COPENHAGEN, Denmark, April 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older.

2024年4月29日，丹麦哥本哈根——巴伐利亚州北欧A/S（OMX:BAVA）今天宣布，它已经开始与美国食品和药物管理局（FDA）一起提交生物制品许可证申请（BLA），以获得其CHIKV VLP候选疫苗的许可证，用于12岁及以上人群的基孔肯雅病毒感染免疫接种。

Bavarian Nordic will submit additional data over the coming months, aiming to complete the BLA submission before the end of the first half of 2024 to support a potential FDA approval of the vaccine in the first half of 2025. “We are pleased to advance our chikungunya vaccine candidate into the registration phase and look forward to working with the regulators in our efforts to bring this novel product to the market.

巴伐利亚北欧将在未来几个月提交更多数据，旨在2024年上半年结束前完成BLA提交，以支持2025年上半年FDA可能批准该疫苗。“我们很高兴将我们的基孔肯雅候选疫苗推进注册阶段，并期待着与监管机构合作，将这种新型产品推向市场。

We have generated robust data in adolescents, adults and older adults, suggesting a strong and durable antibody response against the chikungunya virus and a fast onset of protection, which supports our belief that we can establish our vaccine as the preferred choice in this emerging market,” said Paul Chaplin, President and CEO of Bavarian Nordic.

巴伐利亚北欧公司总裁兼首席执行官保罗·卓别林（Paul Chaplin）说：“我们已经在青少年、成年人和老年人中获得了可靠的数据，表明对基孔肯雅病毒的抗体反应强烈而持久，并且保护作用迅速，这支持了我们的信念，即我们可以将疫苗确立为这个新兴市场的首选疫苗。”。

The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, and PRIME designation from the EMA in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy.

CHIKV VLP疫苗候选人分别于2020年10月和2018年4月获得FDA的突破性治疗指定和快速通道指定，并于2019年9月获得EMA的主要指定。这些名称旨在促进药物的开发或加速审查，这些药物要么针对未满足的医疗需求，要么可能表现出对现有治疗的实质性改善。

In February 2024, the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate, which Bavarian Nordic plans to submit by mid-2024. About chikungunyaCh.

2024年2月，EMA下的人类使用药品委员会（CHMP）批准了CHIKV VLP候选疫苗MAA的加速评估，巴伐利亚北欧计划在2024年年中提交。关于chikungunyaCh。