ArchiveTo analyze the current supply-demand matching in prescription drug information dissemination based on supply-demand balance theory, explore public satisfaction with this dissemination, and propose improvement recommendations to enhance the effectiveness of prescription drug information dissemination.
On the supply side, in-depth interviews were conducted with eight pharmaceutical companies using the interview survey method. On the demand side, an online questionnaire survey was administered, and descriptive statistics and an analysis of fit across four dimensions-relevance, accessibility, appropriateness, and quality-applied to the results.
Pharmaceutical companies utilize multiple online and offline channels for information provision, but these are primarily limited to disease popularization. On the demand side, 560 valid questionnaires were collected, with 66.8% of respondents expressing a strong willingness to access prescription drug information. The public generally demonstrates higher demand for information on health supplements and common-disease prescription drugs, while placing greater emphasis on precautionary information such as adverse reactions and contraindications.
Current prescription drug information dissemination exhibits a supply-demand mismatch. Recommendations include establishing a mechanism to distinguish prescription drug information from advertising, enhancing public education on prescription drug science popularization, and strengthening regulatory oversight over prescription drug information on new media platforms to promote supply-demand balance.
Trastuzumab Deruxtecan has broad application prospects in the treatment of HER2-related tumors. The analysis of patent information can facilitate the research and innovation of this class of drugs. Through patent search and literature review, the molecular patents for the trastuzumab component have expired. The related patents for the linker and the cytotoxic drug remain valid. All the related patents of trastuzumab deruxtecan are valid, and its patent layout structure is reasonable. A progressive application strategy of "structure-process-indication-combination therapy" has been adopted to continuously extend the patent life. From the perspective of patent analysis, this provides new drug research pathways for innovative entities. First, make full use of the antibody drugs whose patent terms have expired; second, retain the GGFG tetrapeptide in the linker and substantially improve the molecular structure of other parts. Taking trastuzumab rezetecan as an example, through creative structural modifications, this strategy is expected to break through the patent barriers of trastuzumab deruxtecan.
China's drug patent term compensation system has officially been implemented, but numerous hot-button issues remain unresolved in practice. This paper delves into several key problems through specific case studies, offering reflections and recommendations on corporate patent strategy and term compensation application approaches. It begins by introducing the legal origins of the drug patent term compensation system, including practices in countries such as the United States, Japan, and Europe. Then, it elaborates on the legal framework of China's system regarding scope of application, compensation duration, calculation methods, and eligibility criteria. Subsequently, it focuses on analyzing practical operational challenges in China, such as the definition of "new drugs", the meaning of "one drug", whether claims encompass new drug technical solutions, and protection scope limitations, while proposing corresponding solutions. Finally, based on legal significance, it provides enterprises with multiple patent strategy recommendations and adjustments to new drug application strategies, aiming to help them better safeguard their rights under the drug patent term compensation system.
This article aims to provide a reference for the dynamic regulatory oversight of clinical trials of stem cell drugs and the enhancement of pharmacovigilance practices.
Using data from the Drug Clinical Trial Registration and Information Disclosure Platform and the Pharmacovigilance Database of the Center for Drug Evaluation of the National Medical Products Administration, we conducted a retrospective analysis of the progress of domestic registered clinical trials for stem cell drugs and of individual case safety reports on suspected unexpected serious adverse reactions (SUSAR).
As of June 30, 2025, a total of 134 Investigational New Drug (IND) applications for stem cell drugs have been approved in China, and 113 registered clinical trials are recorded on the registration platform. From January 2021 to June 2025, a total of 29 domestic SUSAR reports were received, with adverse reactions mainly involving systemic disorders and administration site reactions, as well as respiratory disorders.
Registered clinical trials of stem cell drugs in China have shown a steady development trend in recent years. Sustained attention must be paid to the long-term potential safety risks of stem cells to safeguard the safety of clinical trials.
To systematically explore the antidepressant multi-target mechanism of Shenge Bushen Capsules, and evaluate its direct effect on dopamine (DA) and norepinephrine (NE) system, as well as the inhibition of monoamine oxidase A (MAO-A) activity and the protective effect on glucose-deficient and hypoxic neurons.
The effects of yohimbine on DA and NE systems were evaluated by apomorphine-induced mouse stereotyped behavior model and yohimbine-enhanced toxicity test, respectively. Its effect on MAO-A activity in mouse brain was studied by in vitro fluorescence assay. The model of oxygen-glucose deprivation injury was established by primary cultured mouse cortical neurons, and the neuroprotective activity was evaluated by detecting the leakage rate of lactate dehydrogenase (LDH).
