Lanifibranor

周末，众生药业的甲流特效药昂拉地韦通过国谈正式纳入国家医保目录。 有机构研究显示，进入医保的创新药平均销量增长达300%，峰值渗透率提升至非医保品种的5倍。目前甲流全国平均阳性率（检测率）高达45%，众生药业昂拉地韦片此次成功纳入医保，不但是甲流患者的福音，对众生业绩的提拉不言而喻。 众生药业的昂拉地韦是目前全球最好的甲流特效药，2025年5月获批上市的昂拉地韦片（商品名：安睿威），它是全球首款针对甲型流感病毒PB2靶点的药物。针对儿童的三期仍在临床中。 昂拉地韦片是由众生药业携手钟南山院士团队共同研发的。昂拉地韦片18小时内即可快速缓解全身症状，24小时病毒转阴。在抗病毒活性上，分别是玛巴洛沙韦（由日本盐野义制药公司完成初始研发，后与罗氏制药合同推进研发和商业化）的50倍以上、奥司他韦（由瑞士罗氏制药研发）的1000倍以上，对两种传统药物的耐药株均表现出强大抑制能力。 流感药日本的玛巴在中国市场2年销售额20亿，昂拉地韦抗病毒能力是玛巴的50倍。奥司他韦也已经被证实出现了耐药性。而且昂拉地韦已经纳入了国家医保目录，国产替代势在必行。。。 目前众生价值是被严重低估的。很多人还没意识到众生药业已经从传统中药行业赛跨入了创新药赛道。 除了呼吸管线的创新药之外，众生药业在代谢领域还有更重磅的药物：RAY 1225减重药和zsp1601肝病药。 RAY 1225减重药 这两款药都在三期临床中，RAY1225数据对标礼来的替尔泊肽（礼来万亿市值，一半营收来自替尔泊肽），那么众生药业这款药一旦成功，是不是价值几千亿？ RAY1225是全球首款两周超长效GLP-1/GIP双激动剂，Ⅱ期数据显示减重达标率（≥10%）达75.6%，优于替尔泊肽（71.9%），且胃肠道副作用更小。 RAY1225对肥胖合并高尿酸血症/痛风患者的治疗模式带来三重变革，其核心价值在于同步解决多重代谢异常，打破“肥胖-高尿酸-痛风”的恶性循环。 目前全球尚无既能高效降尿酸又能显著减重的药物上市。即使是近年来大热的GLP-1受体激动剂，司美格鲁肽在减重同时仅能降低尿酸6.5%，替尔泊肽的尿酸降幅也仅有9.2%，均未达到理想水平。RAY1225在II期研究中展现的“《21.8%》”尿酸降幅，不仅填补了临床空白，更重新定义了代谢综合征的治疗标准。 zsp1601肝病药 zsp1601这款原创药更是被市场看好，竞争优势：全球唯一进入临床的泛PDE抑制剂，覆盖炎症-纤维化双通路。ZSP1601片作为国内NASH（非酒精性脂肪性肝炎）领域首个进入临床的创新药，凭借其独特机制和早期临床数据，有望成为填补治疗空白的关键药物。 NASH管线ZSP1601 片是具有全新作用机制的治疗代谢功能障 碍相关脂肪性肝炎(MASH)的一类创新药，为国家重大新药 创制项目，也是首个完成健康人药代及安全性临床试验的用 于治疗 MASH 的国内创新药项目。目前已完成的 Ib/IIa 期临 床试验结果表明，在 4 周的治疗下，ZSP1601 片明显地降低 了 ALT、AST 等肝脏炎症损伤标志物，同时多个纤维化相关生物标志物也有降低趋势，提示其具有改善肝脏炎症、坏死的 潜力及抗纤维化的作用，研究结果已发表在自然杂志子刊 《Nature Communications》。该项目正在开展 IIb 期临床试验，2026年1月读出数据。 全球及中国NASH市场规模 1、全球：2024年市场规模约100亿美元，预计2030年达160亿美元（CAGR 8.5%）。 2、中国：患者约4000万，2024年市场规模约30亿元，预计2030年突破100亿元（CA­GR 20%）。 竞争格局/优势 国际：Resmetirom（2024年FDA获批）、Inventiva的IVA337（Ⅲ期）、Madrigal的Resmetirom（已上市）。 国内：众生药业（ZSP1601）、歌礼制药（TVB-3166）、拓臻生物（TERN-501）等约10家企业布局，但仅ZSP1601进入IIb期临床。 可以说，众生药业的想象空间超乎想象......后续我们将继续跟踪。

Daix (France), New York City (New York, United States), November 28, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Thursday November 27, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Pierre Broqua. Mr. Pierre Broqua proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mr. Eric Duranson, as secretary of the general meeting. All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 5th resolution, which had been the subject of a negative recommendation by the Board of Directors. The 5th resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company. Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for the Chief Executive Officer as described in the Combined Shareholders' Meeting notice brochure available on the Company's website under the heading “Shareholders' Meeting”. Total number of shares composing the share capital: 191 077 498Total number of shares with voting rights: 191 027 885 Ordinary partExtraordinary partShareholdersSharesVotesShareholdersSharesVotesShareholders present45 612 54411 224 768 45 612 54411 224 768 Proxy to third parties000000Proxy to the Chairman2292 321 1212 332 9562292 321 1212 332 956Mail votes20899 868 766106 050 95020899 868 766106 050 950TOTAL441107 802 431119 608 674441107 802 431119 608 674Quorum56,432 %56,432 %VOTE RESULTSOrdinary ResolutionsResolutionResultForAgainstAbstentionTotal number of votes castTotal number of votes castProportion of represented share capitalNon- voting votesInvalid votesQuorumVotes%Votes%Votes%1Adopted107 333 13289,783 %12 214 67310,217 %60 869-119 547 805107 802 43156,418 %0056,432 %2Adopted96 132 88588,746 %12 190 14511,254 %61 196-108 323 030102 190 20753,481 %11 224 448056,432 %3Adopted107 276 65189,711 %12 304 09510,289 %27 928-119 580 746107 802 43156,418 %0056,432 %6Adopted119 450 23599,953 %56 2470,047 %102 192-119 506 482107 802 43156,418 %0056,432 %VOTE RESULTSExtraordinary ResolutionsResolutionResultForAgainstAbstentionTotal number of votes castTotal number of votes castProportion of represented share capitalNon- voting votesInvalid votesQuorumVotes%Votes%Votes%4Adopted107 410 78689,888 %12 083 34210,112 %114 546-119 494 128107 802 43156,418 %0056,432 %5Rejected49 750 40841,642 %69 722 05558,358 %136 211-119 472 463107 802 43156,418 %0056,432 % About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairs media@inventivapharma.com +1 202 499 8937ICR HealthcareMedia Relations Alexis Feinberg inventivapr@icrhealthcare.com +1 203 939 2225ICR HealthcarePatricia L. BankInvestor relationspatti.bank@icrhealthcare.com +1 415 513 1284 Important Notice This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s cash resources, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial of lanifibranor in MASH , including duration, timing and costs, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the potential therapeutic benefits of lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva, and the absence of material adverse events. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of its lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners’ clinical trials may not support Inventiva's and its partners’ product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners’ control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, international trade relations, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Results General Meeting November 2025 - EN - 11 28 2025