RedHill宣布收购 Ferring公司 Rebyota®和 Clenpiq®的商业化权利，实现战略转型-动脉网

RedHill Announces Transformational Acquisition of Commercialization Rights to Ferring's Rebyota® and Clenpiq®

CISION 等信源发布 2026-09-01 18:59

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可切换为仅中文

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Together with the previously announced Talicia

与此前宣布的Talicia一起

strategic divestiture, the acquisition from Ferring of commercialization rights to two larger, proprietary, established gastrointestinal (GI) FDA-approved drugs that together generated approximately $37.5 million in 2025 net sales, completes a major strategic repositioning of RedHill's commercial GI business.

战略性资产剥离，即从Ferring公司收购两款较大规模、自有且已成熟的胃肠道（GI）FDA批准药物的商业化权利，这两款药物在2025年合计产生约3,750万美元的净销售额，此举完成了RedHill公司胃肠道商业业务的重大战略重组。

The divestiture of Talicia and the acquisition of the new GI products from Ferring create a catalyst for commercial growth through a materially larger GI business under RedHill's control, with a significantly stronger liquidity position and provides additional growth and expansion opportunities

剥离Talicia并从Ferring收购新的胃肠道（GI）产品，为RedHill旗下规模显著扩大的胃肠道业务带来了商业增长的催化剂，使其流动性状况大幅增强，并提供了额外的增长和扩张机会。

Under the terms of the agreement, RedHill obtained the exclusive commercialization rights for an upfront payment to Ferring of $12 million plus potential future milestones and tiered royalties.

根据协议条款，RedHill 获得了独家商业化权利，为此需向 Ferring 支付1,200万美元的预付款，以及潜在的后续里程碑付款和分级特许权使用费。

The $12 million upfront payment is fully funded through the previously announced $18 million Talicia divestment, with RedHill securing exclusive global and U.S. commercialization rights to Ferring's Rebyota

1,200万美元的预付款完全通过此前宣布的1,800万美元Talicia资产剥离交易提供资金，RedHill获得了Ferring公司Rebyota在全球及美国的独家商业化权利。

and Clenpiq

以及Clenpiq

注册商标符号

, respectively - two synergistic, revenue-generating, FDA-approved GI drugs

，分别为两种具有协同作用、可产生收入且获美国食品药品监督管理局（FDA）批准的胃肠道药物

Rebyota is a proprietary, first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT for prevention of recurrent C. diff infection (rCDI). FDA-approved in 2022 and Health Canada-approved in 2025, Rebyota, was granted a Breakthrough Therapy and received Orphan Drug designations and generated approximately $16.9 million in 2025 U.S.

Rebyota 是一种专有的、首个且唯一获美国食品药品监督管理局（FDA）批准的单剂量粪便微生物群移植（FMT）产品，用于预防复发性艰难梭菌感染（rCDI）。该产品于 2022 年获得 FDA 批准，并于 2025 年获得加拿大卫生部批准。Rebyota 被授予突破性疗法认定，并获得孤儿药资格认定，在 2025 年于美国市场创造了约 1690 万美元的收入。

net sales.

净销售额。

Proprietary Clenpiq, a ready-to-use (no mixing required) low-volume bowel preparation on the U.S. market, generated $20.6 million in U.S. 2025 net sales with minimal promotion

专有产品Clenpiq是一种在美国市场上市的即用型（无需混合）低容量肠道准备剂，在几乎未进行推广的情况下，2025年在美国实现了2,060万美元的净销售额。

RALEIGH, N.C. and TEL AVIV, Israel

北卡罗来纳州罗利和以色列特拉维夫

，

Sept. 1, 2026

2026年9月1日

/PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq:

/美通社/ -- RedHill Biopharma有限公司（纳斯达克：

RDHL

) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced the transformational acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, from Ferring Pharmaceuticals ('Ferring'), as part of Ferring's ongoing strategic refocusing.

