Shilpa Medicare’s arm gets Orphan Drug Designation from USFDA

28 Jan 2026 Evaluate

Shilpa Medicare’s wholly owned subsidiary -- Shilpa Biologicals together with mAbTree Biologics AG has received Orphan Drug Designation (ODD) from U.S. Food and Drug Administration (USFDA) for their flagship breakthrough biologic product, an investigational monoclonal antibody being developed for the treatment of Essential Thrombocythemia (ET) and Polycythemia Vera (PV)-rare, chronic blood cancers with significant unmet medical need.

The Orphan Drug Designation recognizes both the seriousness of ET and PV and the potential of this first-in-class, immunology-driven biologic to modify disease progression rather than merely manage symptoms. The designation provides meaningful regulatory and commercial incentives, including development support, tax credits, and market exclusivity upon approval.

The investigational biologic targets a previously underexplored immune-evasion pathway implicated in MPN biology, offering the potential for durable disease control and a clearly differentiated clinical profile. Following this regulatory milestone, Shilpa Biologicals and mAbTree Biologics AG will advance the program through IND-enabling studies, with the objective of initiating first-in-human clinical trials in patients with ET and PV.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.


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