Recently, CDE released the "Clinical Value-Oriented Anti-tumor Drug Clinical Development Guidelines" for soliciting comments, further clarifying that drug development should be based on patient needs and clinical value-oriented.

This guiding principle undoubtedly reflects the new requirements, new standards and new trends of the regulatory authorities for the development of new anti-tumor drugs. First of all, it emphasizes patient-oriented needs. The pathogenesis of malignant tumors is complicated. Enterprises should strengthen the research of tumor occurrence, development and drug action mechanism to solve the actual problems of patients. Secondly, pay attention to the dynamic changes of clinical treatment needs. With the launch of many new mechanism drugs and new technology therapies, the clinical needs of patients are also undergoing dynamic changes. Innovative drugs should be based on real unmet needs, improve disease treatment effects, improve drug safety, and treatment convenience and compliance.