Shenge Bushen Capsules had no significant effect on apomorphine-induced stereotyped behavior and did not enhance the lethal toxicity of yohimbine. In vitro experiments showed that the drug had a significant inhibitory effect on MAO-A at a concentration of 4×10-4 g·mL-1. In the neuroprotective experiment, Shenge Bushen Capsules could significantly reduce the LDH leakage rate of glucose-deficient hypoxic neurons at a low concentration of 10×10-6 g·mL-1 in a concentration-dependent manner.
The antidepressant effect of Shenge Bushen Capsules is not achieved by directly regulating the DA or NE system. The mechanism is related to the inhibition of MAO-A activity to reduce the degradation of monoamine neurotransmitters and the direct protection of neurons from damage.
Early screening and precise treatment of malignant tumors are critical for reducing mortality rates. Nanotechnology, owing to its tunable physicochemical properties and biocompatibility, has shown significant potential in the field of tumor diagnosis and therapy. This review systematically summarizes the innovative applications of nanotechnology, with a focus on its advancements in two key areas: tumor screening and targeted therapy. In terms of tumor screening, nanoprobes have markedly enhanced the sensitivity and specificity of detecting circulating tumor cells, exosomes, and tumor biomarkers, thereby promoting the development of multimodal imaging and liquid biopsy. In the realm of targeted therapy, nanocarriers achieve precise drug delivery via passive or active targeting strategies, while intelligent responsive systems further promote the development of theranostic integration. This review also analyzes existing challenges in clinical translation, including safety and standardized manufacturing, and provides perspectives on future directions involving the integration of nanotechnology with cutting-edge fields such as artificial intelligence and immunotherapy.
Ovarian cancer (OVCA) is a gynecological malignancy that poses a serious threat to women's health and life. Despite significant advances in modern medicine and surgery in recent years, the five-year survival rates for patients with stages Ⅲ and Ⅳ OVCA are only 27% and 13%, respectively. Tumor-infiltrating lymphocytes (TILs) are a type of immune cell that infiltrate the tumor parenchyma or stroma. Compared to non-tumor-infiltrating lymphocytes, TILs exhibit a stronger ability for antitumor immune responses. TIL therapy is an innovative cell-based treatment in which the therapeutic preparation is derived from the selection and expansion of autologous TILs obtained from the patient's own tumor tissue, offering potent antitumor activity and low off-target toxicity. Studies have shown that extensive TIL infiltration is associated with improved prognosis in OVCA patients after clinical treatment, and early-phase clinical trials have also demonstrated the feasibility of TIL therapy for OVCA. This review focuses on key TILs within the ovarian tumor microenvironment, the clinical translation of TIL therapy, and the potential challenges and optimization strategies for its clinical application, aiming to provide a scientific reference for TIL-based treatment of OVCA.
Brensocatib is a highly selective, reversible and competitive inhibitor of dipeptidyl peptidase 1 (DPP1), approved on August 12, 2025, for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) in adults and adolescents aged 12 years and older, marking a significant advancement in this therapeutic area. By inhibiting DPP1, it reduces activation of neutrophil serine proteases, thereby effectively attenuating neutrophil-mediated inflammation and tissue damage. Clinical studies have shown that brensocatib significantly reduces the annualized rate of pulmonary exacerbations, decreases the proportion of patients experiencing exacerbations, prolongs the time to first exacerbation, and demonstrates a favorable tolerability profile in patients with NCFBE. This article provides a comprehensive review of brensocatib's mechanism of action, pharmacodynamics, pharmacokinetics, drug interactions, safety assessment, clinical studies, adverse reactions and precautions, use in special populations, and preclinical research in other diseases, to ensure medication safety.
To analyze the current situation and causes of protocol violations in pediatric drug clinical trials, develop strategies to prevent and reduce them, and provide a reference for standardized implementation of pediatric drug clinical trials.
Cases of protocol violations in pediatric drug clinical trials at a Grade Ⅲ Level A specialized women and children's hospital from January 2022 to June 2025 were collected. A retrospective analysis of the types of protocol violations, responsible entities, and specific causes was performed, and targeted improvement measures were formulated accordingly.
Across 24 pediatric drug clinical trials, a total of 186 occurrences of protocol violations were recorded. The primary types included sample-related violations, visit-related violations, medication-related violations, and examination/test-related violations. When classified by the responsible entity and ranked by frequency of occurrence, the order was: subjects/guardians, investigators, clinical research coordinators, sponsors, and other factors.
