The new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) is valid through 2035 and adds to opaganib's strong global intellectual property portfolio across multiple indications

opaganib作为抑制单链RNA病毒复制（特别是埃博拉病毒）的疗法的新中国专利有效期至2035年，并增加了opaganib在多个适应症中强大的全球知识产权组合

--

--

U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability.

U、 美国陆军的研究表明，opaganib可能是第一个在埃博拉病毒疾病体内显示活性的宿主定向分子，在统计学上显着提高了存活率；另外，当与remdesivir（Veklury®；Gilead Sciences，Inc.）联合使用时，opaganib在体外表现出强大的协同作用，在维持细胞活力的同时改善病毒抑制。

--

--

A host-directed and potentially broad acting twice-daily oral, small molecule, opaganib is in development for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure.

opaganib是一种以宿主为导向且可能广泛作用的口服小分子药物，目前正在开发多种适应症，包括新型冠状病毒肺炎、急性呼吸窘迫综合征、肿瘤学和两项美国政府赞助的急性辐射综合征和硫芥暴露对策计划。

It has a demonstrated safety and efficacy profile, and is well-suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute.

它具有公认的安全性和有效性，非常适合对抗核/化学暴露和病毒大流行情况，具有病毒突变抗性，易于管理和分发。

TEL-AVIV, Israel and RALEIGH, N.C., May 6, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent Notice of Allowance covering opaganib[1] as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035 (Chinese Patent Application No.: 202110229970.9 issued April 29, 2024)..

以色列特拉维夫和北卡罗来纳州罗利，2024年5月6日/PRNewswire/--专业生物制药公司RedHill Biopharma Ltd.（纳斯达克：RDHL）（“RedHill”或“公司”）今天宣布，中国国家知识产权局（CNIPA）发布了一项新的中国专利许可通知，该通知涵盖了opaganib[1]作为抑制单链RNA病毒复制（特别是埃博拉病毒）的治疗药物，有效期至2035年（中国专利申请号：202110229970.9，2024年4月29日发布）。。

'This new patent adds to the existing intellectual property portfolio protecting opaganib across multiple indications and represents the first China patent in the Ebola patent family,' said Guy Goldberg, RedHill's Chief Business Officer. 'U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival.

雷德希尔首席商务官盖伊·戈德伯格（GuyGoldberg）说，这项新专利增加了现有的知识产权组合，可以跨多种适应症保护奥帕加尼，是埃博拉病毒专利家族中的第一项中国专利U、 美国陆军的研究表明，opaganib可能是第一个在体内显示埃博拉病毒疾病活性的宿主导向分子，可显着提高生存率。

Targeting multiple indications, including selection by two U.S. government countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure, oral opaganib, has a demonstrated safety and efficacy profile and is well-suited to viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute.'.

针对多种适应症，包括两个美国政府针对急性辐射综合征和硫芥暴露的应对措施计划的选择，口服奥帕加尼具有明显的安全性和有效性，非常适合病毒大流行情况，具有病毒突变抗性，易于管理和分发。”。

About Ebola virus disease:

关于埃博拉病毒病：

According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo.

根据疾病控制和预防中心（CDC）的说法，埃博拉病是一种罕见且通常致命的疾病，由四种病毒之一（称为埃博拉病毒）感染引起，这些病毒主要存在于撒哈拉以南非洲，被称为：扎伊尔，苏丹，塔伊森林（前科特迪瓦）和本迪布焦。

Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from 'dry' symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to 'wet' symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker.

该疾病的传播主要是通过接触受感染的动物（蝙蝠或非人灵长类动物）或感染埃博拉病毒的病人或死者。病程通常从最初的“干燥”症状（如发烧，疼痛和疲劳）发展到“潮湿”症状（如腹泻，呕吐和不明原因的出血，出血或瘀伤），随着病情的加重。

There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™ (atoltivimab/maftivimab/odesivimab, Regeneron Pharmaceuticals, Inc), a combination of three monoclonal antibodies and Ebanga™ (ansuvimab-zykl, Ridgeback Biotherapeutics, LP), a single monoclonal antibody.

