31 August 2025, Volume 34 Issue 16
    

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  • Study of the relationship between technological innovation and industrial development in China's pharmaceutical manufacturing industry using semi-parametric spatial lag model
    ZHANG Xin-duo, BI Hai-yan, FU Shu-yong
    Chinese Journal of New Drugs. 2025, 34(16): 1681-1687. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.001
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To explore the relationship between technological innovation and industrial development in China's pharmaceutical manufacturing industry. Methods: Using the panel data of 29 regions in China from 2009 to 2021, analysis was conducted based on the semi-parametric spatial lag model. Results: The industrial development of pharmaceutical manufacturing industry had a negative spatial spillover effect, and technological innovation had a nonlinear effect on industrial development, showing a promotion-inhibition-promotion fluctuation relationship. Conclusion: It is suggested to rely on regional resource endowment to cultivate characteristic industrial advantages, promote the establishment of trans-regional innovation alliances, and build core competitiveness through differentiated competition strategies to achieve multi-dimensional regional economic high-quality development.
  • Considerations and suggestions on “medicine and excipient homology”
    SUN Hui-min, LI Jin, LI Dan-xi, WANG Jue, ZHAO Xia, NING Bao-ming, YAO Shang-chen
    Chinese Journal of New Drugs. 2025, 34(16): 1688-1696. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.002
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    With the increasing public concern over drug safety and the ongoing advancement of generic drug consistency evaluation in China, the critical role of pharmaceutical excipients has garnered heightened recognition. Based on an in-depth analysis of the definition and properties of pharmaceutical excipients, this study references international research on atypical active substances and reveals that certain excipients can directly function as active pharmaceutical ingredients in drug formulations. Building on this finding, the concept of “medicine and excipient homology” is proposed and comprehensively elaborated, supported by examples of common excipients exhibiting this dual characteristic. Furthermore, the current regulatory frameworks for such excipients in China and other countries are comparatively analyzed, highlighting existing challenges and actionable recommendations are proposed to refine the precision management of pharmaceutical excipient quality in China, aiming to enhance drug efficacy and safety through improved excipient governance.
  • Empirical study on the relationship between government subsidies and innovation efficiency of rare disease drug companies
    ZHAI Jin-long, FU Shu-yong
    Chinese Journal of New Drugs. 2025, 34(16): 1697-1703. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.003
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    Objective: To explore the relationship between government subsidies and innovation efficiency of rare disease drug companies. Methods: This study is based on the panel data of 16 selected rare disease drug pharmaceutical listed companies from 2018 to 2023. Firstly, dynamic and static efficiency analysis was conducted using data envelopment analysis (DEA), and secondly, empirical analysis was conducted using benchmark regression and semi-parametric estimation models. Results: In the DEA results, only Shanghai Pharmaceutical's efficiency value was 1.000, and 56.25% of the enterprises showed a decreasing trend in efficiency, with an average annual decrease of 0.070% in total factor productivity. In the benchmark regression analysis, the regression coefficient of government subsidies was -0.087, which is significant at the 5% level. In the semi-parametric analysis, the partial derivative of government subsidies on innovation efficiency was an exponential change. Conclusion: Except for Shanghai Pharmaceutical, the innovation efficiency of other enterprises has not reached an effective state, showing an overall decreasing trend in efficiency. The current government subsidies have failed to achieve the effect of effectively improving the level of innovation efficiency of pharmaceutical enterprises. Therefore, the relevant government departments must formulate incentive policies for rare diseases, provide government subsidies on an ongoing basis, and gradually improve the R&D efficiency of domestic pharmaceutical enterprises in the development of drugs for rare diseases.
  • Considerations of the quality management and inspection of pharmacology and toxicology studies
    YUAN Ming, CHEN Yi-fei
    Chinese Journal of New Drugs. 2025, 34(16): 1704-1708. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.004
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    Pharmacology and toxicology studies are important evaluation component in drug research and development, and the first line of defense before the application of innovative drugs in humans. In accordance with the international guidance and Chinese regulatory requirements, non-clinical safety evaluation study of drugs should be conducted at institutions certified by the good laboratory practice (GLP), and in compliance with the GLP. Although some pharmacological studies and pharmacokinetic studies are not required to be conducted under GLP conditions, data reliability remains a basic requirement, which shall comply with regulatory requirements and might be inspected. Through analyzing the focus areas of on-site inspections, this paper discusses the quality management of pharmacology and toxicology studies, and explores the risk management of pharmacology and toxicology studies and corresponding inspections. The aim of this paper is to provide guidance for pharmacology and toxicology studies institutions to improve study quality through the construction of quality management system. Meanwhile, it also provides reference for the inspection of pharmacology and toxicology studies.
