Ondansetron Hydrochloride

RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the agreements TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been awarded approximately $8 million (consisting of $6.5 million plus interest amounting to approximately $1.5 million), plus costs in a summary judgment by the Supreme Court of the State of New York, New York County (the "Court"), in its legal proceedings (Index number: 653200/2022) against Kukbo Co. Ltd. ("Kukbo"), domiciled in South Korea. The case refers to Kukbo's failure to make agreed payments to RedHill, pursuant to a Subscription Agreement (the "SA"), dated October 25, 2021, and a subsequent Exclusive License Agreement (the "ELA" and together with the SA, the "Agreements"), dated March 14, 2022, entered into by the two companies. Dror Ben-Asher, RedHill's CEO: "RedHill thanks the Court for this crystal-clear judgment, affirming the Company's just position from the beginning of the relationship, and in making correct provision for full reparation for the contractual breaches. The Company is also grateful to Haynes and Boone, LLP for their expert counsel and legal representation in this case." Upon entry, Kukbo has a right to seek an appeal of the judgment, which may or may not be granted. RedHill intends to pursue its attorneys' fees and collection of the judgment. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), ), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, , 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. More information about the Company is available at / X.com/RedHillBio. Forward-Looking Statements 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 legal process going forward including Kukbo's rights to appeal. 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. Such risks and uncertainties include, without limitation: market and other conditions; the risk that the Court's ruling will not be upheld in any subsequent appeal or that the provisions for reparation for the contractual breaches will not be honored; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; 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 opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 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 COVID-19 studies for opaganib and RHB-107 are likely to 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 clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Category: Corporate Logo: [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024年国家医保目录公布后，已有20多家A股上市药企披露药品纳入情况，涉及数十款创新药。