A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Linaprazan Glurate Compared to Lansoprazole in Maintenance of Healing in Participants With Healed Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

The goal of this clinical trial is to investigate how well linaprazan glurate can maintain healed erosive esophagitis (EE) caused by GERD in participants who have participated in a prior healing trial, compared to lansoprazole (an approved treatment for GERD). Researchers will also examine:
* the effect of linaprazan glurate on heartburn symptoms compared to lansoprazole.
* whether linaprazan glurate treatment is safe and tolerable, based on symptoms and procedures such as blood and urine tests, endoscopy, and electrocardiograms (measure the heart's electrical activity). Endoscopy means that the doctor will insert a thin, flexible tube with a camera down the throat to look at each participant's esophagus area and collect small tissue samples (called biopsies).
* the side effects that may happen during treatment with linaprazan glurate.
Participants must be between 18 to 80 years old and have participated in a prior healing trial with healed EE (due to GERD) confirmed by an endoscopy either from the prior healing trial or from the initial period of this trial. Participants cannot participate if they are not healed, had to stop trial treatment because of a side effect in a prior healing trial, or if they have a condition that could make it unsafe.
The study is a randomized, double-blind, active comparator-controlled clinical trial lasting for almost 14 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups:
* Linaprazan glurate - High dose
* Linaparazan glurate - Low dose, and
* Lansoprazole - marketed approved dose Everyone will take a total of 2 tablets and 1 capsule orally every day for up to 52 weeks. The tablets and capsule will be separated into a morning dose and an evening dose. Some tablets or capsules will be placebos (look like medicine but contain no active drug).
Participants will complete several questionnaires on an electronic device during treatment. An endoscopy will be performed after 24 weeks of treatment to determine if healing has been maintained. If healing has been maintained, the participant will continue taking trial treatment and another endoscopy will be performed at 52 weeks. If healing has not been maintained at 24 weeks or if the participant has reached 52 weeks, the participant will stop taking trial treatment and return for a follow up visit.

开始日期2026-03-01

申办/合作机构

Cinclus Pharma Holding AB

CTR20254718

/ Recruiting临床3期

多中心、随机、双盲双模拟、阳性药平行对照的Ⅲ期临床研究评价X842胶囊用于十二指肠溃疡患者的有效性和安全性

主要目的：评价X842胶囊每日1次50mg连续给药4到6周对十二指肠溃疡的内镜下溃疡愈合的有效性，以验证X842胶囊在6周内的内镜下溃疡愈合受试者比例非劣效于兰索拉唑肠溶胶囊；次要目的：与兰索拉唑肠溶胶囊相比，评价X842胶囊改善十二指肠溃疡受试者的临床症状（上腹疼痛、胃烧灼感、反酸、恶心、呕吐、嗳气和腹胀）的有效性；与兰索拉唑肠溶胶囊相比，评价X842胶囊治疗十二指肠溃疡的安全性；观察X842胶囊用于十二指肠溃疡患者后血清胃泌素的治疗前后变化情况。

开始日期2025-12-17

申办/合作机构

上海生诺医药科技有限公司

[+1]

CTIS2024-518194-34-00

/ Completed临床1期

An open, single arm, single-center, Phase 1 trial investigating the effect of 7-days-repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants

开始日期2025-11-11

申办/合作机构

Cinclus Pharma Holding AB

100 项与戊二酸利那拉生酯相关的临床结果

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100 项与戊二酸利那拉生酯相关的转化医学

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100 项与戊二酸利那拉生酯相关的专利（医药）

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项与戊二酸利那拉生酯相关的文献（医药）

2025-05-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial: Dose‐Finding Study of Linaprazan Glurate, A Novel Potassium‐Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis

Article

作者: Unge, Peter ; Andersson, Kjell ; Popadiyn, Ivan ; Yektaei, Elham ; Rosenholm, Maria ; Vaezi, Michael ; Sharma, Prateek ; Larsson, Kajsa ; Armstrong, David ; Rosztóczy, Andras

ABSTRACT:

Background:

Linaprazan glurate, a potassium‐competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid‐related diseases.

