30 November 2025, Volume 34 Issue 22
    

  • Select all
    |
  • Discussion on the specifications of National Essential Medicines List based on the proportional changes of traditional Chinese patent medicines
    ZHAO Xin-yue, CHEN Hua, GENG Ying
    Chinese Journal of New Drugs. 2025, 34(22): 2353-2357. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.001
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    The National Essential Medicines List, as the core instrument for the implementation of the national essential medicines system, has garnered significant attention from all sectors of society. In this list, the specifications of traditional Chinese patent medicines, due to their unique characteristics, often introduce a degree of uncertainty in clinical medication. This article systematically organized the specifications of traditional Chinese patent medicines and delved into issues such as the proportional conversion of these specifications. The research revealed that there is still a widespread phenomenon of non-standard specification descriptions for traditional Chinese patent medicines on the market, which severely hampers the implementation of proportional specification conversion. In light of this, the article proposed to further deepen and implement the Technical Guidelines for the Description of Specifications of Traditional Chinese Patent Medicines, with particular emphasis on standardizing the specification descriptions of those included in the National Essential Medicines List. This initiative will enhance the efficiency of clinical medication by physicians and facilitate the smooth operation of drug regulation.
  • Analysis and reflection on the marketing authorization of innovative traditional Chinese medicine drugs since 2020
    WU Chen-yue, HAN Wei, QU Jian-bo, TANG Zhen, WANG Zhang-wei, SHEN Xiang-rong, YANG Chang-ming
    Chinese Journal of New Drugs. 2025, 34(22): 2358-2365. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.002
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    The Chinese government prioritizes the inheritance and innovation development of traditional Chinese medicine (TCM). It emphasizes strengthening innovation in TCM research and development (R&D), focusing on major chronic diseases, refractory disorders, emerging infectious diseases, and environmentally associated conditions, to accelerate the launch of innovative TCM drugs with outstanding clinical efficacy and distinct therapeutic advantages. This article systematically analyzed the innovative TCM drugs approved since the enactment of the Drug Registration Regulation in 2020, aiming to serve as a medication reference for clinicians and promote the clinical use of innovative TCM drugs. Our multidimensional analysis included the quantity and registration categories of approved drugs, composition of ingredients in TCM preparations, routes of administration and dosage forms, therapeutic functions and indications, evidence supporting market approval, as well as the review and approval procedures. The finding revealed that with the implementation of policies supporting the inheritance and innovation of TCM, deeper regulatory science research, continuous enhancement of evaluation standards system including efficacy assessment methods and quality control, and ongoing optimization of the review and approval mechanisms, the R&D of innovative TCM drugs is increasingly prioritizing clinical value-oriented paradigm. Greater emphasis is placed on leveraging human experience as evidence to support R&D decisions and regulatory submissions. Consequently, more high-quality innovative TCM drugs with significant clinical value are anticipated to enter the market, better meeting public medication needs.
  • Considerations on pharmaceutical research of co-crystal drugs
    MA Jun-wei, LIU Juan, REN Lian-jie
    Chinese Journal of New Drugs. 2025, 34(22): 2366-2371. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.003
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Developing co-crystals is a technical approach to improve the solubility, stability, and solid-state characteristics of drugs, which shows significant value in drug development. Several co-crystal drugs have been marketed both domestically and internationally. However, regulatory frameworks for co-crystals differ between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). China currently lacks specific technical requirements for co-crystals. This paper references the current regulatory landscape for co-crystal drugs and combines insights from practical review work to discuss the pharmaceutical research of co-crystals from aspects including elucidation of structure, key physicochemical property studies, process development and control, and co-crystal quality studies.
  • Research on the review of experimental data in patent applications for traditional Chinese medicine
    SUN Qing-shan, YAO Jia, LI Kai-nuo
    Chinese Journal of New Drugs. 2025, 34(22): 2372-2377. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.004
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    In China's patent applications for traditional Chinese medicine (TCM), the examination of experimental data constitutes a critical component in determining sufficient disclosure, innovation, and practical applicability. However, current challenges persist in the review process of TCM patent experimental data, including ambiguous regulatory standards, insufficient verification of data authenticity, and inadequate coordination with TCM registration requirements. When evaluating TCM experimental data, it is imperative to not only respect the unique characteristics of TCM research and development (particularly the evidentiary value of “human experience”) but also incentivize the implementation of rigorous clinical trials to advance TCM modernization. Recommendations include establishing a clear “three-in-one” evaluation framework for TCM patent experimental data review, optimizing authenticity verification protocols, enhancing the role of clinical experimental data in patent challenges, and prioritizing clinical evidence during supplementary data evaluations.
