15 March 2026, Volume 35 Issue 5
    

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  • Analysis of older adults inclusion in clinical trials of FDA-approved new drugs in the United States
    DING Jing, XU Yang, YANG Yue, TIAN Li-juan
    Chinese Journal of New Drugs. 2026, 35(5): 449-454. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.001
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To address the underrepresentation of older adults in clinical trials of new drugs, the U.S. FDA has implemented various measures to encourage their participation. This study systematically assesses the enrollment of older adults in clinical trials for FDA-approved new drugs between 2015 and 2023, with the aim of informing strategies for geriatric drug development in China. Methods: Demographic data for approved drug indications were extracted from the FDA drug trials snapshots (DTS). Therapeutic areas were categorized according to the WHO anatomical therapeutic chemical (ATC) classification. The proportions of participants aged <65 years, ≥65 years, and ≥75 years were analyzed. Compliance with the ICH E7 guideline-especifically the inclusion of at least 100 older adults in non-elderly-specific and rare disease indications-was also evaluated. Results: Among 381 non-elderly-specific indications, 85.3% included participants aged ≥65 years. However, only 43.0% included ≥100 older adults, and only 16.8% disclosed data for the ≥75-year-old subgroup. In terms of therapeutic area, the sensory system showed the highest level of inclusion (100% included older adults; 90.9% included ≥100), while the musculoskeletal system had the lowest (only 28.6% included participants aged ≥65). The inclusion rate for older adults in rare disease indications was significantly lower than that in non-rare diseases (79.6% vs 90.8%, P=0.007 4), with only 23.1% meeting the ICH E7 “≥100 older adults” threshold (vs. 60.0% in non-rare diseases, P<0.000 1). Conclusion: Through transparency initiatives and updated regulatory policies, the FDA has made tangible progress in enhancing the representation of older adults in clinical trials. However, gaps remain in the data reporting for very old subgroups (≥75 years). These findings provide key insights for advancing the development of age-inclusive drug research in China.
  • Introduction to the WHO-listed authority framework
    LÜ Xu-feng, SU Yao, WANG Jia, XU Zhen-yu
    Chinese Journal of New Drugs. 2026, 35(5): 455-460. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.002
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    The WHO-listed authority framework (WLA) is a transparent and evidence-based evaluation pathway implemented by WHO for drug regulatory authorities. Regulatory authorities that meet the evaluation requirements can be designated as WLA, representing their regulatory performance at a globally advanced level. This study mainly conducts a detailed examination on the formation process, application and evaluation procedures, and continuous evaluation mechanism of the WLA framework. Based on this analysis, the article proposes several considerations for China's drug regulatory authority regarding its potential participation in in the WLA framework.
  • Research progress on clinical efficacy evaluation of traditional Chinese medicine treatment for chronic obstructive pulmonary disease based on causal learning model framework
    WEI Wei, WANG Bo-ran, WANG Jia-yun, ZHOU Xue-zhong
    Chinese Journal of New Drugs. 2026, 35(5): 461-464. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.003
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    Traditional Chinese medicine (TCM) offers unique clinical advantages in the treatment of chronic obstructive pulmonary disease (COPD) and is recognized as a research hotspot in the field of TCM, holding important scientific value. Considering the complexity of TCM medication and clinical outcomes in terms of temporal, spatial, and individual dimensions, researchers have explored the application of artificial intelligence causal inference technology to establish clinical efficacy evaluation models in recent years. This study mainly introduces two aspects: the research progress on the correlation between the regularity and clinical efficacy of TCM in treating COPD, and the research progress of causal learning model framework in the medical field. It provides ideas for accurately evaluating the causal relationship between TCM and clinical efficacy,  promoting the inheritance and innovation of TCM.
