《生命科学》 2026, 38(2): 281-293

多功能抗体疗法的组合演进与突破——2025年双抗/三抗与抗体偶联药物发展态势

李 伟 , 刘樱霞 , 陈 赟 , 赵若春 , 王 玥^*

中国科学院上海生命科学信息中心，中国科学院上海营养与健康研究所，上海 200031

摘　要：

近年来，肿瘤治疗领域中抗体药物的研发进展迅速。在临床需求、基础研究和工程技术的共同推动下，抗体药物朝着机制创新、功能融合的方向演进，双特异性抗体（双抗）、三特异性抗体（三抗）和抗体药物偶联物（ADC）药物等新型多功能抗体疗法涌现。这些药物不再局限于单一靶点和抗体本身杀伤力，而是通过多靶点协同、精准递送细胞毒性药物等方式，提升肿瘤的精准强效杀伤效果。2025年，双抗/三抗与ADC药物相关技术平台持续优化，包括T细胞衔接器、新型连接子和新一代毒素分子等；临床在研靶点布局逐步差异化，适应证研发重点向实体瘤治疗与一线治疗拓展，并更多尝试联合用药；全球研发管线稳步扩张，中美两国成为主要创新中心。然而，药物疗效、耐药性和毒性控制仍是当前面临的主要挑战。本文梳理了2025年双抗/三抗与ADC药物在靶点选择、技术平台、临床进展、市场格局和产业生态等方面的关键进展，并展望了领域未来发展态势。

通讯作者：王 玥 , Email:wangyue@sinh.ac.cn

Combinatorial evolution and breakthroughs in multi-functional antibody therapies: development trends of bispecific/trispecific antibody and antibody-drug conjugate in 2025

LI Wei , LIU Ying-Xia , CHEN Yun , ZHAO Ruo-Chun , WANG Yue^*

Shanghai Information Center for Life Sciences, Shanghai Institute of Nutrition and Health, Chinese Academy of Sciences, Shanghai 200031, China

Abstract:

The landscape of antibody-based drug development in oncology is undergoing rapid and transformative iteration, driven by unmet clinical needs, advancements in fundamental science, and sophisticated bioengineering. This evolution has given rise to a new generation of antibody therapeutics, exemplified by bispecific/trispecific antibody (BsAb/TsAb) and antibody-drug conjugate (ADC), which are characterized by novel mechanisms of action and integrated functionalities. These innovations mark a pivotal shift from single-target engagement to multifunctional targeting, and from moderate immunomodulation to potent cytotoxic killing. In 2025, significant progress has been achieved with BsAb/TsAb and ADC in tumor therapy. BsAb/TsAb enhance anti-tumor activity through synergistic multi-target engagement, while ADC continuously expand their therapeutic boundaries via precise payload delivery and potent cytotoxicity. The development pipelines for both modalities are robust, fueled by the optimization of newgeneration technology platforms, including bispecific T-cell engagers (BiTE), novel linker designs, and nextgeneration cytotoxic payloads. Concurrently, investigational targets are becoming increasingly differentiated, with clinical indications expanding from hematological malignancies to solid tumors, advancing from later-line to first-line therapy, and evolving from monotherapy to combination regimens. While global R&D pipelines continue to grow, with the U.S. and China emerging as primary innovation hubs, core challenges such as drug efficacy, drug resistance, and toxicity management persist. This review systematically summarizes the key advancements in 2025 concerning target combinations, technology platforms, clinical breakthroughs, market dynamics, and the industrial ecosystem of BsAb/TsAb and ADC, aiming to provide a reference for future research directions.

Communication Author：WANG Yue , Email:wangyue@sinh.ac.cn