Aim:

To evaluate the 4‐week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis.

Methods:

This double‐blind, dose‐finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open‐label lansoprazole.

Results:

Of 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4‐week healing rate of 71.1% in intention‐to‐treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D.

Conclusions:

Linaprazan glurate demonstrated high 4‐week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

Trial Registration:

ClinicalTrials.gov: NCT05055128; EudraCT: 2020‐003319‐91

2024-11-01·Current gastroenterology reports

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments

Review

作者: Scarpignato, Carmelo ; Hunt, Richard H

Abstract:

Purpose of the Review:

Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice.

Recent Findings:

Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs.

Summary:

Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

2024-05-01·Journal of pharmaceutical and biomedical analysis

Absorption, distribution, metabolism and excretion of linaprazan glurate in rats

Article

作者: Jin Xiu ; Ying Yang ; Donghui Liu ; Ming Lu ; Chen Yang ; Xingxing Diao ; Xinyue Zhang ; Yali Yuan ; Yuandong Zheng ; Pingsheng Hu

Linaprazan (AZD0865, TX07) is one of potassium-competitive acid blockers. However, linaprazan is rapidly excreted from the body, shortening its acid inhibition property. Linaprazan glurate (X842) is a prodrug of linaprazan with a prolonged inhibitory effect on gastric acid secretion. Linaprazan glurate has entered clinical trials, but few studies have reported its metabolism in non-clinical and clinical settings. In this study, we studied the pharmacokinetics, tissue distribution, mass balance, and metabolism of linaprazan glurate in rats after a single oral dose of 2.4 mg/kg (100 µCi/kg) [¹⁴C]linaprazan glurate. The results demonstrated that linaprazan glurate was mainly excreted via feces in rats with 70.48% of the dose over 168 h. The plasma AUC₀_-_∞ of linaprazan glurate in female rats was 2 times higher than that in male rats. Drug-related substances were mainly concentrated in the stomach, eyes, liver, small intestine, and large intestine after administration. In blood, drug-related substances were mostly distributed into plasma instead of hemocytes. In total, 13 metabolites were detected in rat plasma, urine, feces, and bile. M150 (2,6-dimethylbenzoic acid) was the predominant metabolite in plasma, accounting for 80.65% and 67.65% of AUC_0-24_h in male and female rats, respectively. Based on the structures, linaprazan glurate was mainly hydrolyzed into linaprazan, followed by a series of oxidation, dehydrogenation, and glucuronidation in rats. Besides, CES2 is the main metabolic enzyme involved in the hydrolysis of linaprazan glurate to linaprazan.