  • Research progress on the mechanism of Huisheng Oral Liquid in the auxiliary treatment of non-small cell lung cancer
    ZHENG Mao-dong, ZHANG Ben-chang, YAN Juan
    Chinese Journal of New Drugs. 2026, 35(5): 465-469. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.004
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    Huisheng Oral Liquid (HSOL) originates from the “Huazheng Huisheng Dan” recorded in the “Treatise on Warm Diseases.” This formula was developed by Wu Jutong by combining “Huisheng Dan” from “Wan Bing Hui Chun” and “Biejia Jian Wan” from the “Synopsis of the Golden Chamber,” with modifications and refinements. It has the effects of promoting blood circulation, removing blood stasis, eliminating masses, and dispersing nodules, as well as reinforcing healthy qi, and combating cancer. It is primarily used in the treatment of malignant tumors such as lung cancer. The drug interactions and side effects of Huisheng Oral Liquid mainly involve its synergistic effects and safety characteristics when used with chemotherapy drugs and immune checkpoint inhibitors (ICIs). Evidence indicates that HSOL exerts its therapeutic effects primarily by inducing tumor cell apoptosis, inhibiting proliferation and metastasis, and regulating immunity. Observational studies and small-sample RCTs suggest that HSOL can improve the quality of life for non-small cell lung cancer patients, stabilize tumors, and potentially prolong survival.
  • Use of Data Monitoring Committees in Clinical Trials, Guidance for Industry （draft guidance）——interpret the development and practice of Data Monitoring Committee from the updated FDA guidelines
    ZHENG Yu, DANG Hai-xia, LIU Jun, WANG Zhong, YU Ya-nan
    Chinese Journal of New Drugs. 2026, 35(5): 470-475. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.005
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    Use of Data Monitoring Committees in Clinical Trials, Guidance for Industry (draft guidance) is an updated draft of the U.S. FDA guidance issued in February 2024 to address developments in Data Monitoring Committees (DMC) since the issuance of the 2006 guidance. The Draft Update, issued by the FDA in February 2024, intends to accommodate developments in DMC since the 2006 the guidance was issued. The draft update focuses on the organizational structure and operational processes of DMC, and improves the 2006 guidance by focusing on six core elements: expansion of the scope of application, integration of innovative clinical trial designs, refinement of the bylaws, globalization, upgrading of the scope of monitoring, and expansion of the functions of the DMC. Based on the practice and development history of DMC in the past 20 years, this paper provides systematic interpretation and analysis of the draft with the six updated points as the core, with a view to help many clinical researchers to better understand and master the draft, promoting the standardized application of DMC in clinical trials, and enabling them to more effectively fulfill their supervisory roles.
  • Analysis and consideration of classification for the causality assessment of adverse events in drug clinical trials
    PEI Xiao-jing, LI Hai-yan, SHEN Yi-feng, LIU Min
    Chinese Journal of New Drugs. 2026, 35(5): 476-480. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.006
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    The evaluation of causality assessment between an adverse event and a drug plays a critical role in safety research and risk management in clinical trials. At present, there is a lack of unified and standardized classification methods and requirements for adverse event causality assessment in the clinical trials internationally. In order to standardize relevant work, in 2024, the Center for Drug Evaluation issued the “Technical Guideline for Causality Assessment of Adverse Events in Drug Clinical Trials (interim)”, which provides technical references for the classification methods in China. This article introduces the research background and analytical approach to better understand and apply the relevant content of the Guideline.
  • Study and analysis of the registration characteristics of clinical trials of poly ADP ribose polymerase inhibitors based on the ClinicalTrials database
    YIN Gui-sen, DONG Bai-hui, SU Jia-hang, LIU Fen, LI Jin-lan
    Chinese Journal of New Drugs. 2026, 35(5): 481-487. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.007
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    Objective: This study aims to analyze the registration status of clinical trials of poly ADP ribose polymerase (PARP) inhibitors in the U.S. clinical trial registration platform (ClinicalTrials database), understand their registration characteristics and development trends, and provide references for clinical research. Methods: All clinical trials registered for PARP inhibitors in the ClinicalTrials database from its establishment to February 28, 2025 were retrieved. Information such as registration time, research phase, sample size, indications, registration status, and country/region was extracted. Data were organized and statistically analyzed using WPS Office and Excel spreadsheets. Results: A total of 488 clinical trials related to PARP inhibitors were included. The number of registrations peaked in 2019 (55 cases, accounting for 11.27%). From 2020 to 2024, the number of registrations gradually stabilized. Among the clinical trials conducted, phase Ⅱ trials were the most common (195 cases, accounting for 39.96%). The main indications were ovarian cancer (122 cases, accounting for 25.00%) and breast cancer (83 cases, accounting for 17.00%). In terms of the regions where the clinical trials were registered, the United States (281 cases, accounting for 57.58%), the United Kingdom (73 cases, accounting for 14.96%), and China (67 cases, accounting for 13.73%) had the largest numbers. The sponsors were mainly from the United States (84 cases, accounting for 17.21%), among which the U.S. National Cancer Institute had the largest number (66 cases, accounting for 13.50%). The research designs were mainly single-group assignment (224 cases, accounting for 45.90%) and open-label (419 cases, accounting for 85.90%). The main endpoint indicators were progression-free survival (PFS, 310 cases) and overall survival (OS, 181 cases). Conclusion: The clinical trials of PARP inhibitors have entered a plateau phase, which may be related to the limited efficacy caused by drug resistance, the narrow scope of existing indications, and the fierce market competition from antibody drugs. Subsequent research can shift to combination therapy, strengthen multi-center cooperation, optimize trial design, and effectively improve the efficiency of transforming scientific research achievements into clinical applications.
  • Standardization of the first batch of national reference standard of lysozyme
    LIU Li-sha, HE Dong-mei, LI Jing, DONG Xin, HE Lan-ying, ZHANG Dou-sheng, REN Li-ping, FAN Hui-hong
    Chinese Journal of New Drugs. 2026, 35(5): 488-494. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.008
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    Objective: To establish the first batch of the national reference standard of lysozyme for content determination. Methods: The structure of the candidate lysozyme reference material was confirmed by HRMS, IR, UV spectroscopy and electrophoresis. Hygroscopicity, isoelectric point (pI), total nitrogen content, and HPLC purity were determined. A collaborative calibration was conducted by six laboratories from drug control institutes and lysozyme manufacturers using two methods: potency determination of the candidate material using the lysozyme potency assay method specified in the 6th volume of the second part of the Ministry of Health's Drug Standards; and content determination using the JP lysozyme hydrochloride assay method with JP lysozyme reference standard (Lot LYS03A) as the reference. Results: The structure of the candidate lysozyme material was confirmed. Hygroscopicity testing indicated it is extremely hygroscopic. The pI was determined to be 10.1, total nitrogen content was 16.8%, and HPLC purity was 94.0%. Collaborative calibration yielded a mean potency of 20 219.85 units·mg-1 with a 95% confidence interval of 18 716.48 units·mg-1 to 21 723.22 units·mg-1 and a mean content of 0.976 5 mg (potency)·mg-1 (anhydrous basis) with a 95% confidence interval of 0.956 5 mg (potency)·mg-1 to 0.996 6 mg (potency)·mg-1 (anhydrous basis). Conclusion: Approved by the National Drug Reference Standards Committee, the first batch of candidate lysozyme reference material (batch 140878-202401) was assigned a value of 0.98 mg (potency)·mg-1 (anhydrous basis), and authorized for use as the national reference standard for content determination in lysozyme raw materials and preparations.
  • Development of the first batch of saxagliptin monohydrate national control product
    ZHAI Chen-fei, FENG Yu-fei, LUO Chen, LIU Qian, YANG Dong-sheng
    Chinese Journal of New Drugs. 2026, 35(5): 495-499. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.009
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    Objective: To establish the first batch of the national reference standard for saxagliptin. Methods: The structure of saxagliptin was confirmed by IR, NMR and LC-MS spectroscopy. The purity of saxagliptin was determined by HPLC, water content and residue on ignition were also determined, and the final content of saxagliptin was calculated using the mass balance method. Results: The structure of saxagliptin was confirmed, and the content was found to be 94.2%. Conclusion: The development of the first batch of saxogliptin chemical reference standard enables its use  as a reference for the identification and content determination of saxagliptin raw material and its related preparations.
  • Research on chemical components of Danggui Beimu Kushen Pills based on UPLC-Q-TOF-MS/MS and in-depth analysis of feature-based molecular network
    SUN Yan, CHENG Mei-ling, LI Zhi-xuan, WANG Rui, WANG Ying-li, QIN Xue-mei, LIU Rui
    Chinese Journal of New Drugs. 2026, 35(5): 500-511. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.010
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    Objective: To establish an indepth analytical method combining chromatography-high resolution mass spectometry with feature-based molecular networking (FBMN) for the comprehensive analysis and identification of chemical components in D-anggui Beimu Kushen Pills (DBKP). Methods： Mass spectrometry data of DBKP were collected in the positive and negative ion modes with ultra-high performance liquid chromatography-quadrupole-time of flight mass spectrometry (UPLC-Q-TOF-MS/MS). The acquired mass spectrometry data were used to construct the FBMN through the Global Natural Products Social Molecular Networking (GNPS) platform, and the network was visualized using Cytoscape 3.10.2 software. On this basis, the known nodes in FBMN were marked by comparison of reference substances, self-established and public databases, and redundant nodes were identified and excluded by combining chromatographic retention time and MS/MS data to improve the accuracy of the known node labeling. Then, their related nodes were inferred according to the network relationship and MS/MS date. Results: A total of 208 chemical constituents were identified from the DBKP by removing the redundant nodes in the molecular clusters of flavonoids and phthalides, including 84 flavonoids, 34 phthalides, 61 alkaloids, and 29 other compounds. Conclusion: The established liquid chromatography-mass spectrometry technology combined with FNMN in-depth analysis method effectively minimizes the false-positive results of redundant nodes. The chemical composition of DBKP can be rapidly, systematically and accurately identified, providing a reference for further study of its pharmacodynamic material basis.
  • In vitro and in vivo antibacterial activity of compound L007-0069 against Staphylococcus epidermidis and its antibacterial mechanism
    YANG Wen-yi, TU Xi-chen, HOU Zheng-li
    Chinese Journal of New Drugs. 2026, 35(5): 512-520. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.011
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    Objective: The drug resistance of Staphylococcus epidermidis (S.epidermidis) and its biofilm have become a thorny problem in clinical work. The exploration of novel antibacterial drugs could provide a breakthrough for the treatment of related infectious diseases in clinical practice. In this study, the antibacterial activity of the novel small molecule compound L007-0069 against S.epidermidis was investigated and its mechanism of action was further elucidated. Methods: The antibacterial susceptibility of L007-0069 against S.epidermidis was evaluated in vitro using disk diffusion and broth microdilution assays. Time-kill curves were used to study the bactericidal activity of L007-0069 against S.epidermidis and its persister cells. A checkerboard dilution assay was used to assess the combined efficacy of L007-0069 when used with gentamicin; an XTT assay was used to detect the antibacterial activity of L007-0069 against S.epidermidis biofilms; SYTO9/PI dual fluorescence staining was used to observe the disruptive effect of L007-0069 on the structural integrity of S.epidermidis biofilms; the disruption of the cell membrane integrity of S.epidermidis by L007-0069 was detected using DiSC3(5) and SYTOX Green fluorescent probes; finally, the in vivo antibacterial effect of L007-0069 on S.epidermidis was studied using a mouse skin abscess model. Results: L007-0069 exhibited a minimum inhibitory concentration(MIC) and minimum bactericidal concentration of 4 μg·mL-1 against S.epidermidis strains RP62A and ATCC 12228, and also showed significant antimicrobial activity against clinical isolates. L007-0069 demonstrated time- and concentration-dependent bactericidal activity. Disk diffusion assays indicated that 80 μg of L007-0069 produced a significant inhibition zone compared to the untreated group [(0.000±0.000) vs (9.267±1.201) mm; q=16.631, P<0.000 1], and the diameter of the inhibition zone increased with higher concentrations of L007-0069. When combined with gentamicin, L007-0069 exhibited synergistic antibacterial activity against S.epidermidis with the fractional inhibitory concentration index of 0.5. At a concentration of 4 μg·mL-1, L007-0069 significantly inhibited S.epidermidis biofilm formation, reducing the absorbance at 570 nm(A570) from (0.896±0.167) to (0.049±0.019)(q=5.551, P=0.000 4). At 4 μg·mL-1, L007-0069 also be effectively destroyed formed biofilms, reducing A570nm from (1.367±0.198) to (0.237±0.072)(q=10.03, P<0.000 1). Confocal laser scanning microscopy revealed that L007-0069 significantly disrupted the three-dimensional structure of the biofilm and significantly reduced the total biofilm. DiSC3(5) assays showed a significant increase in bacterial membrane potential. Similarly, SYTOX Green assays showed that 1/2×MIC of L007-0069 significantly increased SYTOX Green fluorescence intensity in a concentration-dependent manner, further confirming its membrane-disruptive activity. The in vivo animal model indicates that L007-0069 significantly reduced the viable bacterial load in the abscess tissue and decreased the infiltration of inflammatory cells. Conclusion: L007-0069 exerts antibacterial effects both in vitro and in vivo by damaging the cell membranes of S.epidermidis. It is expected to become a potential alternative therapeutic drug for infections related to S.epidermidis biofilm.
