A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers

开始日期2025-12-27

申办/合作机构

HK inno.N Corp.

KCT0011041

/ Not yet recruiting临床3期IIT

A phase 3, randomized, double-blind, placebo-controlled, multicenter, superiority, investigator-initiated trial of Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy

开始日期2025-11-30

申办/合作机构

Hanyang University Guri Hospital

NCT07242443

/ Not yet recruiting临床4期IIT

A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

开始日期2025-11-20

申办/合作机构

杭州市第一人民医院（西湖大学附属杭州市第一人民医院）

100 项与替戈拉生相关的临床结果

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100 项与替戈拉生相关的转化医学

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100 项与替戈拉生相关的专利（医药）

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146

项与替戈拉生相关的文献（医药）

2025-12-10·The Korean Journal of Helicobacter and Upper Gastrointestinal Research

Evaluation of the Safety and Efficacy of K-CAB (Tegoprazan) as Symptomatic Maintenance Therapy in Patients With NERD: A Multicenter, Randomized Double-Blinded Controlled Trial

Article

作者: Bae, June Hwa ; Kwon, Yong Hwan ; Lee, Ju Yup ; Kim, Eun Young ; Lee, Si Hyung ; Chung, Yun Jin ; Jeon, Seong Woo ; Kwon, Joong Goo ; Yang, Chang Hun ; Park, Kyung Sik ; Jo, Hyeong Ho

Objectives: This preliminary, randomized, double-blind, multi-center study evaluated the efficacy of alternate-day tegoprazan (50 mg) versus daily lansoprazole (15 mg) as for maintenance therapy in patients with non-erosive reflux disease (NERD). Methods: Forty five participants were enrolled and treated for 8 weeks. The primary endpoint was the proportion of symptom-free days. The secondary endpoints were changes in Gastrointestinal Symptom Rating Scale (GSRS) and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores. Results: It showed no significant difference between groups in the proportion of symptom-free days between both groups (tegoprazan: 60.4%±6.3%; lansoprazole: 74.0%±6.5%). The GSRS and GERD-HRQL score improvements were also comparable between both groups. Both treatments were well tolerated, with no serious adverse events reported. Conclusions: These findings suggest that alternate-day tegoprazan offers comparable efficacy and safety to daily lansoprazole therapy and may serve as a more flexible and patient-friendly maintenance option for NERD.

2025-12-10·The Korean Journal of Helicobacter and Upper Gastrointestinal Research

The Efficacy of Potassium-Competitive Acid Blocker Compared With Double Dose of Proton Pump Inhibitor in Patients With Refractory Gastro-Esophageal Reflux Disease: A Case-Control Study

Article

作者: Chung, Woo Chul ; Lim, Na Rae

Objectives: A significant number of patients with gastroesophageal reflux disease (GERD) experience refractory symptoms despite conventional doses of a proton pump inhibitor (PPI). Potassium-competitive acid blockers (PCABs) directly inhibit H⁺,K⁺-ATPase in a reversible manner and more profoundly inhibit acid secretion. However, the efficacy of PCABs in the treatment of refractory symptoms has not been thoroughly studied. Methods: This consecutive study was conducted between March 2020 and March 2023; patients with refractory symptoms were enrolled. Esophagogastroduodenoscopy, ambulatory esophageal pH measurements, and manometry were performed. Double split doses of rabeprazole (20 mg) or tegoprazan (50 mg) were prescribed for 2 weeks, and the symptoms were subsequently evaluated. A positive response was defined as more than 50% improvement in the visual analog scale scores for symptom severity. Results: A total of 63 patients were enrolled. In the group that received a double split dose of PPI (n=33), the positive response rate was 63.6% (21/33). There were 18 cases of abnormal acid exposure (excessive esophageal acid exposure time [AET] >4.0%); the positive response rate was 50.0% (9/18). In the group treated with PCAB (n=30), the positive response rate was 80.0% (24/30) (p=0.15). There were 19 cases of abnormal acid exposure; the positive response rate was 84.2% (16/19). The difference was statistically significant in favor of the PCAB group (p=0.02). Conclusions: In patients with refractory GERD symptoms, PCAB therapy had effects corresponding to those of a double split dose of PPIs. PCAB therapy was therefore deemed superior to PPIs, especially in patients with abnormal AETs

2025-12-01·BIOMEDICAL CHROMATOGRAPHY

A Novel UPLC–MS/MS Method for Determining Tegoprazan in Rat Plasma: An Application in a Rat Pharmacokinetic Study

Article

作者: Wang, Yu ; Lin, Manjie ; Xu, Mengjie ; Weng, Qinghua ; Cai, Yize

ABSTRACT:

Tegoprazan (TEG) is a commonly used drug in the treatment of gastroesophageal reflux disease. This work aimed to develop and validate an ultra‐high‐performance liquid chromatography–tandem mass Spectrometry (UPLC–MS/MS) method to determine the levels of TEG in rat plasma and to apply it for a rat pharmacokinetic study. Electrospray ionization source (ESI) positive and multiple reaction monitoring (MRM) mode were selected. The internal standard revaprazan (REV) and TEG were analyzed separately on a Waters ACQUITY UPLC BEH column. Gradient elution with a flow rate of 0.5 mL/min was used. Accuracy and precision were from −8.5% to 12.2%. Linearity was from 2 to 1000 ng/mL. IS‐normalized recovery ranged from 109.3% to 113.6%. IS‐normalized matrix effect was from 99.0% to 102.8%. The coefficient of variation of matrix effect was less than 10%. Dilution integrity showed that a tenfold dilution also met the guidelines. In the rat pharmacokinetic study, AUC(0 − ∞) and Cmax of TEG were 9129.6 ± 1823.3 μg/L*h and 2513.2 ± 707.0 ng/mL, respectively. Tmax and T1/2 were 1.8 ± 1.1 h and 1.6 ± 0.8 h, respectively. We finally established a rapid and robust UPLC–MS/MS quantitative analysis of TEG in rat plasma. Rat pharmacokinetics indicated that TEG was absorbed quickly and fast reached the maximum concentration.

214

项与替戈拉生相关的新闻（医药）

2026-01-14

·乔戈里投研

丽珠集团公司护城河透视

一、竞争优势判断：稳定盈利与市场地位的共振要判断一个行业或公司是否具备真正的竞争优势（即“护城河”），核心在于分析其是否存在结构性进入壁垒。这种壁垒能有效阻挡新竞争者，保护现有企业获得长期超额利润。如果高利润只是昙花一现，很快被新进入者模仿和竞争侵蚀，那说明优势源于卓越的运营效率，而非坚固的护城河。因此，我们的分析聚焦于两个相互印证的维度：市场地位与稳定性：高且稳定的市场份额，意味着公司有能力抵御竞争，这是进入壁垒存在的直接证据。持续超额盈利能力：长期高于行业平均和资本成本的回报率，是竞争优势带来的经济果实。下面从这两个维度对丽珠集团进行评估。 1、市场地位：细分领域的隐形冠军丽珠集团在多个细分治疗领域建立了稳固的市场地位，其优势并非广谱的“化学制药”，而是集中在几个经过深耕的赛道。市场份额与行业排名：在国内辅助生殖促卵泡激素市场，公司的核心产品注射用尿源促卵泡素长期占据绝对领导地位，市场份额超过90%。在国内消化道溃疡治疗领域，其王牌产品“丽珠得乐”（枸橼酸铋钾）上市超过30年，尤其在华南地区市场占有率超过40%，是医生和患者心中的经典品牌。此外，其国家1.1类新药艾普拉唑（片剂+针剂）也在抑酸治疗领域建立了显著的品牌和临床优势。评级：较强评级理由：公司在辅助生殖、消化道等核心细分领域并非仅仅是参与者，而是拥有定义市场格局能力的领导者。这种在利基市场达到近乎垄断或主导级别的份额，是强大竞争地位的明确信号。市场地位稳定性与趋势：上述核心产品的市场领导地位并非短期现象，而是经历了长时间（超过5年甚至10年）的考验。例如，“丽珠得乐”畅销三十余年，艾普拉唑自2008年上市后持续放量并构建产品矩阵。尽管面临国家医保谈判降价和同类新药（如P-CAB）的竞争压力，但凭借深厚的品牌积淀、完整的渠道覆盖和持续的医患教育，公司核心产品的市场地位保持了高度稳定性，份额波动远低于5个百分点的临界值。评级：较强评级理由：在政策与市场竞争加剧的行业环境下，丽珠集团在核心领域的优势份额能够长期维持，表明其护城河有效抵御了竞争侵蚀，地位稳固。 2、盈利能力：穿越周期的稳健回报丽珠集团的财务表现体现了其竞争优势的“含金量”——将市场地位转化为持续、高质量的利润。核心回报率 (ROE)：由于计算精确的税后ROIC需要更多细节数据，我们以净资产收益率（ROE）作为核心替代指标。观察公司近10年（2015-2024年）的财务表现，其ROE长期稳定在14%-15%的区间。例如，2020年至2024年，年度ROE分别为14.74%、14.14%、14.21%、14.00%和14.77%，表现出极强的稳定性。评级：较强评级理由：根据布鲁斯·格林沃尔德的框架，长期（10年）平均ROIC在15%-25%是竞争优势的清晰证明。丽珠集团近10年平均ROE稳定在14%-15%的高位，显著高于社会平均资本回报率（通常为6%-8%），且波动性极小。这证明公司能够持续为股东创造超额价值，盈利能力具有可持续性，而非周期性的波动。利润率与规模水平：公司的销售毛利率长期保持在64%-66%的高水平（2020-2025年三季度），这远高于化学制药行业的平均水平（约50%）。高毛利率源于其产品组合中包含了众多独家品种、品牌中药和高壁垒复杂制剂（如微球）。尽管销售费用和管理费用较高，但其净利率仍能维持在15%-20%的稳健区间。2024年营收达118.12亿元，净利润20.61亿元，规模在同类医药企业中位居前列。评级：较强评级理由：极高的毛利率反映了强大的产品定价权和成本结构优势，这通常来自专利保护、品牌忠诚度或独特工艺。而可观的净利润规模则表明公司具备将营收高效转化为利润的能力，庞大的业务体量也为研发、生产等环节的规模经济奠定了基础。 3、综合评级与核心理由总结论：丽珠集团存在清晰的竞争优势。综合评级：较强核心理由：公司同时满足了护城河判定的两大关键指标。盈利质量过硬：近10年ROE稳定在14%-15%的高位，且毛利率长期领先行业，证明了其持续获取超额回报的能力。市场地位坚固：在辅助生殖、消化道等核心细分领域拥有主导甚至垄断性的市场份额，并且这种地位在长达数年的时间里保持稳定，有效抵御了政策和市场竞争的冲击。这两者的结合，清晰地指向了结构性进入壁垒的存在，而非短暂的运营优势。二、护城河溯源：深挖壁垒的基石与风险基于第一部分“较强”竞争优势的判定，我们深入探究丽珠集团护城河的具体来源。医药行业的竞争壁垒通常不依赖于单一因素，而是技术、法规、规模和客户信任的复合体。对于丽珠而言，其优势主要来源于以下两个相互增强的方面： 2.1、供给侧优势：技术平台与工艺壁垒 · 评级：较强丽珠集团的供给侧优势并非依赖某种单一的稀缺资源，而是建立在特色技术平台和**“原料药-制剂”一体化**的制造能力之上，形成了竞争对手难以短期复制的综合成本与质量控制优势。逻辑链条：公司建立了缓释微球和生物药两大国家级特色技术平台。以微球平台为例，这是一种高端复杂制剂技术，能将药物包裹在微球中于体内缓慢释放，实现每月甚至每季度注射一次，极大提升患者依从性。