Eravacycline Dihydrochloride

在医药行业，"药物经济学"并非一个抽象的概念，而是一把衡量医疗资源分配的尺子。它不仅关注药物的研发成本，更重视药物带来的长期健康效益和经济价值。药物经济学的核心，在于优化资源配置，以期达到成本与效益的最佳平衡。然而，现实情况往往复杂多变。面对像IgA肾病这样缺乏治疗手段的疾病，患者和医疗系统常常不得不做出无奈的选择，依赖有限的支持治疗来缓解症状。但收效甚微，绝大多数IgA肾病患者的肾功能逐渐丧失，最终发展为终末期肾病，带来沉重的长期医疗负担。在亚洲地区，IgA肾病尤为普遍，加之疾病类型、患者治疗理念等因素，使得患者的疾病进展速度更快，医疗负担更重，有时也被称作是"亚洲宿命"。打破这一宿命的关键，在于通过有效的药物经济学策略，确保治疗效果显著的新药能够面世，并提高IgA肾病治疗的可及性和可负担性，从而降低疾病进展为终末期肾病的风险。过去，受限于药物研发难度，“亚洲宿命”一直没有得到改变。眼下，云顶新耀耐赋康的商业化加速，为这场"亚洲宿命"带来了转机。明确的治疗机制、极佳的疗效和安全性，以及符合药物经济学原则的定价策略，由耐赋康发起的一场轰轰烈烈的IgA肾病攻坚战，终于拉开了序幕。01临床颠覆者的底气耐赋康之所以能够扭转“亚洲宿命”，在于其是一个十足的临床颠覆者。研究显示，亚洲人群IgA肾病的疾病进展风险比欧美人群高56%，更容易发展到透析或肾移植。这背后的原因是多方面的。除了人种、基因的差异，两个因素最为关键：第一，缺乏有效的治疗手段。原有的治疗以支持治疗为主，进展患者可考虑应用免疫疗法，在耐赋康之前，没有一个药在随机双盲国际多中心研究中证明可以延缓肾功能的衰退。第二，现有治疗方案不规范。目前的治疗选择相对有限，导致许多没有IgA肾病适应症或缺乏足够证据的药物在临床中被不规范地使用。且全国不同地区、同一地区的不同医院甚至同一医院的不同专家治疗IgA肾病的方案都大相径庭，从而可能让患者错失更为科学的治疗时机。简而言之，在IgA肾病的治疗领域，需要更有效的策略来控制疾病的发展速度，确保患者能够得到及时且有效的治疗。耐赋康，恰好能满足这一要求。首先，耐赋康机制明确，是国内第一，也是唯一一款获FDA批准的对因治疗IgA肾病的药物。目前，市场对于IgA肾病主流的机制是“四重打击”学说，即位于回肠包括派尔淋巴结部位的黏膜B细胞，负责诱导产生的Gd-IgA1引发一系列免疫反应，最终诱发IgA肾病。耐赋康的机制，是精准释放于回肠末端派尔集合淋巴结处，调节B细胞活性，从而治疗IgA肾病。从源头切入，理论上拥有更好效果，而其他进度领先的在研药物，并非从针对“源头”。换句话说，耐赋康将基于“机制”建立起独特的疗效优势。其次，耐赋康长期治疗效果突出，且安全性非常良好。在2年研究期间，耐赋康治疗中国患者肾功能恶化程度较安慰剂减少了66%，预计可将疾病进展至透析或肾移植的时间延缓12.8年。从源头根本上改善了疾病进展，肾功能保护的后延效应就会随之体现。目前三期临床研究证据显示用药9个月，停药15个月后，耐赋康依然有保护肾功能、降低蛋白尿的作用。并且，耐赋康的安全性表现也极为良好。根据三期临床数据，其总体耐受性良好，不良事件主要为轻度，且在治疗期间或治疗后可逆。这同样是建立在其特殊机制之上：胶囊在回肠末端特定水平的pH值环境下才会溶解，能够做到局部给药，并且经过肝肠代谢之后的药物90%失活。因此，耐赋康极少进入血液，安全性较优，而其他在研药物，难以做到局部给药。肾脏疾病权威机构——全球肾脏病预后组织（KDIGO）指南优化后的治疗策略，耐赋康已被推荐为优先于激素类药物的IgA肾病治疗选择，并预计在未来五年内将成为主流的一线基础治疗药物。目前来看，耐赋康在IgA肾病治疗领域，无论是疗效和安全性，还是研发及商业化进度，都“遥遥领先”于潜在的竞争对手。02疗效与经济性并重对于患者来说，青睐耐赋康的逻辑并不复杂，因为这是一个疗效与经济性并重的极佳选择。首先，耐赋康能够显著提高患者生活质量。如无有效干预，分别约有1/3的患者和多达1/2的患者会在10～20年和20～25年的时间里缓慢进展为终末期肾病。这部分患者只能靠透析或肾移植维持生命，生活质量极差。患者一般需要每周做3次透析，每次4小时左右，并且需要在饮食等多方面做控制。而服用耐赋康，副作用小、不影响正常工作，更重要的是，其能够延缓患者12.8年发展至透析/肾移植，真正改善患者预后。其次，耐赋康更具经济性。在美国，耐赋康每瓶的单价超过1万美元，云顶新耀考虑到国内患者的支付能力，每瓶单价为人民币1.86万元，约为美国价格的20%。在此基础上，云顶新耀还联合基金会出台了“买4赠1”、“自购4盒补助3000元”等措施，单价折合1.49万元/瓶，总费用约14.88万元。不光在定价上诚意满满，如果将IgA肾病的总体治疗费用和及时治疗的健康产出考虑进来，耐赋康的经济性就更突出了。一方面，耐赋康能够大大节省患者总体治疗费用。据了解，肾衰竭患者血液透析的费用大约在每次400至1000元之间，考虑到每周需要进行3次透析，一个患者每年的费用大约在6.24万至15.6万元之间；肾移植一次性手术费60万，后续免疫抑制剂使用8万/年。而耐赋康单疗程的费用约为14.88万元。如果患者最终进入透析阶段，考虑到延缓12.8年肾衰竭的效果，也就是相当于，1.1万元买一年延缓进入终末期肾病，总体能够节省约100万元。另一方面，患者接受治疗后的潜在产出提高。透析情况下病人每周都要来医院几次，一次4个小时，对生活、工作的节奏影响很大。而在耐赋康的治疗下影响会变小，工作的选择增多，产出也会随之增加。从药物经济学角度出发，耐赋康对于患者的价值不言而喻。或许，这也将彻底影响、重塑IgA肾病早预防的理念。已经有充分的数据证明，早期积极干预、治疗，是IgA肾病逆转肾衰竭的重要机会。因此，在耐赋康正式上市销售前，无论是在一些患者社群还是小红书等平台，都能够看到不少患者在找药。此前我们的干预治疗跟不上节奏，如今耐赋康已经改变了这一局面。尽管单价看似不低，但对于不少患者来说，现在希望更早的开始治疗。很显然，早用药、早获益，延缓疫病进展，这对于患者的价值，不能仅仅用金钱简单衡量。03优化资源配置的绝佳选择耐赋康的价值，不管在患者层面得到体现，还包括社会层面：对于医疗部门来说，耐赋康则是一个优化资源的绝佳选择。任何一个国家、地区，都会持续通过更低成本的治疗手段，来优化医疗资源配置。例如，国家普及宫颈癌防治知识、加速普及HPV疫苗，目的是保障妇女健康，最终减少宫颈癌的整体社会负担。健康中国2030战略明确提及，要实施慢性病综合防控战略。强化慢性病筛查和早期发现，同时到2030年，实现全人群、全生命周期的慢性病健康管理。对于IgA肾病这类慢性病来说，也必然是如此。慢性肾病患病率、致残致死率均较高，在患者未进入到终末期肾病之前，建立好规范的防控治疗体系，意义重大。不仅能极大提高患者生存状况，更能减少整体社会负担。站在社会层面来说，耐赋康在优化医疗资源配置作用十分突出。终末期肾病作为一项需要终生替代治疗的严重慢性非传染性疾病，其患者一方面对医疗资源依赖度高，若未换肾需终身替代治疗；另一方面占有医疗费用总量大，占用较多的住院资源。医疗费用层面，目前各地医保政策不一，整体对患者透析治疗费用报销在70%-90%间，终末期肾病患者已成为我国慢性非传染性疾病中整体医疗成本最高的疾病之一。这是一道不难算的计算题。作为全球发病率最高的国家，国内IgA肾病成人患者约400-500万。