ArchiveTumor vaccines have great potential in tumor immunotherapy. Effective, controllable and long-acting tumor vaccine therapy will play a greater role in treating tumors, preventing tumor recurrence, prolonging patient survival and tumor prevention. This research analyzes the applications and grants of invention patents in the global tumor vaccine field, from the technology birthplaces, target markets, technology innovation entities, technology innovation topics and other aspects, to reveal the technology innovation trend. There are 5 635 invention patent applications in the global tumor vaccine field, with 1 839 having been granted, close to one third, indication that technological innovation is active. The United States and China are both the main technology birthplaces and also the target market. In addition, the markets in Europe and Japan are also attracting much attention. The global technological innovation entities in the field of tumor vaccines are mainly enterprises and universities/institutes. Immatics Biotechnologies in Germany, Oncotherapy Science in Japan, and Glaxo Smith Kline in the United Kingdom are leading the research and development of global tumor vaccines. The technological innovation entities in China are mainly universities/institutes, but enterprises are also beginning to play an important role. The technology innovation topics focus on antigens related to tumor vaccines, tumor immune activity, polypeptide modification, and vaccine-related biotechnology. This research analyzes the global invention patents in the field of tumor vaccines, reveals the trend and direction of technological innovation, and provides information support for tumor immunotherapy research. At the same time, it provides a new research perspective for technology development from the angle of information science.
Adaptive licensing (AL) is a prospectively planned, flexible approach for the regulation of drugs and biologics. AL is based on the stakeholder model of patients, health-care providers, payers, and regulators, seeking maximizing the positive impact of new drugs on public health by balancing timely access for patients with the need to assess and provide adequate evolving information on benefits and harms, so that better-informed patient-care decisions can be made. This paper reviews the emergence and development of AL, deeply analyzed the principles and design ideas of AL, and discussed the risk management and safeguard measures in AL. This paper will provide theoretical and practical reference for the construction of AL pathway in China.
The aim of this article is to make some suggestions for the regulations on interchangeability and clinical drug switching of biosimilar in China. Literature and relevant policies were reviewed. The development status of biosimilars in China was summarized, the regulatory experiences on the interchangeability of biosimilars in the United State and European Union were combed, and research findings on clinical drug switching were analyzed as well. Biosimilars have developed rapidly in China, but the related regulatory system has not been completely established. The United States and European Union have already initially established the management of biosimilar interchangeability, while the practical experience and clinical evidence are limited, and expert consensus has not been reached. There are still potential risks and concerns on switching from an originator biologic to a biosimilar or from one biosimilar to another. Drug regulatory authority should pay more attention to drug safety, clinical data information transparency, and technical guidelines on interchangeability, drug traceability, and incentive system.
With the optimization of drug evaluation and approval system in China, an increasing number of “global new” innovative drugs, especially those with conditional approval, are being marketed in China. For such drugs that have not yet accumulated sufficient evidence in real world, urgent problems, such as how to balance clinical needs with the risks of medical insurance funds and scientific designing of medical insurance access plans, are yet to be solved by China medical insurance departments. While in the United Kingdom (UK), the Cancer Drugs Fund (CDF) has been set up since 2011, which specializes in compensation for anticancer drugs. Through the managed access agreements (MAAs) signed with drug manufacturers, CDF regularly collects and evaluates the real-world therapeutic data, and decides whether to include or withdraw this anticancer drug in the reimbursement scope of the National Health Service (NHS), solving the “uncertainty of drug therapeutic effect” potently. This paper analyzes the operation mode, drug types, and agreement elements of the MAAs implemented by the CDF in recent years in order to provide a reference for the medical insurance management of high-value innovative drugs reimbursement accessing in China.
Based on the analysis using big data, the medication rules of Tazi prescriptions for Chuangyang were summarizedto provide inheritance basis for the development of modern Chinese medicines for external use, and to explore the development of new Chinese medicines for external use.
The ancient Tazi prescriptions of Chuangyang was screened in Traditional Chinese Medicine Classic Database since the Spring and Autumn Period and the Warring States Period. The data mining technology, such as frequency and correlation analysis were used to analyze the characteristics and regularity of high frequency single-drug, drug groups, and new prescriptions from the view of clinical application combined with the existing commercially available external proprietary Chinese medicines for Chuangyang.
A total of 423 ancient prescriptions were collected, involving 280 traditional Chinese medicines. Spicy, bitter and sweet taste were the main medicinal properties. The high frequency single-drugs meridians enter the spleen, liver and kidney meridians, and their main effects were relieving pain, detoxification, clearing heat, and eliminating dampness. In the results of correlation analysis, high-frequency drug groups include Scutellaria baicalensis-Coptis chinensis, Angelica-Licorice, and Scutellaria baicalensis-Licorice. There are 6 new prescriptions, including Scutellaria-Phellodendron-Sophora-Sophora-Honeysuckle-Dandelion-White Peony-Centipede-Forsythia, Angelica-Asarum-Nepeta-Honeysuckle-Dew Hive-Angelica and so on.