  • Advances in anti-Chikungunya fever drugs
    LI Jin-yu, LI Song, ZHONG Wu
    Chinese Journal of New Drugs. 2025, 34(22): 2378-2398. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.005
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Chikungunya fever (CHIKF) is a mosquito-borne infectious disease caused by the Chikungunya virus (CHIKV). It is primarily characterized by clinical manifestations such as fever, arthralgia and rash. Although the fatality rate is relatively low, it can lead to chronic arthritis and persistent joint dysfunction, significantly impacting patients' quality of life. Currently, there are no specific antiviral drugs available, and clinical management mainly focuses on symptomatic and supportive care. In recent years, advances in virological and molecular biology research have gradually elucidated the life cycle and pathogenic mechanisms of CHIKV, providing new targets for drug development. This article systematically reviews the virological characteristics, epidemiological features, and clinical manifestations of CHIKV, with a focus on summarizing recent progress in the development of small-molecule inhibitors targeting viral entry, replication, and assembly. Additionally, the mechanisms of action and potential applications of these inhibitors are discussed.
  • Research progress and clinical application prospect of betel nut and its active components: pharmacological and toxicological effects
    YUAN Shao-shuang, SUN Zheng-qing, ZHANG Zhao-hui, XU Qiang
    Chinese Journal of New Drugs. 2025, 34(22): 2399-2407. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.006
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Modern research reports that betel nut contains a variety of chemical components, including alkaloids, polyphenols, flavonoids, terpenes, etc., which has antioxidant, anti-inflammatory, antibacterial, anti-tumor, protection of gastrointestinal mucosa, expelling worms, anti-platelet, anti-atherosclerosis, improving osteoporosis, anti-depression and anti-fatigue, regulating endocrine function, regulating intraocular pressure, anti-viral and other effects. Some of these effects have a positive role in the prevention and treatment of related clinical diseases. However, it has certain toxicity to the reproductive system, urinary system, liver, heart, and oral mucosa. In order to fully develop and utilize betel nut, a review of its chemical components and pharmacological effects is presented, with the aim of providing references for the modernization research of betel nut and providing basis for its application in clinic.
  • Progress in research on metabolic pathways, toxicogenic mechanisms and detection methods of drug-reactive metabolites
    FENG Wei-li, LIU Li, DENG Yi-fang
    Chinese Journal of New Drugs. 2025, 34(22): 2408-2422. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.007
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Drug-reactive metabolites are reactive intermediates formed during catalytic reactions of drugs by metabolizing enzymes, which are electrophilic and can covalently bind to nucleophilic groups in biological macromolecules such as DNA or proteins to produce toxicity. A detailed understanding of the toxicogenic mechanisms and easy activation sites of drug-reactive metabolites is important in the screening of reactive metabolites, the structural design of drug candidates, and reduction of drug toxicity. In this paper, we reviewed some drugs with reactive metabolites detected in vivo or in vitro, classified them according to their binding targets and the types of reactive metabolites, discussed their mechanisms of toxicity, located the susceptible activation sites, and briefly described the methods for detecting reactive metabolites.
  • Study on the pharmacokinetics and pharmacodynamics of rhEPO-Fc in patients with renal anemia
    ZHANG Wen-mei, TIAN Fang, QU Heng-yan, XU Hui, LIU Jing, YANG Chun, LI Xiao-wen, GUO Xin-lei, WANG Jia-ning
    Chinese Journal of New Drugs. 2025, 34(22): 2423-2428. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.008
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To explore the pharmacokinetic and pharmacodynamic characteristics of recombinant human erythropoietin-Fc fusion protein (rhEPO-Fc) in patients with renal anemia, and preliminarily observe its efficacy and safety. Methods: Stable chronic renal failure subjects who had received hemodialysis for more than 3 months were enrolled and administered with initial doses of rhEPO-Fc at 12, 18 and 24 μg·kg－1 via intravenous injection once weekly for 6 consecutive weeks. Pharmacokinetics, pharmacodynamics, efficacy, and safety were evaluated. Results: A total of 35 subjects were enrolled, and 31 completed the clinical trial. After intravenous injection of 12, 18 and 24 μg·kg－1 rhEPO-Fc, the mean half-lives were 17.27, 13.29 and 19.63 h, respectively. Cmax and AUC showed a linear relationship with the dose. Steady-state plasma concentration was achieved after 3 weeks of once-weekly intravenous injection. In each dose group, the mean reticulocyte count increased after the first intravenous injection of rhEPO-Fc and peaked after 7 d. After 6 weeks of administration, red blood cell count and hemoglobin levels significantly increased. Adverse reactions occurred in 10 subjects (33 cases), with an incidence of 28.6%. No severe adverse reactions or events leading to patient withdrawal were observed. Conclusion: rhEPO-Fc has a long half-life in patients with renal anemia, shows no accumulation after multiple administrations, can improve the anemia status of these patients, and has good tolerability and safety.