假设500万患者中30%将发展至肾衰竭，其中30%患者长期接受透析治疗，一年透析费用10万元，医保报销70%，算下来这部分费用也将达到315亿元，占2023年基本医疗保险总支出（2.8万亿元）的1.44%。而耐赋康能够通过延缓患者疾病进展、减少肾透析费用，进而降低国家慢性肾脏病医疗开支，提高医保基金的使用效率。显而易见，无论是基于迫切的临床需求，还是及时治疗带来的社会和经济学价值，耐赋康都符合国家医保倡导的“以人为本”、“支持创新”和“价值购买”的理念和逻辑。如果获得医保的“加持”，其在国内市场的放量速度将进一步加快，加速惠及患者的过程。04高效策略下的放量明牌适宜的价格和支付模式，主要是解决经济上的“可及性”，但作为一款新获批上市的药物，其药品可及性（即可获得性）同样重要。目前来看，云顶新耀采用线上、线下同时铺货的模式，解决了这个可及性的问题。首先，是线下采用聚焦核心医院的策略。在国内正式上市前，公司便开始商业化布局，预计今年会逐渐搭建120人的销售团队，覆盖600家主流医院，进而占据约60%的市场。罗永庆加入云顶新耀担任CEO后，通过重新锻造以“创业”为内核的企业文化，具体可以概括为“亲力亲为，自我驱动，务实高效，结果导向”，这也高度概括了公司的人才观。在这样的企业文化驱动下，云顶新耀树立了一个商业化标准，即好的商业化以最快的速度，最高效的投入惠及更多的病人。换句话说，在商业化层面，云顶新耀不采用人海战术，而是讲究精英作战、高效。这已经在依嘉的商业化过程中得到了验证。团队小而精，且保持足够高效，120人对应公司关于耐赋康今年4亿元的销售额指引，人均产出至少会达到300万元。其次，通过互联网医院的方式，能够解决对边远地区患者群体的用药问题。全国各地患者只要通过网上问诊就能买到耐赋康，线上销售会大大帮助放量。不少人可能认为，药价较高，不太有网上购药经验的患者会对远程购药心存疑虑。但实际上，可能并非如此。一方面，IgA肾病群体以年轻患者为主，对互联网等渠道相对了解，因此普遍存在前文所说的“人找药”现象。而耐赋康已于去年底成功在中国澳门商业化上市，其让众多内地患者看到了前所未有的治疗机会，因此在大陆正式上市前，已经有接近3万人进行了登记。这部分患者正在转化为耐赋康的用药群体。另一方面，互联网渠道改变了口口相传的难度。在小红书等渠道，我们能够看到许多患者会持续分享自己的治病心路历程，也包括对耐赋康购药、使用，这也会在一定程度上解决患者对于远程购药的担心。为了加速惠及更多患者，罗永庆曾表示，未来在保证可持续发展的情况下，将会通过进入医保、本土化生产的方式，进一步增加可支付性。在整体高效的商业化策略加持下，耐赋康的放量已然成为一张明牌。05吹响“亚洲宿命”终结号角耐赋康的持续进击，无疑是吹响了“亚洲宿命”的终结号角。今年3月和5月，耐赋康分别在新加坡和中国香港获批，云顶新耀还将积极推进其在韩国和中国台湾的新药上市批准，让更多的患者可以早治疗早获益。另外，云顶新耀还计划推出第一款具商业化价值的IgA肾病检测试剂。目前，IgA肾病确诊金标准为肾活检。肾活检必须要住院接受肾穿刺手术，该手术存在一定的风险和痛苦，患者对于进行肾穿刺术存在一定的顾虑，因此肾活检术不能反复实施用于评估病情进展和治疗效果。而云顶新耀开发的无创血清检测技术，能够极大的提高患者的依从性，进而解决IgA肾病诊断面临的现实问题，提升IgA肾病的诊断率，加速耐赋康的放量，进而终结所谓的“亚洲宿命”。在这个过程中，云顶新耀也将获得相应的商业回报。正如其CEO罗永庆所言，“专注于创造真正的价值，市场最终会给予相应的回报。”对于云顶新耀来说，耐赋康的价值一方面体现在其销售额层面。根据公司预测，耐赋康峰值销售有望达到50亿元。另一方面，更在于检验其国际化战略的核心价值。耐赋康在亚洲地区可及性的不断扩大，不仅是对云顶新耀商业化战略的执行检验，更是其为更多重磅在研产品国际化铺路的宝贵尝试。当然，耐赋康所承载的价值，将远超越云顶新耀在商业层面的成就，其在社会意义上具有更深远的影响。因为耐赋康不仅为亚洲患者带来了更安全、更有效的治疗选择，也是云顶新耀为人类健康事业谋福祉，践行“引领新药，光耀生命”使命的一次深刻诠释。来源 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Drug-resistant Acinetobacter baumannii is a growing global health threat and high priority pathogen needing new antibiotics, according to World Health Organization China NMPA approval based on comprehensive clinical data demonstrating robust activity of SUL-DUR against carbapenem-resistant bacterial strains In China, it is estimated there are approximately 300,000 cases of Acinetobacter infections and approximately 74% of them are carbapenem-resistant SHANGHAI & CAMBRIDGE, Mass. & WALTHAM, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Innoviva Specialty Therapeutics today announced that China’s National Medical Products Administration (NMPA) has approved Zai Lab’s New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older. The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics1. This press release features multimedia. View the full release here: “The NMPA approval of XACDURO demonstrates Zai Lab’s commitment to developing and delivering innovative therapies that address high unmet medical needs for patients in China and around the world,” said Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “The public threat of dangerous pan-resistant Acinetobacter infections requires urgent action, as treatment options are limited and mortality rates remain high. We believe XACDURO represents a major step