Lipid-based nanodelivery drug systems
[Journal Article]ZHANG Zui, DING Tian-hao, JIANG Kuan et al.-Chinese Journal of New Drugs2026, No.03

Abstract:Lipid-based nanodelivery drug systems,which emerged in the 1990s,constitute a novel class of drug delivery platforms,primarily including liposomes,lipid nanoparticles,micelles,and nucleic acid-lipid complexes.These systems have demonstrated significant clinical potential in diverse therapeutic areas,including oncology,infectious diseases,vaccine development,and gene therapy,with particularly promising prospects in nucleic acid drug delivery.This review systematically elaborates on the definition and classification of lipid-based nanodrug delivery systems,outlines the current developmental status of both marketed and investigational drugs,discusses their technological advantages and challenges,and presents an outlook on future research directions.Overall,lipid-based nanodelivery systems exhibit substantial potential in the field of drug delivery.Future research should focus on enhancing targeted delivery efficiency,improving safety profiles,and promoting combination therapy strategies to achieve more precise and effective applications in the treatment of various diseases.

Signal mining and analysis of adverse drug events of azilsartan based on FAERS and JADER database
[Journal Article]CHEN Qing-yu, MA Yin-ling, ZHAO Jian-qun et al.-Chinese Journal of New Drugs2026, No.04

Abstract:Objective:To provide clinical safety supports for azilsartan through mining its potential adverse drug reaction signals based on the FDA Adverse Event Reporting System(FAERS)and Japanese Adverse Drug Event Report(JADER)database.Methods:The adverse drug reaction(ADR)reports were collected by retrieving the FAERS database from the first quarter of 2011 to the third quarter of 2024 and the JADER database from the second quarter of 2012 to the third quarter of 2024,and then classified and described by using the system organ class(SOC)and preferred term(PT)of the Medical Dictionary for Regulatory Activities.The suspicious positive signals were mined and analyzed by the method of reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results:A total of 1660 ADR reports with azilsartan as the primary suspected drug were retrieved,including 753 cases from the FAERS database and 907 cases from the JADER database.After second screening of the data,a total of 312 ADR reports were obtained from the FAERS database,including 32 positive PT signals,involving 10 SOC.A total of 291 ADR reports were obtained from the JADER database,including 29 positive PT signals,involving 12 SOC.PT with high frequency includes hypotension,hyperkalemia,and renal dysfunction,and PT with high signal intensity includes hyperkalemia,pulmonary infarction,abnormal skin odor,and oral inflammatory diarrhea like bowel disease.New adverse reaction effects were discovered,including pulmonary infarction,hyponatremia,and hypoglycemia.Conclusion:In the clinical application of azilsartan,clinicians should be alert to electrolyte imbalance caused by long-term medication,such as hyperkalemia and hyponatremia,and regularly monitor ADR such as blood pressure,blood glucose,renal function damage,and pulmonary infarction,in order to optimize the safety of clinical medication.

Recent advances in biorhythm-mimicking drug delivery and release systems
[Journal Article]ZHOU Miao-miao, YOU Jia-huan, XU Ning-yu et al.-Chinese Journal of New Drugs2026, No.03

Abstract:Biorhythms,originating from the adaptive evolution of organisms to their natural environments,are ubiquitously observed across living systems on Earth.These rhythms play a crucial role in regulating various behavioral and physiological processes such as sleep,body temperature,blood pressure and hormone secretion.Rhythm disorders can negatively impact daily work,study and overall quality of life,and are related to an increase of the risk of various diseases.Conditions including hypertension,asthma,rheumatoid arthritis,and cancer,exhibit significant rhythmicity in their manifestations.Consequently,aligning drug administration strategies with these biological rhythms to maximize therapeutic efficacy has become a prominent focus in current research.Biorhythm-mimicking drug delivery precisely controls the release time and dosage of drugs to simulate the internal hormone secretion or gene expression rhythms of the body.For diseases with periodic fluctuations in symptoms or severity,such delivery systems can improve therapeutic outcomes and enhance compliance of patients.This review focuses on the recent advances in biorhythm-mimicking drug delivery and release systems and their applications in metabolic diseases,cancer,autoimmune diseases and neurological disorders.The potential challenges and future prospects are also discussed.

