Gilead Sciences Ireland UC

- 非排他性自愿许可协议促成了lenacapavir的生产和销售，用于预防HIV以及治疗那些经历多种治疗方案且产生多种药物耐药性的HIV患者 印度海得拉巴 2024年10月11日 /美通社/ -- 作为印度领先且在全球业务覆盖最广泛的制药公司，Hetero今日宣布与Gilead Sciences Ireland UC（简称Gilead Sciences，纳斯达克股票代码：GILD）达成新的合作伙伴关系。双方签订了一份非排他性、免版税的自愿许可协议，在120个主要为低收入和中低收入国家/地区（LMIC）生产和分销lenacapavir。 该协议将扩大对lenacapavir的获取渠道，这是一种与其他抗逆转录病毒药物联合使用的创新性HIV治疗药物，并将支持通过暴露前预防（PrEP）来预防HIV。 通过这项合作，我们朝着为经历多种治疗方案且产生多种药物耐药性的HIV患者提供救生治疗方案的目标迈出了重要的一步，同时也为那些医疗资源有限的地区带来了预防HIV的新希望。 Lenacapavir作为一种突破性的HIV-1衣壳抑制剂，可与其他抗逆转录病毒药物联合使用，治疗多重耐药的HIV-1感染。 它独特的作用机制能够针对HIV病毒生命周期的多个阶段，为治疗选择有限的患者提供高效的治疗方案。 提高可负担HIV治疗的普及率 Hetero集团公司董事总经理Vamsi Krishna Bandi博士强调：“与Gilead Sciences的合作增强了我们突破HIV预防和治疗界限的决心。 三十多年以来，Hetero始终站在全球抗击HIV/AIDS的前线，为最需要的地区开创了经济实惠且能挽救生命的治疗方案。 我们提供超过30种组合方案，解决了全球近40%*的HIV/AIDS患者的问题，对于我们迄今为止努力所取得的积极成效，我们感到无比自豪。 我们将在非洲、印度以及其他中低收入国家加快引入lenacapavir，这些地区一直是我们提供HIV/AIDS治疗的核心区域。” 凭借我们在研究领域的强大专注力、无可匹敌的生产规模以及分销方面的专业知识，我们已完全准备好在120个高发病率且资源有限的国家/地区快速扩大lenacapavir的获取渠道。 他补充道，凭借我们的lenacapavir仿制药，我们将把服务扩展至传统覆盖范围之外的社区，确保即便是在最缺乏资源和最偏远的地区，人们同样能够获得他们应享有的高效且经济的HIV预防和治疗。 突破性临床成果 本月早些时候，Gilead公布了一项关键的三期临床试验取得了令人欣喜的结果。 中期分析显示，与背景HIV感染率相比，lenacapavir使HIV感染率降低了96%。 这突显了lenacapavir作为一种长效治疗和预防选择的变革性潜力。 1 此外，在正在进行的临床试验中，对lenacapavir作为长效HIV预防药物的可能性进行研究。 该药物的长效版本，在初次口服负荷剂量后，每六个月可通过皮下注射进行一次给药。 继2022年8月获得欧盟批准后，lenacapavir在同年12月也获得了美国FDA的批准，用于治疗具有多重耐药性的HIV阳性成人患者。 该药物预防HIV的用途还处于研究阶段，尚未在全球任何地方获得批准。 关于Hetero Hetero是一家全球知名的垂直整合制药公司，专注于高品质化学和生物药品的研发、生产和营销，涵盖广泛的治疗领域。 凭借在制药行业30余年的专业知识，Hetero的战略业务遍及活性药物成分（API）、全球仿制药、生物仿制药以及定制制药服务。 该公司是全球最大的活性药物成分 (API) 生产商之一。 如需了解关于Hetero的更多信息，请访问 www.hetero.com。

2022年医保目录中的协议期内谈判药品，西药涵盖消化道和代谢方面药物、血液和造血器官药、心血管系统用药、β-受体阻滞剂、调节血脂药、皮肤病用药、泌尿生殖系统药和性激素、除性激素和胰岛素外的全身激素制剂、全身用抗感染药、抗肿瘤药及免疫调节剂、肌肉骨骼系统药物、神经系统药物、呼吸系统药物、感觉器官药物、其他类共16种；中药涵盖内科用药、肿瘤用药、骨伤科用药、妇科用药、民族药共5个类别。2022年医保目录将从2023年3月1日起实施，本文将分析协议期内的全身用抗感染药。数据来自于PDB药物综合数据库（pdb.pharmadl.com），CPM新药研发监测数据库（cpm.pharmadl.com）、Pharma ONE智能药物大数据分析平台（one.pharmadl.com）。1.索磷布韦维帕他韦片：该药医保支付标准保密，适用于成人慢性丙型肝炎病毒感染患者，最早由Gilead Sciences Ireland UC引入国内（2018.5.23），2020年销售额大幅提升至7800万元，2022年销售额约为8900万元，2023年第一季度销售额为1800万元。图1：索磷布韦维帕他韦片历年销售额2.盐酸可洛派韦胶囊：该药医保支付标准为113.53元（60mg/粒），限治疗基因1、2、3、6型成人慢性丙型肝炎患者，由北京凯因格领生物技术有限公司申报上市（2020.2.11），2022年销售额为1200万元。图2：盐酸可洛派韦胶囊历年销售额3.索磷维伏片：该药医保支付标准保密，适用于既往接受过含直接抗病毒药物方案、无肝硬化或伴代偿性肝硬化的成人慢性丙型肝炎病毒感染的患者，由Gilead Sciences Ireland UC最早引入国内（2019.12.18），2022年销售额大幅提升，约为141万元，而2023年第一季度销售额就已经达到了134万元。图3：索磷维伏片历年销售额4.达诺瑞韦钠片：该药医保支付标准为8.3元（100mg/片），限与盐酸拉维达韦片等联合治疗初治的非肝硬化的基因1b型慢性丙型肝炎成人患者，由歌礼药业（浙江）有限公司申报上市（2018.6.8），2022年销售额9.17万元。图4：达诺瑞韦钠片历年销售额5.盐酸拉维达韦片：该药医保支付标准为51.12元（0.2g/片），适用于初治的基因1b型慢性丙型肝炎病毒感染的非肝硬化成人患者，不得作为单药治疗，由歌礼药业（浙江）有限公司申报上市（2020.7.29），2022年销售额为28.41万元。图5：盐酸拉维达韦片历年销售额6.磷酸依米他韦胶囊：该药医保支付标准保密，需要与索磷布韦片联合，用于治疗成人基因1型非肝硬化慢性丙型感染患者，不得作为单药进行治疗，由宜昌东阳光长江药业股份有限公司申报上市（2020.12.21），2022年销售额为24.25万元。图6：磷酸依米他韦胶囊历年销售额7.