DB-1303/BNT323

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DB-1303
/BNT323

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· Most clinically advanced HER2 ADC globally for EC patients across HER2-expression levels (IHC 1/2/3+)

· Global Top 2 ADC candidate for chemo-naïve HR+/HER2-low BC patients

· Phase 3 topoisomerase-based ADC for HER2+ BC in China

Main highlights of drug design

· Designed with a cleavable linker and proprietary topoisomerase-based payload

· Aim to lower off-target toxicity and enhance anti-tumor activity, including bystander killing effect

Advantages and Characteristics

Preliminary clinical data*

· Efficacy data:1.HER2 Expressing EC (potential registrational study): N=17, uORR of 58.8% and uDCR of 94.1%
2.HER2-expressing solid tumors (Phase 1/2a): N=52, uORR of 44.2% and uDCR of 88.5%
· Manageable safety profile

DEVELOPMENT PLAN

· Registrational trials for HER2+ BC (2L) and HR+/HER2-low BC (chemo naïve) and potential registrational study for HER2-expressing EC (2L+)

KEY EXPECTED CATALYSTS

· File for accelerated approval with FDA on HER2-expressing EC
· File BLA with NMPA for HER2+ B
· HER2+ BC Phase III pivotal data readoutC