On January 8, the CDE official website announced that the second indication application for the Class 1 new drug Bodu trastuzumab injection submitted by Kelun Biotech has been accepted for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received at least one anti-HER2 treatment.

Bodu trastuzumab is an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) developed by Kelun Biotech (formerly known as A166). This is the second NDA for A166. According to Kelun Biotech's official website, based on the results of the primary analysis, A166 has reached the primary endpoint of its key Phase 2 trial for 3L+ advanced HER2-positive breast cancer and submitted its first marketing application to NMPA in May 2023. This is the second
marketing application for the product, and the indication is for 2L+ advanced HER2-positive breast cancer. In addition, A166 has also conducted Phase Ib clinical trials for other advanced HER2+ solid tumors in China.
I hope that the subsequent registration and research progress of this ADC new drug will be smooth, bringing new treatment options to patients as soon as possible.

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