)（“RedHill”或“公司”），一家专业生物制药公司，今日宣布从Ferring Pharmaceuticals（“Ferring”）收购Rebyota和Clenpiq的独家全球及美国商业化权利，作为Ferring持续战略聚焦的一部分。

Dror Ben-Asher, RedHill's Chief Executive Officer, said

RedHill 首席执行官 Dror Ben-Asher 表示

: 'We have executed a clear strategic sequence. We have monetized Talicia for $18 million cash upfront, plus $35 million in potential upside, used $12 million to secure commercialization rights to two established, proprietary, FDA-approved gastrointestinal drugs, that collectively generated approximately $37.5 million in U.S.

“我们执行了一个清晰的战略序列。我们通过 Talicia 的货币化获得了1800万美元的现金预付款，以及3500万美元的潜在上行收益，并使用1200万美元确保了两款已上市、专有且获FDA批准的胃肠道药物的商业化权利，这些药物在美国 collectively 产生了约3750万美元的收入。”

net sales in 2025, and emerged with a materially larger, fully controlled commercial business and a stronger liquidity position. Rebyota and Clenpiq are expected to generate a positive cash contribution to RedHill. This, combined with RedHill's experienced and lean commercial team and proven development capabilities, creates a scalable foundation for further growth, including additional acquisition of complementary revenue-generating products.' .

2025年的净销售额，并由此形成了一个规模显著更大、完全自主控制的商业化业务以及更强劲的流动性状况。预计Rebyota和Clenpiq将为RedHill带来正向的现金流贡献。结合RedHill经验丰富且精简的商业团队以及经过验证的开发能力，这为未来的进一步增长奠定了可扩展的基础，包括收购更多能够产生收入的互补性产品。

Mr. Ben-Asher added

本-阿舍尔先生补充道

: 'We thank Ferring for a smooth process to date and look forward to a successful collaboration.'

“我们感谢Ferring至今为止的顺利合作，并期待未来取得成功的协作。”

Under the terms of the agreement, RedHill obtained an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq, for an upfront payment to Ferring of $12 million, plus tiered royalties on net sales and potential milestones. Ferring retains its Rebyota manufacturing facilities, and Ferring will continue to supply Rebyota through the term of the agreement..

根据协议条款，RedHill 获得了 Rebyota 的全球独家商业化许可，以及 Clenpiq 的美国独家商业化许可；为此，RedHill 向 Ferring 支付了 1,200 万美元的预付款，并需按净销售额支付阶梯式特许权使用费及可能的里程碑付款。Ferring 保留其 Rebyota 生产设施，并将在协议有效期内继续供应 Rebyota。

'Rebyota is a first-in-class microbiota-based therapy for prevention of recurrent

Rebyota 是一款首创的基于微生物组的疗法，用于预防复发性

Clostridioides difficile

艰难梭菌

(

C. diff)

艰难梭菌

infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and an established customer base of approximately 600 active accounts,' .

用于18岁及以上复发性艰难梭菌感染（rCDI）患者在抗生素治疗后的rCDI。该产品于2022年获美国食品药品监督管理局（FDA）批准，凭借其临床特征、广泛的覆盖范围以及约600个活跃账户的稳固客户基础，在2025年实现了约1,690万美元的美国净销售额。

said Rick Scruggs, RedHill's Chief Commercial Officer

RedHill 首席商务官 Rick Scruggs 表示

. 'Clenpiq, a ready-to-drink low-volume bowel preparation on the U.S. market, delivered $20.6 million in net sales in 2025, with minimal promotion. Together the two assets give RedHill a significantly stronger commercial growth engine in both the U.S. and other new territories.'

“Clenpiq 是美国市场上一种即饮型低容量肠道准备制剂，在几乎未进行推广的情况下，2025 年实现了 2,060 万美元的净销售额。这两项资产共同为 RedHill 在美国及其他新市场显著增强了商业增长动力。”

C. diff

艰难梭菌

(

CDI) infection is a distressing and life-threatening condition – in developed countries it is the most common cause of healthcare-associated (HA) diarrhea

艰难梭菌感染（CDI）是一种令人痛苦且危及生命的疾病——在发达国家，它是医疗相关（HA）腹泻最常见的原因

[1]

. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. 30,000 Americans die every year due to CDI

据估计，全球每年发生360万例艰难梭菌感染（CDI）病例，其中包括美国的大约50万例。每年有3万名美国人因艰难梭菌感染而死亡。

[2]

, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings

，全球死亡率为十分之一，在高风险环境中则上升至近三分之一

. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences

在美国，多达约165,000例艰难梭菌感染（CDI）病例会出现一次或多次复发

[3]

, indicating the need for use of prevention strategies.