Throughout the entire process of pediatric drug clinical trials, continuous summary and optimization work should be carried out, and corresponding strategies should be formulated for each responsible entity to effectively reduce the incidence of protocol violations, thereby providing practical reference for improving the quality of pediatric clinical trials.
To investigate the clinical efficacy of Longmu Ningxin Formula (LMNXF) in treating children with attention deficit hyperactivity disorder (ADHD) and to explore its potential mechanism of action through animal experiments and proteomics.
A total of 80 children with ADHD were randomly divided into a western medicine group (n=40) and a Chinese medicine group (n=40). The western medicine group was treated with methylphenidate hydrochloride extended-release tablets (MPH), while the Chinese medicine group received LMNXF. The treatment lasted for 12 weeks. The scores of the Swanson, Nolan, and Pelham-Ⅳ Rating Scale (SNAP-Ⅳ, parent version), the Weiss Functional Impairment Rating Scale (WFIRS, parent version), the Conners' Parent Rating Scale (CPRS), and the Chinese medicine syndrome scores were compared between the two groups before and after treatment. Safety was also evaluated. For the animal experiment, the spontaneously hypertensive rat (SHR), a classic ADHD model, was used. A total of 18 4-week-old male SHRs were randomly divided into a model group, a Chinese medicine group, and a western medicine group. A total of 6 Wistar-Kyoto rats served as the control group. The Chinese medicine group received LMNXF at 38.00 g·kg-1·d-1, the western medicine group received MPH at 4.22 mg·kg-1·d-1, and the control and model groups were administered an equal volume of saline by gavage. Treatment lasted for 4 weeks. Behavioral tests were conducted to assess the rats' performance. After the experiment, prefrontal cortex tissues were collected for quantitative proteomic analysis, and Western Blot analysis was performed to validate differentially expressed proteins.
After treatment, the scores of the SNAP-Ⅳ, WFIRS, CPRS, and the primary and secondary Chinese medicine syndrome scores in the Chinese medicine group were significantly decreased compared to those before treatment (all P<0.001). The improvements in the WFIRS and CPRS scores and the Chinese medicine syndrome scores in the Chinese medicine group were greater than those in the western medicine group (all P<0.05). No serious adverse reactions related to the study drugs were observed in any child during the treatment period. LMNXF significantly ameliorated hyperactivity/impulsivity and spatial learning/memory deficits in SHRs (all P<0.05). Proteomic analysis of the prefrontal cortex identified 273 differentially expressed proteins between the model group and the Chinese medicine group. These proteins were primarily involved in seven pathways, including the NOD-like receptor signaling pathway, FoxO signaling pathway, and intestinal immune network for IgA production. Western Blot results showed that LMNXF reversed the upregulation of Ripk2, Tab1, and IL-6 in the prefrontal cortex of SHRs.
LMNXF demonstrates favorable efficacy and a high safety profile in treating children with ADHD. Its mechanism of action may involve modulating Ripk2, Tab1, and IL-6 expression in the prefrontal cortex, thereby inhibiting NOD-like receptor signaling pathway-mediated neuroinflammation.
To optimize the extraction and formulation processes for paediatric appetite-enhancing Gel (PAG).
The content of forsythoside, dry extract yield, and total flavonoid content in PAG were used as evaluation indicators. The analytic hierarchy process (AHP) combined with the criteria importance through intercriteria correlation (CRITIC) method was employed to calculate the comprehensive weighting coefficients for each indicator. The factors considered were water-to-raw-material ratio, extraction time, and extraction number. A multi-indicator comprehensive scoring method combined with the Box-Behnken design-response surface methodology (BBD-RSM) was used to design the experiment, aiming to determine the optimal water extraction process for PAG. The formulation process of PAG was optimized based on evaluation criteria including appearance and adhesiveness.
The optimal process for PAG was determined to be a water-to-raw-material ratio of 10-fold, extraction for 1.5 h, and three extraction cycles. Validation experiments confirmed that the extraction process for PAG is stable and feasible. The optimal formulation process for PAG was determined to be: carrageenan∶barley β-glucan∶sucrose∶water (2 g∶1 g∶1 g∶30 mL).
Based on the quality-by-design principle, the extraction process for PAG was optimized through a combined approach of multi-criteria evaluation and the Box-Behnken response surface methodology. Subsequently, the formulation process for the gel was refined using evaluation criteria such as appearance and adhesiveness. This study provides reference data for the modern extraction research on this formulation and for the development of pediatric preparations.
To develop an extemporaneous oral vehicle suitable for dose-splitting administration in special populations and to evaluate its clinical feasibility.
