Full Press Release Details
AHMEDABAD, India and PENNINGTON, N.J.,Jan. 15, 2026/CNW/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") is an innovation-led life-sciences company with an international presence, today announced the successful closure of the Asset Purchase Agreement, Share Purchase Agreement, and the exclusive Licensing Agreement with Agenus Inc. (NASDAQ: AGEN). This comprehensive closure follows the receipt of all the necessary regulatory approvals, including formal clearance from the Committee on Foreign Investment in the United States ("CFIUS").
The transaction establishes Zydus' advanced manufacturing facilities in the global biologics contract development and manufacturing organization ("CDMO") business. All acquired manufacturing assets and operations will be housed under a newly formed, dedicated U.S. based subsidiary named Zylidac Bio LLC.
Commenting on the finalization of the deal, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited., stated, "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. Garo Armen, Chairman and CEO of Agenus, Inc., said, "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."
The launch of Zylidac Bio LLC is particularly significant in light of the BIOSECURE Act, signed into law on December 18, 2025, which restricts U.S. executive agencies from contracting with "Biotechnology Companies of Concern". By establishing a secure, domestic manufacturing footprint in California through Zylidac Bio LLC, Zydus provides a "safe-harbor" for global biopharmaceutical companies seeking to transition their supply chains to compliant, U.S.-based partners.
Earlier in 2025, Zydus announced Global BioCDMO Services through the acquisition of Agenus Inc.'s state-of-the-art facilities in Emeryville and Berkeley. [Under the exclusive manufacturing agreement, Zydus will be the sole provider for the production of drug substance and drug product for Agenus Inc's Phase 3 immuno-oncology candidates, Botensilimab (BOT) and Balstilimab (BAL). Zydus has secured exclusive rights to commercialize Agenus' lead immuno-oncology assets, BOT and BAL, in India and Sri Lanka.
Zydus completed its equity investment in Agenus Inc. through its venture capital arm, Zynext Ventures.
This move complements Zydus' recently announced strategic partnership with Formycon to commercialize a Keytruda® biosimilar (FYB206) in North America. Zylidac Bio LLC will allow for a localized supply chain, ensuring agility and security for Zydus' expanding biosimilar and innovative portfolio.