Interpretation of the expert consensus for clinical application of Danshu Capsules
[Journal Article]ZHANG Yang-yang, LI Bo, MAO Yi-qing et al.-Chinese Journal of New Drugs2026, No.04

Abstract:The expert consensus for clinical application of Danshu Capsules was established by Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University and Beijing Institute of Traditional Chinese Medicine.Forty-three experts in gastroenterology,clinical methodology,and pharmacology from 38 Chinese medicine hospitals and integrated Chinese and Western medicine hospitals participated in this consensus.The consensus standardizes the indications of Danshu Capsules in Western medicine as chronic calculous cholecystitis,chronic cholecystitis,and cholelithiasis.In traditional Chinese medicine(TCM),the syndrome indications are the syndrome of qi stagnation in liver and gallbladder and the syndrome of dampness and heat in the liver and gallbladder.The consensus highlights the medication's efficacy in alleviating abdominal pain,biliary dyspepsia symptoms,and enhancing gallbladder imaging findings.It also outlines specific treatment durations for various therapeutic objectives,including criteria for re-examination and discontinuation in litholytic therapy.Additionally,it assesses the long-term safety and adverse reactions associated with Danshu Capsules and systematically reviews its efficacy in managing acute cholecystitis,postcholecystectomy syndrome,irritable bowel syndrome,and bile reflux gastritis.This article aims to analyze the key aspects of the consensus comprehensively and facilitate the understanding and clinical utilization of Danshu Capsules by clinicians and pharmacists.It will enhance the safety of Chinese patent medicine and suggest potential avenues for future research on Danshu Capsules.

Research progress of nano drug delivery system in the treatment of cholangiocarcinoma
[Journal Article]HUANG Yan-qiu, CHEN Hai-yan, QIU Wei-an et al.-Chinese Journal of New Drugs2026, No.03

Abstract:Cholangiocarcinoma(CCA)is an aggressive epithelial-derived malignant tumor originating from the biliary system.The incidence of CCA has been easing significantly,while patient prognosis remains poor,with a 5-year survival rate of less than 20%.Traditional chemotherapy demonstrates limited efficacy,highlighting the urgent need for novel therapeutic strategies.Nanodrug delivery systems,as multifunctional carriers constructed using emerging drug delivery technologies,offer advantages such as improved drug efficacy,enhanced targeting,and increased safety.These systems effectively overcome the limitations of traditional therapies,introduce innovative momentum in the field of cholangiocarcinoma treatment.This article reviews the applications of different nanocarriers in the treatment of cholangiocarcinoma in the past 10 years,including liposomes,polymer nanoparticles,nanopolymer micelles,nanovesicles,and inorganic nanoparticles.It also explores the use of nanocarrier-mediated drug delivery systems in photodynamic therapy,hyperthermia,immunotherapy,gene/drug combination therapy,and bioinspired integrated nanotherapy.Furthermore,the mechanisms,advantages,and limitations of different nano drug delivery systems are analyzed,along with a discussion of current technological challenges and future directions.This review aims to provide theoretical insights for the design of nanodrug delivery systems and their potential applications in cholangiocarcinoma treatment.

The effect and mechanism of 6-hydroxygenistein in alleviating high-altitude cardiac injury via modulation of the PI3K/Akt signaling pathway
[Journal Article]XIN Yu, SHI Zhi-qun, WANG Ge-ge et al.-Chinese Journal of New Drugs2026, No.04

