Chugai Pharmaceutical Co., Ltd. announced today that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)], for an additional indication of the treatment of choroidal neovascularization associated with angioid streaks.

中外制药株式会社今日宣布，已获得日本厚生劳动省（MHLW）的监管批准，用于抗VEGF/抗Ang-2双特异性抗体Vabysmo®玻璃体内注射液120 mg/mL [通用名：法瑞西单抗（基因重组）]，新增适应症为治疗与血管样条纹相关的脉络膜新生血管化。

Vabysmo is the first approved drug in Japan for the treatment of this disease..

Vabysmo是日本首个获批用于治疗该疾病的药物。

“We are very pleased that we can offer Vabysmo as the first approved treatment in Japan for choroidal neovascularization associated with angioid streaks. This disease is known to cause vision impairment and has a poor prognosis. We expect that treatment with Vabysmo will contribute to maintaining and improving vision for patients.

“我们非常高兴能够提供Vabysmo作为日本首个获批用于治疗与血管样条纹相关的脉络膜新生血管化的疗法。这种疾病会导致视力受损，并且预后较差。我们预计使用Vabysmo进行治疗将有助于维持和改善患者的视力。

We will continue to provide information promptly on the proper use of this medication,” said Dr. Osamu Okuda, Chugai’s President and CEO..

“我们将继续及时提供关于正确使用这种药物的信息，”中外制药总裁兼首席执行官奥田修博士说。

This approval is based on the results from a Japanese phase III NIHONBASHI study for angioid streaks.

该批准基于日本 NIHONBASHI 三期临床试验关于血管样条纹的结果。

Approval Information *Newly added description

审批信息 *新增描述

Indications:

适应症：

choroidal neovascularization associated with angioid streaks

与血管样条纹相关的脉络膜新生血管

Dosage and administrations:

用法和用量：

6 mg (0.05 mL) of faricimab (genetical recombination) is administered by intravitreal injection once every 4 weeks or more.

每4周或更长时间通过玻璃体内注射给予6 mg（0.05 mL）的法利西单抗（基因重组）。

First Positive Phase III Results Presented at Japanese Ophthalmological Society Meeting Demonstrated that Vabysmo Sufficiently Improved Vision in Japanese Patients with Angioid Streaks (Press release by Chugai issued on April 17, 2025)

在第17届日本眼科学会会议上公布的首个III期阳性结果表明，Vabysmo显著改善了日本血管样条纹患者的视力（中外制药于2025年4月17日发布的新闻稿）。

https://www.chugai-pharm.co.jp/english/news/detail/20250417122000_1150.html

https://www.chugai-pharm.co.jp/english/news/detail/20250417122000_1150.html

Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss (Press release by Chugai issued on September 6, 2024)

中外制药在日本提交了Vabysmo用于治疗血管样条纹（导致视力丧失的主要原因之一）的额外适应症申请（中外制药于2024年9月6日发布的新闻稿）

About angioid streaks

关于血管样条纹

Angioid streaks is a disease characterized by cracks in parts of the retina, causing-discoloration (pigmented streak) of the fundus. The disease is often asymptomatic, and when choroidal neovascularization extends to the macula region of the fundus, it causes symptoms such as decreased or distorted vision.

血管样条纹是一种视网膜部分出现裂纹的疾病，导致眼底变色（色素条纹）。该病通常无症状，当脉络膜新生血管延伸到眼底黄斑区域时，会引起视力下降或扭曲等症状。

People with neovascularization have a poor prognosis, but conventional treatments such as surgery and laser are not sufficiently effective, and new treatment options are needed. The number of patients with angioid streaks in Japan is unknown, but approximately 300 patients have pseudoxanthoma elasticum (one of the designated intractable diseases), which is known to be associated with angioid streaks in approximately half of patients.1,2.

新生血管化患者的预后较差，但手术和激光等常规治疗效果不够理想，需要新的治疗选择。日本血管样条纹患者的数量尚不清楚，但大约有300名患者患有弹性假黄瘤（被指定的难治性疾病之一），这种疾病与大约一半的血管样条纹病例相关。1,2.

About Vabysmo

关于Vabysmo

Vabysmo is the first bispecific antibody approved for the eye. 3,4,5 It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation.

Vabysmo是首个获准用于眼部的双特异性抗体。它通过中和血管生成素-2（Ang-2）和血管内皮生长因子-A（VEGF-A），靶向并抑制与多种威胁视力的视网膜疾病相关的两条信号通路。Ang-2和VEGF-A通过使血管不稳定、导致新漏血管形成并加重炎症，从而引发视力丧失。

By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. 5,6 Vabysmo is approved in nearly 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US, EU and Japan, for the treatment of macular edema following retinal vein occlusion.

通过阻断涉及Ang-2和VEGF-A的通路，Vabysmo旨在稳定血管。Vabysmo已在近100个国家获得批准，包括美国、日本、英国和欧盟，用于治疗新生血管性或“湿性”年龄相关性黄斑变性和糖尿病性黄斑水肿，并在包括美国、欧盟和日本在内的多个国家获批用于治疗视网膜静脉阻塞后的黄斑水肿。