SKB BIO-B: Core product Boduocuo Trastuzumab for the treatment of 2L+ HER2+ breast cancer has been approved for marketing by the National Medical Products Administration
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SKB BIO-B announced that its antibody-drug conjugate, trastuzumab deruxtecan, has been approved by the National Medical Products Administration for the treatment of patients with unresectable or metastatic HER2-positive breast cancer. This approval is based on a Phase 3 clinical study, the results of which showed that trastuzumab deruxtecan significantly outperformed the control drug T-DM1 in terms of progression-free survival. The study results will be presented at the 2025 European Society for Medical Oncology Congress. The company has also initiated a Phase 2 clinical study for this drug
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