Shilpa Medicare has announced a strategic licensing agreement between its subsidiary Shilpa Biologicals Pvt Ltd and SteinCares, a leading specialty healthcare company in Latin America. The partnership aims to commercialize biosimilars across Latin American markets, marking Shilpa Biologicals' entry into the region.

Partnership Structure and Scope

Under the licensing agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar across Latin America. Meanwhile, Shilpa Biologicals will complete product development and provide long-term commercial manufacturing from its facility in Dharwad, India.

Executive Leadership Perspectives

Mitchell Waserstein, CEO of SteinCares, expressed enthusiasm about the collaboration: "We are excited to partner with Shilpa Biologicals to bring this biosimilar to Latin America. This agreement reinforces our leadership in biosimilars and our role as a strategic partner for global biopharmaceutical companies seeking to enter Latin America's complex healthcare markets."

Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, highlighted the strategic importance: "SteinCares is a trusted partner in Latin America with proven expertise in the registration and commercialization of specialty therapies. Through this licensing agreement, we are entering Latin America and aim to broaden patient access to safe treatments across the region."

Market Impact and Strategic Value

The partnership combines Shilpa Biologicals' expertise in biologics development and high-quality commercial manufacturing with SteinCares' integrated regional platform. SteinCares brings regulatory capabilities, market access expertise, and deep understanding of Latin American healthcare systems to the collaboration.

This collaboration builds on SteinCares' track record of successfully introducing biosimilars in the region and strengthens its specialty care portfolio. The partnership creates a platform for expanding access to innovative, cost-effective treatments across Latin America while establishing a foundation for future collaborations.

Shilpa Medicare Limited has issued a revised disclosure regarding its strategic partnership with NXI Therapeutics AG, following terminology updates requested by the University for alignment with an upcoming high-impact journal publication. The revised disclosure, dated 14 February 2026, clarifies specific wording related to the novel asset and therapy descriptions.

Revised Disclosure Details

The company informed stock exchanges that NXI Therapeutics requested updates to maintain consistency between the partnership announcement and a forthcoming scientific publication. The revisions specifically address terminology for the "novel asset" and "novel therapy" to treat autoimmune or alloimmune disorders.

Partnership Framework

The strategic collaboration with NXI Therapeutics AG, a Switzerland-based biotechnology company, remains unchanged in its core structure. Under the binding agreement, Shilpa Medicare will provide comprehensive development and manufacturing services for a New Chemical Entity targeting autoimmune and alloimmune disorders.

Strategic Context

This partnership represents the third major international development and manufacturing contract secured by Shilpa group in recent months, demonstrating strengthening demand from Western biotech companies for its integrated R&D capabilities and advanced GMP manufacturing infrastructure.

Management Statements

Mr. Vishnukanth Bhutada, Managing Director, Shilpa Medicare Limited, commented: "This collaboration reinforces Shilpa's transformation into a strategic innovation partner for global biotech companies. Our integrated development and commercial manufacturing capabilities enable us to support complex assets across the full product lifecycle."

Dr. Ruben Herrendorff, CEO, NXI Therapeutics AG, added: "Shilpa's scientific depth, quality systems, and scalable GMP manufacturing capabilities make them an ideal partner as we advance our immunomodulatory program toward clinical and commercial milestones."

Company Profiles

Shilpa Medicare Limited operates as a global pharmaceutical company and integrated CDMO providing end-to-end solutions across small molecules, biologics, and complex therapeutics. NXI Therapeutics is a Swiss biotechnology company focused on developing safe immunotherapies for autoimmune and alloimmune conditions through targeted immunomodulation that preserves immunocompetence.