Zoliflodacin

Zoliflodacin, an investigational single-dose oral antibiotic for uncomplicated gonorrhea, to be featured in oral presentation with key subset analyses from pivotal global Phase 3 trial Waltham, MA – October 20, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), will share new data on zoliflodacin during the Infectious Disease Society of America’s IDWeek 2025 annual meeting in Atlanta, GA, October 19-22, 2025. Zoliflodacin is a first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea. Three sets of data will be presented, including an oral presentation and two poster presentations: Poster Presentation P-1206 Date: Tuesday, October 21, 2025 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B4-B5 Title: Association of Sex Assigned at Birth and Sexual Orientation with Antimicrobial Susceptibility of Baseline Neisseria gonorrhoeae Isolates from Participants Recruited in the Global Zoliflodacin Phase 3 Randomized Controlled Trial Poster Presentation P-1207 Date: Tuesday, October 21, 2025 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B4-B5 Title: In Vitro Activity of Zoliflodacin against Neisseria gonorrhoeae Isolates Collected in 2022 from The United States Oral Presentation Date: Wednesday, October 22, 2025 Time: 1:45-3:00 Location: B211-B212 Title: Subgroup Analyses of Microbiological Cure Rates by Baseline Zoliflodacin MIC and Susceptibility to Ciprofloxacin in Participants from the Global Zoliflodacin Phase 3 Randomize Controlled Trial The oral presentation on Wednesday, October 22, describes key subgroup findings from the pivotal Phase 3 trial, including observation of high microbiological cure rates across urogenital, rectal, and pharyngeal sites in infection caused by Neisseria gonorrhoeae with a zoliflodacin MIC of ≤0.25 µg/mL. Among participants with urogenital infections who received zoliflodacin, ciprofloxacin-resistant strains had a cure rate of 96.6% (346/358; 95% CI: 94.2–98.3) and ciprofloxacin-susceptible strains had a cure rate of 97.4% (113/116; 95% CI: 92.6–99.5). High cure rates were consistent regardless of infection site. In poster P-1206 to be presented on Tuesday October 21, a demographic analysis of baseline isolates from the zoliflodacin Phase 3 trial found that while azithromycin resistance was higher in isolates from men who have sex with men (MSM), zoliflodacin MIC values were comparable across all patient groups, including females, MSM and heterosexual men (HSM). These findings underscore the in vitro activity of zoliflodacin across antibiotic-resistant N. gonorrhoeae from a broad range of sources and support the continued development of zoliflodacin as a single, oral dose treatment for uncomplicated gonorrhea. “Findings from our analyses reinforce our initial conclusions and support the development of zoliflodacin as a potentially transformative treatment for gonorrhea, including infections caused by resistant strains,” stated Dr. David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics. “Achieving high and consistent cure rates across urogenital and extra-genital sites, resistance profiles, and patient demographics represents a significant opportunity to address the growing global threat of antibiotic-resistant Neisseria gonorrhoeae.” Complementary analyses presented in poster P-1207 further support the potential of zoliflodacin as a broadly effective treatment for gonorrhea. In vitro susceptibility testing of Neisseria gonorrhoeae clinical isolates collected in the U.S. during 2022 confirmed that zoliflodacin potency remained consistent compared to prior surveillance years (2020–2021), including against antibiotic-resistant strains and isolates from both male and female patients. “The results from all three presentations show that zoliflodacin mechanism of action is differentiated from fluoroquinolones with cure rates remaining high in the face of antibiotic resistance,” said Dr. Sarah McLeod, Senior Director, Innoviva Specialty Therapeutics. About Zoliflodacin Zoliflodacin is an investigational, first-in-class oral antibiotic from the spiropyrimidinetrione class, currently in development as a single-dose treatment for uncomplicated gonorrhea, including strains resistant to current first-line therapies. Zoliflodacin inhibits bacterial DNA gyrase, an essential enzyme for bacterial survival. Zoliflodacin mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae. Non-inferiority was demonstrated in the global Phase 3 trial (NCT03959527) where a single oral dose of zoliflodacin was compared to ceftriaxone plus azithromycin for uncomplicated urogenital gonorrhea. This trial was sponsored by the Global Antibiotic Research and Development Partnership (GARDP). The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows FDA Priority Review and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. 