项与戊二酸利那拉生酯相关的新闻（医药）

2026-02-18

·cincluspharma.com

Year-end report – Advancing toward Phase III readout

“The past year was marked by significant progress for Cinclus Pharma. Our first Phase III study has had a promising start, and we expect to present topline results during the second half of the year. The strategic licensing agreement with Zentiva provides a strong platform for successful commercialization in Europe and lays a solid foundation for expansion into other markets. Following the inclusion of linaprazan glurate on China’s national reimbursement list, our Chinese partner plans to launch the product on the market in 2026. With superior acid control compared to existing treatment options, linaprazan glurate has the potential to meet the substantial medical need among patients suffering from the more severe forms of erosive GERD, which we aim to confirm in the ongoing Phase III study”, says Christer Ahlberg CEO of Cinclus Pharma. “The past year was marked by significant progress for Cinclus Pharma. Our first Phase III study has had a promising start, and we expect to present topline results during the second half of the year. The strategic licensing agreement with Zentiva provides a strong platform for successful commercialization in Europe and lays a solid foundation for expansion into other markets. Following the inclusion of linaprazan glurate on China’s national reimbursement list, our Chinese partner plans to launch the product on the market in 2026. With superior acid control compared to existing treatment options, linaprazan glurate has the potential to meet the substantial medical need among patients suffering from the more severe forms of erosive GERD, which we aim to confirm in the ongoing Phase III study”, says Christer Ahlberg CEO of Cinclus Pharma. Financial summary, October-December 2025 » Net sales amounted to TSEK 13,632 (4,580). » Operating income/loss (EBIT) amounted to TSEK -62,011 (-56,889). » Net income/loss for the period was TSEK -61,184 (-54,259) and earnings/loss per share before and after dilution were SEK -1.31 (-1.17). » Total cash flow for the period amounted to TSEK -50,814 (-79,197). » Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716). Financial summary, January-December 2025 » Net sales amounted to TSEK 57,470 (4,580). » Operating income/loss (EBIT) amounted to TSEK -199,558 (-169,639). » Net income/loss for the period was TSEK -183,972 (-168,031) and earnings/loss per share before and after dilution were SEK -3.95 (-4.54). » Total cash flow for the period amounted to TSEK -77,836 (476,833). » Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716). Significant events during the period October-December 2025 Financial summary, October-December 2025 Financial summary, January-December 2025 Significant events during the period October-December 2025 » In early October, it was announced that the first patient had been dosed in the company’s Phase III study, HEEALING 1, which aims to confirm the efficacy of linaprazan glurate in patients with erosive gastroesophageal reflux disease. » In the beginning of October Cinclus Pharma presented an abstract on linaprazan glurate at the United European Gastroenterology Week (UEGW) in Berlin. The abstract highlights positive data on the optimized tablet formulation developed for Phase III studies and future commercialization. » In October Cinclus Pharma received positive feedback from a recent Chemistry, Manufacturing and Controls (CMC) meeting with the FDA. During the meeting, the FDA provided clear guidance and alignment with the company’s proposed CMC strategy preparation for the upcoming new drug application (NDA) submission. » Cinclus Pharma announced in November that it had sponsored a scientific abstract highlighting the clinical and economic costs of PPI treatment failures in patients with severe erosive GERD. The abstract was presented at the ISPOR Europe 2025 conference in Glasgow. » Cinclus Pharma hosted a virtual event to share insights on clinical practice for erosive Gastroesophageal Reflux Disease (GERD) patients in December. The event featured Professor Prateek Sharma from the Cancer Center in Kansas City who provided insights on the current treatment landscape and the unmet medical need among patients with erosive GERD, as well as the potential of Cinclus Pharma’s drug candidate linaprazan glurate. » Cinclus Pharma has recruited Magnus Christensen as CFO. He will assume his new role in the spring of 2026. » Linaprazan glurate earns China’s National Reimbursement Listing for the treatment of erosive GERD. This enables broad patient access, and the product is now expected to be launched on the Chinese market in 2026. Significant events after the end of the period Significant events after the end of the period » At an Extraordinary General Meeting on 19 January, Kjell Andersson was elected as a new board member after Peter Unge had announced his wish to step down from his position on the company’s board. » In January, Cinclus Pharma announced that the European Medicines Agency (EMA) has provided positive feedback following scientific advice regarding Chemistry, Manufacturing and Controls (CMC) for linaprazan glurate. » In February, FDA provided a positive assessment of Cinclus Pharma’s nonclincial development plan for linaprazan glurate following a scientific advice meeting. Presentation of the interim report A webcast will be held on February 18, 2026, at 10:00 CET via Inderes. If you wish to participate via webcast please use the link below. Via the webcast you are able to ask written questions. https://cinclus-pharma.events.inderes.com/q4-report-2025 If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. https://events.inderes.com/cinclus-pharma/q4-report-2025/dial-in Presentation of the interim report For additional information, please contact: For additional information, please contact: Christer Ahlberg, CEO Phone: +46 70 675 33 30 e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IR Phone: +46 70 952 80 06 e-mail: henrik.vikström@cincluspharma.com About Cinclus Pharma About Cinclus Pharma Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com. Attachments Attachments Year End Report 2025