  • Research progress and review strategies of monkeypox vaccines in China and abroad
    WU Ying-qi, LIU Ying, SHAO Yi-ming
    Chinese Journal of New Drugs. 2025, 34(16): 1709-1715. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.005
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    Mpox is an acute infectious disease caused by the monkeypox virus. Most of the cases primarily distributed in African countries. Since the global dissemination of the monkeypox outbreak in 2022, the World Health Organization (WHO) has declared twice that it has become a public health emergency of international concern. This highlights the urgent need for preventive vaccines, however currently, no monkeypox vaccine has been approved in China. It is necessary to expedite the clinical research and approval of domestically produced vaccines to meet the demands of the prevention and control of monkeypox epidemic in China. This article presents a summary of the current research and development progress of monkeypox vaccines in China and abroad. It also collates the strategies and bases for the review of the clinical efficacy of monkeypox vaccines by the regulatory authorities of the United States, Europe, Japan and other countries or regions, as well as the WHO. Additionally, we discuss the research and development, as well as review strategies of domestically produced monkeypox vaccines, aiming to promote the development and approval of monkeypox vaccines in China.
  • New lipid-lowering drugs affecting lipid metabolism by regulating autophagy
    JI Hui, YUAN Shan-hui, LU Yun-tao, WANG Qian, TANG Hui
    Chinese Journal of New Drugs. 2025, 34(16): 1716-1722. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.006
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    The drug  treatment related to dyslipidemia is currently a hot research topic in the cardiovascular field. Dyslipidemia is closely related to cardiovascular diseases, especially hyperlipidemia. Autophagy refers to a phenomenon that damaged or excess organelles and proteins are decomposed in lysosomes, which plays an important role in maintaining cell homeostasis and coping with external environmental pressure. Autophagy also plays an important role in lipid metabolism. Autophagy can degrade lipid droplets and reduce lipid deposition, thus maintaining the homeostasis of lipid metabolism. Our previous study found that autophagy may regulate hepatocyte autophagy by regulating the expression of key enzymes of lipid metabolism, thus affecting the homeostasis of liver lipid metabolism. Different autophagy regulation pathways play different roles in the process of lipid metabolism in liver, and interact with the lipolysis pathway mediated by traditional lipase. In this paper, the research progress of new lipid-lowering drugs that affect lipid metabolism by regulating autophagy is systematically reviewed.
  • Study on the quality of echinocandin antibiotics-Ⅱ
    LI Bin, LI Jin, NING Bao-ming, DI Xin, TIAN Ye
    Chinese Journal of New Drugs. 2025, 34(16): 1723-1734. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.007
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    Echinocandin are semi synthetic antibiotics. In the process from strain fermentation to clinical use, process impurities or degradation impurities are easily introduced into these drugs. The above impurities usually have complex structures and are similar to the structures of active components, so they may compete with drugs for the target of action and affect the safety and effectiveness of drugs. Therefore, it is important to study the sources and structures of impurities for the quality control of drugs. This review summarizes the pharmacopoeia inclusion of echinocandin, the precursor structure and the development process of structural modification, and analyzes the possible sources of impurities, structures and quality control, so as to provide a reference for the quality research and control of echinocandin.
  • Clinical research progress in novel drug NK3R antagonists for vasomotor symptoms in menopausal women
    ZHENG Lian, WU Yue, LI Mei, HOU Ying-ying
    Chinese Journal of New Drugs. 2025, 34(16): 1735-1741. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.008
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    Vasomotor symptoms (VMS) are the hallmark symptom of menopausal women. Menopausal hormone therapy (MHT), the first-line treatment for VMS, has been limited in some target populations due to concerns about its venous thromboembolic risk and breast safety. Neurokinin 3 receptor (NK3R) antagonists are a new type of non-hormonal oral drug for the treatment of VMS in menopausal women. They prevent the over-activation of kisspeptin/neurokinin B/dynorphin (KNDy) neurons by blocking the binding of neurokinin B (NKB) to KNDy neurons, reduce the sensitivity of hypothalamic thermoregulatory centers, and restore normal thermoregulatory function, thus reduce the frequency and severity of hot flushes and night sweats. In this article, we will focus on reported NK3R antagonists and their clinical value in the treatment of VMS.
  • Clinical trial of acupoint application combined with doxazosin mesylate in managing benign prostatic hyperplasia with kidney deficiency-blood stasis pattern
    GONG Ying-jie, ZHU Yu-xin, FAN Yan-mei, MA Ru, YU Hui-lan, GAO Xiao-song, LU Jian-xin, ZHANG Ya-qiang, SONG Shu-qi
    Chinese Journal of New Drugs. 2025, 34(16): 1742-1747. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.009
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    Objective: To explore the clinical efficacy of acupoint application combined with doxazosin mesylate in the treatment of benign prostatic hyperplasia (BPH) with kidney deficiency-blood stasis pattern. Methods: A total of 67 patients with BPH of kidney deficiency-blood stasis pattern from July 2022 to December 2024 were selected as the research object in Guang'anmen Hospital of Chinese Academy of Chinese Medical Sciences, of which 33 cases were divided into control group and 34 cases in treatment group by random number table method. The control group was given doxazosin mesylate, and the treatment group was given acupoint application on the basis of the control group, and the course of treatment was four weeks. The changes of international prostate symptom (IPSS) score, quality of life (QOL) score, TCM symptom score, prostate volume (PV), residual urine volume (RUV), maximum urine flow rate (Qmax) and average urine flow rate (Qave) were compared between the two groups before and after the treatment. The clinical efficacy of two groups was compared and analyzed, and the adverse reactions were recorded. Results: After 4 weeks of treatment, the clinical effective rate of the treatment group was 90%, which was significantly higher than that of the control group which was 60% (P＜0.05). The IPSS score, QOL score, TCM symptom score, PV, RUV, Qave and other indicators have been significantly improved in both groups (P＜0.05). In addition, the treatment group was superior to the control group in the reduction of IPSS score, QOL score, TCM symptom score and the improvement of Qmax and Qave (P＜0.05). Conclusion: The treatment of acupoint application in traditional Chinese medicine combined with doxazosin mesylate can significantly improve the clinical symptoms of patients with BPH of kidney deficiency-blood stasis pattern. Meanwhile, the curative effect of the combination is better than that of single western medicine, which can significantly improve the clinical symptoms of patients. The combined treatment has good safety and is worthy of clinical application.
  • Establishment and validation of a reporter gene assay to determine the bioactivity of CpG QCX1 adjuvant in vitro
    GE Jun, HE Peng, JIANG Chuan-wen, HUANG Hong-ying, ZHANG Shuang, LU Jin-biao, LI Jian-qiang, HU Zhong-yu
    Chinese Journal of New Drugs. 2025, 34(16): 1748-1754. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.010
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    Objective: To establish and validate a reporter gene assay for in vitro determining the bioactivity of CpG QCX1 adjuvant. Methods: Following the guidelines of ICH Q2(R2) and the General Chapter 9401 of the Chinese Pharmacopoeia 2020 edition, volume Ⅲ, combined with design of experiment (DOE), the analytical method was optimized and its specificity, relative accuracy, intermediate precision, linearity, and range were validated. Results: The concentration range of the test sample was determined to be 0.195~50 μg·mL－1, dilution factor of 1∶2, cell concentration of 4.5×105 cells·mL-1, and incubation time of 16 hours. The method could specifically detect CpG QCX1, with a linear range of 50%~185%, relative bias of -2.7% to -1.0% for five activity levels, geometric coefficient of variation less than 10%, and a linear regression correlation coefficient (r)  of 0.996, all of which met the requirements. Conclusion: The method established in this study has good specificity, accuracy, robustness, and durability, and can be used for the quality control of related CpG products.
