– The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in China. The approval is based on positive results from the Phase III PULSAR trial at week 48, which demonstrated comparable efficacy and safety of Eylea 8 mg with treatment intervals of 3 or 4 months (12 or 16 weeks) compared to standard of care Eylea™ 2 mg (aflibercept 2 mg) with a fixed bi-monthly (every 8 weeks) interval..

中国国家药品监督管理局（NMPA）药品审评中心（CDE）已批准Eylea™ 8 mg（阿柏西普8 mg）用于治疗中国境内新生血管性（湿性）年龄相关性黄斑变性（nAMD）。该批准基于III期PULSAR试验第48周的积极结果，结果显示，与每8周固定给药间隔的标准治疗药物Eylea™ 2 mg（阿柏西普2 mg）相比，Eylea 8 mg在3个月或4个月（12周或16周）的治疗间隔下表现出相当的疗效和安全性。

“The approval of Eylea 8 mg in China marks a significant advancement in addressing the need for more durable treatment options for patients, caregivers and ophthalmologists,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer.

“Eylea 8 mg在中国的获批标志着在满足患者、护理人员和眼科医生对更持久治疗方案的需求方面取得了重要进展，”拜耳制药执行副总裁、全球产品战略与商业化负责人、制药领导团队成员克里斯汀·罗斯表示。

“Building on the high therapeutic standard of Eylea 2 mg, patients with wet age-related macular degeneration now have the option to benefit from Eylea 8 mg with long treatment intervals and still experience lasting vision gains, rapid and resilient fluid control, and comparable safety to Eylea 2 mg.”.

“在Eylea 2 mg的高治疗标准基础上，湿性年龄相关性黄斑变性患者现在可以选择使用Eylea 8 mg，获得更长的治疗间隔，同时仍然实现持久的视力提升、快速且稳定的液体控制，并且安全性与Eylea 2 mg相当。”

In the PULSAR clinical trial Eylea 8 mg met its primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with 3- or 4-monthly dosing regimens compared to Eylea 2 mg (aflibercept 2 mg) with a fixed bi-monthly treatment interval at week 48, following initial monthly doses. The safety profile of Eylea 8 mg was consistent with the well-established safety profile of Eylea 2 mg..

在PULSAR临床试验中，Eylea 8 mg达到了其主要终点，即在初始每月给药后，与Eylea 2 mg（阿柏西普2 mg）每两月固定治疗间隔相比，使用3个月或4个月给药方案的最佳矫正视力（BCVA）变化不劣于前者。Eylea 8 mg的安全性特征与已确立的Eylea 2 mg的安全性特征一致。

Eylea 8 mg has been approved to date in more than 50 markets for the treatment of nAMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

Eylea 8 mg 已在超过 50 个市场获批用于治疗 nAMD 和 DME。Eylea 8 mg 在其他市场的进一步监管申请正在进行中。

Eylea 8 mg is the only anti-vascular endothelial growth factor-treatment (anti-VEGF) that is approved for extended treatment intervals of up to 5 months for both, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), in the EU and UK. In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg for the treatment of nAMD and DME based on clinical evidence from the PULSAR and PHOTON studies..

Eylea 8 mg 是欧盟和英国唯一获批的抗血管内皮生长因子（抗VEGF）治疗药物，适用于新生血管性（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME），其治疗间隔可延长至最长5个月。2025年2月，拜耳基于PULSAR和PHOTON研究的临床证据，向欧洲药品管理局（EMA）提交了申请，希望将Eylea 8 mg的治疗间隔扩展至最长6个月，用于治疗nAMD和DME。

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg..

Eylea 8 mg（阿柏西普 8 mg；在美国：Eylea HD）由拜耳和再生元共同开发。再生元保留在美国对 Eylea 2 mg（阿柏西普 2 mg）和 Eylea HD 的独家权利。拜耳获得了美国以外的独家营销权，两家公司平分 Eylea 2 mg 和 Eylea 8 mg 的销售利润。

About PULSAR

关于PULSAR

PULSAR is a double-masked, active-controlled pivotal Phase III trial, conducted in multiple centers globally. PULSAR evaluated the efficacy and safety of aflibercept 8 mg in nAMD with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at week 48.

PULSAR 是一项双盲、活性对照的关键性 III 期临床试验，在全球多个中心进行。PULSAR 评估了阿柏西普 8 mg 在 nAMD 中的疗效和安全性，采用 12 周和 16 周给药方案，与初始每月一次剂量后每 8 周给药的 Eylea（阿柏西普 2 mg）进行对比，主要终点是第 48 周最佳矫正视力（BCVA）的非劣效性。

Patients were randomized at baseline and assigned to the three different arms. In PULSAR, 1,009 patients were treated. All patients in the aflibercept 8 mg arms were continuously evaluated under stringent, clinically relevant, patient focused dose regimen modification (DRM) criteria starting from week 16 throughout the study.

患者在基线时被随机分组，并分配到三个不同的治疗组。在PULSAR研究中，共有1009名患者接受了治疗。所有接受8 mg阿柏西普治疗的患者从第16周开始，在整个研究过程中都根据严格、临床相关、以患者为中心的剂量调整（DRM）标准进行了持续评估。

Patients on aflibercept 8 mg arms were assessed at multiple time points for DRM criteria and may have had their dosing interval shortened to 8 or 12 weeks to secure appropriate disease control through week 48..

接受8 mg阿柏西普治疗的患者在多个时间点评估了DRM标准，并可能将其给药间隔缩短至8或12周，以确保在第48周前实现适当的疾病控制。

About nAMD

关于nAMD

Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail.

新生血管性（湿性）年龄相关性黄斑变性（nAMD）是一种进展迅速的眼部疾病，如果不及时治疗，可能在几个月内导致视力丧失。nAMD是全球不可逆失明和视力损害的主要原因之一。随着年龄增长，nAMD可能影响人们。它发生在异常血管生长并在黄斑下方渗漏液体时，黄斑是眼睛中负责清晰中央视力和观察细微细节的部分。

This fluid can damage and scar the macula, which can cause vision loss. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040..

这种液体可能会损伤和毁坏黄斑，导致视力丧失。全球有1.96亿人患有AMD——预计到2040年，这一数字将增加到2.88亿。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域拥有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。