forward in an area of significant patient need.” The NMPA approval of XACDURO in China is based on positive results from the ATTACK trial (NCT03894046), a global, Phase 3 registrational trial evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by A. baumannii. In the pivotal study, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a statistically significant improvement in clinical cure rates. XACDURO was well tolerated and exhibited a favorable safety pro the clinical program. Zai Lab participated in the global ATTACK study by enrolling patients in China. The Chinese patient cohort data confirm the findings of the global study regarding mortality and clinical response improvement. In May 2023, Innoviva Specialty Therapeutics announced that the U.S. Food and Drug Administration (FDA) approved XACDURO for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex – the first such FDA-approved pathogen-targeted therapy. “Six years ago, our two companies shared the vision of creating an innovative antibiotic therapy that could effectively address the global rise of drug-resistant Acinetobacter-related infections,” said Matt Ronsheim, PhD, President of Innoviva Specialty Therapeutics. “This approval is a testament to our strong and successful partnership with Zai Lab. Their invaluable collaboration during the Phase 3 trials provided the crucial data needed to move XACDURO through the regulatory process in China, just one year after it was approved in the U.S.” About XACDURO® (sulbactam-durlobactam) XACDURO® (sulbactam-durlobactam) is an intravenous drug developed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics, which is a combination of sulbactam, a β-lactam antibiotic, and durlobactam, a β-lactamase inhibitor, or BLI. XACDURO has been approved in the United States and mainland China for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Zai Lab has an exclusive license to develop and commercialize XACDURO in Greater China (mainland China, Hong Kong, Taiwan and Macau, collectively), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan. About Acinetobacter Baumannii Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients and often result in severe pneumonia and bloodstream infections.1 They can also infect other body sites, such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems. The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.2 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.3 Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO)4. In the U.S., there are an estimated 40,000 to 80,000 cases of Acinetobacter each year, and about 40 percent of those are carbapenem-resistant Acinetobacter.5,6 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii5. More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter7. About Acinetobacter Baumannii Infections in China and Eastern Asia Based on the 2022 Annual Report of CARSS (China Antimicrobial Resistance Surveillance System), approximately 300,000 Acinetobacter infections were reported in mainland China. According to the most recent CHINET report, resistance of Acinetobacter baumannii to the carbapenem class of