Shares of Shilpa Medicare are likely to remain in focus after the company informed stock exchanges that its material subsidiary, Shilpa Biologicals Pvt. Ltd., along with mAbTree Biologics, has achieved a major regulatory milestone in the United States.
In an exchange filing dated January 28, 2026, Shilpa Medicare said the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the partners’ flagship investigational biologic for the treatment of Essential Thrombocythemia (ET) and Polycythemia Vera (PV)—both rare and chronic blood cancers with significant unmet medical need .
According to the company, the product is a first-in-class monoclonal antibody designed to target immune dysregulation, which is increasingly recognised as a key driver in myeloproliferative neoplasms. The orphan drug status provides several regulatory and commercial benefits, including development support, tax credits and potential market exclusivity in the US upon approval.
Shilpa Medicare said the designation validates the scientific approach behind the biologic and marks an important step in the group’s biologics strategy. Following the FDA’s decision, Shilpa Biologicals and mAbTree Biologics plan to advance the programme through IND-enabling studies, with the aim of initiating first-in-human clinical trials in patients with ET and PV.
The company added that existing treatments for these conditions—such as aspirin, interferon-alpha, hydroxyurea and JAK inhibitors—often face limitations over long-term use, highlighting the need for therapies that directly address disease biology rather than only managing symptoms.
The development is seen as a key regulatory trigger for Shilpa Medicare, as progress in the biologics pipeline and US regulatory traction are closely tracked by investors in the pharmaceutical space.
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