Unither Pharmaceuticals SASU

COURRIER PICARD - 2024年5月 - 亚眠专题 在亚眠的Unither Pharmaceuticals工厂，为Euroject项目而建的大楼正在顺利推进。 这个大楼将用于生产单剂量疫苗，特别是Covid的疫苗。第一条生产线预计将在2025年3月安装。目前，仅有一家美国公司也在开发类似的技术。 事实 Unither Pharmaceuticals成立于1993年的亚眠。 该公司生产无菌单剂量填充产品，如生理盐水，2023年共生产了40亿剂。同时，该公司也是非无菌液体（条形包装、瓶子、喷雾等）领域的专家。 作为全球单剂量药品的领导者，该公司预计2023年的销售额为4.5亿欧元。 该集团的产品销往约一百个国家，并在美国、法国、巴西和中国拥有八个生产基地。 该公司正在亚眠工厂建设一座新大楼，用于生产包括Covid在内的单剂量疫苗，这些疫苗在注射前会附上针头。亚眠工厂目前的面积为14,000平方米，扩建部分将增加6,000平方米。 只有美国公司ApiJect和Unither参与了这种单剂量疫苗的新技术，市场估计为10亿剂。 2023年4月在亚眠北部工业区Unither Pharmaceuticals工厂一座新的6,000平方米大楼正在顺利推进。作为Euroject项目的一部分我们将投资9000万欧元（编者注：欧洲投资计划，旨在欧洲发生流行病时提高产能），其中3480万欧元由法国政府提供。新大楼将容纳三条单剂量疫苗生产线。这些生产线已经订购，第一条将在2025年3月安装，第二条和第三条将分别在同年的9月和12月安装。亚眠工厂的负责人Johann Cauvez解释说：“一旦我们获得签订生产的合同，可能会立即安装另外三条生产线，除了这座新建筑，还宣布了其他投资，包括用于物流的新仓库和升级码头”。 按计划进行 自 2023 年底以来，新建筑已完成封闭和覆盖，并与能源和流体系统连接，同时内部装修也已开始。工业设备将在未来几周内安装完毕。未来的生产线将包括三个工业流程阶段：储罐将接收产品。亚眠生产基地生产 99% 的单剂量包装药品。厂长解释说：“对于疫苗，原材料将由 Unither 制药公司接收和包装，该公司还可能进行稀释等处理阶段"。下一阶段是在包装部完成生产周期之前灌装无菌单剂量小瓶。 在美国只有一个竞争对手 通过Euroject项目，Unither Pharmaceuticals实际上是世界上唯一掌握这种制造技术的公司。工厂经理说:“我们是欧洲唯一拥有这种专业知识的公司，唯一的竞争来自美国。””美国竞争对手ApiJect，他们在一定程度上启发了我们，因为将剂量和针头结合起来的想法由来已久。我们曾经和这个美国团队讨论过他们的技术许可，但一旦我们开始讨论国家或欧洲主权问题，拥有一个美国许可的产品就变得有点困难。由于我们在BFS（见其他地方）方面拥有丰富的经验，我们决定设计一个简单的系统，以便在大流行病情况下在国家或欧洲领土上生产。”Unither Pharmaceuticals的董事长Éric Goupil在2023年3月告诉Courrier picard。Johann Cauvez也表示，鉴于市场规模估计为每年10亿剂，我们有这个竞争对手是件好事。 亚眠 Unither Pharmaceuticals 工厂的经理Johann Cauvez: 对于针头，我们首先与Needle concept进行小批量生产。当我们转向更大量时，我们将与印度供应商合作。 亚眠Unither Pharmaceuticals工厂的经理Johann Cauvez：“为了说服制药和药品行业集团，Unither Pharmaceuticals在这种带针头的单剂量注射器的开发过程中进行了大量的研究和测试。我们与位于比亚里茨的Needle concept合作开发，他们生产针头，而我们负责单剂量。每个无菌的0.6毫升单剂量将手动连接到针头上，并包装在泡罩包装中。”经理解释说。“对于针头，我们首先与Needle concept进行小批量生产。当我们转向更大量时，我们将与印度供应商合作。”负责人继续说。 预计到2027年，Euroject项目将在这座新设施中创造约200个就业机会，该设施将能够每年生产10亿单剂量疫苗和生物制品。 Unither, 一个在亚眠开始的故事 作者：A. B. Unither于1993年在亚眠成立，距今已有32年。该公司正在开发BFS（吹塑、灌装、密封）技术，该技术涉及在制造过程中通过加热模具中的材料，形成、填充和密封无菌单剂量容器，如生理盐水或疫苗。Unither集团在全球拥有约2,000名员工，其中法国有1,000名，亚眠有350名。在法国有四个工厂，包括亚眠、库唐斯（(Manche）、甘纳（Allier）、科洛米耶（Haute-Garonne）和波尔多的创新中心。在美国纽约罗切斯特、巴西有两个工厂，中国南京也有一个工厂。 在英国诊所进行的疫苗单剂量试验 Unither Pharmaceuticals开发的带针头的疫苗单剂量在其开发过程中经历了许多验证阶段。首先，必须保证疫苗在填充到单剂量容器后的有效性，这些容器的材料在制造过程中会被加热。每个剂量的密封性也在三个大气压下进行了检查，同样在按下单剂量的疫苗后也经过了检查。当使用连接器将针头连接到单剂量时，再次检查了相同的密封性。注射时间也被测量，并保持在标准范围内。亚眠Unither Pharmaceuticals的负责人Johann Cauvez说到：“所有这些研究都可供我们的客户使用，并已在两种Covid疫苗上进行，一种带有Spike蛋白，另一种是减毒活疫苗。” 除了这些研究，2023年4月，一个由八名从业者组成的团队在英国的一家诊所成功进行了试验。至于使用说明，Unither Pharmaceuticals已经联系了Amiens-Picardie大学医院的SimuSanté（一个健康模拟教学中心）来制定操作说明。 联系我们以获取更多信息! 优尼特尔制药 Single Best Way to Deliver

BIOPHTA raises 6.5 million Euros Seed Funding to transition its New Standard of Care for Eye Diseases to the Clinical stage The seed round was co-led by UI Investissement (via the Pertinence Invest 2 Fund, advised by Mérieux Equity Partners), Elaia and GO Capital, with participation from one major ophthalmology player, Unither Pharmaceuticals and HTL Biotechnology, the global leader in production and development of pharma grade biopolymers. Proceeds to fund first-in-human trial of breakthrough topical Ophthalmic Inserts in the treatment of Glaucoma and to advance a second program in Macular Edema, thus targeting the two leading causes of blindness. BIOPHTA's unique technology is poised to disrupt the treatment of both the front- and back-of-the-eye. The company is developing the first continuous topical retina treatment to free patients from the need for intraocular injections. Paris, June 3, 2024. BIOPHTA, a preclinical biotech company developing a game-changing technology for the treatment of eye diseases, has just closed a € 6.5 million Seed round to bring its patented technology to clinical development. This funding round was led by leading European VCs – UI Investissement (via the Pertinence Invest 2 Fund, advised by Mérieux Equity Partners), Elaia and GO Capital – as well as one major ophthalmology player, Unither Pharmaceuticals and HTL Biotechnology, the global leader in production and development of pharma grade biopolymers. With a first program in the treatment of Glaucoma (Phase 1 in 2025, $8.7 billion market) and a second program in Macular Edema (Phase 1 in 2026, $9.6 billion market), BIOPHTA is currently targeting the two leading causes of blindness. Compliance is the #1 unmet medical need in ophthalmology Each year, approximately 1.3 million people worldwide become blind and another 36 million become severely visually impaired. The World Health Organization (WHO) estimates that 1 billion of the world's cases of vision impairment could be prevented by adhering to currently available treatment regimens of self-administered daily eye drops or invasive intraocular injections1. However, the under-treatment rate in ophthalmology is still high, with about half of the patients not adhering to their treatment regimens for eye diseases.2,3 BIOPHTA overcomes adherence issues encountered with traditional eye drops as well as the high cost and invasiveness of frequent and painful intraocular injections. With this unique topical, non-invasive and self-administered therapy that provides continuous drug microdosing for 7 days, BIOPHTA improves the efficacy of eye treatments. Breakthrough biopolymers technology that releases drugs on the eye BIOPHTA has developed a new standard of care for ocular diseases based on its “thiomer” biopolymers technological platform, with a strong intellectual property position. BIOPHTA’s ophthalmic insert (3mm diameter mini-tablet) is simply placed on the surface of the eye as easily as a contact lens. Once applied, BIOPHTA’s ophthalmic insert transforms into a hydrogel pellet that stays in place on the eye without moving, and delivers a continuous and controlled low dose of drug for 7 days. It's the first time a therapy has such innovative technological features to disrupt both front-of-the-eye as well as retina treatments. “With this funding, we are taking a major step towards the clinical validation of our technologyin Glaucoma and then in Macular Edema. Our ambition does not stop here, and we remain fully dedicated on bringing sight-saving therapies to all patients in need of simple and efficient treatments,”said Jean Garrec, founder and CEO of BIOPHTA. "Our Seed investors syndicate brings not only the financial resources, but also complementary expertise and networks that will help structure the company. They will play a critical role in our development.” The consortium of VC's with UI Investissement (via the Pertinence Invest 2 Fund, advised by Mérieux Equity Partners), Elaia and GO Capital, commented: "The technology developed by BIOPHTA is truly a game changer for the millions of patients worldwide who struggle with inadequate treatments for their eye diseases. Our VC syndicate is excited to support BIOPHTA's growth.” “We are delighted to support BIOPHTA and bring our respective expertise to this disruptive innovation in ophthalmology, which will improve patients' lives,” statedFrançois Fournier, CEO of HTL Biotechnology and Eric Goupil, CEO of Unither Pharmaceuticals. *** About BIOPHTA BIOPHTA is a preclinical-stage biotech company developing a game-changing technology for the treatment of eye diseases. With its first program in the treatment of Glaucoma (Phase 1 in 2025, $8.7 billion market) and a second program in Macular Edema (Phase 1 in 2026, $9.6 billion market), BIOPHTA is currently targeting the two leading causes of blindness worldwide. The company's unique ophthalmic insert technology could target many indications as it can treat additional diseases both in the front- and back-of-the-eye, such as allergic conjunctivitis (120 million patients), dry eye syndrome (150 million patients), post-cataract surgery (28 million surgeries/year), age-related macular degeneration (196 million patients). BIOPHTA was co-founded in 2020 by 2 pharmacists, Jean Cuiné (Universities of Strasbourg and Monash) and Jean Garrec (Universities of Rennes I and Paris V), who together cumulate over 40 years of experience in ophthalmology and drug development. The initial development phases of the project were conducted in partnership with the Paris Institut de la Vision (leading European center for research on eye and retinal diseases) and the Nancy Université de Lorraine (CITHEFOR research team specialized in biopolymers chemistry and galenic formulation). BIOPHTA has received the EIT health Headstart award from the European Union, the Healthy Longevity award from the US Academy of Medicine, the i-Lab prize by the French Ministry of Research, awardee of the innov’UP Leader PIA by France 2030 and Région Île-de-France, as well as the Gold Medal from the Boston biotechnology summit. About UI INVESTISSEMENT UI Investissement is an independent management company specialising in the development of unlisted French companies. It manages more than €1.5 billion in assets and invests with 300 company directors in sectors that are essential to society, such as healthcare, agri-business, services and industry. The investment teams dedicated to innovation capital deploy funds that enable the emergence of innovative projects and high-potential disruptive technologies in the tech and healthcare sectors by providing financing, advice and support. Expansion and buyout capital, the historical core of UI's business, accounts for more than half of assets under management, enabling more than 60 companies to benefit from the operational expertise and methodological tools developed by UI. Finally, UI also invests in projects aimed at strengthening economic initiatives in local areas. UI currently has more than 80 employees and 10 regional offices in Rennes, Besançon, Clermont-Ferrand, Dijon, Lille, Limoges, Lyon, Nantes, Orléans, Reims and Strasbourg, in addition to its teams in Paris. Pertinence Invest 2 is an investment fund managed by UI Investissement, raised in partnership with leading French engineering schools and colleges. It invests in disruptive technologies in the Engineering Sciences and Health & Nutrition sectors. Pertinence Invest 2 is also sponsored by renowned industrial companies and offers a unique and innovative ecosystem to its portfolio companies. Mérieux Equity Partners is Pertinence Invest 2's advisor in Heath sector. About Mérieux Equity Partners Founded in 2009, Mérieux Equity Partners ("MxEP") is a leading European healthcare-specialized investment firm, with two dedicated platforms, Venture Capital and Buyout, supporting companies ranging from start-ups to established leaders. Benefiting from a longstanding expertise and a large network, MxEP invests in companies with ambitious growth projects and products or services transformative for Health. MxEP is AMF-accredited and currently manages c.€1.5bn of AuM. About ELAIA Elaia Partners is a European top-tier Venture Capital firm with a strong technology DNA. We invest in technology disruptors with global ambition from early stage to growth development. For the past 20 years, our commitment has been to deliver high performance with values. We are proud to have been an active partner in over 100 startups including success stories such as Criteo (Nasdaq), Orchestra Networks (acquired by Tibco), Volterra (acquired by F5), Mirakl (valued $3.5B in Series E), Shift Technology (valued $1B+ in Series D), Mablink Bioscience (acquired by Eli Lilly), Aqemia and Alice&Bob. About GO Capital GO Capital, an independent management company, is a major player in regional seed and venture capital. GO Capital contributes to the funding of responsible innovation in the regions. The team consists of investors with complementary sector experience and has a solid track record in DeepTech. GO Capital has close to €400 million under management and focuses on financing technology leaders in the digital, healthcare and climate transition sectors. About Unither Pharmaceuticals Unither Pharmaceuticals is a pharmaceutical subcontractor specializing in the development and manufacturing of single-dose and multidose liquid formulations (including eye drops, saline solutions, asthma medications in BFS single doses, and oral liquid stick-packs) for originator pharmaceutical companies and generic manufacturers. With 2,200 employees and eight manufacturing plants across France, the United States, Brazil and China, Unither Pharmaceuticals reported sales of €475 million in 2023. About HTL HTL Biotechnology is a French biotech and world leader in the development and responsible biomanufacturing of pharmaceutical-grade biopolymers. These biopolymers are used by healthcare companies for the development of treatments in a variety of leading therapeutic areas such as ophthalmology, dermatology, medical aesthetics and rheumatology. For over 30 years, HTL Biotechnology has been a driving force behind innovation in the sector, collaborating with research entities and biotech companies to meet tomorrow's medical needs (regenerative medicine, drug delivery, etc.). HTL Biotechnology is a fast-growing international company, exporting nearly 80% of its production to more than 30 countries. To meet these growing global needs for biopolymers, HTL Biotechnology has also opened subsidiaries in Singapore and the United States, with the construction of a neuromodulator production unit (HTL BMI – Massachusetts). Historically based in Javené (Brittany), the company brings together production, innovation, research and development, as well as quality activities on its site. HTL Biotechnology employs nearly 300 people worldwide. Contacts BIOPHTA Marie Puvieux Press relations – ATCG Partners biophta@atcg-partners.com UI INVESTISSEMENT Jean-Philippe Zoghbi Directeur associé jean-philippe.zoghbi@ui-investissement.fr Mérieux Equity Partners James MacFarlane MHP Group james.mcfarlane@mhpgroup.com Elaia Louisa Mesnard CMO, Elaia lmesnard@elaia.fr GO Capital Alexandre Boulay Senior Associate alexandre.boulay@gocapital.fr Unither Pharmaceuticals Elisabeth Alidou Communications elisabeth.alidou@unither-pharma.com HTL Biotechnology Nathalie Chevallon Head of Corporate Affairs, Communication & Marketing nchevallon@htlbiotech.com 1 WHO publication, 2019 World Report on Vision. 2 Robin A.L. et al. (2019): Medication adherence in patients with ocular hypertension or glaucoma – Expert Review of Ophthalmology. 3 Ehlken C. et al. (2018): Association of treatment adherence with real-life VA outcomes in AMD, DME, and BRVO – Clinical Ophthalmology. Attachment PR in English

Unither Pharmaceuticals 庆祝 30 周年活动，赞扬公司对创新和专业的追求 巴黎 2023年11月30日 /美通社/ -- 作为一家行业领先的 CDMO （委托开发制造商）公司，Unither Pharmaceuticals 庆祝成立 30 周年。Unither Pharmaceuticals 于 1993 年收购了一家由 17 名员工组成的制药厂，从而开始了在法国的业务运营。如今，公司已成为全球领先的无菌单位剂量生产商，产能达 50 亿剂，业务遍及四大洲。销售额也随之增长，到 2023 年销售额将达到 5 亿欧元。 如需查看多媒体新闻稿，请点击： https://www.multivu.com/players/uk/9229051-unither-pharmaceuticals-celebrates-30-years-innovation-expertise/ Unither 于 1995 年首次采用吹灌封一体化 (BFS) 技术生产无菌生理盐水溶液、哮喘药物和滴眼液。自 1997 年以来，公司一直在发展国际业务，先是出口产品，然后在 2013 年收购了美国的一家工厂后。在 2015 年于巴雷图斯进行收购后，Unither 巩固了在巴西（巴雷图斯）的业务市场。随后，公司于 2020 年在中国（南京）进行了收购，巩固了其全球业务的覆盖。2022 年，Unither 收购了位于圣保罗布坦塔的一家眼科专科医院，进一步扩大了业务范围。这种国际发展更接近客户的目标市场，从而支持客户的国际行业战略。 自成立以来，Unither 一直走在创新的前沿，不断进取，力求改善患者的生活。Unither Pharmaceuticals 总裁 Eric Goupil 重申了集团的愿景："我们的医疗解决方案能改善和简化患者生活，我们希望越来越多的人能够用到这样的方案，认可我们公司。" Unither Pharmaceuticals 首席执行官 Jean-François Hilaire 对未来进行了展望："Unither 的使命是支持我们的客户不断创新，努力满足市场需求。最近，在将一次性剂量与针头合并以创建即用型注射系统方面，我们凭借 Euroject® 取得了突破，这表明我们在控制成本的同时，致力于简化医疗从业者和患者的生活。我们勇于创新，充满热情与活力，从而驱动我们梦想成真，为客户带来裨益。" 关于 Unither Pharmaceuticals： www.unither-pharma.com/about/who-are-we/ 媒体联系： contact@unither-pharma.com Unither Pharmaceuticals celebrates 30 years of innovation and expertise