- Zydus Lifesciences has completed asset, share and licensing agreements with Agenus Inc., following receipt of all regulatory approvals, including CFIUS clearance.
- The transaction establishes Zylidac Bio LLC as a U.S.-based biologics CDMO, housing acquired manufacturing assets in California.
Zydus Lifesciences Limited has completed the closure of an Asset Purchase Agreement, Share Purchase Agreement and an exclusive Licensing Agreement with Agenus Inc., after securing all required regulatory approvals, including clearance from the Committee on Foreign Investment in the United States.
The transaction establishes Zydus’ entry into the global biologics contract development and manufacturing organisation (CDMO) business. All acquired manufacturing assets and operations will be housed under Zylidac Bio LLC, a newly formed, dedicated U.S.-based subsidiary. The facilities are located in California and are intended to support biologics manufacturing for biopharmaceutical companies worldwide.
“With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. The model supports secure, domestic and high-quality supply chains for advanced therapies in the United States.”
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited
Under the exclusive manufacturing agreement, Zydus will be the sole provider of drug substance and drug product manufacturing for Agenus’ Phase III immuno-oncology candidates, botensilimab and balstilimab. Zydus has also secured exclusive rights to commercialise these assets in India and Sri Lanka, while Agenus retains access to dedicated U.S. biologics capacity for its clinical and commercial programmes.
Zydus stated that the launch of Zylidac Bio LLC aligns with recent U.S. policy developments, including the BIOSECURE Act signed into law in December 2025, by providing a compliant, U.S.-based contract manufacturing option. The transaction also complements Zydus’ broader biologics and biosimilar strategy, including its recently announced partnership with Formycon for the commercialisation of a Keytruda® biosimilar in North America.
