Antibody–drug conjugates (ADCs) and bispecific antibodies are becoming increasingly popular. However, their complex structures mandate stringent regulatory guidelines to ensure their safety and efficacy. We have briefly reviewed the existing regulatory guidelines and presented our perspectives on refining them to hasten the transition of these drugs from laboratories to market.

中文翻译：

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管制复杂生物制剂生物活性的监管观点

抗体-药物偶联物（ADC）和双特异性抗体越来越受欢迎。但是，其复杂的结构要求严格的监管指南以确保其安全性和有效性。我们已经简要回顾了现有的法规指南，并提出了完善这些法规的观点，以加快这些药物从实验室到市场的过渡。