Glucagon like peptide 1 (GLP-1) can inhibit the elevation of glucagon, inhibit gastric acid secretion, and slow down gastrointestinal peristalsis. However, the plasma half-life of GLP-1 is only a few minutes to a few hours. Frequent and high-dose administration are required to achieve therapeutic effects which will increase the risk of adverse effects. Therefore, long acting is an important research interest for GLP-1 drugs. Fatty acid chain modification is the widely used long-acting strategy for GLP-1 drugs due to its advantages of definite modification sites, low heterogeneity of modified products, low loss of biological activity, and low toxic effects. To provide references for the CMC research and evaluation of fatty acid chain-modified GLP-1 drugs and other fatty acid chain-modified peptide drugs, this article shares the experience accumulated in the evaluation of fatty acid chain-modified drugs and proposes the evaluation considerations for recombinant fatty acid chain-modified GLP-1 drugs from the perspectives of raw materials for production, production processes, quality control, and stability research.

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.

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.

Glycoprotein hormones, including follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, and thyroid stimulating hormone, are heterodimers consisting of non-convalently bound α and β subunits. Glycosylation complexity and structural heterogeneity are the focus of structural characterization and quality control of glycoprotein hormones. The modification sites, modification types, and sialic acid content of glycosylation are closely related to the receptor binding, signaling, biological function, and clearance rate of glycoprotein hormones in the body. In this paper, we summarize the marketed products of recombinant glycoprotein hormones, analyze the "macro" and "micro" complexity of glycosylation modification of these drugs, clarify the relationship between structural heterogeneity and biological function, sort out the analytical techniques used for structural confirmation and glycan chain identification, and put forward the relevant considerations of R&D pathway and CMC research based on their quality control difficulties.

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.

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.

Antibodies, as an important tool for treatment and prevention of viral infection, have been applied to the treatment and prophylaxis of viral infectious diseases. This article summarized the latest research progress in antibody products that target viruses, and discussed some quality assessment concerns in epitope mapping, neutralization spectrum evaluation, and quality control, expecting to promote the clinical transformation and application of such products.

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.

Cellular therapy industry is booming in China. As increasing cellular therapy products are authorized and commercialized, hence higher requirements are set for the safety and efficacy of cellular therapy. As the essential starting raw material, the quality of donor materials directly affects the safety and quality of cell products, thus, the risk management of donor screening is crucial. Herein, the screening of infectious pathogens is a vital guarantee for the viral safety and biosafety of cellular therapeutics. Currently, no uniform standards or consensus have been reached for donor screening quality management system, thus the regulatory framework needs to be further supplemented. This paper discusses the current obstacles and challenges in donor screening, overall risk management strategies and technical considerations on infectious pathogen detection, and meanwhile reviews the relevant regulatory guidelines and requirements at home and abroad, aiming to provide reference for subsequent standardization and regulatory requirements for donor screening in cellular therapeutics.