  • Analysis of common issues in phase I clinical trials of topical semisolid dermatological preparations of traditional Chinese medicine
    LI Shi-yu, YE Yu-jie, ZHU Zhu, MA Han-wen, YUAN Wei-an, HE Min
    Chinese Journal of New Drugs. 2025, 34(22): 2429-2433. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.009
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Topical semisolid preparations represent the most prevalent dosage form of innovative dermatological preparations of traditional Chinese medicine (TCM). Due to their unique physicochemical properties, these formulations face multiple challenges during Phase I clinical trials. Drawing from our research team's recent clinical trial experience, this paper systematically analyzed the common issues encountered throughout the clinical development process, ranging from protocol design to implementation practices, aiming to provide valuable references for advancing the development and clinical evaluation of innovative TCM semisolid preparations for topical dermatological application.
  • Multi-endpoint neurotoxicity assessment of nanosilver with different particle sizes in human neuronal cell model
    QIU Jing-ru, LI Shuang-xing, JI Ying-lu, YANG Yan-wei, ZHANG Di, GENG Xing-chao, QU Zhe
    Chinese Journal of New Drugs. 2025, 34(22): 2434-2442. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.010
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To evaluate the neurotoxic effects of silver nanoparticles (Ag-NPs) of two different particle sizes using neuronal cells differentiated from human induced pluripotent stem cells (hiPSC) with multiple endpoints. The reason to conduct this study is that in recent years, metal nanoparticles have shown a great deal of potential in pharmaceutical research, but they also pose potential toxicity to human nervous system. Methods: hiPSC-derived neuronal cells were cultured in vitro. After 72 h of administration, CCK-8 assay was used to detect cell viability of neurons, ROS levels were detected using DCFH-DA to evaluate neuronal oxidative stress injury, and γH2AX levels were detected to evaluate neuronal DNA damage. After 24 and 72 h of administration, levels of cytokine (TNF-α, IL-1β, and IL-6) were detected using enzyme-linked immunosorbent assay (ELISA), and the impact on neurite outgrowth was detected using high-content cell imaging. Results: 40 and 70 nm Ag-NPs were cytotoxic to neurons. 40 nm Ag-NPs showed a significant reduction effect (P<0.001) on cell viability from the dose of 12.5 μg·mL－1 and its LD50 was 21.82 μg·mL－1, 70 nm Ag-NPs showed a significant reduction effect (P<0.05) on cell viability from the dose of 25 μg·mL－1 and its LD50 was 51.13 μg·mL－1. From the dose of 2.5 μg·mL－1, 40 and 70 nm Ag-NPs induced a dose-related increase in neuronal ROS levels and DNA damage levels from the dose of 2.5 μg·mL－1. 40 nm Ag-NPs had an inhibitory effect on neurite fiber width and area from the dose of 2.5 μg·mL－1, 70 nm Ag-NPs had an inhibitory effect on neurite count, length, width, branch points, and other parameters from the dose of 10 μg·mL－1. The level of neuronal cytokine release was not significantly altered after the administration of Ag-NPs. Conclusion: In this study, we constructed a human neuronal cell model with multi-endpoints for evaluating the neurotoxicity of Ag-NPs in vitro, effectively assessed the cytotoxicity, oxidative stress damage, DNA damage and inhibition of neurite outgrowth induced by two particle sizes of Ag-NPs, and provided a reference for the safe use of Ag-NPs.
  • Inhibitory effect and mechanism of IgD-Fc-Ig fusion protein on human rheumatoid cell model
    LING Xi, XU Jing, LI Chao-yuan, XIE Jin-xiang, CHEN Meng-qin, LIU Dan-yan, DONG Man-ling, WU Tian-tian, WEI Wei, WU Yu-jing
    Chinese Journal of New Drugs. 2025, 34(22): 2443-2450. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.011
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To explore the mechanism of action of IgD-Fc-Ig fusion protein on a human rheumatoid cell model, which involves co-culturing FcδR high/low expressing Jurkat cells (Jurkat-WT, Jurkat-FcδR+, Jurkat-FcδR+/-) with MH7A cells following immunoglobulin D (IgD) stimulation. Methods: In vitro experiments were set up with a blank control group, an IgD group, and an IgD-Fc-Ig treatment group. The effects of IgD-Fc-Ig on the proliferation of MH7A cells in the human rheumatoid cell model were observed using CCK-8 cell viability assay kit and EDU-488 cell proliferation assay kit. The impact of IgD-Fc-Ig on the invasion and migration of MH7A cells in the human rheumatoid cell model was assessed using Transwell chambers. Results: In the human rheumatoid cell model, Jurkat-FcδR+ cells exhibited stronger promotion of proliferation, migration, and invasion of MH7A cells compared to Jurkat-WT and Jurkat-FcδR+/- cells. IgD-Fc-Ig was found to inhibit the proliferation, migration, and invasion effects of Jurkat-WT and Jurkat-FcδR+ cells on MH7A cells in the human rheumatoid cell model. Conclusion: IgD-Fc-Ig can target high levels of FcδR, thereby inhibiting the abnormal activation of fibroblast-like synoviocytes and the cartilage-destructive effects induced by IgD-stimulated T cells.