  • Comparison of dissolution profiles of carbamazepine tablets by paddle method and flow-through cell method and study on in vitro-in vivo correlation
    WU Bin, ZHU Xiao-yue, ZHU Xue-bin, ZHANG Shu-dong, HU Qin, WANG Lin, WU Zhao-wei
    Chinese Journal of New Drugs. 2026, 35(5): 521-529. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.012
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    Objective: Carbamazepine is a BCS Class II drug with a narrow therapeutic window, for which dissolution is the rate-limiting step for absorption. However, the current dissolution testing method has several limitations, including inconsistent rotational speeds (e.g., 150 r·min－1 for the 0.2 g strength), single-point quality control (where a two-point method is more appropriate for narrow therapeutic window drugs), and a lack of in vitro-in vivo correlation (IVIVC). Therefore, it is necessary to establish an IVIVC-based dissolution method to guide generic drug bioequivalence evaluation. Methods: The paddle and flow-through cell methods were used to determine the dissolution profiles of reference products (Novartis Beijing, 0.2 g and Sun Pharma Japan, 0.1 g) in five different media. GastroPlus modeling was employed to identify the dissolution conditions with the best IVIVC. These optimized conditions were then applied to evaluate the dissolution behaviors of 9 generic products. Results: The optimal dissolution conditions for both paddle and flow-through cell methods with the highest IVIVC were identified. Both methods effectively discriminated between products from different manufacturers, and the flow-through cell method demonstrated superior sensitivity in detecting intrinsic quality differences between generic and reference products. Conclusion: It is recommended to revise the current dissolution standard for carbamazepine tablets by replacing the paddle method with the flow-through cell method and implementing a two-point quality control approach.
  • Comparative assessment of potential risks associated with variable fill volumes in biopharmaceutical glass injection vials
    LI Xiao-yu, QI Yan-fei, YUAN Shu-sheng, ZHAO Xia
    Chinese Journal of New Drugs. 2026, 35(5): 530-537. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.013
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    Objective: This study, focusing on the field of biopharmaceuticals, aims to investigate the impact of fill volume variation in commonly used small-volume glass injection vials on drug compatibility. Methods: Four types of 2 mL glass injection vials were selected and filled with simulated solutions at different volumes. The migration levels of primary glass constituent elements into the solutions and the erosion of the vials were analyzed. Results: As the fill volume decreased, the migration of glass elements increased to varying degrees across all vial types. Significant inner surface erosion was observed in tubular borosilicate glass vials, with a notable correlation to reduced fill volume. In contrast, molded middle borosilicate glass vials and aluminosilicate glass tubing vials exhibited no visible erosion, maintaining consistent performance across fill volumes. Conclusion: Low fill volumes in pharmaceutical products increase exposure to the “susceptible regions” of tubular borosilicate glass vials. In contrast, molded borosilicate glass vials and aluminosilicate glass vials lack such vulnerable areas. Therefore, comprehensive compatibility studies should be conducted when selecting glass vial packaging or adjusting fill volumes for injectable formulations.