，表明需要采取预防策略。

Rebyota's one-time administration, which requires no fasting, bowel prep or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI

Rebyota 的一次性给药方案无需禁食、肠道准备或延长治疗周期，其在预防复发性艰难梭菌感染（rCDI）方面已展现出超过 70% 的成功率。

[4]

. An aging population and accompanying increasing hospital-acquired vulnerabilities will likely increase this need. A streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage including 43% with coverage after 1st recurrence.

人口老龄化以及随之增加的医院获得性脆弱性可能会加剧这一需求。目前，医生已享有简化的处方开具和报销流程，而美国支付方的覆盖范围广泛且不断改善，意味着93%的人群拥有保险保障，其中43%的人在首次复发后仍享有保障。

[5]

。

Rebyota, which was granted, Breakthrough Therapy and Orphan Drug designations - with exclusivities and other patent protections that could run to 2036, provides multiple growth opportunities, including recent approval in Canada. The existing approvals also provide the potential for additional approvals in other territories..

Rebyota 获得了突破性疗法和孤儿药认定，享有可延续至2036年的独占权及其他专利保护，提供了多重增长机遇，包括最近在加拿大获得的批准。现有的批准也为在其他地区获得额外批准带来了潜力。

Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually

结肠镜检查是胃肠病学的基石，美国每年进行的结肠镜检查超过1500万例。

[6]

. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy. Bowel preparation is not a pleasant process and is often poorly performed..

这一数字正在上升，原因包括：无创筛查试验结果呈阳性后需要进行随访、人口老龄化，以及指南建议将筛查起始年龄从50岁提前至45岁，这些因素共同导致对结肠镜检查的需求增加。肠道准备过程并不舒适，且往往执行效果不佳。

Clenpiq is a ready-to-drink low-volume bowel prep. Clenpiq is readily available to patients and has broad commercial and government payer coverage: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. 23m lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12m (21%) lives with preferred position.

Clenpiq 是一种即饮型低容量肠道准备制剂。Clenpiq 对患者易于获取，并拥有广泛的商业保险和政府支付方覆盖：超过 1.08 亿参保人（63%）享有无限制（无需事先授权）的商业保险覆盖，其中 5,700 万参保人（33%）享有优先报销地位。在 Medicare Part D（联邦医疗保险处方药计划）的参保人中，有 2,300 万参保人（41%）可以无限制地使用 Clenpiq，其中 1,200 万参保人（21%）享有优先报销地位。

。

RedHill was advised by Morningstar Law Group and Greenberg Traurig LLP on this transaction.

晨星律师事务所和格林伯格·特劳里格律师事务所在此次交易中为RedHill提供了法律咨询。

About Rebyota®

关于 Rebyota®

Rebyota® (fecal microbiota, live – jslm) is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of live microbes. Rebyota is administered by a healthcare professional in one visit.

Rebyota®（粪便微生物群，活体 – jslm）是一种预包装的单剂量150毫升微生物群悬液，用于直肠给药，由活微生物的液体混合物组成。Rebyota由医疗专业人员在一次就诊中施用。

Indication

适应症

Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. difficile infection.

Rebyota 适用于18岁及以上个体，在复发性艰难梭菌感染接受抗生素治疗后，预防艰难梭菌感染的复发。

Limitation of Use: Rebyota is not indicated for the treatment of C. difficile infection.

使用限制：Rebyota 不适用于治疗艰难梭菌感染。

Important Safety Information

重要安全信息

You should not receive Rebyota if you have a history of a severe allergic reaction (e.g., anaphylaxis) to Rebyota or any of its components.

如果您对 Rebyota 或其任何成分有严重过敏反应（例如过敏性休克）史，则不应接受 Rebyota 治疗。

You should report to your doctor any infection you think you may have acquired after administration.

如果您认为自己在给药后感染了任何疾病，应向医生报告。

Rebyota may contain food allergens.

Rebyota 可能含有食物过敏原。

Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).

最常见的副作用可能包括腹痛（8.9%）、腹泻（7.2%）、腹胀（3.9%）、肠胃胀气（3.3%）和恶心（3.3%）。

Rebyota has not been studied in patients below 18 years of age.

Rebyota 尚未在 18 岁以下患者中进行研究。

Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.

临床研究未能确定65岁及以上的成年人是否与年轻成年人有不同的反应。

You are encouraged to report negative side effects of prescription drugs to FDA. Visit

我们鼓励您向美国食品药品监督管理局（FDA）报告处方药的不良反应。请访问

www.FDA.gov/medwatch

or call 1-800-332-1088.

或拨打 1-800-332-1088。

Please

请

click

点击

to see the full Prescribing Information.

查看完整的处方信息。

About CLENPIQ®

关于 CLENPIQ®

CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a ready-to-drink, low-volume bowel preparation used to cleanse the colon prior to colonoscopy. It combines sodium picosulfate, a stimulant laxative, with magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative..

CLENPIQ®（匹可硫酸钠、氧化镁和无水柠檬酸）口服溶液是一种即饮型、低容量的肠道准备药物，用于在结肠镜检查前清洁结肠。它将刺激性泻药匹可硫酸钠与氧化镁和无水柠檬酸相结合，后者形成枸橼酸镁，一种渗透性泻药。

Indication

适应症

CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and paediatric patients 9 years of age and older.

CLENPIQ 适用于成人及 9 岁及以上儿童患者结肠镜检查前的结肠清洁准备。

Important Safety Information

重要安全信息

CLENPIQ is contraindicated in patients with severe renal impairment, gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or hypersensitivity to any of its ingredients.

CLENPIQ 禁用于严重肾功能损害、胃肠道梗阻或肠麻痹、肠穿孔、中毒性结肠炎或中毒性巨结肠、胃潴留，或对其任何成分过敏的患者。

Bowel preparations, including CLENPIQ, can cause serious fluid and electrolyte disturbances, which may lead to cardiac arrhythmias, seizures and renal impairment. Patients should maintain adequate hydration before, during and after use. Particular caution is required in patients with conditions or taking medications that increase the risk of fluid and electrolyte disturbances, seizures, renal impairment or cardiac arrhythmias..

肠道准备药物（包括CLENPIQ）可能导致严重的体液和电解质紊乱，进而引发心律失常、癫痫发作和肾功能损害。患者在使用前、使用期间和使用后应保持充足的水分摄入。对于患有某些疾病或正在服用可能增加体液和电解质紊乱、癫痫发作、肾功能损害或心律失常风险药物的患者，需特别谨慎。

CLENPIQ may cause colonic mucosal ulceration and has been associated with ischemic colitis. Caution should also be exercised in patients with severe active ulcerative colitis or an impaired gag reflex due to the risk of regurgitation or aspiration.

CLENPIQ 可能导致结肠黏膜溃疡，并与缺血性结肠炎相关。对于患有重度活动性溃疡性结肠炎或因反流或误吸风险而咽反射受损的患者，也应谨慎使用。

CLENPIQ may reduce the absorption of other orally administered medicines. The most common adverse reactions in adults include nausea, headache, hypermagnesemia, dehydration or dizziness, and abdominal pain. In paediatric patients 9 to 16 years of age, the most common adverse reactions include nausea, vomiting and abdominal pain..

CLENPIQ 可能会降低其他口服药物的吸收。成人中最常见的不良反应包括恶心、头痛、高镁血症、脱水或头晕，以及腹痛。在 9 至 16 岁的儿科患者中，最常见的不良反应包括恶心、呕吐和腹痛。

Please see the full Prescribing Information and Medication Guide for CLENPIQ:

请参阅 CLENPIQ 的完整处方信息和用药指南：

www.clenpiq.com

About Ferring Pharmaceuticals

关于辉凌制药

Ferring Pharmaceuticals is a privately owned, specialty biopharmaceutical group committed to building families and helping people live better lives. Ferring is a leader in reproductive medicine with a strong heritage in gastroenterology and urology, and is at the forefront of innovation in uro-oncology gene therapy.

Ferring Pharmaceuticals 是一家私营的专业生物制药集团，致力于帮助人们组建家庭并提升生活质量。Ferring 在生殖医学领域处于领先地位，在胃肠病学和泌尿学方面拥有深厚积淀，并在泌尿肿瘤基因治疗创新方面走在行业前沿。

Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. .

Ferring 成立于1950年，在全球拥有超过7,000名员工。公司总部位于瑞士圣普雷克斯，在50多个国家设有运营子公司，其药品在100多个国家销售。

About RedHill Biopharma

关于红山生物制药

RedHill Biopharma Ltd. (Nasdaq:

RedHill Biopharma有限公司（纳斯达克：

RDHL

) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal therapies

）是一家专业生物制药公司，主要专注于在美国开发和商业化用于治疗胃肠道疾病、传染病和肿瘤学的药物。RedHill 推广经美国食品药品监督管理局（FDA）批准的胃肠道疗法

Rebyota

雷比奥塔

注册商标符号

, for the prevention of recurrent

，用于预防复发性

C. diff

艰难梭菌

infection (rCDI), and the bowel preparation treatment,

感染（rCDI）以及肠道准备治疗，

Clenpiq

. RedHill's key clinical late-stage development programs include: (i)

. RedHill 的关键临床后期开发项目包括：(i)

opaganib (ABC294640)

奥帕加尼布 (ABC294640)

, a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) .

，一种首创新类、口服给药的选择性鞘氨醇激酶-2（SPHK2）抑制剂，具有抗炎、抗病毒、代谢调节和抗癌活性，针对多种适应症，并拥有与美国政府及学术界合作的记录，旨在开发包括埃博拉病毒病（EVD）、辐射暴露相关适应症（如胃肠道急性放射综合征，GI-ARS）在内的医疗对策；一项针对住院COVID-19患者的2/3期临床开发计划；以及一项正在进行的与达罗鲁胺联合治疗前列腺癌的2期研究；（ii）。

RHB-102 (Bekinda)

RHB-102（Bekinda）

, with a planned Phase 2 proof-of-concept study for

，并计划开展第二阶段概念验证研究

GLP-1

胰高血糖素样肽-1

/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) .

与GIP受体激动剂相关的胃肠道不耐受、美国急性胃肠炎和胃炎III期临床试验取得阳性结果、美国IBS-D（腹泻型肠易激综合征）II期临床试验取得阳性结果，以及潜在提交英国用于化疗和放疗引起的恶心和呕吐的注册申请。RHB-102已与Hyloris Pharmaceuticals（股票代码：HYL）合作，在北美以外地区进行全球开发和商业化；(iii)。

RHB-204

, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv)

，RHB-104的下一代优化配方，计划开展针对克罗恩病的2期临床研究（基于RHB-104在克罗恩病3期临床研究中取得的阳性结果）；以及（四）

RHB-107

(

upamostat

乌帕莫司他

), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.

），一种口服广谱、宿主导向的丝氨酸蛋白酶抑制剂，具有应对大流行病（包括 COVID-19）的潜力，同时靶向多种癌症和炎症性胃肠道疾病。

More information about the Company is available at

有关本公司的更多信息，请访问

www.redhillbio.com

X.com/RedHillBio

。

Forward Looking Statements

前瞻性陈述

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 may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words, and include, among others, statements regarding the divestment of Talicia and the potential use of the proceeds of such sale; the expected benefits of the acquisition of commercialization rights to Rebyota® and Clenpiq®, the anticipated commercial growth and cash contribution from these products, expectations regarding market share growth, anticipated payer coverage, the Company's strategic repositioning and path to operational profitability, potential use of milestone and royalty payments, and the Company's ability to successfully commercialize Rebyota® and Clenpiq®.

