Core Insights - Keren Biotechnology's antibody-drug conjugate (ADC) A166 (also known as "Shutailai") has received approval from the National Medical Products Administration (NMPA) for use in adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] - The approval is based on a Phase III clinical trial (KL166-III-06) that demonstrated significant improvement in progression-free survival (PFS) compared to T-DM1, with a trend towards improved overall survival (OS) [1] Company Developments - Keren Biotechnology has initiated a Phase II clinical study for A166 targeting HER2-positive breast cancer patients who have previously received topoisomerase inhibitor ADC therapy [2] - A166 is the second ADC approved by Keren Biotechnology, indicating a growing portfolio in the ADC space [1] Industry Context - The HER2-targeted ADC market is currently dominated by international pharmaceutical companies, with Roche's T-DM1 and Daiichi Sankyo/AstraZeneca's DS-8201 leading the market [2] - DS-8201 was first approved in China in February 2023 and has multiple indications, including breast cancer, gastric cancer, and lung cancer, and is included in the national medical insurance directory [2] - Other domestic ADCs, such as Rongchang Biotech's trastuzumab deruxtecan, have also gained approval for various HER2-related indications, contributing to a competitive landscape [3] - The timeline for A166's inclusion in the national medical insurance directory may be challenging, as the preliminary review for the 2025 adjustments has already been completed [3]