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Press Release Nicox and Kowa Sign Key Agreement worth up to €191.5 million for Exclusive Rights to Glaucoma Treatment NCX 470 in U.S. and all Unlicensed Territories €7.5 million upfront, with total potential development and commercial milestones, depending on Denali trial results, of up to €191.5 millionTiered royalties of up to 20% in the U.S., starting at a minimum of 8%, with tiered high single to double digit royalties elsewhere Kowa will assume full responsibility for the preparation and filing costs of the U.S. NDA for NCX 470, and all future development and commercial costsProvides flexibility for Nicox to explore future growth options July 17, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the signing of a major new agreement concerning NCX 470 with Kowa Company, Ltd., a Japanese company with a global pharmaceutical business engaged in ground-breaking research, development and marketing. The agreement, worth up to €191.5 million, grants Kowa exclusive rights to develop and commercialize NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension in the U.S. and all other territories of the world excluding Japan, China, Korea and Southeast Asia. Kowa already has a license to NCX 470 for Japan, where it is preparing to enter a Phase 3 clinical trial. NCX 470 is also licensed to Ocumension Therapeutics for China, Korea and Southeast Asia.Under the terms of the agreement, Nicox will receive an upfront payment of €7.5 million on signing. Additional near-term milestones payments are due on positive topline results from the Denali clinical trial, expected mid-August to mid-September 2025, and on submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial, plus royalties up to 20% in the U.S. “This new agreement with our existing partner, Kowa, is a major endorsement of NCX 470’s potential in glaucoma and marks a major step forward in strengthening Nicox’s financial position. With NCX 470 now globally licensed, we are focused on delivering the Denali Phase 3 results, which we anticipate releasing mid-August to mid-September.” said Gavin Spencer, Chief Executive Officer of Nicox. “The revenue stream we expect from NCX 470 gives us the flexibility to pursue future growth opportunities, leveraging our expert U.S. ophthalmology development team.”“Expanding our collaboration with Kowa, who now becomes our key commercial partner for NCX 470 in the U.S and other major territories, is based on a very successful history of working together. We believe that Kowa has recognised the significant market potential of NCX 470, which we expect to be confirmed with the upcoming results from the Denali Phase 3 trial.” said Emmet Purtill, VP Business Development of Nicox. “We look forward to continuing to work with Kowa as well as our partner for the Chinese market, Ocumension, to bring NCX 470 to glaucoma patients worldwide.” Details of the AgreementUnder the terms of the exclusive licensing agreement, Kowa is granted rights to develop and commercialize NCX 470 worldwide, excluding the territories already licensed to Ocumension (China, Korea and Southeast Asia) and to Kowa itself (Japan). The collaboration will be managed by a Joint Steering Committee. Key terms include:Milestone PaymentsNicox will receive an upfront payment of €7.5 million upon signing the agreement. Additional near-term milestones payments are due on positive topline results from the Denali Phase 3 clinical trial, expected mid-August to mid-September 2025 and upon submission of an NDA to the FDA, which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial. Royalty PaymentsKowa will pay Nicox tiered royalties in the U.S. which could reach 20% of net sales. Depending on the results of the Denali clinical trial, royalties due in the U.S. will initially be 8% or 10%. Outside of the U.S., Nicox will receive tiered royalties ranging from single-digit to double-digit percentages. Nicox ObligationsNicox is responsible, at its cost, for generating the remaining development data necessary for the NDA submission to the FDA (principally pharmacokinetic studies) and will support Kowa in preparation of the NDA.Kowa ObligationsOther than the activities for which Nicox is responsible, Kowa is responsible, at its cost, for all development, regulatory and commercialization activities for NCX 470 in the licensed territories.Cash Runway and Debt RepaymentAs disclosed in the amended bond agreement announced on 14 October 2024, 70% of the upfront payment from Kowa will be used to partially reimburse Nicox’s debt, reducing the total debt to €9.6 million. Based on the current cash position (estimated1 at €5.9 million as of 30 June 2025) expected revenue and anticipated milestone payments, Nicox forecasts that it has over 12 months of cash at the date of signature of this agreement. Glaucoma Pharmaceutical MarketThe glaucoma pharmaceutical market is estimated at over $7 billion2, with the U.S. market accounting for around 40%, growing globally at around 3% to 5% CAGR and the number of patients globally is estimated to be around 80 million3. About NCX 470NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development in the U.S., China and Japan (clinical trial authorisation granted for Japan) for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last patient in Denali has completed their final visit, and the results are expected mid-August to mid-September 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. A separate Phase 3 program is underway to support Japanese approval, with the first patient expected to be enrolled in H2 2025. NCX 470 is exclusively licensed to Ocumension Therapeutics in China, Korea and Southeast Asia, and to Kowa in the rest of the world.About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Non-audited figure 2 Antiglaucoma Drug Market Size, Trends, Growth Report 2034; Glaucoma Therapeutics Market Report by Drug Class (Prostaglandin Analogs, Beta Blockers, Alpha Adrenergic Agonists, Carbonic Anhydrase Inhibitors, Combination Drugs, and Others), Indication (Open Angle Glaucoma, Angle Closure Glaucoma, and Others); Glaucoma Therapeutics Market Size, Growth, Analysis - 20313 World Glaucoma Association website: World Glaucoma Association » What is glaucoma? Attachment EN_NCX470KowaGlobalLicenseJuly2025_PR_FINAL

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。每年的7月8日是世界过敏性疾病日，这一由世界过敏组织（WAO）发起的全球性倡议，旨在提升公众对过敏性疾病的认知，推动早期预防与规范治疗。当前，随着环境变化与生活方式改变，全球过敏性疾病发病率持续攀升，已成为21世纪最普遍的慢性疾病之一。据摩熵医药数据统计，全球有2.4亿-5.5亿人可能发生食物过敏；超过4亿人受到过敏性鼻炎的困扰 ；大约有3亿人患有哮喘，每年更是有超过40万人因此失去生命，中国发病率达37.3%，且呈年轻化趋势，严重威胁着人们的生活质量与公共健康。01 过敏——免疫系统的“过度防御”过敏是免疫系统对无害物质（如花粉、尘螨、食物）的异常反应。当过敏原进入人体，免疫系统会释放组胺等化学物质，引发呼吸道、皮肤、消化道等多系统症状：呼吸道：频繁打喷嚏、鼻塞、流涕、哮喘，严重者出现喉头水肿；皮肤：荨麻疹、湿疹、瘙痒性红斑；消化道：恶心、呕吐、腹泻；全身反应：过敏性休克（需立即就医抢救）。过敏原种类繁多，包括吸入性（尘螨、花粉）、食入性（海鲜、坚果）、接触性（金属、化妆品）及药物性（青霉素）等。环境恶化、生活方式改变及遗传易感性是过敏高发的主因。02 从症状控制到长期管理的抗过敏药物目前，过敏治疗以“四位一体”方案为核心，即预防、药物、免疫治疗与患者教育协同配合。常用药物包括：1. 抗组胺药：通过阻断组胺H1受体缓解症状，是过敏性鼻炎、荨麻疹的一线用药。其中代表药物包括第二代抗组胺药物氯雷他定、西替利嗪，不易透过血脑屏障，嗜睡等副作用较少，安全性高，适合儿童、驾驶员及需集中注意力者；此外还包括新型药物（如比拉斯汀片），比拉斯汀片（力敏能®）于2023年获NMPA批准上市，用于荨麻疹治疗，30分钟快速起效，疗效持续24小时，对大脑H1受体占用率低，对认知功能影响小，适用于青少年及老年患者，特殊人群（如肝肾功能不全者）亦可安全使用。截图来源：摩熵医药全球药物研发数据库2. 糖皮质激素：具有强效抗炎作用，适用于中重度过敏或局部治疗无效者。包括吸入制剂（如用于哮喘的布地奈德）、鼻用制剂（如过敏性鼻炎一线用药糠酸莫米松）、外用制剂（如用于特应性皮炎的丁酸氢化可的松乳膏）；除局部用药外，还有短期用于严重过敏反应（如喉头水肿），需严格遵医嘱以避免长期使用风险的口服/注射药物。其中糠酸莫米松是由默沙东原研的局部高效抗炎药，作为鼻用制剂时，可适用于变应性鼻炎（季节性/常年性）、鼻息肉（术后预防复发）的治疗，而作为外用制剂时，可用于治疗中轻度特应性皮炎、银屑病（斑块型）、接触性皮炎、神经性皮炎。据摩熵医药全国医院（全终端）销售数据库显示，糠酸莫米松在近年来的销售额呈逐年上升趋势，2023年全国医院（全终端）销售额达15.76亿元，2024年销售额约达16.33亿元，增长率超3.5%，市场潜力巨大。截图来源：摩熵医药全国医院（全终端）销售数据库3.免疫调节剂：例如用于眼角膜移植术后免疫排斥反应的环孢素滴眼液；还有针对IgE的生物制剂，可显著降低过敏性哮喘发作频率的奥马珠单抗，用于中重度过敏性哮喘，可降低50%急性发作风险。4.急救药物：肾上腺素自动注射器（如EpiPen），是过敏性休克首选急救药，需随身携带。03 前沿突破：从基因编辑到细胞疗法随着免疫学研究深入，过敏治疗也正迈向精准化与个性化。1. 基因修饰Treg细胞疗法调节性T细胞（Treg）是维持免疫平衡的关键。传统Treg疗法存在亚型选择困难、临床扩展受限等问题，而基因编辑技术可定向改造Treg细胞，使其特异性抑制过敏相关免疫反应。例如，针对花生过敏的儿童，基因修饰Treg细胞疗法可诱导长期耐受，减少意外暴露风险。2. CAR-T细胞疗法拓展应用嵌合抗原受体T细胞（CAR-T）疗法在肿瘤领域取得突破后，正逐步探索过敏性疾病治疗。2024年研究显示，针对过敏原特异性B细胞的CAR-T疗法可清除体内过敏抗体（IgE），从根源阻断过敏反应。目前该技术仍处于临床前阶段，但为顽固性过敏提供了新方向。3. 早期干预策略花生过敏是儿童最常见的食物过敏之一。2024年《Journal of Allergy and Clinical Immunology》发表的随机对照试验显示，对1-4岁花生过敏儿童进行舌下免疫治疗（SLIT），36个月后脱敏率显著高于安慰剂组，且早期治疗可降低未来严重过敏反应风险。这一发现支持过敏治疗“越早越好”的理念。04 科学防治：从日常管理到紧急应对首先就是要规避过敏原：如定期清洁床品、使用防螨寝具；花粉季关闭门窗，外出佩戴口罩；仔细阅读食品标签，避免误食过敏原。此次要增强免疫力：包括均衡饮食，补充锌、维生素D等微量元素；规律运动，尽可能保证每周150分钟中等强度有氧运动；注重心理上的调节，通过冥想、瑜伽缓解压力。最后是紧急情况的处理：过敏性休克是危及生命的急症，需立即注射肾上腺素并就医。患者应随身携带肾上腺素自动注射器（如EpiPen），并确保家人、同事掌握使用方法。结语过敏不是“矫情”，而是免疫系统的“误判”。从经典药物到基因编辑，从症状控制到根源治疗，科学防治正在不断突破过敏防治的边界。世界过敏性疾病日不仅是一个提醒，更是一个行动的号召。让我们从科学认知开始，通过精准预防、规范治疗与社会支持，共同构建一个远离过敏威胁的健康未来！END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！