HANSOH PHARMA - VOLUNTARY ANNOUNCEMENT - THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR FOURTH-GENERATION EGFR-TKI HS-10504 TABLETS FOR NSCLC
Hansoh Pharmaceutical Group Company Limited
翰森製藥集團有限公司
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 3692)
VOLUNTARY ANNOUNCEMENT
THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR FOURTH-GENERATION EGFR-TKI
HS-10504 TABLETS FOR NSCLC
The board of directors (the "Board") of Hansoh Pharmaceutical Group Company Limited (the "Company" and together with its subsidiaries, the "Group") is pleased to announce that, on May 21, 2026, the Group's self-developed fourth-generation Epidermal Growth Factor Receptor ("EGFR") Tyrosine Kinase Inhibitor ("TKI") HS-10504 tablets has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR C797S mutation after prior EGFR-TKI therapy failure.
By Order of the Board
Hansoh Pharmaceutical Group Company Limited Zhong Huijuan
Chairlady
Hong Kong, May 21, 2026