临床3期引进/卖出临床2期高管变更财报

2026-02-05

·医药代表

上海医药拟10.23亿元转让中美施贵宝30%股权

01 上海医药拟10.23亿元转让中美施贵宝30%股权 2月4日晚间，上海医药（601607.SH）发布公告称，公司拟通过产权交易所以公开挂牌方式转让所持参股子公司中美上海施贵宝制药有限公司30%股权，挂牌转让价格不低于10.23亿元，且需完成相关国有评估管理程序，最终转让价格以公开挂牌成交结果为准。这起转让，之所以引人关注，在于中美上海施贵宝制药有限公司在中国医药发展史上有着特殊的地位，它是中国改革开放后首家中美合资制药企业，最早成立于1982年。从股权结构来看，本次交易前，中美施贵宝的股权由三方持有，其中百时美施贵宝（中国）投资有限公司（以下简称“百时美施贵宝”）持股60%、上海医药持股30%、国药集团资产管理有限公司持股10%。上海医药持有的该部分股权权属清晰，不存在抵押、质押及其他任何限制转让的情况，不涉及诉讼、仲裁事项或查封、冻结等司法措施，不存在妨碍权属转移的其他情形。截至目前，中美施贵宝处于正常运营状态。若本次交易顺利完成，上海医药将不再持有中美施贵宝的股权。上海医药表示，该交易对公司正常经营和财务状况不构成重大影响，有利于维护国有资产权益、实现资产价值最大化，符合公司和全体股东的利益。本次交易不涉及人员安置、土地租赁等情况，不会导致产生同业竞争，也不会导致公司控股股东、实际控制人及其关联人对公司形成非经营性资金占用。 02 从年入47亿的标杆到边缘化事实上，上海医药此次转让股权定价，与此前百时美施贵宝的股权处置计划密切相关。公告显示，百时美施贵宝此前计划对外出售其持有的中美施贵宝60%股权，经多轮竞标与谈判，潜在收购方于2025年6月提交了确认性报价，拟以4.8亿美元等值人民币收购中美施贵宝100%的股权。其中，上海医药所持30%股权对应的价格为1.44亿美元。当时，据媒体报道，百时美施贵宝在相关邮件中表示，此次资产剥离计划体现了公司不断演进的网络战略，有助于百时美施贵宝将内部资源聚焦于最具增长潜力的核心领域，同时借助具备本地化制造与市场经验的外部合作伙伴，进一步优化业务布局。作为最早进入中国市场的合资药企之一，中美施贵宝曾拥有辉煌的过去。据公开资料，中美上海施贵宝涵盖心血管、代谢、抗生素等处方药及解热镇痛、多元维生素等非处方药。旗下多款产品广为大众熟知，包括降压药卡托普利片（开博通）、降糖药盐酸二甲双胍片（格华止，由其负责生产销售），以及抗乙肝病毒药物恩替卡韦片（博路定）等；非处方药方面，有百服咛、施尔康等经典产品。 2016年，中美施贵宝营业收入、净利润分别达47.24亿元、6.22亿元，均达到历史高点，但随后业绩开始走下坡路。中美施贵宝业绩滑坡背后，集采政策的深化以及市场竞争的加剧是关键因素。2020年，在第三批全国药品集采中，中美施贵宝的核心产品卡托普利、二甲双胍均未能中标，此后市场份额被价格显著降低的仿制药逐步蚕食。再加上该合资公司在定位上以上市多年的成熟产品为主，缺乏“新鲜血液”的引入也令其在激烈的市场竞争中败下阵来。因此，近年来，从百时美施贵宝自身经营表现看，在集采政策持续深化和激烈的市场竞争下，中美施贵宝业绩并非可观。最新公告显示，2025年前三季度，中美施贵宝净利润仅为8711.89万元，2024年全年净利润为2.48亿元。同样，国内视角，中美施贵宝旗下成熟药品受集采影响，过专利期原研药价格降幅普遍接近一半，未中选药品价格也下降10%～40%，利润空间被大幅压缩；全球层面，BMS面临显著专利悬崖风险，2025年预计64%的收入受专利损失和仿制药冲击，成熟产品竞争力持续弱化。在多重因素叠加影响下，这家曾经的合资标杆企业，逐步从“明星药企”走向边缘化，也为此次股东相继选择退出埋下伏笔。 03 上海医药聚焦创新的战略布局百时美施贵宝并非近年来唯一一家在华优化资产布局的跨国药企。 2024年8月，另外一家跨国药企优时比宣布，向康桥资本与穆巴达拉投资公司以6.8亿美元（约合49.26亿元人民币）出售公司在中国的成熟产品业务（涉及神经系统和抗过敏），包括开浦兰、维派特、优普洛、仙特明、优泽五大产品及位于珠海的生产基地。事实上，自2019年以来，礼来、葛兰素史克、武田、辉瑞等跨国药企也进行过一些资产剥离行动，而这些资产有一定的共同性，皆以成熟产品为主。面对中国市场变化，上海医药近年来增收不增利情况比较明显，正在优化结构。2025年10月，上实集团进行股权调整，持有的上海医药股份从23.303%增至38.487%，第一大股东持股比例集中，增强了股权结构的稳定性，提升了整体运营效率。上海医药的第二大股东为云南白药，持股比例为17.95%。股权重组后，上海医药的战略布局也逐步清晰，该公司开始发力创新药领域。截至2025年年中，新药管线共计56个，其中创新药管线44个，其自主研发的I001片（SPH3127）针对高血压适应证的上市申请（NDA）已获国家药监局受理。公司另一重点在研药物CD20抗体药物B007（皮下注射液）在重症肌无力和天疱疮适应证的Ⅱ期临床试验中已完成全部受试者入组，为后续Ⅲ期研究奠定了基础。此外，上海医药还在“理性止损”。2025年12月初，上海医药全资子公司上药信谊已正式终止与贵州生诺及其关联方关于新型抑酸剂X842项目的合作协议。12月5日，上药信谊已收到对方返还的1.1亿元首付款及开发注册里程碑费用。X842项目是一款针对反流性食管炎适应证的药物。2021年双方合作签署时，X842已进入国内Ⅲ期临床研究阶段，此后于2024年12月正式获批上市。然而，X842项目面临的市场环境已发生变化。比如，当前抑酸剂市场竞争激烈，传统质子泵抑制剂（PPI）药物已有多款成熟产品占据市场，而新型抑酸剂的研发进展和市场接受度可能未达预期。对于上海医药而言，继续投入后续商业化所需的数亿元市场费用，获得预期回报或存在较大不确定性。来源 | 中经传媒智库综合自界面新闻