  • Investigating the mechanism of Liang-Fu Dropping Pills in anti-gastric ulcer effects based on the PI3K-AKT signaling pathway
    WANG Chang-fu, PAN Jie, LIAO Yong-e, LU Yuan, LIU Chun-hua, SUN Jia, ZHENG Lin, MA Xue, LI Yong-jun
    Chinese Journal of New Drugs. 2025, 34(16): 1755-1766. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.011
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    Objective: To investigates the mechanism by which Liang-Fu Dropping Pills regulate the PI3K-AKT signaling pathway to exert an anti-gastric ulcer effect. Methods: First, the prepared Liang-Fu Dropping Pills, Alpinia officinarum, and Rhizoma Cyperi extracts were respectively detected and analyzed by ultra-high performance liquid chromatography-quadrupole-electrostatic orbitrap high-resolution mass spectrometry (UHPLC-Q-Exactive Plus Orbitrap HRMS). Subsequently, the potential pharmacological substances and potential mechanisms of action for the anti-gastric ulcer of Liang-Fu Dropping Pills were predicted through network pharmacology. Finally, in vivo experiments were conducted to investigate the anti-gastric ulcer effect of Liang-Fu Dropping Pills by observing the apparent morphology of the stomach and examining the stained tissues using histological staining methods. Real-time quantitative PCR and Western blotting were used to verify the regulatory effect of Liang-Fu Dropping Pills on potential targets in rat tissues of gastric ulcer model. Results: A total of 77 chemical constituents were identified from the extract of Liang-Fu Dropping Pills. Pathway enrichment analysis of chemical constituents and common targets of gastric ulcer disease showed that the anti-gastric ulcer mechanism of Liang-Fu Dropping Pills might be related to the regulation of lipid metabolism and PI3K-AKT signaling pathways. Molecular docking showed that protein kinase B1 (AKT1) and cellular tumor antigen P53 (TP53) were well combined with galangin and rhamnocitrin, the main index components of Liang-Fu Dropping Pills. In vivo experimental results showed that Liang-Fu Dropping Pills could significantly increase the level of acidic mucopolysaccharide (P<0.05) in the gastric mucosa, and significantly down-regulate the mRNA and protein expression levels of p-PI3K/PI3K (P<0.01), p-AKT/AKT (P<0.001), nuclear factor-kappa B p65 [NF-κB p65 (P<0.001)] and TP53 (P<0.01) in the gastric ulcer tissue of rats. Conclusion: In this study, we preliminarily explored the mechanism of the anti-gastric ulcer effect of Liang-Fu Dropping Pills through network pharmacology and animal experiments, which may be related to the regulation of PI3K-AKT related signaling pathway, which provided a reference for in depth study of the pharmacodynamic material basis and mechanism of action Liang-Fu Dropping Pills.
  • The study of pogostemonis herba, pogostemonis herba leaves, and pogostemonis herba stalks by HPLC fingerprint and multi-index component determination
    GAO Le, ZHEN Ya-qin, ZHANG Ze-zhao, XIE Ze-yang, TIAN Wei, NIU Li-ying
    Chinese Journal of New Drugs. 2025, 34(16): 1767-1774. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.012
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    Objective: To establish an HPLC method for simultaneous determination of fingerprints and 10 components of pogostemonis herba, pogostemonis herba leaves, and pogostemonis herba stalks, and analyze the differences of chemical components among the three components, so as to provide reference for improvement of quality control methods of pogostemonis herba. Methods: The chromatography was performed by HPLC with Agilent Poroshell 120EC-C18 column (250 mm×4.6 mm，4.0 μm). The mobile phase was acetonitrile-0.1% phosphoric acid solution, gradient elution was performed at a flow rate of 1.0 mL·min－1, and the column temperature was maintained at 35 ℃. The detection wavelength was 330 nm. Results: The similarity between different batches of pogostemonis herba, pogostemonis herba leaves, pogostemonis herba stalks and their control fingerprint was greater than 0.91. Ten chromatographic peaks were identified by reference substances. The similarity indexes between pogostemonis herba leaves control, pogostemonis herba stalks and pogostemonis herba control fingerprint were 0.75 and 0.95, respectively. The similarity between leaves and stalks of pogostemonis herba was only 0.57. The method of content determination of 10 components met the requirements of methodological investigation. The contents of isomonitroside and pogostemonis herba ketone in pogostemonis herba stalks were higher than those in pogostemonis herba leaves, and the contents of other eight components were higher in pogostemonis herba leaves. Conclusion: The fingerprint and content determination method established in this study are simple, stable and reliable, and provide a reference for further improving the quality standard of pogostemonis herba.
  • Analysis of odor differences of Aucklandiae Radix from different producing areas based on electronic nose and HS-GC-MS
    LI Ning, WANG Yi-ning, GAO Le, JIANG Xiao-ya, ZHANG Ze-zhao, NIU Li-ying
    Chinese Journal of New Drugs. 2025, 34(16): 1775-1783. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.013
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    Objective: To explore the differences in odor and volatile components of Aucklandiae Radix from different origins. Methods: Nineteen batches of Aucklandiae Radix were collected. The odor of samples was analyzed by PEN3 electronic nose system. Headspace gas chromatography-mass spectrometry (HS-GC-MS) was used to detect and analyze the volatile chemical components of Aucklandiae Radix. Principal component analysis (PCA) was used to identify the origins and chemical components of samples. Differential components were screened based on the partial least squares discriminant analysis (PLS-DA) and principle of variable importance in projection (VIP) greater than 1. Person correlation analysis was conducted between differential volatile components and electronic nose sensors. Results: The four sensors of the electronic nose had relatively high response. Fifty-three, thirty-six, twenty-seven and thirty-three chemical components from Yunnan, Gansu, Sichuan, and Hubei were identified respectively by HS-GC-MS. The main material basis for the generation of Aucklandiae Radix was speculated. Conclusion: The origin of medicinal herbs can be well distinguished by electronic nose combined with HS-GC-MS. The selected differential compounds and odor substances provide reference for distinguishing the origin of Aucklandiae Radix and evaluating the odor characteristics.
  • Pharmacoeconomic evaluation of ribociclib as first-line treatment in premenopausal women with HR+/HER2- advanced or metastatic breast cancer
    ZHANG Sen, WANG Jie, LI Sai-nan, WANG Mei-qi, JU Ying-bo, WANG Ming-xia, JIA Cai-feng
    Chinese Journal of New Drugs. 2025, 34(16): 1784-1792. https://doi.org/10.20251/j.cnki.1003-3734.2025.16.014
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    Objective: To assess the cost-effectiveness of ribociclib combined with endocrine therapy versus endocrine therapy alone for premenopausal patients with HR+/HER2- advanced or metastatic breast cancer from the perspective of the Chinese healthcare system, providing references for healthcare decision-making. Methods: Based on the clinical efficacy data from the phase Ⅲ MONALEESA-7 trial, a partitioned survival model was constructed with a cycle length of four weeks and a time horizon of 20 years. The model evaluated differences in total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) between ribociclib combined with endocrine therapy and endocrine therapy alone in terms of long-term health and economic benefits. The model's robustness was tested using one-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis. Results: The base case analysis indicated that ribociclib combined with endocrine therapy was clinically superior to endocrine therapy alone, providing an additional 0.86 QALYs at an incremental cost of CNY 234 623.99, with an ICER of 272 632.70 CNY·QALY-1. One-way sensitivity analysis showed that the three most influential factors on ICER were the utility value of progression-free survival, discount rate, and cost of ribociclib. The results of the probabilistic sensitivity analysis indicate that when the willingness-to-pay (WTP) threshold was set at three times the per capita GDP of China in 2023 (268 074 CNY·QALY-1), the probability of the ribociclib combined endocrine therapy regimen being cost-effective was 45%. Scenario analysis showed that with longer simulation time horizons, the ICER of the ribociclib combined with endocrine therapy gradually decreased, with the magnitude of decrease diminishing. Conclusion: At a WTP of 268 074 CNY·QALY-1, ribociclib combined with endocrine therapy is not cost-effective compared to endocrine therapy alone for the first-line treatment of premenopausal patients with HR+/HER2- advanced or metastatic breast cancer.
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