Tegoprazan

近日，罗欣药业集团股份有限公司（股票代码：002793.SZ，以下简称“罗欣药业”）下属子公司山东罗欣药业集团股份有限公司、罗欣药业（上海）有限公司已正式获得国家药品监督管理局下发的《药物临床试验批准通知书》，注射用LX22001新增适应症“预防重症患者应激性溃疡出血”获批开展临床试验。 图为：国家药品监督管理局药品审评中心公示 有望成为全球首个P-CAB注射剂型 注射用LX22001是钾离子竞争性酸阻滞剂类药物（P-CAB），目前在全球范围内尚无同类注射剂产品上市。其抑制酸分泌的作用机制为竞争性结合壁细胞内H+/K+-ATP酶（质子泵）的钾离子结合部位。与质子泵抑制剂（PPI）不同，P-CAB可直接抑制H+/K+-ATP酶，而无需在强酸环境下活化。而且，无论H+/K+-ATP酶活化与否，P-CAB均可与之结合[1]。 2024年6月，罗欣药业研发的注射用LX22001首次获批开展临床试验，适应症为：（1）本品可作为当口服疗法不适用时，用于下列病症的替代疗法：反流性食管炎、十二指肠溃疡；（2）消化性溃疡出血。此次“预防重症患者应激性溃疡出血”新增适应症获批开展临床试验，标志着这一新剂型将进一步拓展其临床应用范围，特别针对手术、住院等无法口服治疗的患者群体，将进一步满足抑酸治疗的临床需求。 中国抑酸市场体量巨大，整体抑酸剂市场规模可达200亿元以上，其中注射剂以55%份额主导市场。注射用LX22001全球范围内尚无同类注射剂产品上市，有望填补市场空白，为罗欣药业业绩大添增量。 不仅如此，罗欣药业此次布局P-CAB注射剂型，将进一步丰富公司消化管线，形成口服与注射剂型的协同效应，通过差异化优势进一步巩固在消化领域的市场地位，并抢占未来抑酸药物迭代升级的先机。 国家1类创新药泰欣赞®已全面进入收获期 2022年4月，罗欣药业消化疾病领域重磅产品、国家1类创新药泰欣赞®获批上市，用于治疗反流性食管炎（RE）；2023年11月，新适应症十二指肠溃疡（DU）获批上市；2024年10月，新适应症“与适当的抗生素联用以根除幽门螺杆菌（Hp）”获批上市。泰欣赞®是中国首款自研、首个获批三项适应症(Hp/RE/DU)的钾离子竞争性酸阻滞剂（P-CAB），也是山东省首个国家1类化学创新药，具有30分钟快速起效、强效持久抑酸、服用方便等特点，RE/DU两项适应症被纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》，为临床用药带来新选择。 为做好泰欣赞®商业化，罗欣药业自建创新直营模式，组建了一支400余人，由直营销售部、市场投资部、医学部、商务部及运营分析部等部门构成的完整的创新药商业化团队。通过消化领域核心创新产品泰欣赞®的商业化实践，积累了大量的临床、商业化经验，使罗欣药业在创新药产品商业化方面具有准入更快速、商业化成功率更高的优势，为后续获批上市的创新药产品快速、成功商业化，并降低综合运营成本奠定基础，从而进一步巩固并提升罗欣药业在创新药领域的综合竞争实力。 泰欣赞®自2022年上市后快速实现商业化覆盖，至今已准入全国2000余家医院，包括北京协和医院、解放军总医院、华西医院等头部医疗机构；与此同时，为了满足抑酸患者的购买便利需求，罗欣药业已在浙江地区率先试点零售药店销售，未来将逐步拓展至全国连锁渠道，进一步扩大市场增量。 罗欣药业创新之路，再迈坚实步伐 罗欣药业坚持科技创新，坚持“自主研发+合作研发”双轨并进，逐步打造了以消化、呼吸系统疾病和儿童用药为主线、兼顾抗肿瘤等多个治疗领域的创新产品研发管线，继续强化在消化和呼吸领域所具备的显著竞争优势，促进创新科研成果不断落地。 除泰欣赞®外，普卡那肽现已完成III期临床研究，达成主要疗效终点，有望成为国内首个治疗慢性特发性便秘的鸟苷酸环化酶激动剂。FMT肠道菌群移植领域，与国际领先的AI+BT微生态研发企业-深圳未知君达成战略合作，并签署《独家代理经销合作协议》。该技术可用于治疗多种菌群失调相关性疾病，应用安全，范围广泛，潜力巨大。2024年国家已设立该领域的重大专项，罗欣药业与深圳未知君正在积极推进全国FMT医院终端准入工作和科研合作，近期大型三甲医院将陆续开展招标工作，罗欣药业销售团队已完成投标策略部署，积极推动该技术规范化应用场景落地。 本次注射用LX22001新增适应症获批临床试验，标志着罗欣药业科技创新工作又迈出了坚实的一步，体现了罗欣药业在保持该领域的技术优势的基础上持续发力，彰显了公司科技创新能力，有助于丰富产品管线，提升公司核心竞争力。 未来，罗欣药业将持续秉持“传递健康”理念，深耕消化领域，进一步做强、做大优势产品，重点挖掘并解决上下消化道及消化腺肝胆胰相关疾病治疗中未被满足的、迫切的临床需求，持续推进高质量创新药品研发成果落地，为全球患者提供更多创新药物选择。 参考文献 [1]杨君,刘芳,臧雷.新型钾离子竞争性酸阻滞剂:替戈拉生[J].中国新药与临床杂志, 2022(041-005).DOI:10.14109/j.cnki.xyylc.2022.05.04.    关于罗欣药业    罗欣药业集团股份有限公司（简称“罗欣药业”，002793.SZ）始创于1988年，秉承“传递健康”的企业使命，以科技创新为己任，专注于消化、呼吸、抗肿瘤等疾病领域未满足的临床需求，致力于为患者提供更多创新药物选择。 罗欣药业已上市丰富且有竞争力的产品组合，核心产品处于消化、呼吸疾病用药市场领先地位。公司多个产品被列入“国家重点新产品计划”、“国家火炬计划”、“重大新药创制”等科技重大专项。公司自2006年开始连续进入中国制药工业百强企业，自2011年以来连续被评为中国医药研发产品线最佳工业企业，是国家重点高新技术企业、国家技术创新示范企业、全国工业质量标杆企业，多项产品科研成果获得国家科学技术进步二等奖。 更多信息，请访问www.luoxin.cn

ROSWELL, Ga., Feb. 25, 2025 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) granted approval of MIUDELLA ® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. MIUDELLA is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years. Continue Reading The U.S. Food and Drug Administration (FDA) granted approval of MIUDELLA® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years - the first hormone-free IUD to be approved in over 40 years. (Sebela Women's Health Inc.) "Sebela Women's Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States," said Kelly Culwell, MD, Head of Research and Development, Sebela Women's Health. "Our innovative copper IUD MIUDELLA ® offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer." Guidelines from the American College of Obstetrics and Gynecology state that long-acting reversible contraceptive (LARC) methods, including intrauterine devices and contraceptive implants, are the most effective contraceptive methods, have few contraindications, and are appropriate for almost all patients.1 While there are a variety of contraceptive methods available to women, 41.6 percent of pregnancies in the U.S. are unintended.2 MIUDELLA ® is a hormone-free IUD with a flexible frame made of nitinol, a material that has super-elastic properties that enables strategic placement of the copper in a manner that allows the device to achieve similar efficacy to the currently available copper IUD with less than half the dose of copper (175mm2). MIUDELLA ® uses the smallest hormone-free flexible IUD frame available in the United States, measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. Miudella does not require loading by a healthcare professional; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm.3 "Considering it has been four decades since we've been able to offer women a new hormone-free IUD option, I find the clinical data supporting MIUDELLA ® efficacy and safety to be very exciting," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options." About MIUDELLA ® MIUDELLA was investigated in three clinical trials in the U.S. in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter single-arm open-label