Hengrui Pharma Subunit's SHR-A2009 Injection Named Breakthrough Therapy for EGFR-Mutant NSCLC

Hengrui Pharma announced on September 11, 2026, that the injectable SHR-A2009 developed by its subsidiary Suzhou Suncadia Biopharmaceuticals has been included in the breakthrough therapy designation list by the Center for Drug Evaluation of the National Medical Products Administration.

The proposed indication is for use in combination with bevacizumab to treat patients with EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer who have failed prior treatment with epidermal growth factor receptor tyrosine kinase inhibitors.

The drug is an antibody-drug conjugate targeting HER3. No comparable drug has been approved globally for the treatment of NSCLC, and cumulative research and development investment in the related project amounts to approximately RMB 355 million.