艾考恩丙替片：该药医保支付标准保密，适用于治疗HIV-1感染的且无任何与整合酶抑制剂类药物、恩曲他滨或替诺福韦耐药性相关的已知突变的成人和青少年，最早由Gilead Sciences Ireland UC（2018.7.31）引入国内，2021年销售额达到峰值1.01亿元，2023年第一季度销售额仅为800万元。图7：艾考恩丙替片历年销售额8.奈韦拉平齐多拉米双夫定片：该药医保支付标准为12.1元（每片含奈韦拉平0.2g，齐多夫定0.3g和拉米夫定0.15g），限艾滋病患者使用。该药由上海迪赛诺医药集团股份有限公司申报上市（2018.5.23），2021年销售额仅为1.09万元，2022年为2200元。图8：奈韦拉平齐多拉米双夫定片历年销售额9.注射用艾博韦泰：医保支付标准为532元（160mg/支），限艾滋病患者使用，由前沿生物药业（南京）股份有限公司申报上市（2018.5.23），2020年销售额增长迅速，为626万元，2022年增长至1542万元。图9：注射用艾博韦泰历年销售额下期医药地理将会分析全身用抗感染药物：比克恩丙诺片、艾诺韦林片、拉米夫定多替拉韦片、多拉米替片、阿兹夫定片、重组细胞因子基因衍生蛋白注射液、盐酸阿比多尔颗粒、法维拉韦片（法匹拉韦片）、玛巴洛沙韦片、来特莫韦片。如有想要试用PDB药物综合数据库（pdb.pharmadl.com），CPM新药研发监测数据库（cpm.pharmadl.com）、Pharma ONE智能药物大数据分析平台（one.pharmadl.com）的读者，欢迎扫描底部的试用码或添加医药地理小助手公众号。年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）《2023年专利到期药品概述》医药行业专项报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告中国口服血糖调节类原料药市场调研报告中国中枢兴奋类原料药市场调研报告中国抗痛风类原料药市场调研报告中国脑血管病类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

SAN FRANCISCO, Dec. 28, 2022 /PRNewswire/ -- If you purchased Atripla®, Biktarvy®, Complera®, Descovy®, Evotaz®, Genvoya®, Odefsey®, Prezcobix®, Stribild®, Symtuza®, Truvada®, or Viread®, a class action lawsuit may affect your rights. If you are a member of one or both classes, your legal rights will be affected whether you act or don't act, so please read this notice carefully. You must decide whether to remain a member of the class(es) or to exclude yourself from the class(es). A class action lawsuit is pending in the United States District Court for the Northern District of California (the "Court") involving the antiretroviral products Atripla, Biktarvy, Complera, Descovy, Evotaz, Genvoya, Odefsey, Prezcobix, Stribild, Symtuza, Truvada, and Viread ("Products"). The lawsuit claims that Gilead Sciences, Inc., Gilead Holdings, LLC, Gilead Sciences, LLC, and Gilead Sciences Ireland UC ("Gilead"), and Johnson & Johnson, Janssen Products LP, and Janssen R&D Ireland ("Janssen") (collectively, "Defendants") engaged in allegedly anticompetitive conduct that caused certain consumers and third-party payors to pay too much for certain of the Products . Defendants deny any wrongdoing. PLEASE NOTE: No one is claiming that any of these products is unsafe or ineffective. WHO IS INCLUDED IN THE CLASSES? The Court has certified three Damages Classes and three Injunctive Classes in this lawsuit (the "Classes"). The Damages Classes are made up of third-party payors ("TPPs") only (i.e., not individual consumers); the Injunctive Classes are made up of both TPPs and consumers. Damages Classes : The Truvada Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Truvada, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States1 for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through May 31, 2021; The