Zydus Lifesciences has successfully completed its strategic acquisition of Agenus Inc.'s biologics manufacturing assets and equity stake, marking a significant milestone in the company's expansion into the US biologics manufacturing sector. The comprehensive transaction was finalized on January 15, 2026, following receipt of all necessary regulatory approvals, including formal clearance from the Committee on Foreign Investment in the United States (CFIUS).

Transaction Components and Structure

The completed acquisition encompasses three key components originally announced on June 3, 2025. The deal structure involved multiple subsidiaries and comprehensive agreements across manufacturing, equity, and licensing arrangements.

Strategic Business Implications

The transaction establishes Zydus' advanced manufacturing capabilities in the global biologics CDMO business through the newly formed Zylidac Bio LLC. This US-based subsidiary will provide biologics manufacturing services to biopharmaceutical companies globally, positioning Zydus to serve the evolving landscape of biological product manufacturing that prioritizes secure, domestic, and high-quality supply chains.

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, emphasized the strategic importance: "With this deal, Zylidac Bio LLC will now provide biologics 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."

Regulatory Environment and Compliance

The establishment of Zylidac Bio LLC gains particular significance following the BIOSECURE Act, signed into law on December 18, 2025. This legislation restricts US executive agencies from contracting with "Biotechnology Companies of Concern." By establishing a secure, domestic manufacturing footprint in California, Zydus provides a compliant solution for global biopharmaceutical companies seeking to transition their supply chains to US-based partners.

Manufacturing and Development Capabilities

Under the exclusive manufacturing agreement, Zydus will serve as the sole provider for production of drug substance and drug product for Agenus Inc.'s Phase 3 immuno-oncology candidates, Botensilimab (BOT) and Balstilimab (BAL). The company has secured exclusive rights to commercialize these lead immuno-oncology assets in India and Sri Lanka territories.

Partnership Perspectives

Dr. Garo Armen, Chairman and CEO of Agenus, Inc., highlighted the collaborative benefits: "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."

The move complements Zydus' recently announced strategic partnership with Formycon to commercialize a Keytruda® biosimilar (FYB206) in North America, with Zylidac Bio LLC enabling a localized supply chain for the company's expanding biosimilar and innovative portfolio. Zydus completed its equity investment in Agenus Inc. through its venture capital arm, Zynext Ventures.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Eltrombopag Tablets in multiple strengths, marking another significant regulatory milestone for the pharmaceutical company. The company announced this development on Thursday, January 15, highlighting the approval's coverage of four different dosage strengths for thrombocytopenia treatment.

Product Specifications and Market Opportunity

The USFDA approval encompasses Eltrombopag Tablets in four distinct strengths, positioning the company to serve diverse patient needs in the thrombocytopenia treatment market. The approval represents access to a substantial market opportunity based on latest sales data.

Therapeutic Applications and Mechanism

Eltrombopag tablets are specifically indicated for treating thrombocytopenia, a condition characterized by low platelet count associated with certain blood disorders. The medication functions by stimulating bone marrow cells to increase platelet production, thereby helping lower bleeding risks for patients suffering from this condition.

The therapeutic approach addresses a critical medical need, as thrombocytopenia can lead to serious bleeding complications. By targeting the bone marrow's platelet production mechanism, Eltrombopag provides healthcare providers with an effective treatment option for managing this challenging condition.

Manufacturing and Production Details

Zydus Lifesciences will produce the approved Eltrombopag tablets at its formulation manufacturing facility located in the Special Economic Zone (SEZ) in Ahmedabad. This facility represents part of the company's established manufacturing infrastructure, ensuring quality production capabilities for the US market supply.

Regulatory Portfolio Expansion

The Eltrombopag approval contributes to Zydus Lifesciences' expanding regulatory portfolio in the United States pharmaceutical market. The latest approval brings the company's cumulative achievements to significant milestones in its regulatory journey.

The company has maintained an active filing strategy since commencing its ANDA submission process, resulting in a substantial portfolio of approved products. This latest approval reinforces the company's commitment to expanding its presence in the competitive US generics market through strategic product development and regulatory execution.