The ancient prescriptions for the treatment of Chuangyang are mainly used to relieving pain and detoxification, clearing heat and drying dampness, promoting blood circulation, as well as removing rot and pus. Combined with the current marketed external medicines for the treatment of Chuangyang, new drugs still need further research and development.
Radioisotope tracer technology, as a method to analyze labeled drugs using radioisotopes as tracers, is internationally recognized as the “gold standard” in human mass balance and metabolism study. The first [14C]-radiolabeled drug clinical trial regarding human radiolabeled mass balance and metabolism study was completed in Phase I clinical trial unit of our hospital. Up to now, we have completed six trials, and several trials are in progress. The Standard Operating Procedures for clinical trial of [14C]-radiolabeled drug have been established, and the construction of isotope tracer technology platform for new drug clinical trails in human have been explored. This paper introduces the key points of technology platform operation, such as protocol design and consideration, project establishment and ethical review, management of subjects, study drug, biological sample, and environment, requirement of investigator, project training and other contents. The objective of this paper is to provide information for the application of isotope labeling technique in mass balance, metabolism and other clinical trials of innovative drugs.
To identify the quality risks of medical records in clinical research and propose strategies according to the risk levels.
By analyzing the quality inspection findings of clinical research in the recent 3 years, the quality risks of medical records in clinical research were identified. The risk coefficient was obtained by multiplying the degree of risk influence with the possibility of occurrence, and the risk grade was evaluated according to the risk coefficient.
A total of 54 risks were identified, mostly medium and low risks. The only high risk is inconsistent recording of the same data in different source files. Incomplete records, insufficient records to determine the clinical significance of detection outliers, missing adverse events and incomplete or incorrect records of adverse event elements are common risks of medical record quality, and the risk coefficient of which is second to the only high risk. Other risks with low risk coefficients are infrequently met.
The risk of medical record quality exists in every link of clinical study. Clinical research related personnel can establish the initial priority of risk treatment according to risk level and coefficient.
Lung cancer is the malignant tumor with the highest mortality, of which non-small cell lung cancer (NSCLC) is the most common type. Studies have confirmed that mutations of epidermal growth factor receptor (EGFR) are closely related to the development of non-small cell lung cancer. Related drugs targeting EGFR common mutations, such as deletion of exon 19, insertion of exon 20 and point mutation of exon 21, have been applied in clinical practice. However, mutations in the extracellular domain of EGFR were found in some patients with NSCLC. This rare mutation also affects the treatment of these patients. This review introduces the research progress of EGFR extracellular region mutations in non-small cell lung cancer, and explores effective treatments for such mutations, with the hope of providing a reference for the diagnosis and treatment of lung cancer patients with EGFR extracellular region mutations.
Alzheimer's disease (AD), as a multifactorial syndrome with several interconnected and deregulated pathological pathways, is one of the diseases with the highest incidence among the elderly population. The discovery and development of multitarget-directed ligands (MTDLs) have opened up a promising innovative drug therapy for neurodegenerative diseases, in particular for AD. Two or more pharmacophores are incorporated into a single drug small molecule of MTDLs, leading to a better pharmacokinetic profile and alleviated side effects. MTDLs are more helpful to treat AD than a single pharmacophore molecule. The innovative design and synthesis study of novel-type multi-targeted small-molecule anti-AD candidate drugs in recent years are summarized in this paper, providing theoretical basis for the development of effective anti-AD molecules.
Microspheres, as a new delivery system, are widely concerned in the field of medicine. Microspheres can be divided into solid microspheres, double-walled microspheres, hollow microspheres and porous microspheres according to their different structures. Different microstructure endows the microspheres with different characteristics, which makes the microspheres suitable for different drug delivery forms and clinical applications. In this paper, the characteristics, preparation methods and applications of microspheres with different structures are briefly introduced.
Solid dispersion (SD) is one of the most valuable methods to improve the solubility, dissolution rate and oral bioavailability of poorly soluble drugs. SD disperses poorly soluble drugs into carrier materials, and improves the solubility and dissolution of drugs by changing their dispersion state, increasing specific surface area, increasing wettability, and so on, so as to improve the bioavailability. Dissolution is one of the most important pharmacological properties of SD and is the basis for determining whether it can successfully improve the bioavailability for the poorly soluble drugs. In SD, the carrier material is the largest component in the formulation, and the nature of it is an important factor that affects the dissolution process and dissolution behavior. Based on these, this article reviews the effects of carrier materials on the dissolution behavior and saturation solubility of SD, and provides references of selecting a suitable carrier material for SD.
To establish a standard quality assessment method and a quality attribute standard of human mesenchymal stem cells (hMSCs) regulating the regulatory T cells (Treg).
