科倫博泰生物-B：核心產品博度曲妥珠單抗治療 2L+ HER2+ 乳腺癌獲國家藥品監督管理局批准上市
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
According to the Zhitong Finance APP, SKB BIO-B (06990) announced that its antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), known as A166 (also called Sutent®), has been approved by the National Medical Products Administration (NMPA) for use in adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies.
This approval is based on a multicenter, randomized, open-label, controlled Phase 3 study KL166-III-06, aimed at evaluating the efficacy and safety of A166 compared to trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic BC patients who have previously received trastuzumab and taxane treatments. In the pre-specified interim analysis, A166 monotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by blinded independent central review (BICR) compared to T-DM1; a trend towards improved overall survival (OS) with A166 was also observed. The study results will be presented in a verbal report at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin, Germany (Report No: LBA24, Preferred Paper Session 1 - Metastatic Breast Cancer).
The company has initiated an open-label, multicenter Phase 2 clinical study of A166 for the treatment of HER2+ unresectable or metastatic BC previously treated with an ADC with a payload of topoisomerase inhibitors.
It is reported that A166 is a differentiated HER2 ADC for the treatment of advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the company, it conjugates a novel monomethyl auristatin F (MMAF) derivative (a highly cytotoxic microtubule inhibitor Duo-5) with a HER2 monoclonal antibody through a stable enzyme-cleavable linker, with a drug-antibody ratio (DAR) of 2. A166 specifically binds to HER2 on the surface of tumor cells and is internalized by the tumor cells, releasing the toxic molecule Duo-5 intracellularly. Duo-5 induces cell cycle arrest in the G2/M phase of tumor cells, leading to apoptosis. After targeting and binding to HER2, A166 can also inhibit HER2-mediated signaling pathways; it exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity
