Hengrui’s HER3 ADC, SHR-A2009 for injection, included in China’s Breakthrough Therapy list for NSCLC

CAR-T Digest - August 2020

14 September 2026: Hengrui’s HER3 ADC, SHR-A2009 for injection, included in China’s Breakthrough Therapy list for NSCLC

Hengrui Medicine announced that its HER3-directed ADC SHR-A2009 has been included in China’s NMPA CDE Breakthrough Therapy Designation list for combination treatment with bevacizumab in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed following EGFR-TKI therapy
The designation follows clinical development of SHR-A2009 across multiple phase 1-3 studies, including the phase 3 SHR-A2009-301 study, which supported acceptance of its marketing application in July 2026 for EGFR-mutated locally advanced or metastatic non-squamous NSCLC after EGFR-TKI progression
The designation addresses a major unmet need in EGFR-mutated advanced NSCLC, where patients inevitably develop resistance to EGFR-TKIs and subsequent treatment options remain limited, while HER3 expression is observed in a high proportion of NSCLC tumors and may increase following EGFR-TKI treatment
SHR-A2009 is a HER3-directed ADC comprising a fully human HER3 monoclonal antibody conjugated to a DNA topoisomerase I inhibitor payload, enabling targeted delivery of the cytotoxic agent to HER3-expressing tumor cells
Strategically, the BTD expands SHR-A2009’s development beyond its pending post-EGFR-TKI monotherapy indication, while the asset is also advancing in a phase 3 first-line EGFR-mutated NSCLC study and has received U.S. FDA FTD for metastatic EGFR-mutated NSCLC following third-generation EGFR-TKI and platinum chemotherapy