目前只有两种FDA批准的疗法可以治疗成人和儿童中由埃博拉病毒（扎伊尔埃博拉病毒）引起的EVD；Inmazeb™（atoltivimab/maftivimab/odesivimab，Regeneron Pharmaceuticals，Inc）是三种单克隆抗体和单一单克隆抗体Ebanga™（ansuvimab zykl，Ridgeback Biotherapeutics，LP）的组合。

Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal..

两者都是静脉注射的直接作用单克隆抗体抗病毒药物，与埃博拉病毒表面的糖蛋白结合，以防止病毒进入人体细胞。迫切需要针对宿主的小分子疗法，这种疗法可能对多种埃博拉病毒株有效，不太可能受到病毒突变的影响，并且易于储存，分发和管理，特别是在医疗服务和基础设施可能不理想的地区。。

About Opaganib (ABC294640)

关于Opaganib（ABC294640）

Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer)..

Opaganib是一种专有的研究宿主导向和潜在的广泛作用药物，是一种一流的口服鞘氨醇激酶-2（SPHK2）选择性抑制剂，具有抗癌，抗炎和抗病毒活性，针对多种潜在疾病，包括胃肠道急性放射综合征（GI-ARS），新型冠状病毒-19，其他病毒作为大流行准备的一部分，以及胆管癌（胆管癌）。。

Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib的宿主导向作用被认为是通过同时抑制人类细胞中的三种鞘脂代谢酶（SPHK2，DES1和GCS）来抑制多种途径，诱导自噬和凋亡，破坏病毒复制。

Opaganib was selected by the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the HHS National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS)..

Opaganib被美国政府辐射与核应对计划（RNCP）选中，该计划由美国卫生与公众服务部国立卫生研究院（HHS National Institutes of Health）下属的国家过敏与传染病研究所（National Institute of Allergy and Infectious Diseases）领导，用于核医学应对产品开发管道，作为急性辐射综合征（ARS）的潜在治疗方法。。

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.

Opaganib已证明对SARS-CoV-2，多种变体和其他几种病毒（如甲型流感和埃博拉）具有抗病毒活性。在美国陆军传染病医学研究所（USAMRIID）的体内埃博拉病毒研究中，每天两次（BID）以150 mg/kg的剂量给药时，Opaganib的存活时间在统计学上显着增加，使其成为第一个宿主定向分子在埃博拉病毒病中显示活性。

Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study..

Opaganib最近在一项由美国陆军资助并进行的体外埃博拉病毒研究中，与remdesivir（Veklury®，Gilead Sciences Inc.）单独联合使用时，也表现出明显的协同作用，在维持细胞活力的同时显着提高了效力。。

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care.

作为宿主靶向药物，根据迄今为止积累的数据，opaganib有望对新出现的病毒变异保持作用。在对中度至重度新型冠状病毒肺炎住院患者的2/3期临床数据进行的预先分析中，口服奥帕加尼显示，与安慰剂相比，关键患者亚群的病毒RNA清除率提高，恢复时间加快，死亡率显着降低。

Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv..

Opaganib在多项临床研究中已在470多人中证明了其安全性和耐受性，并扩大了使用范围。opaganib全球2/3期研究的数据发表在medRxiv上。。

Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib已获得FDA指定用于治疗胆管癌的孤儿药，并已接受了晚期胆管癌（2a期）和前列腺癌的研究。Opaganib还有一个1期放化疗研究方案，可供FDA-IND提交。

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

Opaganib在肾纤维化方面也显示出积极的临床前结果，并且有可能针对多种肿瘤学，放射防护，病毒，炎症和胃肠道适应症。

About RedHill Biopharma

关于RedHill Biopharma

RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo®, for the treatment of travelers' diarrhea in adults[3].

RedHill Biopharma Ltd.（纳斯达克：RDHL）是一家专业的生物制药公司，主要专注于胃肠道和传染病。RedHill推广胃肠道药物Talicia®，用于治疗成人幽门螺杆菌（H.pylori）感染（2），以及Aemcolo®，用于治疗成人旅行者腹泻（3）。

RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease..

