Trastuzumab Ruikang has received BTD from China’s NMPA for the treatment of HER2‑positive breast cancer

CAR-T Digest - August 2020

22 April 2026: Trastuzumab Ruikang has received BTD from China’s NMPA for the treatment of HER2‑positive breast cancer

Jiangsu Hengrui Pharmaceuticals announced that its HER2-targeting ADC Trastuzumab Ruikang in combination with Pertuzumab has been included in China’s Breakthrough Therapy Designation (BTD) list, reflecting strong regulatory recognition of its ongoing clinical development
This designation focuses on first-line treatment in patients who have not previously received anti-HER2 therapy, further expanding the drug’s clinical positioning and reinforcing its potential across earlier lines of therapy in HER2-positive breast cancer
Notably, Trastuzumab Ruikang has now received breakthrough designation across 11 different indications, spanning multiple solid tumors including breast, lung, gastric, colorectal, biliary, gynecologic, and cervical cancers, highlighting its broad anti-tumor applicability and development versatility
The HER2-targeted ADC is designed to deliver its payload directly to tumor cells, while also triggering a bystander effect that can help enhance overall anti-tumor activity
Overall, this milestone reinforces the drug’s growing importance in China’s oncology pipeline, especially as next-generation ADCs aim to improve outcomes in HER2-positive cancers where recurrence, resistance, and limited first-line ADC options remain key challenges