Recent Updates — HCM
The US FDA has granted Orphan Drug Designation to HUTCHMED's sovleplenib for the treatment of autoimmune hemolytic anemia (AIHA). This marks the second such designation for sovleplenib, following a prior grant for primary immune thrombocytopenia. The designation provides eligibility for development incentives including seven years of US market exclusivity upon approval, tax credits for qualified clinical trials, and user fee waivers. HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies.
The European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare have accepted the Marketing Authorization Application and New Drug Application, respectively, for ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib). The filings seek approval for treating locally advanced or metastatic non-small cell lung cancer in patients with MET overexpression or amplification who progressed on EGFR tyrosine kinase inhibitor therapy. These submissions follow a New Drug Application filed with the US FDA in September 2026 and are supported by positive Phase III SAFFRON trial data showing significant improvements in progression-free and overall survival. HUTCHMED is an innovative biopharmaceutical company focused on discovering and commercializing targeted therapies for cancer.
The US Food and Drug Administration has granted Orphan Drug Designation to HUTCHMED's investigational drug sovleplenib for the treatment of primary immune thrombocytopenia (ITP). This designation recognizes the drug's potential to address significant unmet medical needs in patients with this rare autoimmune disorder. If approved, the drug becomes eligible for development incentives including seven years of US market exclusivity upon regulatory approval, tax credits for qualified clinical trials, and user fee waivers under the Prescription Drug User Fee Act. HUTCHMED is an innovative biopharmaceutical company focused on the discovery and global commercialization of targeted therapies and immunotherapies for cancer and immunological diseases.
HUTCHMED (China) Limited announced a virtual webcast scheduled for November 5, 2026, co-hosted with Citigroup Global Markets Asia Limited. The event will feature Professor Yi-Long Wu and Dr. Weiguo Su to discuss recent Phase III clinical data for savolitinib in MET-driven non-small cell lung cancer presented at the ESMO Congress 2026. Savolitinib is a selective MET inhibitor marketed in China, jointly developed with AstraZeneca. HUTCHMED (China) Limited is an innovative biopharmaceutical company focused on targeted therapies and immunotherapies for cancer.
HUTCHMED announced positive top-line results from the global Phase III SAFFRON trial evaluating ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib) versus chemotherapy in patients with MET-driven EGFR-mutated non-small cell lung cancer who progressed on prior osimertinib treatment. The combination reduced the risk of disease progression or death by 45% and the risk of death by 32%, extending median overall survival by nearly five months (17.8 versus 12.9 months). HUTCHMED also highlighted data from the SANOVO Phase III trial in China, where the same combination reduced the risk of disease progression or death by 44% in treatment-naïve patients with MET overexpression. Based on these results, a New Drug Application has been submitted to the US FDA for the SAFFRON indication, and HUTCHMED plans to submit a supplemental NDA in China for the SANOVO first-line setting. HUTCHMED is an innovative biopharmaceutical company focused on discovering and commercializing targeted therapies and immunotherapies for cancer.
HUTCHMED (China) Limited announced that its partner AstraZeneca submitted a New Drug Application to the US FDA for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib). The application seeks approval for this all-oral combination therapy in patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and who progressed on EGFR tyrosine kinase inhibitor therapy. The filing is supported by the global SAFFRON Phase III trial, which demonstrated statistically significant improvements in progression-free and overall survival compared to chemotherapy. HUTCHMED operates as an innovative biopharmaceutical company focused on the discovery and commercialization of targeted cancer therapies.