Since joining the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 2017, China has gradually strengthened the research on the extrapolation of overseas clinical trial data. Standardization of bridging studies and international multi-center clinical trials will become the trend of the times. Extrapolation of overseas clinical trial data is particularly important in the registration process of drugs that have been listed overseas and not listed in China. Usually, the Center for Drug Evaluation of NMPA needs to consider the completeness of clinical trial packages to determine whether a drug is racially sensitive and whether bridging studies are needed. At present, to investigate the influence of ethnic factors on the acceptability of overseas clinical trials, the ICH E5 (R1) Guidelines are generally followed internationally. In addition, the United States, Japan, the European Union, and other ICH member states have issued their own relevant regulations or guidelines. This article introduces the basis and key points of current review of overseas clinical trial data in China, summarizes and analyzes the design of bridging studies based on international experience, and finally puts forward reasonable suggestions for extrapolation of overseas clinical trial data in China.

It has been nearly 40 years since the Hatch-Waxman Act was enacted in 1984. Generics have developed tremendously during this period, which shows the importance of promoting the development of generics. The Hatch-Waxman Act is important, but it is not the whole story of how generics develop in the United States. After the promulgate of Hatch-Waxman Act, the development mechanism of generic drugs in the United States did not stick to the original state, but continuously made dynamic adjustments in many aspects, including combating misconduct in abbreviated new drug application (ANDA) to standardize the procedures, greatly improving the time efficiency for ANDA, establishing a generic drug replacement mechanism, establishing two patent invalidation procedures [inter parte review (IPR) and post grant review (PGR)], revising the Orange Book, exclusivity period, containment period, etc. to improve patent links system, and establishing a drug price negotiation system and a drug inflation penalty system. China should shorten the period of drug patent reexamination and invalidation examination. The first generic drug exclusivity period system should be coordinated with anti-monopoly. A user payment system should be established in China, but innovative drugs can be exempted. The drug approval and review mechanism, patent law, anti-monopoly law and other fields need to work together to continuously track and improve relevant systems.

The aim of the article was to clarify the factors affecting the investment in cooperation and innovation in different sub-sectors of China's pharmaceutical manufacturing industry and its mechanism of action, and provide a reference for improving the level of investment in this field. Based on the relevant indicator data of different sub-sectors of China's pharmaceutical manufacturing industry from 2009 to 2019, the factor analysis method is used to empirically analyze the impact of the summarized factors on the investment in cooperative innovation. It was found that internal investment in research and development funds, investment in scientific and technological activities, investment in new product development, profitability, effective invention patents, and government funding all have a positive impact on investment in cooperative innovation in different sub-sectors of China's pharmaceutical manufacturing industry. Their impact on biopharmaceutical manufacturing industry is greater than that on chemical manufacturing industry, followed by the Chinese patent medicine manufacturing industry. Whereas the degree of enterprise openness has a negative impact on the investment in cooperation and innovation in different sub-sectors of the Chinese pharmaceutical manufacturing industry.

To establish a "three-in-one" traditional Chinese medicine registration review evidence system, the formation of a traditional Chinese medicine theoretical evidence evaluation system is crucial. The existing traditional Chinese medicine theory evidence system is still immature, lack of standardized retrieval steps for the retrieval of ancient documents, and the evaluation elements of the evidence are not comprehensive enough. So the retrieval process of ancient documents was standardized in this study. Propose six elements of DSPMRE to clarify retrieval issues and needs, and the integrity of the documents, the source and consensus of literature were innovatively proposed to be the three elements of evidence evaluation. Recommendations were made on the level of traditional Chinese medicine theoretical evidence to improve the three key links, i.e., literature retrieval, analysis and evaluation, and classified recommendation, thus to build a traditional Chinese medicine theoretical evidence system that supports the research and development and registration approval of new Chinese medicines under the triple-combination system.

