NMPA accepts New Drug Application for Trastuzumab Envedotin injection

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17 July 2026: NMPA accepts New Drug Application for Trastuzumab Envedotin injection

CSPC Pharmaceutical Group announced that China’s NMPA has accepted the new drug application for Trastuzumab envedotin injection, a HER2-targeted antibody-drug conjugate, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies
The submission is supported by a pivotal phase 3 trial, where Trastuzumab envedotin demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with T-DM1 in the second-line and later treatment of HER2-positive advanced breast cancer. Secondary endpoints and subgroup analyses consistently showed superior antitumor efficacy, while maintaining a favorable safety and tolerability profile
The application addresses an important unmet need in HER2-positive metastatic breast cancer by offering a potential new treatment option for patients who have progressed following prior HER2-directed therapies, where effective subsequent-line treatment remains critical to improving long-term outcomes
Trastuzumab envedotin is a HER2-directed ADC comprising a monoclonal antibody conjugated to the microtubule inhibitor monomethyl auristatin E. Following HER2-mediated internalization, lysosomal cleavage releases MMAE to inhibit tubulin polymerization, resulting in tumor cell cycle arrest and apoptosis
Strategically, the NDA acceptance strengthens CSPC’s expanding ADC portfolio, reinforces its presence in the competitive HER2-targeted breast cancer landscape, and supports the company’s strategy of advancing differentiated oncology biologics with the potential to compete against established HER2-directed ADC therapies