这种技术研发难度大、生产工艺复杂、质量控制要求极高。研发端，公司在此领域深耕十余年，积累了从研发、放大到产业化的全链条know-how（技术诀窍），并构建了丰富的产品管线（如已上市的亮丙瑞林微球、在研的阿立哌唑微球等）。新进入者或跟随者需要漫长的时间和高昂的试错成本才能追赶。生产端，公司执行远高于行业标准的质量管理体系，生产线100%通过GMP符合性检查。更重要的是，公司在特色原料药领域具备强大实力，实现了从关键原料到制剂的垂直整合。这不仅保障了供应链的稳定和安全，更能通过优化工艺来显著降低生产成本。最终体现：这些供给侧优势共同作用，使得公司能够持续推出具有显著临床差异化的高壁垒产品（如长效微球制剂），并凭借稳定的质量和可控的成本，在集采等严峻政策环境下保持盈利韧性，构筑了仿制药企业难以逾越的工艺壁垒和特色原料药企业难以具备的终端产品能力。 2.2、需求侧优势：品牌信任与转换成本 · 评级：较强在医药行业，真正的需求侧优势不在于广告投放，而在于在医生和患者心中建立起基于疗效和信任的“锁定”。丽珠集团通过“经典品牌”与“专业学术”双轮驱动，成功构建了这种锁定。逻辑链条：经典品牌形成的“习惯”与“信任”：像“丽珠得乐”这样的产品，上市超过30年，历经数代医生和患者的使用验证，其疗效和安全性已深入人心，成为治疗某种适应症（如胃溃疡）的“默认选项”或“首选药物”。这种品牌认知构成了极高的心理转换成本——医生在处方时倾向于选择经过时间检验的方案，患者也对其有天然的信赖感。专业学术构建的“转换成本”：对于处方药，尤其是创新药和复杂制剂，丽珠通过强大的学术营销团队，与关键意见领袖（KOL）深度合作，积累了大量临床循证证据。例如，艾普拉唑拥有完整的头对头临床研究数据。当一种治疗方案被写入诊疗指南、形成成熟的临床路径后，更换为其他产品意味着医生需要重新学习、医院药事委员会需要重新评审，这带来了实质性的时间和精力转换成本。完整解决方案提升“搜寻成本”：在辅助生殖等领域，丽珠提供了覆盖全周期（促排、黄体支持、诱发排卵）的完整产品矩阵。对于生殖中心而言，与一个能提供全线产品、服务稳定的供应商合作，远比从多家供应商分别采购、协调要高效可靠。这提高了客户更换整体方案的“搜寻成本”和协作成本。最终体现：这种由品牌信任和学术壁垒共同构成的客户锁定，赋予了公司一定的定价权（在医保谈判前）和份额防御能力。即使面临仿制药或新机制药物的竞争，其产品生命周期也得以显著延长，不易被轻易替代。 2.3、规模经济效益 · 评级：中等公司的规模优势更多体现在研发和销售的协同效应上，而非传统制造业的单一产品产量规模。相对份额与高固定成本分摊：在它主导的细分市场（如尿源促卵泡素），其绝对市场份额带来了无与伦比的规模效应。但更关键的是，公司近万人的营销网络覆盖全国超5000家医院，这支团队的固定成本可以被其丰富的产品组合（400多个品种）共同分摊。同样，900多人的研发团队、以及微球、生物药等大型技术平台的投入，这些高额固定成本也通过多个在研项目进行分摊。关键组合：这种规模经济与前述的需求侧优势（客户锁定）紧密结合。正是因为医生和医院对其品牌和已有产品形成了使用习惯和信任，其庞大的销售团队推广新产品、其研发平台产出新成果时，才能更高效地被市场接受。反之，如果没有客户基础，再大的销售团队和研发投入也难以快速转化为商业成功。评级理由：给予“中等”评级，是因为其规模经济更多是竞争优势的“放大器”和“结果”，而非最原始的驱动力。它的核心壁垒首先来自于特定技术和产品构建的供给侧与需求侧优势，规模效应在此基础上进一步巩固了其竞争地位，并提升了运营效率。 2.5、可持续性风险：替代威胁的达摩克利斯之剑尽管护城河深厚，但丽珠集团依然面临来自技术迭代和支付方压力的替代威胁，这决定了其护城河价值的“天花板”。技术性替代：这是最直接的威胁。例如，在消化道领域，其王牌产品艾普拉唑（属于PPI类药物）正面临新一代P-CAB（钾离子竞争性酸阻滞剂）药物的冲击。P-CAB起效更快、作用更持久，代表了技术迭代的方向。尽管丽珠也已布局P-CAB产品以应对，但原有主力产品的增长空间无疑会受到挤压。支付方（医保）压力带来的“性价比”替代：在国家医保控费、集采常态化的背景下，任何药品都可能面临“灵魂砍价”。即使拥有品牌和疗效优势，如果价格远超医保支付标准或集采中标价，也可能被更便宜的仿制药或同类产品替代。这对公司的定价权和利润空间构成长期约束。结论：丽珠的护城河使其有能力应对这些威胁——通过前瞻性研发布局新靶点药物（如司美格鲁肽、IL-17A/F双抗）、通过工艺优化控制成本以应对集采、通过国际化开拓新市场来平滑国内政策风险。其竞争优势并非固步自封，而是具备动态演进的能力，但替代威胁始终是需要持续监控的最大风险。四、主要竞争对手对比分析主要竞争对手的来源、竞争优势排名与可持续性。本节内容请打开「口袋分析师」微信小程序搜索公司名继续阅读。五、护城河透视总结护城河总结，优势、劣势及归因以及对投资者的启示。本节内容请打开「口袋分析师」微信小程序，搜索公司名继续阅读。

财报

2026-01-12

·BioSpace

Sebela Pharmaceuticals® Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease

Key Highlights: Sebela Pharmaceuticals ® submitted its New Drug Application (NDA) for tegoprazan on January 9, 2026. The NDA seeks approval for three indications: Non-Erosive Reflux Disease (NERD), Erosive Esophagitis (EE) Healing, and EE Maintenance Once approved, tegoprazan will be the first Potassium-Competitive Acid Blocker (P-CAB) to demonstrate superiority in EE healing across all severity grades (LA Grades A-D) and at all time points versus a proton pump inhibitor (PPI) In NERD, tegoprazan achieved meaningful improvement in 24-hour heartburn, overnight heartburn, and regurgitation, the hallmark symptoms of GERD, versus placebo Tegoprazan has demonstrated rapid acid control (pH>4) within 45 minutes Safety and tolerability for tegoprazan was favorable across all studies, with adverse events occurring at similar rates to study comparators and mean serum gastrin levels remaining within normal limits (0-180 pg/ml) throughout treatment Tegoprazan has already received marketing authorization in 21 countries worldwide. US approval anticipated in January 2027 BRAINTREE, Mass. , Jan. 12, 2026 /PRNewswire/ -- Braintree Laboratories, Inc. a part of Sebela Pharmaceuticals® and a leading manufacturer of gastroenterology pharmaceutical products, announced that it submitted a New Drug Application (NDA) on January 9, 2026 to the U.S. Food and Drug Administration (FDA) for tegoprazan, a novel potassium-competitive acid blocker (P-CAB), for the treatment of adults with gastroesophageal reflux disease (GERD). The NDA seeks simultaneous approval for three indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing. The NDA submission is supported by robust data from the pivotal Phase 3 TRIUMpH clinical program, which enrolled over 2,000 US patients and demonstrated tegoprazan's clinical superiority over a PPI across multiple endpoints. All endpoints were evaluated under a prespecified hierarchical multiple testing procedure. In NERD, tegoprazan demonstrated superiority over placebo for the percentage of 24-hour heartburn-free days (p4) within 45 minutes. Tegoprazan has received marketing authorization in 21 countries worldwide. If approved by the FDA, tegoprazan would be indicated in the US for the treatment of heartburn in NERD and for the healing and maintenance of healing of EE in adults. About Sebela Pharmaceuticals At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the US and developing innovative products in women's health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing and commercializing gastroenterology products for over 40 years. Braintree's lead program is tegoprazan, a novel potassium competitive acid blocker (P-CAB) which has completed its Phase 3 program in gastroesophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). In addition, Sebela Women's Health obtained FDA approval for Miudella® in 2025, the first non-hormonal intra-uterine device (IUD) for contraception to be approved in over 40 years. Miudella was recently featured in Time Magazine's Best Inventions of 2025. Sebela Women's Health also has another next-generation hormonal IUD for contraception in late-stage clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. For more information, visit . Forward-looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "may", "will", "forecast," "estimated," "expected," and "intend," among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to obtaining FDA approval of tegoprazan; the development, launch, introduction and commercial potential of tegoprazan; growth and opportunity, including peak sales and the potential demand for tegoprazan, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the NDA discussed in this press release will be approved or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References: 1 El-Serag HB, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014. 2 Chey WD, et al. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci. 2010. 3 Armstrong D, et al. Symptom Profile, Proton Pump Inhibitor Therapy, and Diagnostic Testing in Patients with Persistent Reflux-Like Symptoms: Results from a Population-Based Survey. Foregut. 2023. † Dr. Katz has served as a paid consultant for Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals. View original content to download multimedia: SOURCE Sebela Pharmaceuticals

临床3期申请上市上市批准临床结果生物类似药

2026-01-07

·E药经理人

17字医保支付新规引爆200亿市场，武田、罗欣、复星“三国杀”，谁赢？

一场关于中国人“胃”来的健康升级，已然拉开序幕。撰文| 张烨静一个堪比减重药的大赛道，正在起风。今日，国家医保局公布了2025年医保药品目录支付范围调整名单。其中，两款重磅抑酸新药——“替戈拉生片”与“盐酸凯普拉生片”新增的“与适当的抗生素联用以根除幽门螺杆菌”适应证，被正式纳入医保支付。这新增的17个字，或将撬动一个庞大而持久的治疗市场。数据显示，中国幽门螺杆菌感染率约50%，对应感染人群近7亿，蕴含着巨大的临床需求。它不仅是慢性胃炎、消化性溃疡的主要病因，更是被世界卫生组织定义的I类致癌物。研究证实，有效根除治疗可使胃癌发生风险降低约40%。然而，该领域长期面临“高感染率、高致病性、高耐药率、低根除率”的“三高一低”困局，传统治疗方案存在局限，临床亟需更优解。 2024年底，替戈拉生片与盐酸凯普拉生片先后获批幽门螺杆菌根除新适应证，为临床带来了新一代抑酸武器。如今，在医保支付的强力助推下，这条赛道正迎来爆发前夜。新一代抑酸药破局替戈拉生和凯普拉生，究竟是什么药？要理解其价值，需先看清它们所处的战场。我国消化道疾病患者基数庞大，发病率高，胃食管反流病、反流性食管炎、胃溃疡、十二指肠溃疡及幽门螺杆菌感染在18至64岁成年人群中的患病率分别约为10.5%、5.4%、2.5%、4.5%和41.5%。这些疾病共同指向了庞大的抑酸药物市场：胃酸是维持上消化道生理功能的关键因素，非正常的胃酸水平是多种消化道疾病的病理基础。过去数十年，质子泵抑制剂（PPI）是抑酸治疗的主流药物，例如奥美拉唑、泮托拉唑、艾司奥美拉唑等。不过，传统药物存在起效慢、作用时间短、药物相互作用风险高，需在餐前服用的痛点。钾离子竞争性酸阻滞剂（P-CAB）的出现，改变了游戏规则。作为新一代抑酸药物，P-CAB具有独特的作用机制，在胃酸中不被降解，也无需胃酸激活，且服药不受进食限制，在起效速度、抑酸持久性和稳定性上显著优于传统PPI。目前，我国已上市的P-CAB药物包括伏诺拉生、替戈拉生、凯普拉生、利那拉生酯四种。全球首款P-CAB药物“伏诺拉生”由武田制药研发，扮演了“市场拓荒者”角色。早在1980年代，科研人员便开始了对P-CAB类药物的研究，但早期探索布满荆棘，最初以化合物sch28080为代表的第一代候选药物，虽证实了“钾离子竞争性抑酸”概念的可行性，却因严重的肝毒性而折戟。此后数十年间，利拉帕赞等多个衍生化合物相继进入研究，却始终无法在安全性与疗效间找到完美平衡，研发陷入僵局。此后，武田与大冢的科研团队联合攻关，跳出传统结构框架，成功设计出伏诺拉生，不仅彻底规避了困扰前代的毒性问题，更赋予了药物与质子泵更强、更持久的结合力，效果显著超越传统PPI药物。这场攻坚最终在2014年12月迎来了里程碑时刻：伏诺拉生在日本获批上市，成为全球首个面世的P-CAB类药物，用于治疗胃溃疡、十二指肠溃、根除幽门螺旋杆菌、小剂量阿司匹林给药期间预防胃溃疡或十二指肠溃疡复发。可以说，伏诺拉生正式开启了抑酸治疗的“P-CAB新时代”。伏诺拉生2018年3月在中国市场“登台”，彼时武田在国内提交了国内上市申请，并凭借显著的临床优势被纳入优先审评，最终于2019年12月率先获批用于治疗反流性食管炎，2023年11月又添“与适当的抗生素联用以根除幽门螺杆菌”新适应证。 2020年底，富马酸伏诺拉生片成功进入国家医保药品目录。2024年11月，其根除幽门螺杆菌的适应证也获医保覆盖，进一步拓宽了临床使用场景。伏诺拉生是一款名副其实的重磅炸弹。米内网数据显示，富马酸伏诺拉生片在中国三大终端六大市场的销售额一路飙涨，2024年已经突破8亿元关口，2025上半年增长率为34.34%，是治疗与胃酸分泌相关疾病的药物内服TOP4产品。先驱早已被虎视眈眈。伏诺拉生的化合物专利将于2026年8月到期，一场仿制药的争夺战即将打响。仅2024年，伏诺拉生就新增95个上市申请受理号，受理号和申报企业数量排名都是第一，成为当年最炙手可热的仿制标的。 2022年，山东新时代药业已率先拿下国内首仿+首家过评，迄今共有约30家国内药企获批。可以说，各方药企已就位，静待“专利悬崖”降临，一场深刻的市场格局重塑即将开始。在仿制药浪潮之外，替戈拉生和凯普拉生这对国产“双子星”已然登场。替戈拉生是中国首款自主研发的P-CAB药物，由罗欣药业2015年从一家韩国药企引进，2022年4月获批上市，随后两年内接连获批反流性食管炎、十二指肠溃疡、幽门螺杆菌根除三大核心适应证，成为目前国内首个获批三个适应证的P-CAB药物。