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The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
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German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…