2026-01-29

·药明生物

药明生物与生诺医药达成战略合作加速创新双抗开发和生产

Swipe Left For English News 上海， 2026年1月29日全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）与生诺医药今日共同宣布，双方就创新双特异性抗体SND006的工艺开发和生产达成战略合作。SND006拟用于治疗炎症性肠病（IBD）等自身免疫性疾病。药明生物首席执行官陈智胜博士（右）与生诺医药董事长兼总经理胡平生博士（左）签署战略合作协议根据双方签署的协议，生诺医药将借助药明生物在生物药开发和生产领域积累的丰富经验和规模化生产能力，推进SND006的临床前药学研究和临床样品制备，加速临床申报进程。SND006系生诺医药自主研发、享有全球权益的双特异性抗体，目前已完成体外功能验证研究。生诺医药计划于2026年向中国国家药品监督管理局（NMPA）和美国食品药品监督管理局（FDA）提交新药临床试验申请（IND）。未来，双方还将围绕生诺医药潜在管线展开深入合作，覆盖从分子发现到临床生产的多个一体化项目。陈智胜博士首席执行官药明生物双抗药物是公司增长最快的细分领域之一，过去十年我们已积累数百个项目的经验。我们很高兴通过一体化生物制药能力和技术平台，加速生诺医药创新双抗SND006的开发和生产进程。展望未来，我们也将持续践行加快和变革生物药发现、开发和生产进程的使命，赋能全球合作伙伴，让更多患者用得到、用得起创新生物药。胡平生博士董事长兼总经理生诺医药 SND006是生诺医药自主研发、具有Best-in-Class潜力的创新双抗，有望在胃肠道疾病以及多种自身免疫性疾病治疗中取得突破。药明生物是全球领先的CRDMO，能够全方位和端到端赋能于项目的发展，特别是在双抗领域里具有丰富的研发经验，完备的技术平台以及多个成功的案例。我们相信双方的合作，将加速公司创新生物药在中国和国际的临床申报进程，解决自免领域未满足的临床需求，为患者提供安全有效的创新疗法。关于药明生物药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。药明生物在中国、美国、爱尔兰、德国、新加坡和卡塔尔拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2025年12月底，药明生物帮助客户研发和生产的综合项目高达945个，其中包括74个临床III期项目，25个商业化生产项目。药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。更多信息，请访问：www.wuxibiologics.com。关于生诺医药贵州生诺生物科技有限公司成立于2010年，是一家商业化阶段的生物医药创新公司。公司聚焦于消化道疾病、肿瘤免疫和自免疾病创新药物研发及产业化，拥有生物创新药技术平台、临床医学研发平台以及经验丰富的国际化研发团队，具有中国、欧美等多国创新药申报的成功经验。公司的SND001项目，1.1类新药利那拉生酯（X842），治疗胃酸相关疾病，已成功获批上市并纳入2025年国家医保目录，实现商业化和产业化，同时已经在欧美进入临床III期研究。SND002项目前哨淋巴结T细胞注射液，治疗消化道和多种实体瘤，已提交中国IND申报。公司自免疾病IBD管线双特异抗体（SND006）及多种体内CAR-T产品也在迅速开发。通过与国内外制药企业和研发机构的广泛合作，致力于成为可持续发展的国际化创新药企业。更多信息，请访问：www.sinorda.com。业务垂询 info@wuxibiologics.com 媒体关系 PR@wuxibiologics.com WuXi Biologics and Sinorda Biomedicine Enter Strategic Collaboration to Accelerate Development and Manufacturing of Innovative Bispecific Antibody Shanghai, January 29, 2026 WuXi Biologics (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), and Sinorda Biomedicine today jointly announced a strategic collaboration for the development and manufacturing of SND006, a novel bispecific antibody, for the potential treatment of inflammatory bowel disease (IBD) and other autoimmune diseases. Under the agreement, Sinorda Biomedicine will leverage WuXi Biologics' extensive experience and manufacturing capabilities in biologics development and manufacturing to advance SND006's preclinical pharmacology studies and clinical supply, accelerating the Investigational New Drug (IND) application process. SND006 is an innovative bispecific antibody independently developed by Sinorda Biomedicine, for which the company holds worldwide rights. Sinorda Biomedicine has completed in vitro functional validation studies of SND006 and plans to submit IND applications to both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) in 2026. In the future, the two companies will further expand their collaboration around Sinorda Biomedicine's potential pipeline, including multiple integrated projects spanning from molecule discovery to clinical manufacturing. Dr. Chris Chen CEO WuXi Biologics