Zydus Lifesciences Limited announced it has completed a set of agreements with Agenus Inc. that transfers ownership of Agenus’ biologics manufacturing facilities and operations to Zydus, establishing a new U.S.-based platform that will operate under a newly formed subsidiary, Zylidac Bio LLC.
The company said the closing covers an Asset Purchase Agreement, a Share Purchase Agreement and an exclusive Licensing Agreement, and comes after securing required regulatory approvals, including formal clearance from the Committee on Foreign Investment in the United States (CFIUS). With the transaction finalized, Zydus is positioning the acquired sites as the foundation of its global biologics contract development and manufacturing organization (CDMO) business, offering manufacturing services to biopharmaceutical companies worldwide from a U.S. footprint.
Zylidac Bio LLC will house the acquired manufacturing assets and operations, which Zydus previously identified as state-of-the-art facilities located in Emeryville and Berkeley, California. Zydus framed the move as a way to support a growing industry emphasis on domestic, secure supply chains for advanced biologics and next-generation therapies, while expanding its own capabilities in biologics manufacturing and CDMO services.
Agenus, which has been developing immuno-oncology therapies, said the transaction allows it to monetize manufacturing assets while preserving access to U.S.-based biologics capacity needed to support late-stage development of its lead candidates. Under an exclusive manufacturing arrangement described by Zydus, Zydus will be the sole provider of drug substance and drug product manufacturing for Agenus’ Phase 3 immuno-oncology candidates botensilimab (BOT) and balstilimab (BAL). Zydus also said it has secured exclusive rights to commercialize BOT and BAL in India and Sri Lanka.
Zydus also emphasized the timing of the launch of Zylidac Bio LLC amid evolving U.S. policy. The company pointed to the BIOSECURE Act—signed into law on December 18, 2025—which restricts U.S. executive agencies from contracting with “Biotechnology Companies of Concern.” Zydus said establishing a domestic manufacturing footprint in California through Zylidac Bio LLC creates a compliant “safe-harbor” option for biopharmaceutical companies seeking to transition supply chains to U.S.-based manufacturing partners.
The transaction also connects to Zydus’ broader biologics and biosimilars ambitions. The company said Zylidac Bio LLC will support a localized supply chain as Zydus expands its biosimilar and innovative portfolio, and noted that it recently announced a strategic partnership with Formycon to commercialize a Keytruda biosimilar candidate (FYB206) in North America. Zydus added that it completed an equity investment in Agenus through its venture capital arm, Zynext Ventures. Financial terms of the manufacturing asset acquisition were not disclosed in the announcement.
KEY QUOTES:
“With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation.”
Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences
“This collaboration unites Agenus’ pioneering immunotherapy pipeline and U.S.-based clinical development capabilities with Zydus’ global manufacturing, operational scale, and commercial infrastructure. The transaction allows Agenus to monetize manufacturing assets while securing dedicated, high-quality U.S. biologics capacity to support botensilimab and balstilimab. Importantly, it sharpens our focus on advancing BOT and BAL through late-stage development and expanding paid access to patients globally who have limited treatment options.”
Dr. Garo Armen, Chairman and CEO, Agenus
