Hengrui's HER2-Targeting ADC Meets Primary Endpoint in Phase III Breast Cancer Trial
Hengrui Medicine's subsidiary Suzhou Suncadia Biopharmaceuticals reported that its HER2-targeting antibody-drug conjugate, Ruikang trastuzumab (SHR-A1811), met the primary endpoint of progression-free survival in a pivotal Phase III trial for first-line treatment of HER2-positive recurrent or metastatic breast cancer. Both trial arms showed statistically significant and clinically meaningful improvement versus standard therapy. The company plans to file a pre-marketing communication application with China's drug regulator.
Hengrui Medicine announced that a pre-specified interim analysis of its pivotal Phase III clinical study of Ruikang trastuzumab (SHR-A1811), an HER2-targeting antibody-drug conjugate independently developed by its subsidiary Suzhou Suncadia Biopharmaceuticals Co. , Ltd. , met the primary endpoint of progression-free survival (PFS) in both treatment arms for first-line treatment of HER2-positive recurrent or metastatic breast cancer. The results showed statistically significant and clinically meaningful improvements in PFS compared with standard therapy.
The study demonstrated that Ruikang trastuzumab, with or without pertuzumab, significantly extended PFS in first-line patients compared with docetaxel plus trastuzumab and pertuzumab (the THP regimen). The company plans to submit a pre-marketing communication application to the Center for Drug Evaluation of the National Medical Products Administration in the near future.
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