Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted for review a new indication filing for trastuzumab rezetecan, its in-house developed HER2-targeted antibody-drug conjugate (ADC). The submission seeks approval for HER2-positive colorectal cancer in patients who have failed prior oxaliplatin, fluorouracil, and irinotecan therapy, based on positive Phase III data demonstrating significant progression-free survival (PFS) improvement and disease progression risk reduction.
HER2-positive colorectal cancer (post-chemotherapy failure)
Under NMPA review
2026-2027
HER2-positive breast cancer (post-anti-HER2 therapy)
Awaiting regulatory decision
2026
Strategic Positioning & Market Context
Factor
Strategic Analysis
HER2+ Colorectal Cancer Prevalence
~3-5% of metastatic colorectal cancers HER2-amplified; no approved HER2-targeted therapies in China for this indication – first-mover opportunity
ADC Competitive Landscape
Trastuzumab deruxtecan (Enhertu, AstraZeneca/Daiichi) approved for HER2+ colorectal cancer in US/Japan; Hengrui’s domestic manufacturing and pricing advantage for China market
Hengrui Oncology Portfolio
Trastuzumab rezetecan anchors HER2 ADC franchise; complements SHR-A1811 (HER2 ADC) and pyrotinib (HER2 TKI) in breast cancer
NMPA approval supports ex-China partnership discussions; HER2+ colorectal cancer represents orphan indication with premium pricing in US/EU
Forward‑Looking Statements This brief contains forward‑looking statements regarding trastuzumab rezetecan NMPA approval timelines for HER2+ colorectal cancer, commercial market penetration, and competitive positioning vs. trastuzumab deruxtecan. Actual results may differ due to regulatory review delays, pricing pressure from national procurement programs, and biomarker testing adoption in Chinese oncology practice.-Fineline Info & Tech
By Fineline Cube