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). ZEVTERA® (ceftobiprole) is an FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). The Company’s clinical pipeline includes zoliflodacin, an investigational antibiotic for uncomplicated gonorrhea, which is being developed in collaboration with the Global Antibiotic Research and Development Partnership (GARDP), and is currently under review by the U.S. Food and Drug Administration. For more information about Innoviva Specialty Therapeutics, please visit here. 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; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® 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 beyond the existing respiratory portfolio); 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). 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, 2022 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. 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. Media Contact: David Patti Corporate Communications Innoviva, Inc. david.patti@inva.com Investor Contact: Eleanor Barisser Eleanor.barisser@inva.com

2025年，美国FDA的新药审批节奏明显放缓，全年批准数量或将创下近三年以来的新低。 尽管批准数量有所放缓，但今年已获批的新药在肿瘤精准治疗、罕见病治疗以及药物作用机制多元化等方面，展现出显著的创新质量。 本文将从批准趋势、重点领域突破、待批重磅药物等角度，系统梳理2025年FDA新药批准的总体图景。 01 审批数量“断崖式”下降，创近三年新低 根据Endpoints News的统计，FDA今年迄今已批准42种新药和生物制剂，剩余约16项审批决定将在2026年前完成。 不过，即便剩余申请全部获批，2025年全年总量也仅能达到58种左右，远低于2023年的80种和2024年的69种。 将时间线继续向前推，2020年-2022年，FDA分别批准了61种、63种以及51种新药和生物制剂。由此看来，2025年或将成为近五年以来，FDA审批数量次低水平的一年。 尽管审批数量下降，但数量并不完全等同于创新质量。真正的价值在于其是否解决了未被满足的临床需求。例如，2025年前三季度批准的32款新药中，包含多款First-in-class（首创机制）和孤儿药，显示出“少而精”的特点。 值得注意的是，FDA发言人明确表示，药物审评与审批未受民主党主导的政府停摆影响，相关工作仍在持续推进。不过，目前还不清楚数千名FDA工作人员的流失，是否在今年减慢审批进程方面发挥了作用。 如果申请继续以目前的速度被延迟，今年的批准数量不太可能达到历史高位。早在7月，FDA专员Marty Makary在接受CNBC采访时表示，该机构“可能在2025年创下批准数量的新纪录”。FDA发言人并未对这一预测是否仍然有效发表评论。 02 肿瘤与罕见病：创新药物的主战场 据FDA新药图鉴统计显示，2025年1-9月FDA共批准上市32款新药。 按季度看，Q1季度共批准上市7款新药，Q2季度共获批9款新药，Q3季度共获批16款新药。 按分子类型看，前三季度共获批小分子药物22款，生物大分子药物10款。其中，10款生物大分子药物中，包括5款单克隆抗体药物、2款抗体药物偶联物（ADC）、2款小核酸药物，以及1款双特异性抗体药物。 按获批适应症看，包括肿瘤12款、罕见病11款、感染性疾病2款、眼部疾病2款、皮肤病2款、肺部、免疫和神经性疾病各1款。 涉及新药认定包括孤儿药（18/32）、First-in-class（17/32）、突破性疗法（10/32）、首轮批准、优先审批及快速通道。此外，4款药物带黑框警告上市。 总体而言，2025年FDA现批准的新药呈现出肿瘤治疗继续向精准化、免疫化与联合化深入；罕见病药物开发蓬勃，许多既往无药可治的疾病迎来了首款疗法；药物作用机制日益多元，技术平台丰富化等研发趋势。 这些进展共同体现了医药研发从传统机制向前沿技术平台的拓展，为治疗提供了更多可能性。 03 年底冲刺：18款重磅新药待批 尽管2025年全年审批量遇冷，但在今年剩余的两个多月，仍有18款新药等待FDA的最终审批。这些待批药物涵盖了眼科、心血管、代谢疾病、抗感染等多个领域，其中不乏备受关注的重磅产品。 而这些药物的审评结果，将直接影响2025年最终的新药批准总量和创新成色。 以下为今年年底待批的18款新药产品： 10月20日：Glaukos的Epioxa，这是一种用于圆锥角膜患者的角膜疗法，无需去除角膜上皮； 10月23日：Sydnexis的SYD-101，一种用于儿童近视进展的低剂量阿托品眼药水； 10月26日：拜耳的elinzanetant，一种用于缓解中度至重度潮热（由更年期引起）的神经激肽1和神经激肽3受体拮抗剂； 11月18日：Arrowhead Pharmaceuticals的plozasiran，一种用于治疗高甘油三酯水平的RNAi药物； 11月28日：大冢制药的sibeprenlimab，用于IgA肾病； 11月30日：Kura Oncology的ziftomenib，用于治疗携带核磷蛋白1突变的成人复发或难治性急性髓系白血病； 11月30日：Ascendis Pharma的TransCon CNP，一种C型利钠肽的前药，用于治疗软骨发育不全患者； 12月5日：Axogen的Avance神经移植，一种用于桥接断裂周围神经的现成人类神经异体移植； 12月12日：BioCryst的Orladeyo口服颗粒，用于治疗遗传性血管性水肿儿童； 12月13日：Milestone Pharmaceuticals的etripamil鼻喷雾剂，用于治疗阵发性室上性心动过速患者； 12月15日：Innoviva的zoliflodacin，一种用于治疗12岁及以上成人和儿童单纯性淋病的口服抗生素； 12月16日：GSK的depemokimab，用于两种哮喘适应症； 12月16日：Aldeyra的reproxalap，用于缓解干眼症的体征和症状； 12月26日：Cytokinetics的aficamten，用于治疗梗阻性肥厚型心肌病； 12月26日：Omeros的narsoplimab，用于治疗造血干细胞移植相关血栓性微血管病； 12月30日：Vanda Pharmaceuticals的tradipitant，用于治疗胃轻瘫； 第四季度：Biohaven的troriluzole，用于治疗脊髓小脑性共济失调； 第四季度：三菱田边制药的帕金森病治疗药物。 总的来说，2025年FDA新药审批的“降温”，更多是周期性波动而非创新衰退。在研发成本高企、监管趋严、靶点竞争激烈的背景下，药企正从“追求数量”转向“追求质量”。 尽管全年批准总数可能下降，但First-in-class药物、罕见病突破和精准治疗的进展，依然为患者带来了新的希望。 参考资料： [1] FDA on pace for lowest number of new drug approvals since 2022.Endpoints News.October 13, 2025 03:30 PM EDTUpdated 04:01 PM FDA+. [2] 2025年：FDA已批准33款新药. 药事纵横. 2025-10-10. [3] 新药图鉴 | 2025年1-9月FDA批准上市32款新药可视化盘点，一图胜千言！FDA新药图鉴. 2025-10-01.