数据显示，替戈拉生片近年来在中国公立医疗机构终端的销售额均以三位数的增速快速增长，2024年接近3亿元，同比增长约246%；2025年上半年超过4亿元，同比增长约190%。凯普拉生由复星医药与柯菲平医药联合开发，于2023年2月获批，同年12月快速纳入国家医保。它的核心突破在于对伏诺拉生的分子结构进行了优化，通过增强水溶性和提升胃内分布浓度，在从药代动力学层面实现更快速、更高效的抑酸效率。此外，利那拉生酯于2024年12月获批上市，是国内第四款获批上市P-CAB药物。还有扬子江药业、丽珠医药等药企正在加速布局P-CAB抑制剂。荐阅读 * PD-1阵亡，GLP-1迟到，手持百亿现金的初代“胃药大王”为何掉队？ * 石药、丽珠再演拉锯战！恒瑞、先声、微芯也危矣？这些本土新药将遭仿制药围剿？闯入核心战场如今，新适应证纳入医保，进一步将两款国产新药推向了幽门螺杆菌（Hp）根除治疗——这个需求巨大且充满挑战的核心战场。当前，国内Hp根除治疗的主流方案是《2022年中国幽门螺杆菌感染治疗指南》推荐的“铋剂四联疗法”和“高剂量双联疗法”。其中铋剂四联疗法是目前应用最广泛的方案，平均感染根除率为81.3%。该方案需要同时服用四种药物，分别是一种抑酸药、一种铋剂和两种抗生素：抑酸药，例如雷贝拉唑、奥美拉唑等PPI抑制剂，能够帮胃里少产酸，给抗生素创造杀菌环境；铋剂，例如胶体果胶铋，能够保护胃黏膜还能直接杀细菌；抗生素，直接消灭细菌，有多种组合方案，比如阿莫西林+克拉霉素。如果考虑到服药种类多、负担重，或对抗生素耐受性较差，则可选择高剂量双联疗法。该方案仅包含两种药物：大剂量抑酸药（如双倍剂量雷贝拉唑）联合大剂量阿莫西林（每日3-4次）。其优势在于用药简单、副作用相对较小，尤其适用于老年患者或耐药情况较为严重的病例。不过正如前文所说，Hp治疗长期存在“高感染率、高致病力、高耐药率和低根除率”的“三高一低”严峻局面。一方面，以克拉霉素、左氧氟沙星为代表的关键抗生素耐药率持续攀升。数据显示，克拉霉素、左氧氟沙星耐药率为20%-40%，甲硝唑耐药率为60%-90%。并且，这三款药存在交叉耐药，增加了再次治疗难度。另一方面，部分患者对标准剂量质子泵抑制剂（PPI）代谢较快，导致抑酸强度与持久性不足，难以在治疗期间维持理想的胃内pH环境，从而影响抗生素的杀菌效果。面对高耐药现状与抑酸瓶颈，临床亟须更有效的治疗方案与药物选择，提升整体根除率，降低相关疾病与胃癌的发病风险。事实上，指南中早已给出解法：对于含PPI的铋剂四联方案和含P-CAB的铋剂四联方案，均被推荐作为幽门螺杆菌感染初次和再次根除治疗方案。替戈拉生一项关键临床研究数据显示，替戈拉生组和艾司奥美拉唑组（PPI药物）的Hp根除率分别为93.5%和86.4%（FAS分析集），是国内首个在Hp根除率上证明优效于PPI的P-CAB药物。凭借优越的作用机制和亮眼的根除率数据，P-CAB已经呈现出与PPI完全不同的发展走向。米内网数据显示，2013-2017年在重点省市公立医院终端，PPI药物奥美拉唑是治疗与胃酸分泌相关疾病的药物TOP3品种，市场份额在15%以上，2017年起该品种出现连续下滑态势，经历了“8连跌”后2024年Q1市场份额仅剩2.68%。与此同时，P-CAB药物一路高增。替戈拉生2023年销售额增长了2704%，2024年Q1仍有845%的增长。国元证券预计，P-CAB抑制剂在我国市场的总体规模有望超过200亿元。在日本，P-CAB抑制剂已经逐步开始取代PPI抑制剂。日本是P-CAB抑制剂上市最早的国家，伏诺拉生的销售额目前仍处于增长中，而原研企业的泮托拉唑、兰索拉唑和雷贝拉唑销售额均开始下滑。医保支付一直是创新药放量的关键引擎。如今，随着替戈拉生和凯普拉生新适应症纳入医保，丰富了幽门螺杆菌的临床治疗选择，也将降低患者的用药负担，为消化道疾病全病程管理的体系建设提供有力支持。目前，盐酸凯普拉生片医保支付价格为5.68元/10mg片，富马酸伏诺拉生片定价为28元/20mg。更重要的是，头部药企推动的创新药上市与医保覆盖，往往能重构疾病的治疗路径与患者认知度提升。在幽门螺杆菌感染领域，我国公众知晓率与检测率仍有待提高，目前我国幽门螺杆菌感染知晓率约为50%，检测率仅为22%。新药的可及性提升，结合企业端的市场教育，有望推动更多患者从“不治疗、不规范治疗”转向“主动筛查、规范根除”，从而带动整个早期筛查、诊断和治疗链条的发展。从伏诺拉生开拓市场，到国产“双子星”创新破局，再到仿制药浪潮到来，P-CAB赛道正经历从进口原研引领，到国产创新并跑，即将迈向全面竞争的关键阶段。而幽门螺杆菌这个巨大的适应症，正是这场变革中最具潜力的爆发点之一。一场关于中国人“胃”来的健康升级，已然拉开序幕。一审| 石宛佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

