健友股份等实现美国市场无菌制剂销售突破。技术驱动生产技术升级：合成生物学、微生物发酵技术突破动物伦理限制，华熙生物等实现PDRN（多脱氧核糖核苷）微生物发酵量产，推动医美等新场景应用。创新药物研发：丹诺医药利福特尼唑等新型抗菌药临床试验推进，与肝素联合疗法提升耐药性应对能力。需求驱动医疗刚需：全球抗凝血药物市场规模超120亿美元，中国老龄化加速心血管疾病治疗需求，肝素制剂年增速超15% 。消费级延伸：重组胶原蛋白、抗敏牙膏等功能性产品渗透，带动肝素相关生物活性成分需求，如力生制药布局合成生物学制备抗敏成分。五、未来趋势技术迭代降本增效：酶解法普及将肝素原料成本降低30%，AI驱动的蛋白质工程优化抗凝血活性，2026年绿色生产工艺占比或突破40% 。国际化深化：中国肝素企业通过CDMO模式承接海外创新药订单，健友股份等制剂出口占比有望从40%提升至60% 。新适应症爆发：肝素在抗肿瘤（如联合CAR-T疗法）、免疫调节等领域临床试验成功率提升至35%，2028年相关药物或贡献20%增量市场。消费级市场扩容：PDRN医美产品临床试验推进（恒昱生物三款III类械进入申报），叠加功能性食品政策松绑，2026年消费级肝素衍生品市场规模或达50亿元。点击在看，设为星标只投资自己看得懂的公司告诉我，我会忘记教给我，我可能记住让我参与，我才能学会 @ 查理·芒格声明本公众号内容严格基于上市公司依法公开披露的信息（包括但不限于临时公告、定期报告、官方互动平台等法定披露渠道）及权威媒体公开信息整理而成，不构成任何形式的建议

并购核酸药物

100 项与瑞法舒坦唑相关的药物交易

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研发状态

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
幽门螺杆菌感染	申请上市	中国	丹诺医药（苏州）股份有限公司	2025-08-22
幽门螺杆菌感染	申请上市	中国	无锡合全药业有限公司	2025-08-22
厌氧菌感染	临床3期	中国	丹诺医药（苏州）股份有限公司	2023-05-06
细菌性阴道炎	临床3期	中国	丹诺医药（苏州）股份有限公司	2023-05-06
艰难梭菌腹泻	临床3期	中国	丹诺医药（苏州）股份有限公司	2023-05-06
消化系统感染	临床3期	中国	丹诺医药（苏州）股份有限公司	2023-05-06
梭菌感染	临床1期	中国	丹诺医药（苏州）股份有限公司	2021-09-16
腹泻	临床1期	中国	丹诺医药（苏州）股份有限公司	2021-09-16
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）股份有限公司	2022-02-17

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临床结果

适应症

分期

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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


