HUTCHMED Receives FDA Orphan Drug Designation for Sovleplenib in AIHA
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 Advances Regulatory Filings for ORPATHYS and TAGRISSO Combination in Europe and Japan
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.
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HUTCHMED Receives US FDA Orphan Drug Designation for Sovleplenib
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.
Reported Earlier, HUTCHMED Closes Exclusive License Of KRAS-EGFR ATTC HMPL-A830 To GSK Outside China, Expects $110M Upfront Payment And Up To $1.185B In Milestones
Reported Earlier, HUTCHMED Announces AstraZeneca Submitted US NDA For ORPATHYS Plus TAGRISSO In MET-Driven EGFR-Mutated NSCLC, Supported By Phase III SAFFRON Trial
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 Initiates Global Trial of KRAS-EGFR-Antibody Conjugate Therapy HMPL-A830 in Patients with Solid Tumors
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.
Reported Sunday, HUTCHMED Doses First Patient In Phase Ia Dose Escalation Of First-In-Class HMPL-A830 To Determine Maximum Tolerated Dose In Advanced Solid Tumors