Hengrui Medicine's HER2-targeting antibody-drug conjugate (ADC) trastuzumab rezetecan combined with checkpoint inhibitor adebrelimab has received breakthrough therapy designation (BTD) in China for first-line treatment of PD-L1-positive (CPS≥1) triple-negative breast cancer (TNBC). The combination showed a 77.8% objective response rate (ORR) in PD-L1-positive patients and 86.2% 6-month progression-free survival (PFS) in Phase Ib/II trials. Trastuzumab rezetecan, conditionally approved in May for HER2-mutant NSCLC, disrupts tumour cells through protease-cleavable payload delivery.

The designation marks Hengrui's ninth BTD for trastuzumab rezetecan across eight cancer types including HER2-low breast cancer and platinum-resistant ovarian cancer. The therapy demonstrated manageable safety in trials, positioning Hengrui to challenge Roche's dominant HER2 ADC franchise in China's rapidly evolving targeted therapy market.

PharmCube's NextBiopharm® database shows that Hengrui shared the third position globally in terms of TNBC ADC pipeline size. Click here to request a free trial for NextBiopharm®.