Abstract:Objective:To elucidate the protective mechanism of 6-hydroxygenistein(6-OHG)against high-altitude induced heart injury(HAHI).Methods:6-OHG-related targets were predicted using SwissTargetPrediction,Similarity ensemble approach,SuperPred and PharmMapper databases.HAHI-related targets were obtained from GeneCards and OMIM databases.R package was used to draw Venn diagram.STRING 11.5 software was applied for constructing the protein-protein interaction network of the intersection targets.Cytoscape 3.8.0 software was used to screen core targets.GO and KEGG enrichment analysis were performed using DAVID database.AutoDock Vina software and PyMOL 3.0.0 software were used for molecular docking and visualization.The in vivo HAHI mouse model was established and for pharmacological intervention.Hematoxylin-eosin(HE)staining was used to observe the pathological changes of myocardial tissue.Oxidative stress indexes and inflammatory factors in myocardial tissues were detected using commercial assay kits.Expression of related proteins in myocardial tissue was detected by Western blot.Results:70 overlapping targets of 6-OHG and HAHI were screened,with AKT1,HSP90AA1,ACE and HMOX1 regarded as core targets.Molecular docking results showed strong binding affinities between 6-OHG and these core proteins.GO functional enrichment analysis and KEGG pathway enrichment analysis indicated that the regulation of oxidative stress and inflammatory response through the PI3K/Akt signaling pathway may play an important role in 6-OHG treatment of HAHI.In vivo animal experiments showed that high-altitude hypoxia exposure could induce pathological changes of myocardial tissue in mice,increase the levels of creatine kinase(CK),lactate dehydrogenase(LDH),lactic acid(LD),malondialdehyde(MDA),hydrogen peroxide(H2O2)and pro-inflammatory factors interleukin-1β(IL-1β)and tumor necrosis factor-α(TNF-α),decrease the levels of glutathione(GSH),superoxide dismutase(SOD)and anti-inflammatory factor interleukin-10(IL-10),down-regulate the ratio of p-PI3K/PI3K and p-Akt/Akt in mouse myocardial tissue.6-OHG pretreatment could significantly reverse these changes.Conclusion:6-OHG alleviates oxidative stress and inflammatory response induced by high-altitude hypoxia exposure by activating PI3K/Akt signaling pathway,thereby alleviating HAHI.

Artificial intelligence reshaping lipid nanoparticle-mediated nucleic acid delivery
[Journal Article]HUANG Jun-ming, LI Yi-kun, YANG Bo-wen et al.-Chinese Journal of New Drugs2026, No.03

Abstract:Harnessing its powerful capabilities in data processing and intelligent decision-making,artificial intelligence(AI)has shown significant advantages and promising potential in advancing the development of nucleic acid delivery systems.This article provides a systematic review of how AI technologies are reshaping the research and development of lipid nanoparticles(LNPs),the leading nucleic acid delivery platform,detailing recent progress and breakthroughs in molecular design,targeted delivery,and prediction of in vitro and in vivo performance.Strategies for AI-enabled clinical translation are highlighted,including multimodal data-guided tissue-specific delivery,closed-loop"design-experiment-feedback"optimization via automation,and digital twin-based cross-species prediction.The article also examines current challenges in AI-driven LNP development,such as data quality and model interpretability,and looks forward to next-generation AI technologies that integrate causal inference and physics-informed modeling to achieve"designable,predictable,and verifiable"LNPs,offering valuable insights for nucleic acid drug delivery.

Analysis and standardization strategies of serious adverse event reports in pediatric drug clinical trials
[Journal Article]GUO Chun-yan, ZHANG Yi, YANG Yu-xin et al.-Chinese Journal of New Drugs2026, No.07

Abstract:Objective:To analyze the issues in the reporting of serious adverse events(SAEs)in pediatric drug clinical trials,propose standardized reporting strategies,ensure the safety and legitimate rights and interests of pediatric research participants,and improve the pharmacovigilance system for pediatric clinical trials.Methods:An analysis was conducted on 136 SAEs reported to the medical ethics committee of our hospital from our hospital between January 1,2015 and April 30,2025.The analysis covered the gender and age of affected children,medical specialities involved,types of drugs,patterns of SAE occurrence,causal relationship with the study drug,reporting issues,and whether they were judged as suspected unexpected serious adverse reactions(SUSARs).Results:Among the 136 SAEs,the pediatric hematology specialty had the highest number of cases(35 cases);the number of male cases(77 cases)was higher than that of female cases(59 cases),and most occurred during childhood(86 cases);among the drug types,therapeutic biological products had the highest number of cases(76 cases);the most significant impact on research participants was the requirement for hospitalization(124 cases);the number of cases where SAEs were"definitely unrelated"to the trial drug was the highest(47 cases),and the most significant impact on clinical trials was"no change in dose,continue medication"(76 cases);13 cases were judged as SUSARs.Conclusion:It is necessary to establish a standardized reporting and handling system for SAEs in pediatric drug clinical trials,to develop SAE reporting forms suitable for children,and to attach great importance to the assessment of children's specific conditions.Sponsors,researchers,and ethics committees must fully understand the differences in SAE spectra between children and adults,strengthen safety monitoring,and maximize the protection of the rights and safety of pediatric subjects.

