CDE releases the "Guidelines for Clinical Research and Development of Antibody-Drug Conjugates”
2023.04.06On April 6th, the Drug Review Center of the National Medical Products Administration issued the "Guidelines for Clinical Research and Development of Antibody-Drug Conjugates ", proposing suggestions on the issues that need to be paid attention to in the clinical research and development of ADC class anti-tumor drugs. Antibody Drug Conjugates (ADC) is currently one of the hot spots in the research and development of new anti-tumor drugs, especially in the field of tumor treatment, drug development of ADC. With the continuous expansion of the target and indication of ADC drugs, ADC drugs are leading a new era of targeted therapy. Due to the complexity of the constituent factors of ADC, the selection of different target antigens and antibodies, effective loads with different mechanisms of action, different linkers and their coupling methods may have a significant impact on its biological effects. Therefore, CDE encourages to conduct research on relevant mechanisms and to design ADC reasonably based on clinical needs. For ADC drugs, it is also recommended to pay attention to the following points in order to improve the success rate of the research: 1. Differences in therapeutic effects between different drugs with the same target antigen; 2. Differences in therapeutic effects of the same drug on different target antigen expression states. 3. Exploration of the optimal drug administration plan; 4. Pay attention to safety risks; 5 Combination therapy.
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