With China's accession to ICH and implementing a series of ICH guidelines, the pharmaceutical innovation system of China has been in line with international standards and deeply integrated into the global innovation system, making overseas declaration data can be used in China's new drug marketing application. The ability of global synchronous investigation and registration has been largely improved along with these development. Clinical trials gradually need to involve healthy foreign subjects, especially those who need to be compared in the pharmacokinetic characteristics of different races in order to bridge the existing data abroad. What are the similarities and differences between the management process of clinical research on healthy foreign subjects and their Chinese counterparts? What factors should be paid attention to? This article takes a phase I clinical trial involving Caucasian subjects as an example to share and discuss the implementation and management experience of clinical studies involving foreign subjects to answer these questions.

Autologous chimeric antigen receptor T cell (CAR-T) cell therapy products have brought significant survival benefits to tumor patients, especially in the treatment of hematologic tumors. However, the common production mode of autologous CAR-T therapy products is complicated and has a long cycle. As a result, the production capacity of this kind of products has limited their clinical application to a certain extent. In this paper, based on the analysis of the common production mode of autologous CAR-T cell products, the content and evaluation of the capacity confirmation study and capacity change study of autologous CAR-T therapeutic products are proposed in combination with the current research progress, hoping to effectively promote the development and clinical application of such products.

As the continuous in-depth research on prophylactic mRNA vaccines, new questions have been raised about lipid nanoparticles in aspects of structures and morphologies. Based on the principle of ICH Q6B, the characteristics and changes of the structures of lipid nanoparticles were preliminarily discussed from the perspective of pharmaceutical evaluation, and the additional study for the structural characteristics were also addressed for providing a reference for the quality assessment and control of prophylactic mRNA vaccines.

As a critical part of the lifecycle management of biological products, post-approval changes may bring potential impact on the quality of biological products. Compared with other therapeutic products, prophylactic vaccines show different emphasis on regulatory requirements, product characteristics, manufacturing quality control, etc. so there are special considerations on the research and registration of post-approval changes. Aiming to help vaccine applicants increase knowledge about post-approval changes, the technical requirements on post-approval change of vaccine products and other biological products are compared and analyzed in this paper, and some special considerations for the study of post-approval change of vaccine are refined.

The investigation shows that malignant tumor is one of the major diseases threatening human health and life safety. In recent years, the cancer prevalence and mortality rate remain high, making anti-tumor drug research a hot field of drug research and development. For a better understanding of the industry development situation and to grasp the latest development of antitumor drug patent applications, Derwent Innovations Index was used for mining and analysis on the patent document against cancer drugs. At the same time, we complemented public patent data in recent years, as well as the overall intelligence information updates, statistics, analysis, and visualization, in order to provide information reference and decision support for the research and development of anti-tumor drugs and medicine.

Control of cell cycle progression plays a significant role in tumor development. The cyclin-dependent kinase (CDK) family governs cell cycle progression, and the activations of CDK4 and CDK6 allow cells to transit from G1 phase to S phase to start mitosis. Overactivation of CDK4/6 is closely related to tumor progression, thus CDK4/6 can be used as a potential target of oncotherapy. CDK4/6 inhibitors can not only arrest the tumor cells at G1 phase to prevent tumor overgrowth, but also affect the tumor microenvironment and enhance immune activity. Trilaciclib is a small-molecule CDK4/6 inhibitor, which is highly efficient, selective and reversible. Trilaciclib administrated before chemotherapy can temporarily block the hematopoietic stem cells and progenitor cells in bone marrow at G1 phase to reduce the cytotoxic damage caused by chemotherapy, thus protecting bone marrow and the immune system. Trilaciclib was first approved by FDA in the United States in February 2021 for extensive stage small cell lung cancer (ES-SCLC) before platinum/etoposide or topotecan chemotherapy to reduce the incidences of myelosuppression in adult patients. In July 2022, National Medical Products Administration (NMPA) also approved the administration of trilaciclib in patients with ES-SCLC who had not previously received systemic chemotherapy. In addition, the positive effects of trilaciclib on overall survival (OS) were observed in patients with triple-negative breast cancer (TNBC) treated with chemotherapy. Other clinical studies related to trilaciclib were still ongoing. This review summarizes the anti-tumor mechanisms of trilaciclib and the relative preclinical and clinical studies, aiming to provide further reference for clinical application and future research.

To analyze the pattern, characteristics and causes of protocol violation in anti-tumor drug clinical trials from the perspective of ethical review. The number and categories of violation projects were retrospectively analyzed and compared in different departments and the area of clinical trials (domestic or international). The impact of protocol violation on clinical trials carried out in our hospital from 2018 to 2021 was also analyzed. From 2018 to 2021, 1256 protocol violation cases occurred in clinical trials of anti-tumor drugs carried out in our hospital. The number of continuous protocol violations (318, 25.32%) was the largest, and the number of researchers' failure to cooperate with supervision/audit (6, 0.50%) was the fewest. The difference in the number of protocol violation between internal and surgical, domestic and global clinical trials were both statistically significant (P<0.01). The proportion of protocol violations affecting the safety, rights of subjects and trials results were 5.81%, 4.78% and 5.41%, respectively. Various protocol violations may occur during clinical trials of anti-tumor drugs. In order to improve the quality of clinical trials, it can be effectively avoided by strengthening quality control and conducting targeted training for the research team and subjects.

Molecular targeted therapy has become a research hotspot in the field of cancer therapy in recent years. Regorafenib belongs to the multi-target tyrosine kinase inhibitor class of antitumor drug developed by Bayer company, which was approved by NMPA in March 2017. This article introduces the status of regorafenib-related Chinese patent applications and focuses on combing and analyzing the development context of patent technology, in order to provide reference for the drug R&D and patent portfolio for relevant domestic pharmaceutical companies.

Lung cancer is one of the most common cancers worldwide. As reported in 2020, there were approximately 2.2 million new cases of lung cancer worldwide, accounting for 11.4% of newly diagnosed malignant tumors. Additionally, there were 1.8 million deaths resulting from lung cancer in 2020, representing about 18% of all cancer-related deaths globally. Lung cancer remains the leading cause of cancer-associated morbidity and mortality in China. Despite the increasing popularity of immunotherapy and targeted therapy, chemotherapy remains one of the most dominant treatment modalities for lung cancer (particularly for small-cell lung cancer). However, chemotherapeutic drugs in clinical practice lack specificity and kill normal cells while killing tumor cells, especially cells that are relatively active in proliferation or metabolism. Chemotherapy-induced myelosuppression (CIM) is the most common dose-limiting and potentially fatal complication in cancer therapy and a key factor affecting the course and dose of chemotherapy, and nearly 90% of chemotherapeutic drugs may be associated with myelosuppression. Myelosuppression is the biggest obstacle to cancer chemotherapy. Myelosuppression seriously affects the life quality of cancer patients, reduces patient compliance, delays treatment, and even threatens the lives of patients, which we should pay attention to in clinical practice. At present, the main treatment regimens for bone marrow suppression are those follows, such as drugs promoting neutrophils, red blood cells, thrombopoietic drugs and blood transfusion. As the world's first approved CDK4/6 inhibitor with full myeloprotection, the use of trilaciclib before chemotherapy is effective in reducing the incidences of CIM. This review aims to summarize the relevant research progress in recent years from the mechanism of bone marrow suppression, related treatment measures of bone marrow suppression after chemotherapy for lung cancer, and provides further ideas and clinical basis for clinical application, monitoring and management of CIM.