Exploring the therapeutic effects and underlying mechanisms of Tibetan medicine Xiaoboyuganzi decoction on type 2 diabetes mellitus via network pharmacology
[Journal Article]TIAN Mei-gui, ZONG Yi, PENG Jia-yan et al.-Chinese Journal of New Drugs2026, No.07

Abstract:Objective:To investigate the potential active ingredients and mechanism of action of Xiaobo Yuganzi Ddecoction in the treatment of type 2 diabetes mellitus(T2DM).Methods:UPLC-Q-Exactive Orbitrap MS was employed to characterize the chemical constituents of Xiaobo Yuganzi Decoction.Potential targets of these chemical constituents and known T2DM-related targets were retrieved from public databases,and their overlapping targets were identified.A protein-protein interaction network was constructed to screen for core targets,followed by gene ontology(GO)and Kyoto encyclopedia of genes and genomes(KEGG)pathway enrichment analysis.Cytoscape 3.9.1 software was utilized to construct a'drug-constituent-target-pathway'network,and molecular docking was performed between chemical constituents and key targets to screen for potential active ingredients.Western blotting was employed to investigate the effects of Xiaobo Yuganzi Decoction on the expression levels of proteins related to the PI3K/AKT pathway in HepG2 cells.Results:A total of 39 chemical constituents were identified in Xiaobo Yuganzi Decoction,and 443 intersecting targets were obtained.These targets were primarily involved in biological processes such as protein phosphorylation.Molecular docking results indicated that jatrorrhizine,berberine,ellagic acid,bufotenidine,bufotenine,and palmatine exhibited good binding affinities to key protein receptors.Compared with the model group,Xiaobo Yuganzi Decoction significantly upregulated the expression of p-PI3K/PI3K and p-AKT/AKT proteins in HepG2 cells(P<0.05),consistent with the predictions from network pharmacology.Conclusion:Potential active ingredients in Xiaobo Yuganzi Decoction,such as jatrorrhizine and ellagic acid,may target core proteins including SRC,HSP90AA1,and STAT3,thereby modulating the PI3K/AKT signaling pathway to exert therapeutic effects on T2DM.

Bibliometric analysis of AI technologies applied in drug clinical trials:perspectives from global and Chinese research domains
[Journal Article]XIONG Xue-mei, GU Jin, HU Chen-xi et al.-Chinese Journal of New Drugs2026, No.07

Abstract:Objective:To analyze the current status,hotspots,and trends of artificial intelligence(AI)technologies applied in the field of drug clinical trials,providing a reference for the application of AI technologies in this domain.Methods:A visual analysis of literature on AI applications in drug clinical trials was conducted using CiteSpace across Chinese databases(CNKI and Wanfang)and the English database(Web of Science).Results:A total of 135 Chinese and 122 English publications were included.The volume of Chinese publications on AI technologies in drug clinical trials exhibited fluctuating growth,while international English publications demonstrated steady and rapid growth.The institution with the highest number of domestic publications was the China National Medical Products Administration,while internationally,it was Harvard University.Collaborative networks among researchers were relatively decentralized both domestically and internationally.Domestic collaborations primarily occurred among pharmaceutical companies,exhibiting a fragmented overall structure.International collaborations were concentrated among universities,with regional clusters of intensive collaboration.Keyword co-occurrence and clustering analyses revealed both commonalities and differences in AI applications between domestic and international reaserch.Currently,machine learning technologies represent a hotspot in both domestic and international research.Applications in participant recruitment are observed globally,and machine learning is leveraged for data analysis to optimize clinical trials,assess outcomes,and diagnose diseases.Domestically,AI applications focused on clinical trial data management,information system design,and implementation.Internationally,key areas included patient recruitment,disease diagnosis within trials,and biomarker prediction.Domestic research emphasized compliance in AI applications,whereas international research prioritized the refinement of AI algorithmics.Conclusion:The application of AI in drug clinical trials is evolving from foundational data processing toward complex scenario implementation.Future research may advance in areas such as standardization of data formats,data compliance,and the application of AI in complex clinical trial scenarios.