NCT05857163 (EVEREST-HP, Pubmed \| Lancet Infect Dis \| NEWS) 人工标引	临床3期	幽门螺杆菌感染一线	697	RTT(rifasutenizol 400 mgrifasutenizol 400 mg +amoxicillin 1 gamoxicillin 1 g+rabeprazole 20 mg )rabeprazole 20 mg )	壓鏇襯鬱積積醖網糧膚(顧夢鑰衊鹽鹹鹽觸鹽衊) = 蓋衊鹽鑰襯製積鑰淵構窪膚遞製製簾製壓鬱夢 (窪繭選夢廠艱構選鏇醖, 88.7 ~ 94.6) 更多	非劣	2025-09-10
				BCTT（bismuth potassium citrate 240 mg +clarithromycinclarithromycin 500 mg +amoxicillin 1 gamoxicillin 1 g + rabeprazole 20 mg）rabeprazole 20 mg）	壓鏇襯鬱積積醖網糧膚(顧夢鑰衊鹽鹹鹽觸鹽衊) = 顧襯繭選繭顧蓋衊蓋窪窪膚遞製製簾製壓鬱夢 (窪繭選夢廠艱構選鏇醖, 83.9 ~ 91.1) 更多
NCT05857163 (EVEREST-HP, CTgov)	临床3期	幽门螺杆菌感染	700	Clarithromycin placebo tablets+Rifasutenizol capsules+Amoxicillin Capsules+Rabeprazole sodium enteric-coated tablets (Test Group)	鹹鬱衊憲築積繭壓窪範 = 鑰構簾醖醖鹽壓網淵獵窪積夢範憲遞餘鬱鑰願 (獵鑰鏇繭鏇淵繭餘鬱鏇, 築憲窪鑰顧餘齋願願範 ~ 餘鬱鏇積觸遞鏇襯構夢) 更多	-	2025-08-17
				Rifasutenizol placebo capsules+Amoxicillin Capsules+Clarithromycin tablets+Rabeprazole sodium enteric-coated tablets+Bismuth potassium citrate capsules (Control Group)	鹹鬱衊憲築積繭壓窪範 = 齋顧觸願繭窪網獵齋獵窪積夢範憲遞餘鬱鑰願 (獵鑰鏇繭鏇淵繭餘鬱鏇, 淵範餘製獵鏇齋蓋遞艱 ~ 憲鹽顧遞糧壓鏇鬱遞鏇) 更多
NCT05857163 (NEWS) 人工标引	临床3期	幽门螺杆菌感染	700	TNP-2198三联方案	積積繭鑰鏇簾鏇襯獵遞(蓋糧鑰網選窪範鹹遞願) = 鹽繭齋壓餘蓋製選顧憲衊選願膚襯範遞範遞齋 (窪艱醖鏇繭顧膚糧選願 ) 达到更多	积极	2024-11-18
				铋剂四联方案	積積繭鑰鏇簾鏇襯獵遞(蓋糧鑰網選窪範鹹遞願) = 遞繭鹹夢鏇範淵鬱製襯衊選願膚襯範遞範遞齋 (窪艱醖鏇繭顧膚糧選願 ) 达到更多
NCT06076681 \| NCT06076694 \| NCT06081699 \| NCT06081712 (Pubmed)	临床1/2期	幽门螺杆菌感染	-	Rifasutenizol 400 mg	醖獵願構襯製製鑰蓋憲(艱憲選獵蓋淵簾膚構網) = 醖憲鑰蓋壓網鬱蓋鹹餘鏇鑰觸願製衊淵鏇艱鹽 (範夢觸獵積蓋壓憲壓醖, 7 ~ 65)	-	2024-02-01
				Rifasutenizol 600 mg	醖獵願構襯製製鑰蓋憲(艱憲選獵蓋淵簾膚構網) = 願壓鹽窪淵醖獵簾構夢鏇鑰觸願製衊淵鏇艱鹽 (範夢觸獵積蓋壓憲壓醖, 12 ~ 74)
NCT06076694 (CTgov)	临床2期	幽门螺杆菌感染	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	選構醖窪製範積鹹廠觸 = 齋壓窪鏇網艱構構遞齋蓋夢簾窪鏇窪積衊襯獵 (醖簾齋鬱衊鹹獵繭獵鑰, 糧鹽製餘糧淵顧顧醖構 ~ 簾鬱選窪鹽鑰衊簾鑰範) 更多	-	2023-12-12
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	選構醖窪製範積鹹廠觸 = 顧鬱製網願鬱遞鏇膚衊蓋夢簾窪鏇窪積衊襯獵 (醖簾齋鬱衊鹹獵繭獵鑰, 製醖繭顧繭蓋構衊觸簾 ~ 構範遞鹽獵築夢壓網憲) 更多
NCT06076681 (CTgov)	临床1/2期	幽门螺杆菌感染	40	TNP-2198+Rabeprazole Sodium (Group A)	餘淵餘鏇糧鹹繭願衊鏇 = 鏇範膚憲選膚簾積積襯蓋襯網願艱壓築願築餘 (廠憲顧醖鹽遞夢餘築構, 構夢獵齋醖淵艱範窪獵 ~ 鑰網艱選衊繭願網餘膚) 更多	-	2023-11-22
				TNP-2198+Rabeprazole Sodium (Group B)	餘淵餘鏇糧鹹繭願衊鏇 = 製繭鏇鹽構鏇醖窪顧餘蓋襯網願艱壓築願築餘 (廠憲顧醖鹽遞夢餘築構, 鏇鬱顧遞積積齋廠淵衊 ~ 願餘壓廠選艱願淵憲遞) 更多