RedHill的关键临床晚期开发计划包括：（i）opaganib（ABC294640），一种一流的口服广谱，宿主导向的SPHK2选择性抑制剂，具有大流行防范潜力，与美国政府合作开发急性辐射综合征（ARS），住院COVID-19的2/3期计划和肿瘤学的2期计划；（ii）RHB-107（upamostat）是一种口服广谱，宿主导向的丝氨酸蛋白酶抑制剂，具有大流行防范潜力，作为非住院症状性新型冠状病毒肺炎的治疗，目前处于后期开发阶段，非稀释性外部资金覆盖了300名患者的2期适应性平台试验的整个RHB-107组，并且还针对多种其他癌症和炎症性胃肠道疾病；（iii）RHB-102，英国可能提交化疗和放疗引起的恶心和呕吐，急性胃肠炎和胃炎的3期研究的阳性结果以及IBS-D的2期研究的阳性结果；（iv）RHB-104，克罗恩病第一阶段3研究的阳性结果；（v）RHB-204，一种针对肺部非结核分枝杆菌（NTM）疾病的三期计划。。

More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.

有关该公司的更多信息，请访问www.redhillbio.com/twitter.com/redhillbio。

[1] Opaganib is an investigational new drug, not available for commercial distribution.

[1] Opaganib是一种研究性新药，不可用于商业分销。

[2] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

[2] Talicia®（奥美拉唑镁，阿莫西林和利福布汀）适用于治疗成人幽门螺杆菌感染。有关完整的处方信息，请参阅：www.Talicia.com。

[3] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.Aemcolo.com.

[3] Aemcolo®（利福霉素）适用于治疗成人非侵入性大肠杆菌引起的旅行者腹泻。有关完整的处方信息，请参阅：www.Aemcolo.com。

Forward Looking Statements

前瞻性声明

This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ('Nasdaq') to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，可能会讨论投资机会、股票分析、财务表现、投资者关系和市场趋势。此类声明，包括但不限于关于本次发行净收益的预期用途的声明，可以在前面加上“打算”、“可能”、“将会”、“计划”、“预期”、“预期”、“项目”、“预测”、“估计”、“目标”、“相信”、“希望”、“潜在”或类似的词语，还包括关于公司不符合纳斯达克资本市场（“纳斯达克”）的上市要求在纳斯达克上市交易的风险的声明，新的创收产品的添加，公司开发管道资产的外许可，opaganib开发急性辐射综合征的时间，RHB-107的非稀释性开发资金及其包含在关键平台研究。

Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements.

前瞻性陈述基于某些假设，并受到各种已知和未知风险和不确定性的影响，其中许多风险和不确定性超出了公司的控制范围，无法预测或量化，因此，实际结果可能与此类前瞻性陈述所明示或暗示的结果存在重大差异。

Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for op.

此类风险和不确定性包括但不限于市场和其他条件，即不会增加新的创收产品或许可外交易的风险；接受RNCP产品开发管道不会保证持续开发或任何此类开发无法完成或成功的风险；FDA不同意该公司提出的op发展计划的风险。

Company contact:

公司联系人：

Adi Frish

阿迪·弗里希

Chief Corporate & Business Development Officer

首席企业与业务发展官

RedHill Biopharma

RedHill生物制药

+972-54-6543-112

+972-54-6543-112

adi@redhillbio.com

adi@redhillbio.com

Category: R&D

类别：研发

Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

标志https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/redhill-announces-new-opaganib-chinese-patent-against-ebola-virus-valid-through-2035-302136648.html

查看原始内容：https://www.prnewswire.com/news-releases/redhill-announces-new-opaganib-chinese-patent-against-ebola-virus-valid-through-2035-302136648.html

SOURCE RedHill Biopharma Ltd.

来源：RedHill生物制药有限公司

Company Codes: NASDAQ-SMALL:RDHL, Berlin:2RH0.BE, Frankfurt:2RH0.F, Munich:2RH0.MU, Stuttgart:2RH0.SG

公司代码：NASDAQ-SMALL:RDHL，柏林：2RH0.BE，法兰克福：2RH0.F，慕尼黑：2RH0.MU，斯图加特：2RH0.SG