)--Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE

)--全球生物技术领导者CSL（ASX:CSL；USOTC:CSLLY）和sa mRNA先驱Arcturus Therapeutics（Nasdaq:ARCT）今天宣布，欧盟委员会已授予KOSTAIVE上市许可

(ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19.

（ARCT-154），一种自我扩增的mRNA COVID-19疫苗，适用于18岁及以上的个体。。KOSTAIVE目前在日本销售抗新型冠状病毒肺炎。

The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. The centralised marketing authorization of KOSTAIVE is valid in all EU member states and in the EEA countries..

2024年12月12日，欧洲药品管理局（EMA）人类使用药品委员会（CHMP）通过了欧盟委员会的批准。KOSTAIVE的集中营销授权在所有欧盟成员国和欧洲经济区国家均有效。。

“The European Commission's approval marks a significant milestone in our ongoing development program for KOSTAIVE,” said Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit, CSL. “We are actively working to optimize KOSTAIVE's formulation to better meet the needs of healthcare professionals and their patients.

CSL疫苗创新部门高级副总裁乔纳森·埃德尔曼（JonathanEdelman）医学博士说：“欧盟委员会的批准标志着我们正在进行的KOSTAIVE开发计划的一个重要里程碑。“我们正在积极优化KOSTAIVE的配方，以更好地满足医疗保健专业人员及其患者的需求。

As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing these technical enhancements and making this innovative vaccine available in Europe as soon as possible.”.

由于新型冠状病毒仍然是一种不可预测的全球威胁，CSL致力于完成这些技术改进，并尽快在欧洲提供这种创新疫苗。”。

The approval is based on positive clinical data from several studies, including an integrated phase 1/2/3 study demonstrating KOSTAIVE’s efficacy and tolerability, and Phase 3 COVID-19 booster trials, which achieved higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine comparator.

该批准基于多项研究的阳性临床数据，包括证明KOSTAIVE疗效和耐受性的综合1/2/3期研究，以及与常规mRNA COVID-19疫苗比较物相比获得更高免疫原性结果的3期COVID-19加强试验。

A follow-up analysis evaluating a booster dose of KOSTAIVE also showed that the vaccine elicited superior immunogenicity and antibody persistence.

评估KOSTAIVE增强剂量的后续分析还表明，该疫苗引发了优异的免疫原性和抗体持久性。

for up to 12 months postvaccination against multiple SARS-CoV-2 strains in both younger and older adult age groups versus the same mRNA comparator.

与相同的 mRNA 比较物相比，在接种后 12 个月内，年轻和年长的成年人组均可对多种 SARS-CoV-2 株系产生抗药性。

“KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection,” said Joseph Payne, CEO of Arcturus. “This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus.”.

Arcturus首席执行官约瑟夫·佩恩（JosephPayne）表示：“KOSTAIVE和sa mRNA技术标志着疫苗创新的重大进步，为更广泛和更持久的保护提供了潜力。”。“这一批准突显了KOSTAIVE的临床前景及其抵御不断变化的新型冠状病毒的能力。”。

About sa-mRNA

关于sa mRNA

mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response..

mRNA疫苗通过为体内细胞提供蓝图，使其产生蛋白质，帮助我们的免疫系统识别和抗击疾病，从而有助于预防传染病。与标准的mRNA疫苗不同，自我扩增的mRNA疫苗指导身体产生更多的mRNA和蛋白质来增强免疫反应。。

About CSL

关于CSL

CSL (ASX: CSL; USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

CSL（ASX:CSL；USOTC:CSLLY）是一家全球生物技术公司，拥有一系列充满活力的救生药物，包括治疗血友病和免疫缺陷的药物，预防流感的疫苗以及缺铁和肾脏病的疗法。自1916年成立以来，我们一直致力于使用最新技术拯救生命。

Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

如今，CSL（包括我们的三大业务：CSL Behring、CSL Sequirus和CSL Vifor）为100多个国家的患者提供救生产品，拥有32000名员工。我们独特的商业实力、研发重点和卓越运营相结合，使我们能够识别、开发和提供创新，使我们的患者能够过上最充实的生活。

About Arcturus

关于Arcturus

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR

Arcturus Therapeutics Holdings Inc.（纳斯达克：ARCT）成立于2013年，总部位于加利福尼亚州圣地亚哥，是一家商业mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR

lipid-mediated delivery, (ii) STARR

脂质介导的递送，（ii）STARR

mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE

mRNA技术（sa-mRNA）和(iii)mRNA药物物质以及药物产品制造技术。Arcturus 开发了 KOSTAIVE

, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza.

，这是世界上第一个被批准的自扩增信使RNA（sa mRNA）新型冠状病毒疫苗。Arcturus正在与CSL-Seqirus进行创新mRNA疫苗的全球合作，并在日本成立了一家合资企业ARCALIS，专注于mRNA疫苗和治疗剂的生产。Arcturus的管道包括可能治疗鸟氨酸转氨甲酰酶（OTC）缺乏症和囊性纤维化（CF）的RNA治疗候选物，以及针对SARS-CoV-2（COVID-19）和流感的合作mRNA疫苗计划。

Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries).

大角星的多功能RNA治疗平台可应用于多种类型的核酸药物，包括信使RNA，小干扰RNA，环状RNA，反义RNA，自扩增RNA，DNA和基因编辑疗法。大角星的技术涵盖了其广泛的专利组合（在美国、欧洲、日本、中国和其他国家拥有400多项专利和专利申请）。