其中，除了不少创新药成功续约，还有一批上半年获批的创新药或新增适应症被纳入。近年来，创新药纳入医保的速度不断加快，推动我国医药产业创新升级。药企普遍表示，“入保”将对药品销售和公司长期经营发展产生积极作用。 药企密集披露进展 国家医保局近日发布新版国家医保药品目录，将于2025年1月1日起正式实施。目录新增91种药品，其中有卡度尼利单抗注射液等26种肿瘤用药、利鲁唑口服混悬液等13种罕见病用药以及15种慢性病用药，药品总数增至3159种。 截至发稿，已有20多家A股上市药企发布公告，披露了药品纳入国家医保目录情况，龙头企业均有新增纳入的药品或适应症。 如恒瑞医药公告称，通过医保谈判，富马酸泰吉利定注射液、奥特康唑胶囊、恒格列净二甲双胍缓释片（Ⅰ）（Ⅱ）首次纳入国家医保目录；氟唑帕利胶囊通过简易续约规则新增适应症纳入国家医保目录；注射用卡瑞利珠单抗通过简易续约规则续约成功并新增适应症纳入国家医保目录；羟乙磺酸达尔西利片、瑞维鲁胺片、普瑞巴林缓释片通过简易续约规则续约成功保留在国家医保目录；脯氨酸恒格列净片续约成功并新增适应症保留在国家医保目录；昂丹司琼口溶膜续约成功保留在国家医保目录；盐酸艾司氯胺酮注射液、盐酸右美托咪定鼻喷雾剂调整至常规目录管理。据披露，上述药品2023年度合计销售额约为34.60亿元，2024年1至3季度合计销售额约为40.08亿元。 百济神州公告称，公司自主研发的抗PD-1抗体药物百泽安（替雷利珠单抗注射液）、BTK抑制剂百悦泽（泽布替尼胶囊）分别新增三项适应症和一项适应症被纳入国家医保目录；绿叶制药合作引进产品百拓维（注射用戈舍瑞林微球）新增一项适应症被纳入国家医保目录；安进公司授权引进产品凯洛斯（注射用卡非佐米）成功续约。 中成药方面，华润三九披露，公司药品温经汤颗粒及公司全资子公司浙江华润九众医药有限公司药品注射用头孢比罗酯钠通过谈判首次纳入国家医保目录。其中，温经汤颗粒注册分类为中药3.1类，于2024年5月获得国家药品监督管理局批准上市。 以岭药业公告称，公司独家产品通络明目胶囊通过了医保谈判，首次被纳入国家医保目录。通络明目胶囊药品注册分类为中药1.1类，于2023年10月获得国家药监局核准签发的《药品注册批件》。此外，公司还有10个独家品种在国家医保目录中。 目录调整创新特点显著 近年来，创新药纳入医保的速度不断加快。记者根据上市公司公告梳理发现，新版国家医保目录中，多款新纳入的1类创新药为今年上半年获批上市的新药。 恒瑞医药的富马酸泰吉利定注射液为今年年初上市1类化药。恒瑞医药在1月31日发布的关于获得药品注册证书的公告中披露，富马酸泰吉利定注射液上市标志着公司在镇痛麻醉领域上市1类创新药增至2款，该药品相关项目累计已投入研发费用约16569万元。 信立泰公告称，公司创新药阿利沙坦酯氨氯地平片、苯甲酸福格列汀片通过谈判新纳入国家医保目录乙类范围。根据该公司此前披露，苯甲酸福格列汀片为今年6月28日获批的1类化药，用于改善成人2型糖尿病患者的血糖控制。 “今年目录调整范围以新药为主，新增的91种药品中有90种为5年内新上市品种。我们将包括1类化药、1类治疗用生物制品、1类和3类中成药在内的‘全球新’作为重点支持对象，确保‘好钢用在刀刃上’。”国家医保局医药管理司司长黄心宇在11月28日举行的新闻发布会上介绍说。 国金证券研究认为，此次医保目录调整，创新与结构优化特点显著。今年纳入的91个目录外药品中，有38个是属于“全球新”的创新药，创新药的谈判成功率超过90%，国内企业的药品占比超过了70%，这个比例近几年都在逐步提升。 对于药企而言，创新药上市后尽快进入国家医保目录，是实现药品快速放量的重要一步。多家公司都在公告中表示，产品纳入国家医保目录将有利于药品销售和公司长期经营发展。如此次新纳入医保目录的地达西尼是京新药业首个1类新药，于2023年年末获批，适用于失眠患者的短期治疗。“本次公司地达西尼胶囊被纳入《国家医保目录（2024）》将有利于该产品的市场推广及未来销售，会对公司的销售增长和长期经营发展产生积极作用。”该公司在11月28日晚间发布的公告中称。 “真创新”政策导向明晰 “7轮调整，累计将149种创新药纳入医保目录。监测表明，截至2024年10月，医保基金对协议期内药品支付累计超3500亿元，带动相关销售超过5100亿元。随着品种增多和进目录后持续放量，医保基金对协议期内药品的支付金额逐年上涨。今年前10个月医保基金对协议期内谈判药品支付约920亿元，按相同周期计算，是2019年的21倍。可以说医保基金是‘真金白银’地在支持创新药发展。”黄心宇在新闻发布会上表示。 国家医保局11月27日在官方公众号上发文表示，正在积极谋划、持续推出一揽子新增量政策，以进一步增进人民健康福祉、激发经济社会发展新动能。 其中，在大力赋能医药企业方面，国家医保局提出，在坚持推进对创新药医保谈判、对仿制药开展集采的基础上，进一步采取实质性措施助力医药企业高质量发展。一是逐步扩大医保基金对医药企业的直接结算，国家医保局将在更大范围推进医保基金对药品耗材企业的直接结算，帮助企业减轻资金成本。二是引导企业提升能力开拓更大市场。一致性评价、集中带量采购等政策推动我国仿制药产业“减脂增肌”。改变带金销售的灰色发展模式后，绝大多数集采中选企业的技术水平、生产工艺、供应能力持续提升。国家医保局支持鼓励相关企业利用自身技术、供应优势，在保障国内市场用量的前提下，在“一带一路”共建国家出口产品或建厂投资，在全球医药市场打造中国制造品牌。 国金证券研究表示，国家医保局坚决树立支持“真创新”的政策导向，运用药品价值评估、药物经济学评价等技术工具，在有限的基金支撑能力下尽可能平衡好参保人多元化需求、医务人员临床用药以及医药产业发展创新的需要，助力高临床价值、高创新水平的药品获得与之匹配的价格，引领医药产业发展方向。 来源：中国经济网 商务合作 130 6172 3098 zakk.cui@siqibest.com 点击 阅读原文 了解更多