Over the past decade, we have accumulated experience across hundreds of projects in bispecific and multispecific antibodies, which have become one of our fastest‑growing areas. We are pleased to accelerate the development and manufacturing of Sinorda Biomedicine's innovative bispecific antibody SND006 through our integrated technology platforms and comprehensive capabilities. Looking ahead, we will continue accelerating and transforming biologics discovery, development and manufacturing to empower global partners and make innovative biologics more accessible and affordable for patients worldwide. Dr. Pingsheng Hu Chairman General Manager Sinorda Biomedicine SND006 is a potentially best‑in‑class innovative bispecific antibody discovered and developed by Sinorda Biomedicine, with the potential to deliver breakthroughs in the treatment of gastrointestinal and multiple autoimmune diseases. WuXi Biologics is a global leader in CRDMO services, offering truly end‑to‑end solutions underpinned by accumulated know-how, comprehensive technology platforms, and a strong track record—particularly in the development and manufacturing of bispecific antibodies. We believe this collaboration will accelerate the IND filings of our innovative biologics in China and worldwide, address unmet medical needs in autoimmune diseases, and ultimately bring safe and effective therapies to patients. About WuXi Biologics WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany, Singapore and Qatar, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing. WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com About Sinorda Biomedicine Sinorda Biomedicine was established in 2010 and is a biomedical innovation company in the commercialization stage. The company focuses on the research and development and industrialization of innovative drugs for digestive tract diseases, tumor immunity and autoimmune diseases. It has a bioinnovative drug technology platform, a clinical medical R & D platform and an experienced international R & D team, with successful experience in innovative drug applications in China, Europe, America and other countries. Linaprazan glureta (X842), the company's self-developed class 1.1 new drug for treatment of gastric acid-related diseases, has been successfully approved for commercialization and industrialization. The sentinel lymph node T cell project for solid tumor treatment has clinical IIT research results for various tumors. In addition, the company has a number of early-stage product pipelines, including bispecific antibodies for the treatment of autoimmune disease IBD. The company has developed rapidly through extensive cooperation with domestic and foreign pharmaceutical companies and R & D institutions, and is committed to becoming the most valuable innovative pharmaceutical enterprise in China. Business info@wuxibiologics.com Media PR@wuxibiologics.com 注：本信息不构成药明生物的信息披露或投资建议请点击右下角【爱心】，并将公众号设为【星标】，第一时间接收药明生物最新动态

