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The US Food and Drug Administration has granted Orphan Drug Designation to HUTCHMED's sovleplenib for the treatment of autoimmune hemolytic anemia.
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HUTCHMED announced that regulatory authorities in Europe and Japan have accepted for review the filings for the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for lung cancer treatment.
HUTCHMED (China) Limited has been granted Orphan Drug Designation by the US FDA for its drug candidate, sovleplenib, intended for the treatment of primary immune thrombocytopenia.
Filing seeks approval for a biomarker-directed, all-oral treatment option for patients whose tumors have MET overexpression or amplification, after progression on an EGFR-TKI therapy —Application supported by SAFFRON,
HUTCHMED has initiated a Phase Ia global clinical trial of HMPL-A830, a first-in-class antibody-targeted therapy conjugate combining a KRAS inhibitor with an anti-EGFR antibody for treating solid tumors. The first patient was dosed on September 24, 2026. HUTCHMED entered an exclusive development and licensing agreement with GSK on September 3, 2026, granting GSK worldwide rights (excluding Greater China) for development and commercialization.