  • Pharmacoeconomic evaluation of jiuwei zhike oral liquid in the treatment of acute bronchitis with cough due to windheat syndrome
    CHEN Yu, FANG Gang, PI Zhi-peng, LI Wei, DING Jin-xi
    Chinese Journal of New Drugs. 2025, 34(22): 2451-2455. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.012
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To evaluate the cost-effectiveness of Jiuwei zhike oral liquid versus jizhi syrup in the treatment of acute bronchitis with cough due to windheat syndrome. Methods: The short-term cost-effectiveness analysis was conducted from the perspective of Chinese health system based on the phase III clinical study of jiuwei xhike oral liquid. The health outcome was evaluated by cough disappearance time. The single factor and possibility sensitivity analysis were performed for key indicators. Furthermore, the disappearance rate of throat-drying symptom was used as the efficacy indicator in the scenario analysis to verify the robustness of the base case analysis. Results: The average cough disappearance time was shortened by 0.46 days while the cost was 26.41 Yuan higher. The incremental cost-effectiveness ratio value of jiuwei zhike oral liquid compared with jizhi syrup was 57.7 Yuan per day, which was less than China's daily per capita disposable income in 2023. Possibility sensitivity analysis showed that when the willingness to pay threshold was set up as 107.4 Yuan, jiuwei zhike oral liquid had a 93.8% chance of being more cost-effective compared to jizhi syrup. Results of scenario analysis was consistent with base case analysis results. Conclusion: jiuwei zhike oral liquid is cost-effective for acute bronchitis patients with cough due to windheat syndrome.
  • Rapid health technology assessment of nintedanib for the treatment of pulmonary fibrosis
    ZHANG Yu-xi, ZHANG Ran-ran, GAO Sheng-nan, GAO Ning, FENG Bing, LIU Guo-qiang
    Chinese Journal of New Drugs. 2025, 34(22): 2456-2464. https://doi.org/10.20251/j.cnki.1003-3734.2025.22.013
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To evaluate the effectiveness, safety, and economic value of nintedanib in the treatment of pulmonary fibrosis, with the aim of providing a scientific basis for clinical decision-making and healthcare resource allocation. Methods: By searching databases including CNKI, Wanfang, VIP, PubMed, Cochrane Library, Embase, Web of Science, and health technology assessment (HTA) websites, systematic reviews/meta-analyses, pharmacoeconomic studies, and HTA reports related to nintedanib were collected. The search timeframe spanned from the establishment of each database to August 2024. Literature was screened according to inclusion and exclusion criteria, and the quality of the included studies was assessed using appropriate evaluation tools. Data from the literature were extracted for qualitative description. Results: A total of 20 studies were included, comprising 1 HTA report, 13 Meta-analyses/systematic reviews, and 6 pharmacoeconomic studies. The overall quality of the literature was good. In terms of effectiveness, nintedanib showed superior forced vital capacity (FVC) changes compared to placebo. Most studies indicated that the percentage of predicted FVC after nintedanib treatment was better than that of placebo. Nintedanib also demonstrated similar or superior effects to placebo and pirfenidone in reducing acute exacerbations and mortality. Regarding safety, nintedanib was associated with higher incidences of adverse events such as nausea, vomiting, diarrhea, and study discontinuation due to adverse events compared to placebo, but it did not increase the incidence of cardiovascular adverse events. In terms of economic value, nintedanib showed cost-effectiveness advantages over pirfenidone in multiple countries, including China, France, and Belgium. Conclusion: Nintedanib is effective in treating pulmonary fibrosis, with multiple indicators showing superiority over placebo. In terms of safety, it increases gastrointestinal adverse events but does not raise the risk of cardiovascular adverse events. Economically, nintedanib demonstrates cost-effectiveness advantages in multiple countries, indicating significant potential for clinical application.
Total:
Copyright © Chinese Journal of New Drugs, All Rights Reserved.
Tel: 010-52722697 | 010-52723707
　 Powered by Beijing Magtech Co., Ltd.