Ustekinumab-ttwe

• 本协议涵盖至多五个研发项目，其中包括以维得利珠单抗（安吉优）为参照药的生物类似药候选药物 SB36；双方将在除中国内地、中国香港、中国台湾、中国澳门及韩国以外的全球市场，开展上述药物的联合开发与商业化合作 • 三星生物制剂持续推进免疫学与肿瘤学领域的生物类似药管线，为患者获取改变生命的药物不断开辟道路 三星生物制剂有限公司今日宣布，已与山德士签署全球许可、开发及商业化协议 (DCA)，针对三星生物制剂在研的至多五个生物类似药候选药物开展合作，其中包括参照安吉优研发的生物类似药候选药物 SB36。1本协议的其他条款均未对外披露。 根据协议条款，三星生物制剂将负责上述生物类似药的研发、核心市场的药品注册申报及生产工作；山德士则负责在除中国内地、中国香港、中国台湾、中国澳门及韩国以外的全球市场，开展相关药物的商业化运营。 三星生物制剂公司总裁兼首席执行官 Kyung-Ah Kim 表示：“我们非常高兴能拓展与山德士这段已经成功的合作关系，并就多个处于早期研发阶段的生物类似药产品达成商业化协议。这一协议的达成意味着改善重症患者获取生物药途径的努力取得了重要进展，这些患者往往难以获得能够改变命运的药物。在三星生物制剂，我们将继续彰显对生物类似药领域的长期承诺，进一步强化产品管线，让药物更容易获得，惠及全球患者与医疗体系。” 目前三星生物制剂正针对 SB36 开展临床前研究，该药物以安吉优（维得利珠单抗）为参照药，该药物适用于治疗成年克罗恩病、溃疡性结肠炎及储袋炎患者。2 本协议是在双方于 2023 年 9 月就 PYZCHIVA®（乌司奴单抗）建立全球合作关系的基础上达成的。PYZCHIVA 于 2024 年 7 月在欧洲首次上市，并于 2025 年 2 月在美国上市。2025 年 12 月，双方还签署了一项协议，针对 EPYSQLI™ 这款舒立瑞生物类似药3在中东和非洲地区开展商业化合作。 关于Samsung Bioepis Co., Ltd. 三星生物制剂成立于 201 2年，是一家生物制药公司，致力于实现人人可得的医疗保健服务。通过产品研发创新以及对品质的坚定承诺，三星生物制剂立志成为全球领先的生物制药企业。作为三星生物制剂控股有限公司的全资子公司，公司持续推进涵盖多个治疗领域的丰富生物药候选产品管线，包括免疫学、肿瘤学、眼科、血液学、肾病学以及内分泌学领域。 1 安吉优为武田药品工业的注册商标 2 欧洲药品管理局 (EMA). 安吉优，产品特性概要。查阅链接：Entyvio, INN-vedolizumab.最后查阅时间：2026 年 3 月 3 舒立瑞为亚力兄制药的注册商标 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。 三星生物制剂公司，韩国仁川松岛办事处

Sandoz has inked a deal with Korean biosimilars specialist Samsung Bioepis to commercialize up to five copycats, including a knockoff of Takeda's Entyvio. Sandoz has struck a deal with Samsung Bioepis to partner on up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio (vedolizumab), which is being developed by the South Korea-based biosimilars specialist. Switzerland-based Sandoz gains the right to commercialize the biosimilars around the world, with Samsung Bioepis retaining commercial rights in China, Hong Kong, Taiwan, Macau and its home country. Samsung Bioepis will continue to develop, manufacture and handle the regulatory submissions for the biosimilars. Financial terms of the partnership were not disclosed.  The deal, which builds on the existing partnership of the companies, has the potential to expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets, the company said in a release. The growing pipeline of products will allow Sandoz to capture a “significant share” of the $320 billion biosimilar loss-of-exclusivity market opportunity in the next decade, the company added.The companies initially got together in 2023, with Sandoz gaining commercial rights to Samsung’s Pyzchiva (ustekinumab), which is a knockoff of Johnson & Johnson’s Stelara. Sandoz launched it in Europe in July 2024 and in the U.S. in February 2025. Three months ago, the companies also paired up on Epysqli (eculizumab), which is Samsung’s biosimilar version of AstraZeneca’s Soliris.With the most recent agreement, analysts from Jefferies credited Sandoz’s “commercial infrastructure” as key to its ability to attract partners. They also noted that the Samsung Bioepis arrangement provides Sandoz with “improved long-term visibility on both R&D productivity and future launch cadence.” Samsung Bioepis plans to expand its biosimilar portfolio by 20 products by 2030, the company said two months ago at the J.P. Morgan Healthcare Conference. In addition to its Entyvio copycat, the company said it will develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AZ’s Enhertu, Roche’s Ocrevus and Eli Lilly’s Taltz.As for Samsung and Sandoz’s plan to sell their Entyvio knockoff, Takeda has said its regulatory protection on the ulcerative colitis and Crohn’s disease treatment extends into May 2026. But some patents on the drug expire in 2032, according to the company's most recent annual report (PDF).“Any biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain,” the Japanese company explained in the report.For the last three quarters of 2025, Takeda reported Entyvio worldwide sales were up by 7% at 744.5 billion Japanese yen ($4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen ($3.03 billion).