ENHERTU®? approved in China as the First and Only HER2 Directed ADC for the Second-Line Treatment of Patients with HER2 Positive Metastatic Gastric Cancer Based on DESTINY-Gastric04 phase 3 trial results that showed ENHERTU demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to ramucirumab plus paclitaxel. Sixth approval for Daiichi Sankyo and AstraZeneca's ENHERTU in China across three tumor types in less than three years.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo andAstraZeneca and being jointly developed and commercialized by Daiichi Sankyo. More than one third of the global cases of gastric cancer occur in China, with about 65% of patients presenting with advanced disease at the time of diagnosis. Approximately 359,000 cases of gastric cancer and 260,000 deaths were reported in China in 2022.1 About one in five gastric cancers are considered HER2 positive.4,5 Prior to the results of DESTINY-GASTric04, no other HER2 directed medicine has demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.6. The approval of ENHERTU by China's National Medical Products Administration (NMPA) is based on results from the DESTINY- Gastric04 phase 3 trial presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and simultaneously published in The New England Journal of Medicine.

The China Center for Drug Evaluation (CDE) granted Breakthrough Therapy Designation for ENHERTU for the second-line metastatic cancer indication in 2020 due to efficacy data from early trials and the unmet clinical need. The safety profile of ENHERTU in DESTINY-Gastingric04 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or grade 4 adverse reactions from a pooled safety population receiving at least one dose of ENHERTU 6.4 mg/kg (n=1,133) across multiple tumor types in clinical studies were nausea (64.3%), fatigue (57.3%), anemia (47.9%), decreased appetite (46.8%), neutropenia (45.9%), vomiting (34.7%), diarrhea (33.0%), thrombocytopenia (32.9%), leukopenia (31.2%), alopecia (29.0%), constipation (28.2%) and increased transaminases (26.4%).

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancer-related death, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.