多款新药获批上市,数百款新药正在临床开发!这类疗法正在为癌症患者带来新曙光
Xin Lang Cai Jing·2025-12-22 10:56

Core Insights - Antibody-drug conjugates (ADCs) are rapidly evolving as a targeted therapy in oncology, with numerous ADC therapies approved globally and hundreds in active clinical research, indicating a robust growth trend [1][13][15] - The complexity of ADC's multi-component structure presents challenges in efficacy and safety evaluation, as well as resistance prediction, necessitating comprehensive support for drug development [1][8][22] ADC Development Progress - Since 2025, several innovative ADCs have received regulatory approval, providing new treatment options for various cancers, including breast cancer and non-small cell lung cancer [15][16] - Notable approvals include Enhertu for HER2-positive breast cancer, Blenrep for relapsed multiple myeloma, and Emrelis for c-Met expressing non-small cell lung cancer [15][16] Clinical Trials and Data - Ongoing ADCs have reported promising clinical data, targeting various antigens such as CDH6 and EGFR/HER3, with indications covering ovarian cancer and endometrial cancer [18][19] - For instance, the CDH6-targeting ADC R-DXd showed a 50.5% objective response rate in platinum-resistant ovarian cancer patients [18] ADC Safety and Efficacy Evaluation - The evaluation of ADC efficacy relies on the synergistic interaction of its three core components: antibody, linker, and payload, which significantly affect drug stability and pharmacokinetics [20][21] - Safety assessments are critical, addressing potential risks such as payload release and immune responses, with comprehensive testing solutions provided to ensure quality and efficiency [21] Addressing Resistance Mechanisms - ADC resistance mechanisms, including antigen downregulation and altered payload metabolism, pose significant challenges, prompting the industry to focus on early-stage strategies to mitigate resistance [22][23] - Strategies include leveraging the "bystander effect" and exploring combinations with immunotherapy to enhance overall immune response [23] Comprehensive Support Solutions - WuXi AppTec has established a complete ADC research platform that integrates high-resolution mass spectrometry and targeted data analysis to address the complexities of ADC development [20] - The company has assisted partners in completing over 100 IND submissions, providing integrated solutions for efficacy evaluation, safety validation, and resistance analysis [23]