Lansoprazole

5月6日，海辰药业涨1.59%，成交额1.31亿元，换手率3.71%，总市值51.53亿元。异动分析幽门螺杆菌概念+辅助生殖+猴痘概念+创新药+仿制药一致性评价1、质子泵抑制剂（PPIs）是目前治疗消化性溃疡最先进的一类药物，它通过高效快速抑制胃酸分泌和清除幽门螺旋杆菌而达到快速治愈溃疡的目的。公司已通过一致性评价的PPI质子泵抑制剂为注射用兰索拉唑和注射用艾司奥美拉唑钠。2、根据2024年年报：公司注射用醋酸西曲瑞克属于 辅助生殖用药，目前已经申请生产批件，正在审评审批中 。3、公司生产的注射用更昔洛韦钠是一款经典的抗病毒药物，临床上主要用于治疗：巨细胞病毒感染、传染性单核细胞增多症、带状疱疹、水痘。（注：国泰君安研报表示：根据美国CDC，目前尚无针对猴痘的特效疗法，但可结合天花疫苗，以及西多福韦、Brincidofovir、特考韦瑞、痘苗免疫球蛋白等药物，将猴痘疫情控制住。）4、出资1亿(总额3亿),与东城投资、一村资本、控股股东曹于平等共同注资收购意大利NMS90%股权,标的是一家专注于抗肿瘤创新药的研发与生产的公司,拥有药物研发、临床前试验、临床试验和药品定制研发与生产服务;安徽成立海辰安徽作为创新药和高端制剂基地;在研品种包括利格列汀、托法替布、阿哌沙班等。5、2024年10月28日公告，公司伏格列波糖片通过仿制药一致性评价。(免责声明：分析内容来源于互联网，不构成投资建议，请投资者根据不同行情独立判断)资金分析今日主力净流入-553.92万，占比0.04%，行业排名108/158，连续2日被主力资金减仓；所属行业主力净流入-7.08亿，连续3日被主力资金减仓。区间今日近3日近5日近10日近20日主力净流入-553.92万-45.25万-1520.14万-3056.39万-1.18亿主力持仓主力没有控盘，筹码分布非常分散，主力成交额4658.69万，占总成交额的5.4%。技术面：筹码平均交易成本为44.16元该股筹码平均交易成本为44.16元，近期该股有吸筹现象，但吸筹力度不强；目前股价靠近支撑位42.50，注意支撑位处反弹，若跌破支撑位则可能会开启一波下跌行情。公司简介资料显示，南京海辰药业股份有限公司位于江苏省南京经济技术开发区恒发路1号，成立日期2003年1月15日，上市日期2017年1月12日，公司主营业务涉及化学制剂、原料药及中间体的研发、生产、销售。主营业务收入构成为：医药制造业95.10%，锂电材料行业4.12%，其他业务0.78%。海辰药业所属申万行业为：医药生物-化学制药-化学制剂。所属概念板块包括：熊去氧胆酸、仿制药、幽门螺杆概念、仿制药一致性评价、肿瘤治疗等。截至4月10日，海辰药业股东户数2.25万，较上期减少1.31%；人均流通股3648股，较上期增加1.33%。2026年1月-3月，海辰药业实现营业收入1.60亿元，同比增长12.40%；归母净利润1736.30万元，同比增长15.47%。分红方面，海辰药业A股上市后累计派现1.61亿元。近三年，累计派现1800.00万元。机构持仓方面，截止2026年3月31日，海辰药业十大流通股东中，香港中央结算有限公司位居第四大流通股东，持股90.51万股，相比上期增加36.97万股。景顺长城医疗健康混合A类（011876）位居第五大流通股东，持股50.00万股，为新进股东。中信建投低碳成长混合A（013851）、博时丝路主题股票A（001236）退出十大流通股东之列。声明：市场有风险，投资需谨慎。本文基于第三方数据库自动发布，不代表新浪财经观点，任何在本文出现的信息均只作为参考，不构成个人投资建议。如有出入请以实际公告为准。如有疑问，请联系biz@staff.sina.com.cn。

Two oral presentations at DDW 2026 built upon previously reported topline results from the TRIUMpH-EE Phase 3 trials for tegoprazan and covered both erosive esophagitis (EE) healing and maintenance. These presentations highlight tegoprazan's superiority to a PPI, lansoprazole, in healing all grades of EE at weeks 2 and 8, in maintenance of healing at 24 weeks, and in relieving heartburn symptoms in the most severe patients (LA Grade C/D) at weeks 8 and 24. BRAINTREE, Mass., May 5, 2026 /PRNewswire/ -- Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals and a leading manufacturer of gastroenterology pharmaceutical products, today announced that positive results from the Phase 3 TRIUMpH-EE clinical program evaluating tegoprazan were presented in two oral abstract sessions at DDW 2026. Tegoprazan is a novel, fast acting, potassium-competitive acid blocker (P‑CAB), with a self-regulating mechanism of action, developed for the healing and maintenance of healing of erosive esophagitis (EE) and for the relief of heartburn associated with non-erosive reflux disease (NERD). The TRIUMpH-EE program was conducted entirely in the United States and enrolled 1,245 adults with EE, including 463 patients with severe disease (Los Angeles (LA) Grade C/D), to evaluate tegoprazan versus the proton pump inhibitor (PPI) lansoprazole for both acute healing and 24‑week maintenance of healing. As previously reported, tegoprazan met all primary and secondary endpoints in the healing phase and demonstrated statistically superior healing at Weeks 2 and 8 across all LA grades and in patients with severe EE. Additionally, tegoprazan showed superior sustained healing over 24 weeks compared with lansoprazole in the maintenance phase across all LA grades of EE, with greater therapeutic differences observed in patients with severe EE (LA Grade C/D). Once-daily dose of 100 mg of tegoprazan was also effective in reducing 24-hour heart-burn free days and statistically superior in patients with severe EE (LA Grade C/D). "These oral presentations at DDW provided the GI community with the first in‑depth look at our Phase 3 erosive esophagitis data for tegoprazan," said Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals. "Across the TRIUMpH program, tegoprazan has demonstrated the potential to deliver faster and more complete healing, sustained maintenance of healing, and meaningful relief of heartburn and regurgitation in patients with GERD, including