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Bioeq AG ('Bioeq'), a Swiss biopharmaceutical company, and Zydus Lifesciences Limited ('Zydus'), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeq`s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO®, an interchangeable biosimilar of Lucentis®1 (Ranibizumab) for the U.S.
Bioeq AG(“Bioeq”),一家瑞士生物制药公司,与创新驱动的国际生命科学公司Zydus Lifesciences Limited(“Zydus”)今天宣布,其全资子公司Zydus Lifesciences Global FZE(阿拉伯联合酋长国)已与Bioeq达成战略合作伙伴关系,针对Bioeq的血管内皮生长因子(VEGF)抑制剂NUFYMCO®(Lucentis®1(雷珠单抗)的可互换生物类似药)在美国的许可、供应和商业化展开合作。
market. The Biologics License Application (BLA) for NUFYMCO® has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. This transaction marks an expansion of Zydus' U.S. biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda®2 (Pembrolizumab)..
市场。NUFYMCO®的生物制品许可申请(BLA)已于2025年12月18日获得美国食品药品监督管理局(USFDA)批准。此次交易标志着Zydus在美国生物类似药业务的扩展,继其近期与Formycon AG合作开发Keytruda®(Pembrolizumab)的生物类似药之后。
Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO® in the U.S. market.
根据该协议的条款,Bioeq将负责成品的开发、生产、注册和供应,而Zydus将负责NUFYMCO®在美国市场的商业化。
Speaking on the development, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, said, 'We are happy to collaborate with Bioeq to bring an interchangeable biosimilar to Lucentis® (Ranibizumab) in the US market. Through this partnership, we will leverage our combined expertise and resources to accelerate organisational growth while ensuring maximum value to patients through an expanded access to affordable ophthalmology care.'.
在谈到这一进展时,Zydus Lifesciences Limited董事总经理Sharvil P. Patel博士表示:“我们很高兴与Bioeq合作,将一款可互换的Lucentis®(雷珠单抗)生物类似药引入美国市场。通过此次合作,我们将利用双方的专业知识和资源,加速组织增长,同时通过扩大眼科护理的可及性,为患者提供最大的价值。
Dr. Thiemo Schreiber, Vice President Commercial at Bioeq, stated, 'We are excited about the regulatory approval of 'NUFYMCO® by USFDA as an interchangeable biosimilar of Lucentis® (Ranibizumab). This latest addition to our portfolio reflects Bioeq's advanced expertise in developing complex biosimilar medicines for highly regulated markets.
Bioeq公司商业副总裁蒂莫·施雷伯博士表示:“我们对NUFYMCO®获得美国食品药品监督管理局(USFDA)批准作为Lucentis®(雷珠单抗)的可互换生物类似药感到兴奋。这一最新成果加入我们的产品组合,体现了Bioeq在为高度监管市场开发复杂生物类似药方面的先进专业知识。”
Our partnership with Zydus will leverage its extensive distribution network and strong sales and marketing capabilities across the US to broaden treatment options for patients. We are committed to delivering high-quality, affordable therapies and look forward to this collaboration tailored to driving innovation and improving healthcare accessibility.'.
我们与Zydus的合作将利用其在美国广泛的分销网络和强大的销售及营销能力,为患者拓宽治疗选择。我们致力于提供高质量、可负担的治疗方案,并期待此次合作能够推动创新并改善医疗保健的可及性。
The total addressable market opportunity for biosimilar Ranibizumab in the US is approximately US$210 million as per IQVIA MAT Sep 2025.
根据IQVIA MAT 2025年9月的数据,美国生物类似药雷珠单抗的总体可触达市场机会约为2.1亿美元。
About Zydus
关于Zydus
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 29,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives.
Zydus Lifesciences Limited是一家创新驱动的生命科学公司,在制药和消费者健康领域占据领先地位,依托新兴的医疗技术业务,并在美国、印度及其他国际市场拥有全球影响力。截至2025年9月30日,该集团在全球拥有29,000名员工,其中包括1,500名从事研发的科学家,其使命是通过优质的医疗保健解决方案开拓生命科学的新可能性,从而影响人们的生活。
The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com.
该集团希望通过开创性的发现来改变生活。欲了解更多信息,请访问 www.zyduslife.com。
About Bioeq
关于Bioeq
Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Established in 2014, Bioeq specializes in the development, licensing, and commercialization of high-quality biosimilars for highly regulated markets worldwide. The company focuses on creating cost-effective alternatives to leading biologics, ensuring broader patient access to advanced therapies.
Bioeq AG 是波兰生物制药集团 Polpharma Biologics 与 Formycon AG 之间的瑞士生物制药合资企业。Bioeq 成立于 2014 年,专注于为全球高度监管市场开发、授权和商业化高质量的生物类似药。该公司致力于为领先的生物制品提供具有成本效益的替代品,确保更多患者能够获得先进的治疗方案。
For more details visit http://www.bioeq.ch.
欲了解更多信息,请访问 http://www.bioeq.ch。
Source: prnewswire.com
来源:prnewswire.com