DualityBio now plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of an application for Trastuzumab Pamirtecan approval.
BioNTech SE (BNTX) announced on Friday that a late-stage trial, conducted by its partner Duality Biologics in China, has met its primary endpoint of progression-free survival at a pre-specified interim analysis. The trial is evaluating Trastuzumab Pamirtecan versus Trastuzumab Emtansine in patients with certain types of breast cancer.
Shares of the company traded 10% higher in the pre-market session on Friday. The trial enrolled 228 patients with HER2-positive unresectable or metastatic breast cancer, an aggressive form of the disease that has spread and cannot be surgically removed, who previously received Trastuzumab and a taxane-based chemotherapy.
On Stocktwits, retail sentiment around BNTX stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
DualityBio now plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of an application for Trastuzumab Pamirtecan approval.
DualityBio Global Medical Officer Hua Mu noted that breast cancer has a high incidence rate in China, with over 350,000 new cases annually.
“Together with our partner BioNTech, we plan the development of Trastuzumab Pamirtecan in further tumor types towards BLA application in other regions including the United States and the European Union to maximize its potential for patients around the world,” Mu said.
BioNTech also noted that this is the first positive late-stage data readout achieved in the collaboration between the two companies initiated in April 2023. The collaboration aims to accelerate the development of differentiated antibody drug-conjugate therapeutics for solid tumors.
BioNTech holds global commercial rights for Trastuzumab Pamirtecan, while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.
BNTX stock is down by 9% this year but up by about 15% over the past 12 months.
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