HUTCHMED's Sovleplenib Gains US FDA Orphan Drug Designation for Autoimmune Hemolytic Anemia

• HUTCHMED received US FDA orphan drug designation for sovleplenib to treat autoimmune hemolytic anemia.
• The designation offers development incentives, including seven years of US market exclusivity upon regulatory approval.
• This is sovleplenib’s second FDA orphan drug designation, following one for primary immune thrombocytopenia in October 2026.
• Chinese regulators are reviewing sovleplenib applications for primary immune thrombocytopenia and warm autoimmune hemolytic anemia.
• The applications are supported by positive results from the pivotal ESLIM-01 and ESLIM-02 trials, respectively.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. HUTCHMED (China) Ltd. published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20261105-12400953), on November 05, 2026, and is solely responsible for the information contained therein.