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DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…

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Avenzo Therapeutics Join Forces with DualityBio to Develop AVZO-1418 (DB-1418) for Solid Tumors

Shots: Avenzo Therapeutics and DualityBio have signed an exclusive license agreement to develop, manufacture & commercialize the former’s AVZO-1418/DB-1418 across the globe (excl. Greater China) As per the terms, DualityBio will get $50M upfront, ~$1.15B development, regulatory and commercial milestones as well as tiered royalties in Avenzo’s territory AVZO-1418, an EGFR/HER3-targeting ADC developed…

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