study was conducted in 42 centers in the U.S. with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). In the efficacy cohort from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60) or 99% efficacy. Both clinicians and study participants also reported positive experiences with placement of Miudella, with an overall placement success rate of 98.8%. The most common adverse events across all three clinical trials were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea and intermenstrual bleeding. The incidence of these adverse events decreased over time. In the first year, 8.5% of participants across all three studies discontinued due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates were low ranging from 1.9% in year 1 to 0.9% in year 3. MIUDELLA ® will be available to patients through trained healthcare providers in the U.S. later in 2025. For more information on MIUDELLA, please visit miudella.com. IMPORTANT SAFETY INFORMATION Warning: Improper insertion of intrauterine systems, including MIUDELLA ®, increases the risk of complications. Proper training prior to first use of MIUDELLA ® can minimize the risk of improper insertion. MIUDELLA ® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA® REMS program to ensure all healthcare providers are trained on the proper insertion of MIUDELLA® prior to first use. Further information is available at miudellarems.com and 1-855-337-0772. Contraindications: Don't use MIUDELLA ® if you are or may be pregnant, have a uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement, acute pelvic inflammatory disease, postpartum endometritis or postabortal endometritis in past 3 months, known or suspected uterine or cervical malignancy, uterine bleeding of unknown etiology, untreated acute cervicitis or vaginitis or other lower genital tract infection, conditions associated with increased susceptibility to pelvic infections, Wilson's disease, a previously placed IUS that has not been removed and/or hypersensitivity to any component of Miudella including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any trace elements present in the copper components of Miudella ®. Do not use MIUDELLA ® for post-coital contraception (emergency contraception) Pregnancy with MIUDELLA ® is rare but can be life threatening and cause infertility or loss of pregnancy. MIUDELLA ® may attach to or go through the uterus and cause other problems. Tell your healthcare provider (HCP) if you develop severe pain or fever shortly after placement, miss a period, have abdominal pain, or if MIUDELLA ® comes out. If it comes out, use backup birth control. At first, periods may be altered and result in heavier and longer bleeding with spotting in between. Tell your HCP you have MIUDELLA ® before having an MRI or a medical procedure using heat therapy. Additional common side effects include painful periods, pelvic discomfort/pain, procedural pain, post procedural bleeding, and pain during sex. MIUDELLA ® does not protect against HIV or STDs. Only you and your HCP can decide if MIUDELLA ® is right for you. Available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA at or call 1-800-FDA-1088. For important risk and use information about Miudella, please see Full Prescribing Information. About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. In addition to the newly approved MIUDELLA, Sebela Women's Health has another next-generation hormonal IUD for contraception in late-stage clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. Please visit sebelapharma.com for more information or call 844-732-3521. MIUDELLA is a registered trademark of Sebela Women's Health Inc. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of 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, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; 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 future clinical trials discussed in this press release will be completed or successful 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 to be 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, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. Contact Sebela Women's Health Erinn White [email protected] 917-769-2785 References ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on April 18, 2023: and Centers for Disease Control and Prevention. Accessed on Feb. 18, 2025. Creinin MD, Gawron LM, Roe AH, et al.; Copper 175mm2 IUD Phase 3 Clinical Investigator Group. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2024 Nov 22:110771. doi: 10.1016/j.contraception.2024.110771. SOURCE Sebela Pharmaceuticals Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED