KING OF PRUSSIA, PA & SAN DIEGO--(BUSINESS WIRE)--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and sa-mRNA pioneer Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®.

普鲁士国王，宾夕法尼亚州和圣地亚哥--（商业新闻短讯）--全球生物技术领导者CSL（ASX:CSL；USOTC:CSLLY）和sa mRNA先驱Arcturus Therapeutics今天宣布，日本厚生劳动省（MHLWs）批准并授权其更新的自扩增mRNA（sa mRNA）COVID-19疫苗KOSTAIVE®。

The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older..

更新后的疫苗旨在针对18岁及以上的成年人预防Omicron亚型的JN.1谱系。。

CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the world's first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.

CSL在日本的独家合作伙伴明治精嘉制药（Meiji Seika Pharma）将开始为10月的新型冠状病毒疫苗接种活动及时分发最新疫苗，这标志着世界上第一个针对18岁及以上成年人的sa mRNA新型冠状病毒疫苗。

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization.

2024年5月，日本厚生省的一个小组建议更新COVID-19疫苗，以针对2024/2025年国家免疫计划的Omicron亚型的JN.1谱系。这与世界卫生组织最近的建议一致。

“We are pleased to receive the updated approval from Japan’s Ministry of Health, Labor and Welfare, and remain on track to distribute KOSTAIVE® in time for the October COVID-19 vaccination campaign,” said Emmanuelle Lecomte-Brisset, Senior Vice President and Head of Global Regulatory Affairs, CSL. “We look forward to introducing KOSTAIVE® in Japan as a safe, tolerable and more durable option in protecting against COVID-19.”.

CSL高级副总裁兼全球监管事务负责人Emmanuelle Lecomte Brisset表示：“我们很高兴获得日本厚生劳动省的最新批准，并将继续按计划在10月的新型冠状病毒疫苗接种活动中及时分发KOSTAIVE®。”。“我们期待在日本推出KOSTAIVE®作为一种安全，可耐受且更耐用的预防新型冠状病毒肺炎的选择。”。

“We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. “Today’s approval further demonstrates CSL's promise to pursue, develop and deliver new innovative treatment options to protect public health.”.

CSL疫苗创新部高级副总裁乔纳森·埃德尔曼医学博士说：“我们相信KOSTAIVE®有可能改变日本新型冠状病毒肺炎疫苗的模式。”。“今天的批准进一步证明了CSL致力于寻求、开发和提供新的创新治疗方案以保护公众健康的承诺。”。

The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year..

该批准基于支持CSL和Arcturus Therapeutics的sa mRNA COVID-19疫苗的安全性和有效性的临床证据，包括已发表的数据，证明与传统的mRNA COVID-19疫苗增强剂相比，Omicron BA 4/5具有更高的免疫原性，以及证明免疫持续时间长达一年的随访数据。。

“We are pleased that our sa-mRNA technology will be available to vaccinate people in Japan against COVID-19, which remains an ongoing risk to public health around the world,” said Joseph Payne, Chief Executive Officer of Arcturus Therapeutics. “We look forward to continuing to work with CSL and regulators to explore the development of KOSTAIVE® in additional countries.”.

Arcturus Therapeutics首席执行官约瑟夫·佩恩（JosephPayne）表示：“我们很高兴我们的sa mRNA技术将用于为日本人民接种新型冠状病毒（COVID-19）疫苗，这仍然是全球公共卫生的持续风险。”。。

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 conventional 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一个蓝图来制造蛋白质，帮助我们的免疫系统识别和对抗疾病，从而有助于预防传染病。与传统的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。

For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit www.CSL.com..

有关生物技术前景的鼓舞人心的故事，请访问CSLBehring.com/Vita，并在Twitter.com/CSL上关注我们。有关CSL的更多信息，请访问www.CSL.com。。

About Arcturus

关于大角星

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise.

Arcturus Therapeutics Holdings Inc.（纳斯达克股票代码：ARCT）成立于2013年，总部位于加利福尼亚州圣地亚哥，是一家全球mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR®脂质介导的递送，（ii）STARR®mRNA技术（sa mRNA）和（iii）mRNA药物以及药品制造专业知识。

Arcturus developed 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开发了KOSTAIVE®，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’ 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. 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。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。

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). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn..

大角星的技术涵盖了其广泛的专利组合（在美国、欧洲、日本、中国和其他国家有400多项专利和专利申请）。有关更多信息，请访问www.ArcturusRx.com。此外，请通过Twitter和LinkedIn与我们联系。。

About Meiji Seika Pharma Co., Ltd.

关于明治精嘉制药有限公司。

Meiji Seika Pharma, since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products such as therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases as well as generic drugs in response to various medical needs.

明治世家制药自1946年推出青霉素以来，一直在提供有效和高质量的药品，如传染病治疗剂和疫苗，中枢神经系统疾病治疗剂以及仿制药，以应对各种医疗需求。

As a leading company in the field of infectious diseases, we are strengthening our platform for infection control and prevention with vaccines and antimicrobial agents..

作为传染病领域的领先公司，我们正在通过疫苗和抗菌剂加强感染控制和预防平台。。