Based on co-culturing of hMSCs with allogenic human peripheral blood mononuclear cells (PBMCs), flow cytometry, and a reference cell line CCRC-hMSC-S1 (CCRC1), a standard evaluation technique for hMSCs regulating Treg was established, which was further applied in quality attribute standard of hMSCs of various origins.
A percentage of (47.9±23.3)% was established as the preliminary standard quality attribute value of hMSCs regulating Treg. The differences in manufacturing processes, cell growth media, cell passage numbers, and tissue origins significantly affected the quality of hMSCs regulating Treg.
Through the development of the standardized evaluation technique, a preliminary quality attribute value of hMSCs regulating Treg function was established for the first time. The combination of the standardized assessment technique and the quality attribute value proved to be effective for quantitative evaluation of the quality of hMSCs and of great value in guiding the development of hMSCs products.
To determine the stable relationship of the polymorph system of prasugrel hydrogen sulfate, to clarify the influence rule of solvent on the polymorph nucleation of prasugrel hydrogen sulfate, and to reveal the crystal transformation mechanism of prasugrel hydrogen sulfate.
In this study, crystal forms Ⅰ and Ⅱ of prasugrel hydrogen sulfate were selected as the research subjects, focusing on their solvent-mediated transcrystallisation proces, the off-line monitoring of the crystal form composition of suspended solid phase and the change of the solution concentration with time during the crystallization process. The influence mechanism of solvent on the crystal transformation process was also revealed.
Solvent-mediated crystallization of Prasugrel hydrogen sulfate form Ⅰ to form Ⅱ was monitored by X-ray diffraction, the results of which indicated that the rate-determining step during this process was the nucleation and growth of the prasugrel hydrogen sulfate form Ⅱ.
Consider the crystal transformation rate of prasugrel hydrogen sulfate in three solvents, including butanone, MIK and methyl acetate, and the solubility relationship of crystal form Ⅱ in them, it can be concluded that the nucleation process of prasugrel hydrogen sulfate form Ⅱ is affected not only by solubility, but also by the strength of hydrogen bond between the molecules.
To develop an HPLC-DAD method for the simultaneous determination of the contents of 5 components (isochlorogenic acid A, isochlorogenic acid C, linarin, rupestonic acid, and chrysosptertin B) in Artemisia rupestris L.
The chromatographic separation was achieved on a InerSustainR C18 (250 mm×4.6 mm, 5 μm) column with acetonitrile (A)-0.2% phosphoric acid (B) as mobile phase at a flow rate of 1.0 mL·min-1 for gradient elution. Isochlorogenic acid A, isochlorogenic acid C, linarin, rupestonic acid and chrysosptertin B were detected at 320, 320, 334, 245, 350 nm, respectively. Injection volume was set at 10 μL. To establish an HPLC chromatographic fingerprint of Artemisia rupestris L., the similarity evaluation was carried out. The cluster analysis was performed by using SPSS 23.0 software.
There were 25 common peaks in HPLC fingerprint of 15 batches of Artemisia rupestris L. The similarities of 10 batches of samples were more than 0.85. The 10 batches of samples can be divided into 2 categories by cluster analysis.
The method is simple, quick, accurate, and helpful for the quality control of Artemisia rupestris L.
To explore the security alert signals of evolocumab after marketing using data mining technology in order to provide the basis for safe drug use in clinical.
FDA Adverse Event Reporting System (FAERS) were searched for 19 quarters since the drug was approved for marketing (3rd quarter of 2015) by the FDA to the 1st quarter of 2020. The measure of disproportionality included the reporting odds ratio and the proportional reporting ratio, the correlation degree of the adverse drug event (ADE) signals was simultaneously calculated.
After multiple screenings, the signals obtained by ROR and PRR completely overlapped in a total of 46 cases, of which 28 adverse event specifications were not appear in the specification. The strong signals of evolocumab were mainly concentrated in myalgia, injection site reaction, and back pain, etc. The largest number of system organ classification (SOC) signals were mainly concentrated in musculoskeletal and connective tissue disorders, infection and infectious diseases, and perception dysfunction, etc. At the same time, it has been discovered that the drug may cause nerve perception dysfunction and increased blood glucose, etc. Through further analysis of the adverse events related to gender and age differences, a total of 14 high-risk signals with gender differences were found. Male patients should be alert to increased blood creatine phosphokinase, and hypoacusis, etc; female patients should be alert to nervousness and swelling face, etc. There were 15 high risk signals with age differences. Non-elderly patients should be alert to increased blood creatine phosphokinase, and increased hepatic enzyme, etc; elderly patients should be alert to hypoacusis, and arthritis, etc.
The signal mining of adverse events through FAERS can deeply analyze the safety of evolocumab after it enters marketed, and then effectively reduce the risk of clinical medication.
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