Myelofibrosis (MF) is a myeloproliferative neoplasms (MPN), usually accomplies with thrombocytopenia, severely impacts the life quality of patients and presents a risk for leukemic transformation. Pacritinib is a kind of Janus activated kinase 2 (JAK2) and Fms-like tyrosine kinase 3 (FLT3) inhibitor. U.S. FDA has granted accelerated approval for pacritinib capsules (Vonjo), on Feb 28, 2022, in the treatment of adult patients with the platelet (blood clotting cells) levels below 50 000·μL^-1 who have a rare form of bone marrow disorder known as intermediate or high-risk primary and secondary myelofibrosis. The oral dose of 200 mg twice daily showed good clinical efficacy and manageable safety. In this paper, the mechanism of action, pharmacodynamics, pharmacokinetics, safety, and clinical efficacy of daridorexant are reviewed.

The COVID-19 pandemic highlights the necessity of stockpiling rapid-response vaccine technology. Represented by nucleic acid vaccine and viral vector vaccine, the vaccine platform technology only needs the virus gene sequence to start research and development, and can rapidly expand production in a short period of time. It shows huge potential capacity of preventing and controlling emerging infectious diseases that spread fast, and affect a wide range of people who generally lack immunity. However, due to the rapid development of this field, few domestic literatures have described relevant concepts, definitions, and classifications. This review combed the related literatures and documents, summarized the definition, development and application of vaccine platform technology and explained its important role for emergent research and development of emerging infectious diseases. It provided scientific basis and suggestions for China to build up strategic stockpiles of related vaccine platform technologies and improve the capability of preparedness and response to emerging infectious diseases.

Alzheimer's disease (AD) is a chronic degenerative disease of the central nervous system, characterized by β-amyloid deposition and abnormal phosphorylation of Tau protein, while its etiology and pathogenesis have not been fully elucidated. The most common presentation of AD is of an elderly individual with progressive problems of memory impairment, cognitive dysfunction, mental symptoms, and loss of living ability. Dual-specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) is a highly evolutionary conserved protein kinase, which is related to retardation, neurodegeneration, severe cognitive impairment, and early onset AD. Compelling data have implicated that DYRK1A phosphorylates a variety of substrates on serine or threonine residues, thereby regulating the different cellular processes involved in brain development and function. Thus, DYRK1A might be a promising target for the prevention and treatment of AD, as it is implicated in the formation of senile plaques, neurofibrillary tangles, oxidative stress injury and inflammatory responses. In this paper, we reviews the structure, distribution, and function of DYRK1A, as well as its role in the pathogenesis of AD, in order to provide a theoretical basis for the treatment of AD.

Cancer has always been a major disease that threatens human lives. Traditional treatment modalities cannot guarantee efficient killing of tumor cells and good prognosis after treatment, mainly because people do not have sufficient understanding of tumors and their microenvironment. In recent years, with the advancement of tumor research, the mechanism of tumorigenesis and the impact of tumors on human immune system have become hot topics of research. Various preclinical tumor models have been developed, including in vivo models represented by patient tumor-derived xenograft models (PDX) and in vitro models represented by organoid microarrays, which have different functions in preclinical tumor research and play important roles. As a convenient and effective tool, preclinical tumor models play an irreplaceable role in exploring tumor-immune system interactions, preclinical evaluation of anti-tumor drugs, and discovery of biomarkers for immunotherapy.

Chronic inflammation is considered as a potential pathological state, which is the long-term presence of low concentrations of inflammatory factors in the body and continuous infection of the body, manifested by aggregation and infiltration of monocytes, lymphocytes and other cells, tissue proliferation, lesions, etc. Research shows that chronic inflammation can mediate cancer, diabetes, cardiovascular, nervous system, inflammatory bowel disease, lung disease and other diseases. Curcumin is an active component of polyphenols extracted from turmeric, a traditional Chinese medicine. It has significant anti-inflammatory activity, and its efficacy in controlling or treating a variety of chronic inflammatory diseases has been widely reported. On the other hand, inflammation-related signaling pathways, such as JAKs/STATs, PI3K/AKT/mTOR, Wnt/β-catenin, NF-κB, MAPK/ERK, etc., play key roles in the pathogenesis of various chronic inflammatory diseases. Signaling molecules in the pathway are considered to be important targets of new therapeutic approaches, and curcumin can participate in related inflammation-related signaling pathways to produce anti-inflammatory effects. In this paper, the pharmacological studies of curcumin in chronic inflammatory diseases in the past five years and the regulatory role of curcumin in the inflammatory signaling pathway were reviewed, to provide a reference for the research and development of curcumin in the prevention and treatment of chronic inflammatory diseases.