Hengrui Medicine’s HER2 ADC, Trastuzumab Ruikang, has been included in the Breakthrough Therapy List for a new indication

CAR-T Digest - August 2020

Weekly Digest - February 2026

14 February 2026: Hengrui Medicine’s HER2 ADC, Trastuzumab Ruikang, has been included in the Breakthrough Therapy List for a new indication

Hengrui Medicine announced that its independently developed HER2-targeting antibody–drug conjugate, Trastuzumab Ruikang (Avida), has been included once again in China’s National Medical Products Administration Breakthrough Therapy Product List, this time for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 (ERBB2) activating mutations
This marks the tenth Breakthrough Therapy designation granted to Trastuzumab Ruikang across multiple tumor types, underscoring its broad clinical development potential and expanding role in HER2-driven cancers
Lung cancer remains the most commonly diagnosed malignancy worldwide and the leading cause of cancer-related death, with non-small cell lung cancer accounting for approximately 85% of cases; among these, 2–4% harbor HER2 mutations, a subgroup associated with aggressive disease and poor prognosis, and for which targeted first-line options remain limited
While trastuzumab Ruikang previously received marketing approval in China for patients with HER2-mutant NSCLC who had received prior systemic therapy, this new Breakthrough Therapy designation supports its advancement into the first-line setting, where current standards still rely largely on chemotherapy with or without immunotherapy
Beyond lung cancer, trastuzumab Ruikang has received breakthrough recognition across nine additional indications – including breast, colorectal, gastric, biliary tract, ovarian, and cervical cancers, and is supported by Hengrui’s broader ADC platform, which continues to advance multiple differentiated ADC candidates across solid tumor indications