Allergic diseases are recognized by the World Health Organization (WHO) as a major health problem in the world. At present, allergen products have been widely used in the treatment of various allergic diseases at home and abroad. Allergen therapy is currently the only therapy that can regulate the immune system in patients with allergic rhinitis. However, high quality allergen products are related to the effectiveness of the products. In view of the important clinical value of allergen products, combined with the status quo of listed allergen products and registered allergen products, this paper briefly introduces the registration management classification of allergen products in China and the United States and the technical requirements for the registration of such products in China.

Based on the requirement on the experimental data in the pharmaceutical patent examination of China National Intellectual Property Office (CNIPA), some recent administrative decisions of CNIPA, the repetition of experimental data in the development of some "blockbuster" drugs, and the relevant cases of the US Federal Circuit, this paper discusses the two sides of supplementary experimental data in pharmaceutical patent protection.

Hypophosphatasia (HPP) is a rare hereditary endocrine system disease characterized by bone and/or tooth mineralization disorders accompanied by decreased serum alkaline phosphatase activity. Asfotase alfa (AA) received orphan drug approval by FDA as a recombinant bone-targeted human nonspecific alkaline phosphatase and was marketed in 2015 for the treatment of HPP. This paper reviews the mechanism of action, pharmacokinetic characteristics, efficacy, safety, usage and dosage of AA to provide reference and evidence support for the use of AA in the patients with HPP.

There are many kinds of drugs for insomnia, but the current hypnotics on the market cannot fully meet the clinical needs. As a new treatment for insomnia disorder, dural orexin receptor antagonist (DORAs) has a different mechanism of action from the traditional hypnotics, it can avoid a series of common side effects of traditional hypnotics and has a good safety profile. A newly developed dual orexin receptor antagonist, daridorexant, has been studied in a number of clinical studies in global, and data shows that it improves both the sleeping disorder at night and daily functions, with good safety feature. This review comprehensively summarizes the efficacy, safety, and clinical data of the dual orexin antibody antagonist daridorexant in various clinical trials.

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.

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.

Chemotherapy-induced myelosupression (CIM) is the most common toxicity of chemotherapy drugs. Usually, more than 80% of chemotherapy drugs lead to myelosuppression, and CIM is usually characterized by neutropenia, thrombocytopenia and erythrocytopenia. Dose reduction and delayed administration of chemotherapy drugs by CIM seriously reduce the life quality of patients and the overall anti-tumor effect of chemotherapy. As the first drug approved for bone marrow protection, trilaciclib is a highly effective, selective and reversible cyclin-dependent kinase (CDK) 4/6 inhibitor, which can temporarily block cell cycle of hematopoietic stem/progenitor cells and immune cells in G1 phase, so as to reduce the damage caused by chemotherapy and protect bone marrow protection. In April 2021, trilaciclib was approved by FDA as a myelo preservation in the United States. In July 2022, trilaciclib was approved by the National Medical Products Administration for marketing in China, and the first indication of trilaciclib in China was for patients with extensive stage small-cell lung cancer. In this review, the mechanisms of action, pharmacokinetics, drug interaction mechanism, clinical evaluation, safety and other related research progress of trilaciclib are systematically reviewed, aiming to provide further reference and basis for clinical practice.

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.

Chemotherapy still plays pivotal roles in the comprehensive treatment of tumors. Chemotherapy-induced myelosuppression (CIM) is the most common adverse event of chemotherapy, which has posed serious impacts on the anti-tumor efficacy of chemotherapy and the quality of patients' lives, and also resulted in increased treatment burden of patients and more medical resources at the same time. Trilaciclib is a highly potent, selective, reversible cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Clinical data showed that trilaciclib could temporarily arrest bone marrow cells in G1 phase to reduce the incidences of CIM and the proportion of chemotherapy dose adjustment and delay, increasing the tolerance of chemotherapy and reducing the economic burden. This article systematically elaborates on the CIM-caused hazards, clinical prevention, and current status of treatment of CIM, as well as the roles of trilaciclib in the prevention of CIM and its economic value, aiming to provide scientific reference for patients to select reasonable prevention and therapeutic treatment regimens of CIM.