本新闻稿包含1995年《私人证券诉讼改革法案》所定义的“前瞻性陈述”，并可能涉及投资机会、股票分析、财务表现、投资者关系及市场趋势。此类陈述通常以“打算”、“可能”、“将”、“计划”、“预期”、“预计”、“规划”、“预测”、“估计”、“旨在”、“相信”、“希望”、“潜在”或类似词语为前缀，其中包括但不限于以下陈述：关于剥离Talicia及其所得款项的潜在用途；关于获得Rebyota®和Clenpiq®商业化权利的预期收益；这些产品带来的预期商业增长和现金贡献；对市场份额增长的预期；预期的支付方覆盖范围；公司的战略重新定位及实现运营盈利的路径；里程碑付款和特许权使用费支付的潜在用途；以及公司成功商业化Rebyota®和Clenpiq®的能力。

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，并受各种已知和未知的风险及不确定性的影响，其中许多风险和不确定性超出公司的控制范围，且无法预测或量化，因此，实际结果可能与这些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: the risk that the acquisition of commercialization rights for Rebyota.

此类风险和不确定性包括但不限于：收购Rebyota商业化权利的风险。

and Clenpiq

以及Clenpiq

does not result in the planned commercial growth; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda.

未能实现预期的商业增长；奥帕加尼布未被纳入埃博拉病毒病控制项目，或即使被纳入也未能显示出疗效的风险；RHB-204用于克罗恩病的开发可能无法完成，或即使完成也可能未获批准或无法取得商业成功的风险；奥帕加尼布对我们产品开发所针对的适应症无效的风险；RHB-102（Bekinda

) does not effectively reduce

）并未有效降低

GLP-1

/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S.

与GIP相关的恶心、呕吐和腹泻；公司恢复并维持符合纳斯达克上市要求（包括最低投标价格要求）的能力相关风险；新增创收产品或对外许可交易未能实现的风险；公司无法根据现有协议收到未来里程碑付款，或实际收款低于预期的风险；以及当前美国方面存在的不确定性风险

government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs 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 its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into .

政府研发资金，且美国政府没有义务继续支持我们产品的开发，并可以随时终止此类支持；进入RNCP产品开发管道或其他政府和非政府开发项目并不保证持续开发，或任何此类开发可能无法完成或成功；FDA可能不同意公司为其项目提出的开发计划的风险；公司的开发项目和研究可能不会成功，即使成功，这些研究和结果也可能不足以用于监管申请（包括紧急使用或上市申请），并且可能需要额外的研究；公司无法成功将其产品商业化的风险；以及与公司以下方面相关的风险和不确定性：(i) 公司研究、制造、临床前研究、临床试验和其他治疗候选药物开发工作的启动、时间安排、进展和结果，以及其商业化产品及未来可能收购或开发的产品的商业发布时间；(ii) 公司推进其治疗候选药物的能力。

Company contact:

公司联系人：

Adi Frish

阿迪·弗里什

Chief Corporate & Business Development Officer

首席企业与业务发展官

RedHill Biopharma

红山生物制药

[email protected]

Category: Corporate

类别：企业

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PMID: 25714160；PMCID: PMC10966662。

[3]

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[4]

Khanna S, Assi M, Lee C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x..

Khanna S, Assi M, Lee C, 等. RBX2660在PUNCH CD3研究中的有效性和安全性：一项采用贝叶斯主要分析的III期、随机、双盲、安慰剂对照试验，用于预防复发性艰难梭菌感染. Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x.

[5]

Data on file. Ferring Pharmaceuticals

存档数据。辉凌制药

[6]

MarketScan Commercial Claims and Encounters and Medicare Supplemental database

MarketScan商业索赔与就诊记录及医疗保险补充数据库

Logo:

标志：

https://mmx.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

SOURCE RedHill Biopharma Ltd.

来源：RedHill Biopharma Ltd.

二十一