# HUTCHMED's Sovleplenib Gets FDA Orphan Drug Designation for Immune Thrombocytopenia

> HUTCHMED's sovleplenib received FDA orphan drug designation for primary immune thrombocytopenia, making it eligible for seven years of US market exclusivity if approved.

- Published: 2026-10-29T00:28:47+00:00
- Section: Regulation & Approvals
- Author: News Desk
- URL: https://newsforagent.com/news/2026-10-29/hutchmed-sovleplenib-fda-orphan-drug-designation
- Source: [Stock Titan](https://www.stocktitan.net/news/HCM/hutchmed-announces-sovleplenib-granted-us-fda-orphan-drug-gmbc4q41oj0z.html)

## Key takeaways

- The FDA granted orphan drug designation to HUTCHMED's sovleplenib for primary immune thrombocytopenia.
- Sovleplenib would be eligible for seven years of US market exclusivity if the FDA approves it for the designated indication.
- NDAs for sovleplenib in primary ITP and warm antibody autoimmune hemolytic anemia are under review by China's NMPA.

HUTCHMED (China) Limited said the US Food and Drug Administration granted orphan drug designation to sovleplenib for the treatment of primary immune thrombocytopenia, an autoimmune disorder that can raise the risk of bleeding. [Stock Titan](https://www.stocktitan.net/news/HCM/hutchmed-announces-sovleplenib-granted-us-fda-orphan-drug-gmbc4q41oj0z.html) reported the designation on October 28, 2026.

## What the Sovleplenib Designation Covers

Sovleplenib is a novel, selective, oral spleen tyrosine kinase inhibitor taken once daily. The FDA's orphan drug program covers diseases and conditions affecting fewer than 200,000 people in the United States. If approved for the designated indication, a drug with orphan designation is eligible for seven years of US market exclusivity, tax credits for qualified clinical trials, user fee waivers under the Prescription Drug User Fee Act and specialized regulatory guidance during development.

HUTCHMED retains all rights to sovleplenib worldwide. In China, New Drug Applications for sovleplenib in primary ITP and warm antibody autoimmune hemolytic anemia are under review by the National Medical Products Administration, supported by data from the pivotal ESLIM-01 and ESLIM-02 trials. The company describes ITP as a condition in which platelets are destroyed immunologically and production falls, leaving patients prone to excessive bleeding and bruising; it cites an incidence of 3.3 per 100,000 adults per year and a prevalence of 9.5 per 100,000 adults.

## HUTCHMED's Run of Regulatory and Deal News

On September 3, 2026, HUTCHMED entered a co-development and licensing agreement with GSK for ex-China rights to HMPL-A830, a KRAS-EGFR antibody-drug conjugate, in a deal with potential value up to $1.3 billion, MarketBeat reported. On September 29, 2026, AstraZeneca submitted an FDA NDA for ORPATHYS plus TAGRISSO in MET-driven EGFR-mutated lung cancer after EGFR-TKI progression, FinancialContent Business Page reported. On October 27, 2026, HUTCHMED said it will co-host a webcast with Citigroup on November 5, 2026, to discuss Phase III savolitinib data in MET-driven non-small cell lung cancer, Stock Titan reported.

## Orphan Status Elsewhere in Rare Disease

Novartis received European Commission approval of Cosentyx (secukinumab) for polymyalgia rheumatica in patients unresponsive to glucocorticoids on October 21, 2026, [Seeking Alpha](https://seekingalpha.com/news/4655372-novartis-gains-ec-approval-cosentyx-polymyalgia-rheumatica) reported. Merck said the FDA granted Fast Track designation for cladribine capsules to treat generalized myasthenia gravis on October 21, 2026, with Orphan Drug Designation already granted in June 2023, [AETOSWire](https://www.aetoswire.com/en/news/2411202551239) reported.

## HUTCHMED's November 5 Webcast

HUTCHMED's November 5, 2026 webcast with Citigroup will cover Phase III savolitinib data in MET-driven non-small cell lung cancer, with Professor Yi-Long Wu and Dr. Weiguo Su on the panel. The company's [own announcement](https://www.hutch-med.com) lists the event.

## Companies in this story

- HUTCHMED (China) Limited · website: https://www.hutch-med.com

---
News for Agent · https://newsforagent.com/llms.txt