Atripla Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Atripla, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through July 31, 2021; and The Complera Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Complera in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through September 27, 2022. Excluded from the Truvada, Atripla, and Complera Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; and (d) Pharmacy Benefit Managers. Injunctive Classes : The Evotaz Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Evotaz for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; The Prezcobix Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Prezcobix for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; and The cART Foundation Drug Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of a cART Foundation Drug2 for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022. Excluded from each of the Injunctive Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; (d) Pharmacy Benefit Managers; and (e) The Judges in this case and any members of their immediate families. Additionally, excluded from the cART Foundation Drug Injunctive Class are natural persons who have filed a claim for personal injury against any of the Defendants or Bristol-Myers Squibb Company or E. R. Squibb & Sons, L.L.C., alleged to be caused by the consumption of a tenofovir-containing product. YOUR RIGHTS AND OPTIONS Your options depend on whether you are a member of one of the Damages Classes or a member of one of the Injunctive Classes. If you are a member of one of the Damages Classes, you have the right to exclude yourself from (to opt out of) the Damages Classes no later than March 15, 2023. Details on how to request exclusion can be found at . If you do nothing, you will remain a member of the class(es) and be bound by the outcome of this lawsuit, whether by a settlement or by a judgment rendered for or against the Defendants. If you are a member of one of the Injunctive Classes, you cannot exclude yourself from the Class. The deadlines contained in this notice may be amended by Court Order, so check the website for any updates. A trial is scheduled for March 27, 2023 and any updates will be provided on the website. FOR MORE INFORMATION AND A CLAIM FORM Visit Call 1-877-388-1751 Source: Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP 1 The "Specified States" for each of the Damages Classes are: Alabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Vermont, West Virginia, Wisconsin, and the District of Columbia. 2 For the purposes of this class definition a cART Foundation Drug is any of one or more of: Atripla, Biktarvy, Complera, Descovy, Genvoya, Odefsey, Stribild, Symtuza, Truvada, and Viread. SOURCE Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP