Hansoh Gains EU Approval for Aumolertinib; HS-10504 Gets Breakthrough Therapy Status in China
Hansoh received EU approval for Aumolertinib for EGFR-mutated NSCLC, while China's NMPA granted Breakthrough Therapy status to HS-10504 for EGFR C797S-mutated NSCLC.
Hansoh Pharmaceutical Group announced that its innovative lung cancer drug Aumolertinib Mesylate Tablets has received European Union approval as a monotherapy, while its self-developed fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), HS-10504 tablets, was approved by China's National Medical Products Administration for inclusion as a Breakthrough Therapy.
The EU approval, which followed a positive opinion from the EMA's Committee for Medicinal Products for Human Use, covers first-line treatment of adults with advanced EGFR-mutated non-small cell lung cancer, as well as patients with advanced EGFR T790M mutation-positive disease. Aumolertinib is marketed as Ameile in China and Aumseqa outside China. The approval significantly extends the global reach of the drug, which already holds multiple indications in China and marketing authorization in the U.K.
Hansoh Pharmaceutical Group is a China-based pharmaceutical company focused on innovative therapies, particularly in oncology. Aumolertinib Mesylate Tablets is a third-generation EGFR tyrosine kinase inhibitor used to treat various forms and stages of non-small cell lung cancer.
Separately, on May 21, Hansoh's fourth-generation EGFR-TKI HS-10504 tablets received Breakthrough Therapy designation from the National Medical Products Administration. The proposed indication is for the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR C797S mutation following failure of prior EGFR-TKI therapy.