Shilpa Medicare unit gets USFDA orphan drug tag for new biologic

29 Jan 2026 , 10:35 AM

Shilpa Medicare Limited reported that one of its substantial subsidiaries, Shilpa Biologicals, along with partner mAbTree Biologics, has received Orphan Drug Designation from the US Food and Drug Administration (USFDA). The company said that this designation is for its flagship experimental biologic to treat rare blood cancers.

In its filing with the bourses, Shilpa Medicare stated that this designation has been provided for a monoclonal antibody being developed for Essential Thrombocythemia and Polycythemia Vera — chronic myeloproliferative disorders with very few treatment options.

With the Orphan Drug status, the company can secure regulatory and commercial incentives. This includes development support, tax credits and potential market exclusivity upon approval.

After completing the regulatory milestone, the company plans to expand the biologic through IND-enabling studies. It targets to initiate first-in-human clinical trials in patients with Essential Thrombocythemia and Polycythemia Vera.

Chief executive officer of mAbTree Biologics AG, Raj Andhuvan, commented that the differentiated mechanism of the programme secures validation with this FDA designation. Further, this could assist in establishing a new therapeutic approach in rare blood cancers by targeting immune dysregulation.

The company further iterated that the programme aims at a previously underexplored immune-evasion pathway implicated in myeloproliferative neoplasm biology.

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