  • Clinical application expert consensus on Compound Phellodendron Liquid Coating for vaginitis and perineum wound infection (2025 edition)
    LI Jun, MEN Ao-xue, XUE Xiao-ou
    Chinese Journal of New Drugs. 2026, 35(5): 538-545. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.014
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    Compound Phellodendron Liquid Coating has been clinically available since its launch in 1995. With multiple pharmacological properties including anti-inflammatory activity, tissue repair promotion, and immune regulation, it has demonstrated favorable clinical efficacy in the management of various gynecological vaginal inflammations and perineal wound infections. To further standardize its clinical application in the treatment of vaginitis and perineal wound infections, our academic society has convened experts from relevant fields to formulate this guideline consensus. By integrating evidence-based research findings with the rich clinical experience of experts, this consensus aims to address 13 key clinical issues, including the clinical efficacy profile, optimal administration methods, and dosage regimens of Compound Phellodendron Liquid Coating in the treatment of vaginitis and perineal wound infections.
  • Efficacy and safety of baloxavir and oseltamivir for children with influenza: a Meta-analysis
    ZENG Yuan-yuan, LI Wen-jing
    Chinese Journal of New Drugs. 2026, 35(5): 546-551. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.015
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    Objective: To investigate the safety and efficacy of baloxavir marboxil versus oseltamivir in children treated for influenza. Methods: Databases including PubMed, The Cochrane Library, Embase, CNKI, WanFang Data and VIP were searched to collect cohort studies on the use of baloxavir marboxil and oseltamivir in children with influenza. This Meta-analysis was conducted using RevMan 5.4 software. Results: A total of 6 cohort studies involving 2 395 children were included. The result of the Meta-analysis showed that baloxavir marboxil group had a significantly shorter duration of fever (95%CI: [-29.03~-6.69], P=0.002) and the duration of symptoms (95%CI: [-20.55~-3.74], P=0.005) compared to the oseltamivir group. Additionally, the incidence of total adverse events (95%CI: [0.2~0.5], P<0.000 01) and the incidence of gastrointestinal adverse reactions (95%CI: [0.17~0.52], P<0.000 1） were significantly lower in the baloxavir marboxil group. Conclusion: Current evidence suggests that baloxavir marboxil may offer superior efficacy and a better safety profile compared to oseltamivir for treating influenza in children. However, further support from long-term large-scale clinical data on children is still needed.
  • To investigate and analyze the signal of semaglutide adverse events based on the FAERS database in the United States
    LI Zhe, FU Yang
    Chinese Journal of New Drugs. 2026, 35(5): 552-560. https://doi.org/10.20251/j.cnki.1003-3734.2026.05.016
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    Objective: To explore the adverse event signals of semaglutide after its marketing and provide references for clinical safe medication. Methods: The reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and multi-item gamma poisson shrinker (MGPS) methods were used to mine the adverse event data of semaglutide in the Adverse Event Reporting System (FAERS) of the US Food and Drug Administration (FDA) from the first quarter of 2004 to the second quarter of 2024. The adverse event signals of various injuries, poisonings, and operative complications were screened and comparatively analyzed. Results: A total of 17 947 720 background patients (with 53 352 754 adverse event occurrences) and 28 747 patients in the target drug group (with 82 931 adverse event occurrences) were included. A total of 430 positive signals of semaglutide were identified, involving 27 system organ classes (SOCs), mainly concentrated in gastrointestinal system diseases, general disorders and administration site reactions, various injuries, poisonings, and operative complications, etc. Among the preferred terms (PTs) related to various injuries, poisonings, and operative complications, the top 5 in frequency ranking included off-label use, product use in unapproved indications, etc.; the top 5 in intensity ranking included failure to perform drug dose titration, product communication issues, etc. Conclusion: There are multiple potential risks in the clinical use of semaglutide, especially issues related to medication norms and products. Clinicians should standardize medication use and closely monitor adverse reactions, and pharmaceutical manufacturers and regulatory authorities need to strengthen management to ensure the safety of patients' medication.
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