Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Stock Code: 6990) has announced that its core human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate, trastuzumab botidotin (also known as A166, brand name 舒泰萊®), received marketing approval from the National Medical Products Administration. The approval covers adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2 treatment.

According to the announcement, this decision is supported by a multi-center, randomized, open-label, controlled Phase 3 study (KL166-III-06), in which trastuzumab botidotin demonstrated a statistically and clinically meaningful improvement in progression-free survival compared with T-DM1, as assessed by a blinded independent central review. Additionally, a beneficial trend in overall survival was observed. Detailed results will be presented at the 2025 European Society for Medical Oncology Congress in Berlin (Presentation #LBA24).

The company also initiated a multi-center Phase 2 clinical study of trastuzumab botidotin in patients with HER2-positive unresectable or metastatic breast cancer previously treated with a topoisomerase inhibitor ADC. The product is not yet approved for other indications, and there is no guarantee of successful commercialization for those uses. Shareholders and potential investors are advised to exercise caution when dealing in the company’s securities.