Hengrui ADC innovative drug Ruikang Trastuzumab new indication marketing application accepted and included in priority review

CAR-T Digest - August 2020

Weekly Digest - July 2026

8 July 2026: Hengrui ADC innovative drug Ruikang Trastuzumab new indication marketing application accepted and included in priority review

Hengrui Pharma’s HER2-targeted antibody-drug conjugate Trastuzumab rezetecan has had its new indication marketing application accepted by China’s NMPA and included in the priority review pathway for the treatment of patients with unresectable or metastatic HER2-low breast cancer who are chemotherapy-naïve in the metastatic setting or relapse within six months of adjuvant chemotherapy
The submission is supported by results from the phase 3 SHR-A1811-III-306 trial, where Trastuzumab rezetecan significantly improved progression-free survival compared with physician’s choice chemotherapy and reduced the risk of disease progression or death in patients with HER2-low recurrent or metastatic breast cancer. Overall survival data remain immature, although an early trend toward survival benefit has been observed
The application addresses a major unmet need in HER2-low breast cancer, which represents approximately 55% of breast cancer cases and has historically had limited benefit from conventional HER2-targeted therapies, leaving patients with relatively few effective treatment options in the advanced disease setting
Trastuzumab rezetecan is a HER2-directed ADC that delivers a topoisomerase I inhibitor payload through a protease-cleavable linker. Following HER2-mediated internalization, the payload is released intracellularly to induce tumor cell death while also generating a bystander effect that enhances antitumor activity in heterogeneous HER2-expressing tumors
Strategically, the priority review acceptance further expands Hengrui’s leadership in the HER2 ADC landscape, strengthens the commercial potential of trastuzumab rezetecan in breast cancer, and reinforces the company’s broader strategy of establishing the ADC across multiple HER2-expressing solid tumors through an increasingly diversified clinical development program