antibiotics has risen to approximately 74% in China. Acinetobacter is also the most common pathogen that leads to hospital-acquired pneumonia and ventilator-associated pneumonia in China8. With commercially available therapy, the mortality rate is estimated to be 38% in China and 43% in Eastern Asia9. XACDURO® INDICATION & USAGE FROM U.S. PRESCRIBING INFORMATION Indication XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii- calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION FROM U.S. PRESCRIBING INFORMATION Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). For U.S. patients: please see the Full Prescribing Information for XACDURO. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious disease and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at . Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to the possible benefits, safety, and efficacy of SUL-DUR; the treatment of infections caused by Acinetobacter baumannii, including carbapenem-resistant strains; clinical trial data; and risks and uncertainties associated with drug development and commercialization. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC’s website at . About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here. Innoviva Forward-Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; the commercialization of XACDURO® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2023, and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (SEC) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Notes: (1) Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L., Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular Bacterial Pathogenesis Volume 7 – 2017: (2) Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: (3) Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext (4) World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: (5) Spellberg B, Rex JH. The value of single-pathogen antibacterial agents. Nat Rev Drug Discov. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. (6) Centers for Disease Control and Prevention. Antibiotic Resistance & Patient Safety Portal. “Carbapenem-resistant Acinetobacter,” May 2023: (7) Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. Supplementary Material. Supplementary appendix. (21)02724-0/fulltext (8) China Diagnosis and Treatment Guideline for hospital-acquired pneumonia and ventilator-associated pneumonia, 2018; (9) Mohd 2021Sazlly Lim S, et al. The global prevalence of multidrug-resistance among Acinetobacter baumannii causing hospital-acquired and ventilator-associated pneumonia and its associated mortality: A systematic review and meta-analysis. J Infect. 2019 Dec;79(6):593-600. View source version on businesswire.com: Contacts For more information: Zai Lab Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Innoviva, Inc. Investor Relations Argot Partners +1 212.600.1902 Innoviva@argotpartners.com Zai Lab Corporate Communications: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Innoviva Specialty Therapeutics Corporate Communications David Patti +1 908.421.5971 David.Patti@inva.com Source: Zai Lab Limited View this news release online at: