Hengrui’s Aiweida receives NMPA approval for HER2-positive Colorectal cancer

CAR-T Digest - August 2020

Weekly Digest - August 2026

07 August 2026: Hengrui’s Aiweida receives NMPA approval for HER2-positive Colorectal cancer

Hengrui Pharma’s HER2-targeted ADC Aiweida has been approved in China for the treatment of adults with HER2-positive colorectal cancer who have progressed following treatment with oxaliplatin, fluorouracil and irinotecan, making it the first anti-HER2 product approved in China for colorectal cancer and Aiweida’s third approved indication
The approval is based on the Phase 3 HORIZON-CRC01/SHR-A1811-III-309 trial, where Aiweida significantly improved median PFS versus standard treatment (5.5 vs. 2.8 months; PFS HR=0.33), reducing the risk of disease progression or death by 67%, while achieving an ORR of 40.7% vs. 4.5%; OS data were immature but showed a favorable trend (HR=0.77)
The approval addresses a major unmet need in HER2-positive colorectal cancer, particularly for patients who have progressed after oxaliplatin-, fluorouracil- and irinotecan-based therapy, for whom treatment options remain limited and no anti-HER2 therapy had previously been approved in China
Aiweida is a HER2-directed ADC that uses a cleavable tetrapeptide linker and a topoisomerase I inhibitor payload with an optimized DAR of 6:1; its stable linker-toxin system and enhanced membrane permeability are designed to maximize tumor-cell killing while maintaining a favorable therapeutic window
Strategically, the approval establishes Aiweida as the first anti-HER2 product in China for colorectal cancer and expands Hengrui’s HER2 ADC franchise across lung, breast and colorectal cancers, while ongoing development in first-line HER2-positive colorectal cancer could further broaden its market opportunity