100 项与戊二酸利那拉生酯相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
反流性食管炎	中国	上海生诺医药科技有限公司	2024-12-01

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
食管炎	临床3期	-	Cinclus Pharma Holding AB	2026-03-01
幽门螺杆菌感染	临床3期	中国	上海合全医药有限公司	2026-01-21
幽门螺杆菌感染	临床3期	中国	上海生诺医药科技有限公司	2026-01-21
十二指肠溃疡	临床3期	中国	上海生诺医药科技有限公司	2025-12-17
糜烂性食管炎	临床3期	美国	Cinclus Pharma Holding AB	2025-10-03
糜烂性食管炎	临床3期	保加利亚	Cinclus Pharma Holding AB	2025-10-03
糜烂性食管炎	临床3期	捷克	Cinclus Pharma Holding AB	2025-10-03
糜烂性食管炎	临床3期	德国	Cinclus Pharma Holding AB	2025-10-03
糜烂性食管炎	临床3期	匈牙利	Cinclus Pharma Holding AB	2025-10-03
糜烂性食管炎	临床3期	波兰	Cinclus Pharma Holding AB	2025-10-03

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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


NCT05742984 (CTgov)	临床1期	胃食管反流	75	Linaprazan Glurate (25 mg Linaprazan Glurate QD)	艱醖鏇憲壓構醖積糧鹽(積構蓋範築鹽餘觸艱醖) = 憲壓齋獵淵膚窪齋襯衊鑰憲遞簾襯獵製鏇鑰壓 (簾醖艱餘願繭觸蓋壓醖, 1650.6) 更多	-	2025-05-07
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	艱醖鏇憲壓構醖積糧鹽(積構蓋範築鹽餘觸艱醖) = 簾壓積鏇齋糧繭淵夢壓鑰憲遞簾襯獵製鏇鑰壓 (簾醖艱餘願繭觸蓋壓醖, 2281.0) 更多
NCT05055128 (Pubmed \| Aliment Pharmacol Ther) 人工标引	临床2期	糜烂性食管炎	248	Linaprazan Glurate	簾餘夢鬱夢築蓋廠膚鬱(繭壓鑰築願構構繭餘願) = 衊餘遞膚遞鑰艱遞鹹壓壓襯膚鏇齋膚鏇齋鹹遞 (蓋簾範廠選觸襯衊遞壓 ) 更多	积极	2025-04-04
				Lansoprazole	簾餘夢鬱夢築蓋廠膚鬱(繭壓鑰築願構構繭餘願) = 網觸淵艱範廠網鏇製願壓襯膚鏇齋膚鏇齋鹹遞 (蓋簾範廠選觸襯衊遞壓 ) 更多
NCT05627518 (BA, CTgov)	临床1期	-	67	Linaprazan glurate (Reference Formulation (Treatment A))	醖夢窪積鹽襯淵膚淵繭(選襯襯顧範窪觸鑰顧憲) = 積廠製淵壓鹹艱糧夢範獵壓積膚構壓製願鬱膚 (襯遞選艱製憲網構範築, 1.51) 更多	-	2025-04-03
				Linaprazan glurate (Test Formulation (Treatment B))	醖夢窪積鹽襯淵膚淵繭(選襯襯顧範窪觸鑰顧憲) = 選憲積鹽鹹鬱蓋獵壓選獵壓積膚構壓製願鬱膚 (襯遞選艱製憲網構範築, 1.32) 更多
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	临床2期	糜烂性食管炎	90	X842 50 mg	膚觸膚遞憲範鬱鹹襯簾(壓醖鏇鬱衊廠艱蓋積壓) = The incidence of drug-related treatment-emergent adverse events did not differ among groups 餘構艱壓範選衊願構範 (醖範衊鏇願選憲夢淵願 ) 更多	积极	2025-04-01
				X842 100 mg
NCT05633147 (CTgov)	临床1期	药物相互作用	35	Linaprazan glurate+Clarithromycin (Part I)	襯鏇鹹襯網獵獵鑰膚網(鏇遞選壓醖淵窪築願壓) = 鹹顧鏇齋窪鹹憲膚憲鑰艱積艱選選構製鹽鹹糧 (糧壓膚製觸襯繭鑰製築, 5649) 更多	-	2025-01-03
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	蓋鹽壓鏇齋餘簾蓋繭鏇(願膚襯艱蓋淵襯醖醖齋) = 選積鬱簾築簾齋膚願顧製範醖觸膚鏇艱糧範鹹 (膚積獵膚鹽艱醖膚衊選, 13.98) 更多
NCT05055128 (CTgov)	临床2期	糜烂性食管炎 \| 胃食管反流	248	Lansoprazole+X842 Dummy (X842 25 mg BID)	蓋夢壓鑰鑰鏇鏇遞選顧 = 憲衊壓窪醖構醖鹹膚窪鹹範鑰齋餘衊膚齋鹽膚 (淵觸網繭廠鬱淵膚簾醖, 憲網鏇醖積醖鑰鏇衊網 ~ 衊夢廠獵選糧餘醖願憲) 更多	-	2023-11-01
				Lansoprazole+X842 Dummy (X842 50 mg BID)	蓋夢壓鑰鑰鏇鏇遞選顧 = 艱衊範選艱憲艱餘積網鹹範鑰齋餘衊膚齋鹽膚 (淵觸網繭廠鬱淵膚簾醖, 網糧積艱選齋鬱鹹願襯 ~ 簾獵醖膚鑰衊積醖夢網) 更多
UEGW2023	N/A	-	-	Linaprazan glurate 25 mg BID	築夢衊醖鹽醖構鏇齋積(齋齋繭築獵鹹鑰願壓糧) = 鑰齋艱艱窪網選製餘壓願衊夢鬱憲糧鑰鬱築繭 (襯夢顧醖鑰蓋齋醖築築, 59.7 ~ 84.7)	-	2023-10-15
				Linaprazan glurate 50 mg BID	築夢衊醖鹽醖構鏇齋積(齋齋繭築獵鹹鑰願壓糧) = 壓製顧餘選選築網積築願衊夢鬱憲糧鑰鬱築繭 (襯夢顧醖鑰蓋齋醖築築, 73.8 ~ 91.1)