Based on analysis of reference product and formulation screening, an oral vehicle was prepared and evaluated for critical quality attributes (CQAs) and stability. Using spironolactone tablets as a model drug, the solubility, content stability, and dispersion uniformity of the drug in the vehicle were investigated. A preliminary subjective assessment of palatability was also performed.
The prepared vehicle met the specifications for appearance, pH, relative density, preservative content, and microbial limits. It remained stable under accelerated and long-term storage conditions, enabling a 24-month shelf life for routine stocking in medical institutions. Spironolactone was uniformly dispersed in the vehicle and remained physicochemically stable for 60 days, with drug content maintained above 90% and a dispersion uniformity relative standard deviation (RSD=1.29%). Subjective palatability evaluation showed improved palatability.
The developed oral vehicle demonstrates robust control of critical quality attributes and system stability, enabling the model drug to maintain uniform dispersion and physicochemical stability during dose-splitting compounding. It holds promise for providing a feasible approach for individualized dose-splitting administration in special populations.
To compare the cost-effectiveness of recombinant human follicle-stimulating hormone alfa (follitropin alfa, GONAL-f®) versus other recombinant human follicle-stimulating hormone injections (Jinsaheng®, Fangleshu®, and Anxinbao®) for controlled ovarian stimulation (COS) in infertile women undergoing assisted reproductive technology (ART).
A decision tree model was developed, simulating the treatment pathway of patients undergoing one ART cycle including one fresh embryo transfer cycle and three frozen embryo transfer cycles following a single COS treatment. Clinical parameters were derived from three independent randomized controlled trials and expert interviews. Drug utilization data for cost parameters came from the same trials, while drug prices were sourced from Yaozh.com. Costs of other medical services were obtained from provincial/city medical price lists and expert opinions. The base-case analysis used cumulative live birth rate (CLBR) as the effectiveness measure to calculate the incremental cost-effectiveness ratio (ICER). The robustness of the results was tested through one-way sensitivity analysis and probabilistic sensitivity analysis (PSA).
Although the total cost of the GONAL-f strategy was higher than that of Jinsaheng, Anxinbao, and Fangleshu (incremental cost: ￥1 219.44, ￥643.19, and ￥250.61, respectively), it also yielded higher CLBRs (incremental CLBRs: 3.91%, 3.13%, and 3.84%, respectively). The average cost per live birth was ￥44 238.72 vs ￥44 844.00 (GONAL-f vs Jinsaheng), ￥52 701.11 vs ￥54 096.63 (GONAL-f vs Anxinbao), and ￥44 028.08 vs ￥45 775.20 (GONAL-f vs Fangleshu). The corresponding ICERs were ￥31 174.32, ￥13 795.07, and ￥6 530.83 per additional live birth, respectively. Sensitivity analyses supported the base-case findings. In the PSA, as the willingness-to-pay (WTP) threshold increased to over ￥100 000, the probability of GONAL-f being cost-effective stabilized at approximately 92.9%, 69.9%, and 81.9% compared to Jinsaheng, Anxinbao, and Fangleshu, respectively. At a WTP of ￥35 000, these probabilities were 58.0%, 71.9%, and 77.8%, respectively.
This study indicates that for COS in ART, GONAL-f incurs higher costs but also achieves higher CLBRs compared to Jinsaheng, Anxinbao, and Fangleshu. GONAL-f is the more cost-effective option when the WTP exceeds ￥31 174.32 per additional live birth.
From the perspective of the Chinese healthcare system, to evaluate the cost-effectiveness of enfortumab vedotin and pembrolizumab in the treatment of advanced urothelial carcinoma.
A dynamic Markov model was constructed based on data from the EV-302 trial, and cost-utility analysis (CUA) was used for economic evaluation. Deterministic (one-way) sensitivity analysis and probabilistic sensitivity analysis (PSA) were conducted on main parameters to verify the robustness of the base-case analysis results.
The analysis showed that for every additional quality-adjusted life year (QALY) in the enfortumab vedotin plus pembrolizumab group compared to the standard chemotherapy group, an additional cost of 2 358 823.11 yuan was required. The results of the deterministic sensitivity analysis showed that the most influential factors on incremental cost-effectiveness ratio (ICER) were the utility value of the progression-free state and the cost of enfortumab vedotin. The probabilistic sensitivity analysis results indicated that the combination of enfortumab vedotin and pembrolizumab was not cost-effective at a willingness-to-pay threshold equivalent to three times China's 2024 per capita GDP.
The combination of enfortumab vedotin and pembrolizumab does not represent a cost-effectiveness strategy compared with the standard chemotherapy group in the treatment of advanced urothelial carcinoma.
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