100 项与替戈拉生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A02BC	DB16690

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
糜烂性胃食管反流病	印度	Dr. Reddy's Laboratories Ltd.	2025-09-17
非糜烂性胃食管反流病	印度	Dr. Reddy's Laboratories Ltd.	2025-09-17
胃溃疡	印度	Dr. Reddy's Laboratories Ltd.	2025-09-17
十二指肠溃疡	中国	山东罗欣药业集团股份有限公司	2023-11-14
反流性食管炎	中国	山东罗欣药业集团股份有限公司	2022-04-08
胃食管反流	韩国	HK inno.N Corp.	2018-07-05
幽门螺杆菌感染	韩国	HK inno.N Corp.	2018-07-05

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
糜烂性食管炎	申请上市	美国	Sebela Pharmaceuticals, Inc.	2026-01-09
非糜烂性反流病	申请上市	美国	Sebela Pharmaceuticals, Inc.	2026-01-09
肝损伤	临床1期	美国	HK inno.N Corp.	2020-09-08

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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


NCT05933031 (NEWS) 人工标引	临床2期	幽门螺杆菌感染	382	Tegoprazan 50 mgTegoprazan 50 mg + Amoxicillin + Clarithromycin	積構壓膚構獵積網構鹹(糧遞願壓繭觸齋衊願製) = 衊鬱壓夢窪願膚壓鑰窪壓膚壓築鏇齋製簾範膚 (鬱餘鏇繭憲鹽築製淵糧 )	非劣	2025-10-15
				Tegoprazan 100 mgTegoprazan 100 mg+Amoxicillin+Clarithromycin	積構壓膚構獵積網構鹹(糧遞願壓繭觸齋衊願製) = 窪選觸鹹憲鹹膚願淵鏇壓膚壓築鏇齋製簾範膚 (鬱餘鏇繭憲鹽築製淵糧 )
NCT03615677 (Pubmed \| Chin Med J (Engl))	临床3期	糜烂性食管炎	261	Tegoprazan 50 mg/day	糧願簾壓鏇窪遞艱齋鬱(糧鹽鹹製積繭夢獵艱襯) = 選餘鹽築夢觸鑰蓋糧鹽餘鏇衊夢鏇顧醖餘範範 (鹽顧壓淵糧醖構齋範獵 )	积极	2025-10-05
				Esomeprazole 40 mg/day	糧願簾壓鏇窪遞艱齋鬱(糧鹽鹹製積繭夢獵艱襯) = 築繭構壓簾醖製壓製築餘鏇衊夢鏇顧醖餘範範 (鹽顧壓淵糧醖構齋範獵 )
NCT04128917 (Pubmed \| Gut Liver)	临床3期	幽门螺杆菌感染	102	Tegoprazan 50 mg	鑰鬱範鹹鹹糧繭鹽繭壓(遞膚繭鹹餘餘築夢觸獵) = 鹹糧膚願蓋糧膚構糧積衊鏇淵壓遞齋構製淵齋 (鬱鑰襯鹹遞製齋廠製願, 43.93 ~ 77.28)	积极	2025-09-15
				Tegoprazan 100 mg	鑰鬱範鹹鹹糧繭鹽繭壓(遞膚繭鹹餘餘築夢觸獵) = 鑰蓋築糧衊膚夢夢鏇遞衊鏇淵壓遞齋構製淵齋 (鬱鑰襯鹹遞製齋廠製願, 64.84 ~ 92.74)
NCT05577468 (Pubmed \| Chin Med J (Engl))	临床3期	幽门螺杆菌感染一线	561	Tegoprazan-based TTPB	廠觸鹹願膚齋憲選鏇製(製範糧艱顧廠蓋構製獵) = 鏇齋夢願構網壓網壓築憲繭鹽鹽顧衊淵廠獵鏇 (繭築範窪繭願遞簾選鹹 ) 更多	非劣	2025-08-22
				Esomeprazole-based TTPB	廠觸鹹願膚齋憲選鏇製(製範糧艱顧廠蓋構製獵) = 餘蓋網網鹹鏇齋網鹹製憲繭鹽鹽顧衊淵廠獵鏇 (繭築範窪繭願遞簾選鹹 ) 更多
NCT05883306 (Pubmed \| Expert Opin Drug Metab Toxicol)	临床1期	-	6	Tegoprazan 50 mg/150 μCi	簾選憲構窪鏇獵壓遞簾(鹹構餘簾糧鹹壓壓簾齋) = 艱齋襯繭願窪範餘獵鹽醖獵獵鏇顧範繭觸網廠 (築衊觸遞繭憲築觸積淵 ) 更多	-	2025-05-13
NCT05267743 (Pubmed)	临床4期	非糜烂性胃食管反流病	218	替戈拉生	獵糧製積鬱鑰顧艱醖鏇(顧糧廠醖鬱蓋蓋選繭鬱) = 鑰範鏇窪選淵鹽鹽襯壓製窪築觸網顧簾艱鏇艱 (構築衊鬱醖艱齋艱願廠 )	非劣	2024-11-25
				兰索拉唑	獵糧製積鬱鑰顧艱醖鏇(顧糧廠醖鬱蓋蓋選繭鬱) = 獵願窪衊壓壓醖窪鬱壓製窪築觸網顧簾艱鏇艱 (構築衊鬱醖艱齋艱願廠 )
UEGW2024	N/A	幽门螺杆菌感染一线	80	Tegoprazan-based BQT	構鹹餘範範顧窪構願衊(鹽繭顧蓋鏇顧襯膚蓋窪) = There was no significant difference in the rate of adverse events between the TBMT and OBMT groups (42.5% vs. 55,5%, p = 0.37). Nausea was the most common adverse effect (37.5% vs 40%, p=0.92) , followed by abdominal pain (12.5% vs 17.5%, p=0.16%) 糧築憲襯鬱憲構製膚膚 (製餘憲構觸齋襯願糧襯 )	积极	2024-10-13
				Omeprazole-based BQT
UEGW2024	N/A	-	-	Tegoprazan 50mg	觸鏇願齋窪鹹築繭鹹糧(願構構獵觸齋醖觸壓膚) = No significant differences in the incidence of adverse events between the trial group and the placebo group. No severe adverse events occurred in this study. 鏇餘醖糧齋壓壓蓋繭鹹 (齋襯壓簾構範衊壓衊構 )	-	2024-10-13
				Placebo
UEGW2024	N/A	-	-	Esomeprazole-containing sequential therapy	範觸夢艱餘鬱夢蓋齋窪(淵鏇積獵壓蓋鏇壓窪鏇) = In tegoprazan-containing sequential, nausea was more prevalent (23.3%, 27/202), which was statistically higher than esomeprazole-containing sequential (14.2%, 29/204) (p = 0.022) 願齋繭鬱夢選選鏇鏇積 (觸鏇衊獵壓鏇鹽觸鑰獵 )	-	2024-10-13
				Tegoprazan-containing sequential therapy
NCT05010954 (Pubmed \| Curr Med Res Opin) 人工标引	临床3期	十二指肠溃疡	399	Tegoprazan 50 mg	築淵膚觸範積艱觸醖選(鬱繭鑰醖襯壓獵膚範膚) = 襯鏇獵蓋鬱鑰壓膚範繭淵網襯範顧範鹹簾齋遞 (糧築窪築壓衊襯淵醖醖 ) 更多	非劣	2024-10-08
				Lansoprazole 30 mg	築淵膚觸範積艱觸醖選(鬱繭鑰醖襯壓獵膚範膚) = 蓋壓獵顧憲醖鹽製鏇醖淵網襯範顧範鹹簾齋遞 (糧築窪築壓衊襯淵醖醖 ) 更多