those with more severe disease who often remain symptomatic despite conventional PPI therapy. These positive results are directly related to the self-regulating mechanism of action of tegoprazan which differentiates it from other products on the market." DDW 2026 TRIUMpH-EE Oral Presentations Erosive Esophagitis Healing Presenter: Felice Schnoll-Sussman, MD (Weill Cornell Medicine) Session Title: Clinical Advances in GERD Session Date & Time: May 4, 2026, 8:00–9:30 AM CDT Presentation Title: TEGOPRAZAN 100MG DEMONSTRATES SUPERIOR AND FASTER HEALING OF EROSIVE ESOPHAGITIS AND HEARTBURN RELIEF VERSUS LANSOPRAZOLE: RESULTS FROM THE PHASE 3 TRIUMPH STUDY This presentation reported detailed results from the 8‑week healing phase of TRIUMpH-EE, a randomized, double-blind, multicenter study comparing tegoprazan 100 mg once daily with lansoprazole 30 mg once daily in adults with EE (LA Grades A–D). The primary endpoint was the proportion of patients with complete endoscopic healing at Week 8, evaluated for non-inferiority, with a prespecified hierarchical testing strategy for key secondary endpoints including Week 2 and Week 8 healing superiority and 24‑hour heartburn‑free days. Key results: Proportion of patients with complete healing at Week 8: tegoprazan [84.6%] vs lansoprazole [78.0%] (Δ=6.6%); non‑inferiority achieved and superiority achieved; (p=0.0083). Proportion of patients with complete healing at Week 2: tegoprazan [76.4%] vs lansoprazole [67.0%] (Δ=9.4%); superiority achieved (p<0.0001). Healing outcomes in patients with severe EE (LA Grade C/D) at Weeks 2 and 8: Week 2: tegoprazan [74.1%] vs lansoprazole [54.5%] (Δ=19.6%); superiority achieved (p<0.0001); Week 8: tegoprazan [83.2%] vs lansoprazole [68.0%] (Δ=15.2%); superiority achieved (p=0.0002). Percentage of 24‑hour heartburn‑free days through Week 8: tegoprazan [54.3%] vs lansoprazole [51.9%] (p<0.0001 for non-inferiority). In patients with severe EE (LA Grade C/D): tegoprazan [60.1%] vs lansoprazole [53.6%] (Δ=6.5%); superiority achieved (p=0.0289). Tegoprazan 100mg was shown to be safe for the healing of EE, with no differences in treatment emergent adverse events (TEAEs) or adverse events of special interest (AESIs) versus lansoprazole 30mg. Mean serum gastrin levels remained within normal limits throughout the study. Erosive Esophagitis Maintenance of Healing Presenter: C. Prakash Gyawali, MD (Washington University School of Medicine) Session Title: GERD Quickshots: What's New From Presentation to Management Session Date & Time: May 5, 2026, 8:00–9:30 AM CDT Presentation Title: TEGOPRAZAN PROVIDES SUPERIOR 24‑WEEK MAINTENANCE OF HEALING AND CONTROL OF HEARTBURN SYMPTOMS IN PATIENTS WITH EROSIVE ESOPHAGITIS: RESULTS FROM THE PHASE 3 TRIUMPH STUDY This presentation highlighted the 24‑week maintenance data from TRIUMpH-EE in patients who achieved complete endoscopic healing after up to 8 weeks of treatment and were re‑randomized to receive tegoprazan 100 mg, tegoprazan 50 mg, or lansoprazole 15 mg once daily. The primary endpoint was the proportion of patients with sustained complete healing at Week 24; secondary endpoints included 24‑hour heartburn‑free days and outcomes in patients with severe EE. All key secondary endpoints were tested in a prespecified hierarchical manner. Key results: Proportion of patients with sustained complete healing at Week 24 (all LA grades): tegoprazan 100 mg [69.4%], tegoprazan 50 mg [61.4%], lansoprazole 15 mg [50.6%] (Δs=18.8% & 10.8%, respectively) (non‑inferiority achieved; superiority achieved vs lansoprazole: 100 mg p<0.0001, 50 mg p=0.0145). Sustained healing at Week 24 in patients with LA Grade C/D: tegoprazan 100 mg [76.4%] vs lansoprazole 15 mg [44.3%] (Δ=32.1%); superiority achieved (p<0.0001); tegoprazan 50 mg [57.9%] (Δ=13.6%) (p=0.061 for superiority). Percentage of 24‑hour heartburn‑free days at 24 weeks for tegoprazan 100mg [72.9%] and 50mg [69.9%] versus lansoprazole [69.4%] (Δs=3.5% & 0.5%, respectively) (p<0.0001 for non-inferiority). In patients