Hansoh Pharma Receives NMPA Breakthrough-Therapy Designation for Fourth-Gen EGFR-TKI HS-10504

Bulletin Express05-21 18:43

Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma) reported that on 21 May 2026 the National Medical Products Administration of China granted Breakthrough-Therapy designation to the company’s self-developed fourth-generation EGFR tyrosine kinase inhibitor, HS-10504 tablets.

The proposed indication covers patients with locally advanced or metastatic non-small cell lung cancer that harbours the EGFR C797S mutation following failure of prior EGFR-TKI therapy. The designation positions HS-10504 as a potential treatment option for this genetically defined group, which currently faces limited therapeutic choices.

The announcement was issued under the authority of the company’s board, chaired by Ms. Zhong Huijuan, and classifies the development as a voluntary disclosure to the Hong Kong market.

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