• ADC candidate BNT323/DB-1303 (Trastuzumab Pamirtecan) met primary endpoint (PFS) in Phase 3 trial (NCT06265428) for HER2-positive, inoperable or metastatic breast cancer in China
• Compared vs. approved ADC Trastuzumab Emtansin (T-DM1); interim analysis confirmed by independent review committee
• DualityBio to discuss potential Biologics License Application (BLA) with China’s NMPA
• Marks first BioNTech oncology program in late-stage development to reach a pivotal Phase 3 endpoint
• Global Phase 3 DYNASTY-Breast02 trial ongoing in HER2-low metastatic breast cancer
• Partnership between BioNTech and DualityBio established in April 2023, expanding ADC pipeline across solid tumors
