Zydus Lifesciences Limited has completed the acquisition of biologics manufacturing facilities from U.S.-based Agenus Inc., marking a major step in its global biologics and contract development and manufacturing (CDMO) strategy. Following regulatory clearances, including approval from the Committee on Foreign Investment in the United States (CFIUS), the acquired assets will operate under a newly formed U.S. subsidiary, Zylidac Bio LLC.
The transaction involved the closure of an Asset Purchase Agreement, Share Purchase Agreement, and an exclusive Licensing Agreement between Zydus and Agenus. With this development, Zydus establishes an advanced biologics manufacturing footprint in the United States, strengthening its position in the rapidly growing global CDMO space.
Zylidac Bio LLC will house state-of-the-art biologics manufacturing facilities located in Emeryville and Berkeley, California. The new entity will provide end-to-end biologics CDMO services to biopharmaceutical companies worldwide, supporting both clinical and commercial manufacturing needs.
Commenting on the milestone, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences Limited, said the launch of Zylidac Bio LLC aligns with the increasing emphasis on secure, high-quality, and domestic manufacturing of advanced therapies in the U.S.
“With this deal, Zylidac Bio LLC will offer compliant and reliable biologics manufacturing services to global innovators. It enables localized supply chains and reinforces our commitment to serving the international biopharmaceutical industry with innovation and operational excellence,” he said.
From Agenus’ perspective, the transaction allows the company to unlock value from its manufacturing assets while retaining access to high-quality U.S.-based biologics capacity. Dr. Garo Armen, Chairman and CEO of Agenus Inc., noted that the collaboration brings together Agenus’ immunotherapy pipeline with Zydus’ global manufacturing and commercial capabilities.
“The transaction sharpens our focus on advancing botensilimab and balstilimab through late-stage development while expanding patient access globally,” he said.
Under an exclusive manufacturing agreement, Zydus will serve as the sole manufacturer of drug substance and drug product for Agenus’ Phase 3 immuno-oncology candidates, Botensilimab (BOT) and Balstilimab (BAL). Zydus has also secured exclusive commercialization rights for BOT and BAL in India and Sri Lanka. In addition, Zydus has completed an equity investment in Agenus through its venture capital arm, Zynext Ventures.
The launch of Zylidac Bio LLC is particularly significant in the context of the BIOSECURE Act, signed into law on December 18, 2025, which limits U.S. government engagement with certain overseas biotechnology entities. By establishing a compliant, U.S.-based manufacturing operation in California, Zydus positions Zylidac Bio LLC as a secure partner for global biopharmaceutical companies seeking to transition their supply chains to U.S.-based facilities.
This development also complements Zydus’ broader biologics strategy, including its recent partnership with Formycon to commercialize a Keytruda® biosimilar (FYB206) in North America. With Zylidac Bio LLC, Zydus aims to ensure agility, supply chain security, and scalable manufacturing support for its expanding biosimilar and innovative biologics portfolio.
The acquisition and launch underscore Zydus Lifesciences’ growing role as a global biologics player, bridging innovation, manufacturing excellence, and regulatory compliance across key international markets.