with severe EE (LA Grade C/D); tegoprazan 100mg [84.2%] vs lansoprazole [70.4%], superiority achieved (p=0.0018) (Δ=13.8%). Rates of TEAEs and AESIs were low for both doses of tegoprazan and comparable to lansoprazole with no dose effect. Mean serum gastrin levels remained within the normal range for the duration of treatment. About Digestive Disease Week® Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2 to May 5, 2026. Additional information can be found at ddw.org. About the TRIUMpH Program The TRIUMpH clinical program comprises two pivotal Phase 3 studies of tegoprazan in US patients with gastroesophageal reflux disease (GERD), including an erosive esophagitis (TRIUMpH-EE; NCT05587309) study and a non‑erosive reflux disease (TRIUMpH-NERD; NCT05587322) study. TRIUMpH-EE evaluated the healing and maintenance of healing of EE and the relief of heartburn, while TRIUMpH-NERD evaluated tegoprazan 50 mg and 100 mg vs placebo in patients with NERD. Sebela expects to submit data from TRIUMpH-NERD for presentation at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. Across the TRIUMpH program, individual treatment-emergent adverse events occurred at a rate of approximately 3% and were generally mild and transient, and serious events occurred at approximately 2% with similar rates between tegoprazan and active or placebo comparators. Mean serum gastrin levels for tegoprazan and lansoprazole remained within the normal range (0–180 pg/mL) throughout the treatment periods. About Tegoprazan Tegoprazan is a novel, fast acting, once-daily, oral potassium-competitive acid blocker (P‑CAB) with a self-regulating mechanism of action, in development in the United States for the treatment of adults with gastroesophageal reflux disease (GERD). P‑CABs provide rapid, reversible, potassium‑competitive inhibition of the gastric proton pump and have been shown to provide faster onset and sustained control of gastric acidity compared to proton pump inhibitors (PPIs). In Phase 1 pharmacodynamic studies, tegoprazan demonstrated rapid acid control, achieving an intragastric pH above 4 within 45 minutes of dosing. Tegoprazan has received marketing authorization in 23 countries worldwide and is marketed as K‑CAB® in several regions outside the United States, including South Korea. In January 2026, Sebela submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of tegoprazan for the treatment of heartburn associated with non‑erosive reflux disease (NERD), the healing of EE, and the maintenance of healing of EE in adults. US approval is anticipated in January 2027. About GERD and Erosive Esophagitis GERD is a chronic, highly prevalent gastrointestinal disorder affecting approximately 65 million people in the United States and characterized by symptoms such as heartburn and acid regurgitation.1 EE is a phenotype of GERD in which reflux of gastric contents leads to visible erosions in the esophageal mucosa, and patients with severe EE (LA Grade C/D) are at increased risk of complications and often require long‑term maintenance therapy. PPIs have been the mainstay of GERD therapy for decades, yet 35–54% of patients experience incomplete symptom relief, highlighting a significant unmet need.2,3 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. Tegoprazan is Braintree's lead program in GERD, and in 2025 Sebela Women's Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non‑hormonal intra‑uterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has 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: 1El-Serag HB, et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014. 2Chey WD, et al. Patient and physician satisfaction with proton pump inhibitors (PPIs): are there opportunities for improvement? Dig Dis Sci. 2010. 3Armstrong 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. Digestive Disease Week® and DDW® are registered trademarks of DDW, LLC. K-CAB® is a trademark of HK inno.N Corporation. SOURCE Sebela Pharmaceuticals 21% more press release views with Request a Demo