Current status and considerations on the control of ethylene glycol,diethylene glycol,and triethylene glycol impurities in pharmaceutical excipients
[Journal Article]WANG Jue, WANG Xiao-feng, ZHANG Xue-yan et al.-Chinese Journal of New Drugs2026, No.07

Abstract:This article provides an in-depth exploration of the current quality control status and regulatory developments concerning ethylene glycol,diethylene glycol,and triethylene glycol impurities in pharmaceutical excipients.Since the 1940s,global public safety incidents caused by the misuse or contamination of ethylene glycol or diethylene glycol have occurred frequently,drawing significant attention from regulatory authorities worldwide.Regulatory agencies have introduced corresponding measures to prevent the recurrence of such incidents.The article details the sources,uses,safety profiles of ethylene glycol,diethylene glycol,and triethylene glycol,as well as their respective pharmacopoeial standards and the current regulatory landscape.Testing for the presence of these three impurities in representative excipient products has revealed potential risks posed by ethylene glycol,diethylene glycol,and triethylene glycol in pharmaceutical excipients.Based on these findings,the article proposes recom-mendations for strengthening detection standards,enhancing regulatory oversight,and improving safety assessments to ensure the safety of pharmaceutical excipients and prevent similar pharmaceutical disasters.The results indicate that establishing rigorous detection methods and standards for these three impurities is crucial for ensuring the overall quality and safety of pharmaceuticals,especially in the quality control of excipients,which should be given equal importance as that of active pharmaceutical ingredients.

Research progress on the mechanism of Huisheng Oral Liquid in the auxiliary treatment of non-small cell lung cancer
[Journal Article]ZHENG Mao-dong, ZHANG Ben-chang, YAN Juan-Chinese Journal of New Drugs2026, No.05

Abstract: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.

Study and analysis of the registration characteristics of clinical trials of poly ADP ribose polymerase inhibitors based on the ClinicalTrials database
[Journal Article]YIN Gui-sen, DONG Bai-hui, SU Jia-hang et al.-Chinese Journal of New Drugs2026, No.05

Abstract: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,phaseⅡtrials were the most common(195 cases,accounting for39.96%).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 for57.58%),the United Kingdom(73 cases,accounting for14.96%),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.

Efficacy and safety of baloxavir and oseltamivir for children with influenza:a Meta-analysis
[Journal Article]ZENG Yuan-yuan, LI Wen-jing-Chinese Journal of New Drugs2026, No.05

Abstract: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.

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
[Journal Article]SUN Yan, CHENG Mei-ling, LI Zhi-xuan et al.-Chinese Journal of New Drugs2026, No.05

Abstract: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.

Clinical application expert consensus on Compound Phellodendron Liquid Coating for vaginitis and perineum wound infection(2025 edition)
[Journal Article]LI Jun, MEN Ao-xue, XUE Xiao-ou-Chinese Journal of New Drugs2026, No.05

Abstract: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.

Guideline for drug therapy of severe fever with thrombocytopenia syndrome(2025 edition)
[Journal Article]WANG Chang-tai, LI Jin-yu, XIA Guo-mei et al.-Chinese Journal of New Drugs2026, No.06

Abstract:Severe fever with thrombocytopenia syndrome(SFTS)is an acute infectious disease caused by Dabie bandavirus,with increasing incidence reported worldwide.It is clinically characterized by fever,fatigue,gastrointestinal symptoms,leukopenia,and thrombocytopenia.Severe cases often present with multiple organ dysfunction and are associated with high mortality.Currently,in some regions,physicians have limited experience in diagnosing and treating SFTS,and optimal therapeutic strategies remain under debate.Integrating the latest global evidence and clinical experience,this guideline provides a systematic overview of the etiology,epidemiology,early diagnosis,and risk stratification of SFTS,and offers evidence-based evaluations and recommendations regarding the efficacy and safety of various treatment options.It aims to enhance clinicians'ability to diagnose and treat SFTS,thereby reducing the rate of severe cases and mortality.

Key considerations in CMC research on neoantigen prediction processes
[Journal Article]DAI Yi-fei, MA Xiao-juan, LI Huan et al.-Chinese Journal of New Drugs2026, No.06

Abstract:Neoantigens,also known as tumor-specific antigens,are novel antigenic epitopes generated by unique genetic alterations in tumor cells and,are considered ideal targets for immunotherapy.In recent years,personalized therapies based on neoantigens have made remarkable progress in the field of cancer immunotherapy.However,the accuracy and reliability of neoantigen prediction processes have become the key factors restricting the development of personalized neoantigen immunotherapies.The biological basis of neoantigens and the overview of prediction processes,with a focus on the considerations in chemistry,manufacturing,and control(CMC)research on neoantigen prediction processes are reviewed in this article,and the key points and quality control measures across all stages,from tissue sample acquisition,sequencing data analysis to prediction pipeline development are detailed,aiming to provide a reference for the CMC research and evaluation of personalized neoantigen treatment products,promote the standardization and normalization of neoantigen prediction processes,and facilitate the application and development of neoantigens in precision immunotherapy for cancer.

Precise in situ analysis of liposome physical stability based on cryo-electron microscopy
[Journal Article]LIU Jing, YAN Meng-yu, HAN Yao et al.-Chinese Journal of New Drugs2026, No.08

Abstract:This study employs cryo-electron microscopy(Cryo-EM)to precisely evaluate the physical sta-bility of liposomes in situ.Cryo-EM eliminates the need for drying and staining,thereby preserving the native mor-phology of liposomes to the greatest extent.It clearly reveals the bilayer membrane structure and the spatial distri-bution of encapsulated substances,overcoming issues such as deformation,hydration layer interference,and probe convolution effects associated with traditional characterization methods.Cryo-EM enables efficient and intuitive as-sessment of liposome morphology,particle size,size distribution,and the state of encapsulated materials.Cryo-EM provides reliable scientific evidence and quality control standards for the development and optimization of liposomal formulations.Ultimately,it enhances the consistency and comparability of drug development and production,meet-ing the growing clinical demands.

Analysis of influenza vaccine development trends from a patent perspective
[Journal Article]ZHANG Zhi-yuan, DONG Li-Chinese Journal of New Drugs2026, No.08

Abstract:Vaccination against influenza serves as a critical measure for disease prevention,significantly mitigating the socio-economic impacts of influenza epidemics.This study conducted a comprehensive analysis of global influenza vaccine-related patents retrieved from the PatSnap global patent database,examining multiple di-mensions including patent application trends,geographical distribution,patent classifications,and rankings of key applicants.Furthermore,it investigated the technological focal points in existing patents and analyzed the patent portfolios of major applicants,with the aim of providing strategic recommendations for domestic influenza vaccine R&D and patent deployment.Statistical analysis revealed a phased growth pattern in influenza vaccine patent appli-cations,with China and the United States dominating both technology origination and target markets.While multi-national corporations like GlaxoSmithKline lead in industrial applications,China's applicants primarily consist of u-niversities and research institutions,demonstrating lower industrialization rates.The study proposes three strategic initiatives:enhancing international collaboration for universal vaccine development,strengthening quality supervi-sion systems,and prioritizing intellectual property protection for next-generation vaccine technologies such as nucle-ic acid vaccines.These recommendations aim to bolster the global competitiveness of China's influenza vaccine in-dustry.