Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', a biosimilar referencing Stelara1 (ustekinumab), developed by Samsung Bioepis. This is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025..

三星生物制药有限公司今天宣布，其开发的生物类似药乌司奴单抗BS皮下注射45毫克注射器“尼普洛”（参照Stelara1（乌司奴单抗））已获得上市批准。这是根据与尼普洛公司于2025年6月达成的合作关系下，首个在日本获得上市批准的产品。

“Japan allocates about 10% of its GDP to healthcare2, one of the highest among OECD countries which is why biosimilars are playing an increasingly important role in alleviating the financial burden for Japan’s healthcare system. With this biosimilar approval, we are paving the way for expanding access to high-quality, affordable treatment options for patients with autoimmune conditions,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis.

“日本将其 GDP 的约 10% 用于医疗保健2，是经合组织国家中最高的国家之一，这就是为什么生物类似药在减轻日本医疗保健系统的经济负担方面发挥着越来越重要的作用。通过这次生物类似药的批准，我们正在为扩大自身免疫疾病患者的高质量、可负担治疗选择铺平道路。”三星 Bioepis 副总裁兼监管事务团队负责人 Byoungin Jung 表示。

“As a proven biosimilar leader, we remain committed to delivering quality-assured biologics that support better care for patients and strengthen healthcare systems around the world.”.

“作为公认的生物仿制药领域的领导者，我们始终致力于提供质量可靠的生物制品，以支持患者获得更好的治疗，并加强全球的医疗保健系统。”

Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. ‘NIPRO’ has been approved for the treatment of plaque psoriasis, and psoriatic arthritis. The product is set to be listed in the Japan’s National Health Insurance (NHI) drug list in May 2026, allowing for commercialization by NIPRO immediately after drug listing..

乌司奴单抗是一种人免疫球蛋白G1 kappa（IgG1κ）单克隆抗体，可防止与免疫介导疾病相关的IL-12和IL-23的异常调节。“NIPRO”已被批准用于治疗斑块状银屑病和银屑病关节炎。该产品预计将在2026年5月被列入日本国家健康保险（NHI）药品清单，之后NIPRO即可立即进行商业化销售。

Samsung Bioepis’s ustekinumab is also approved and available across Australia, Brazil, Canada, Europe, Korea, Switzerland, the United Kingdom, and the United States.

三星Bioepis的乌司奴单抗也已在澳大利亚、巴西、加拿大、欧洲、韩国、瑞士、英国和美国获得批准并上市。

About Samsung Bioepis Co., Ltd.

三星生物制药有限公司简介

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology.

三星Bioepis成立于2012年，是一家致力于实现人人可及的医疗保健的生物制药公司。通过产品开发的创新和对质量的坚定承诺，三星Bioepis旨在成为全球领先的生物制药公司。三星Bioepis持续推动覆盖多种治疗领域的生物类似药候选药物的广泛研发，包括免疫学、肿瘤学、眼科、血液学、肾脏病学、神经病学和内分泌学。

For more information, please visit www.samsungbioepis.com and follow us on social media – X, LinkedIn..

欲了解更多信息，请访问www.samsungbioepis.com并关注我们的社交媒体——X、LinkedIn。

Contacts

联系人

Meda ontact

媒体联系

Yoon Kim, yoon1.kim@samsung.com

尹金，yoon1.kim@samsung.com

Anna Nayun Kim, nayun86.kim@samsung.com

安娜·纳云·金，nayun86.kim@samsung.com

Source: businesswire.com

来源：businesswire.com