Formycon AG and Zydus Lifesciences have entered a strategic partnership for the exclusive licensing and supply of FYB206, a biosimilar version of pembrolizumab, for the U.S. and Canadian markets.

Formycon AG 和 Zydus Lifesciences 就 pembrolizumab 的生物类似药 FYB206 达成了战略合作伙伴关系，获得该药物在美国和加拿大市场的独家许可和供应权。

Pembrolizumab is a humanised monoclonal antibody used across multiple cancer indications. Keytruda®, its reference product, recorded global sales of US$29.5 billion in 2024, reflecting strong demand and significant market potential in oncology.

帕博利珠单抗是一种人源化单克隆抗体，用于多种癌症适应症。其参考产品Keytruda®在2024年实现了295亿美元的全球销售额，反映了在肿瘤学领域的强劲需求和巨大的市场潜力。

Under the agreement, Formycon will complete the development of FYB206, prepare the regulatory dossier, file the application, and handle product supply. Zydus will oversee commercialisation in both countries. FYB206 is nearing the end of its clinical development, with primary endpoint data expected in the first quarter of 2026.

根据协议，Formycon将完成FYB206的开发，准备监管文件，提交申请，并负责产品供应。Zydus将监督在两国的商业化进程。FYB206即将完成临床开发阶段，预计将在2026年第一季度获得主要终点数据。

Once the data package is completed, Formycon plans to submit a Biologics License Application to the U.S. FDA..

一旦数据包完成，Formycon 计划向美国 FDA 提交生物制品许可申请。

The companies noted that the partnership marks a significant step for both sides. Zydus has a strong commercial presence in the U.S., where it generates a large share of its global revenue and markets more than 225 FDA-approved products, including injectables and hospital medicines. This track record is expected to support the future launch of FYB206.

这些公司指出，该合作伙伴关系标志着双方迈出了重要的一步。Zydus 在美国有着强大的商业存在，在那里它创造了其全球收入的很大一部分，并销售超过 225 种 FDA 批准的产品，包括注射剂和医院药品。这一业绩记录预计将支持 FYB206 的未来上市。

Formycon highlighted its progress in developing complex biosimilars for highly regulated markets and sees this agreement as part of its broader strategy of working with strong regional partners..

Formycon 强调了其在为高度监管市场开发复杂生物仿制药方面取得的进展，并将此协议视为其与强大区域合作伙伴合作的更广泛战略的一部分。

Zydus stated that the collaboration represents its entry into the North American biosimilar market, beginning with an immunotherapy product.

Zydus 表示，此次合作代表了其进入北美生物仿制药市场的开端，首先是免疫治疗产品。

The agreement also aligns with the company’s plan to expand manufacturing capabilities in the U.S. through a proposed acquisition of Agenus Inc.’s facilities in California.

该协议还与公司通过拟议收购Agenus Inc.位于加州的设施来扩展其在美国的制造能力的计划相一致。

Source: formycon.com

来源：formycon.com