Abstract:In recent years,multiple stem cell-derived pancreatic islet cell medicinal products globally have advanced rapidly into clinical trials,demonstrating great application potential in the treatment and functional cure of diabetes mellitus.Currently,the similar medicinal products that have been approved for registration clinical trials in China are still in the early clinical research stages.Given the limited scientific cognition and application experience in human beings,the correlation between critical quality attributes of such products and their clinical safety and efficacy has not been established.Both the pharmaceutical research and development as well as regulation face major challenges.In view of differences between such medicinal products and other cell therapy medicinal products in terms of active ingredients,structures,functions and mechanisms of action,particular attention should be given to the evaluation of safety,efficacy,and quality controllability.Based on the characteristics,the progress in research and development as well as application of such products,including relevant guidelines for cell therapy medicinal products and the quality control practices for pancreatic islet transplantation technology for reference,this article aims at focusing on the quality risk management strategies and pharmaceutical evaluation considerations during the development and application of stem cell-derived pancreatic islet cell medicinal products,providing references for the research and development,as well as evaluation of such products.

Abstract:As an emerging therapeutic approach,mesenchymal cell therapeutic drugs have shown broad application prospects.This article focuses on the progress in quality research in this field,elaborating on aspects such as the characteristics of mesenchymal cells,key points of quality control,and challenges we are facing.It aims to provide references for the research and development,production,and quality supervision of such drugs,and promote their safe and effective clinical application.

Abstract: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.

Abstract:Objective:To develop a quantitative structure-activity relationship(QSAR)liver toxicity prediction and evaluation method for medicinal and food homologous(MFH)substances,and apply it to the liver toxicity evaluation of Ginkgo biloba and Polygonum multiflorum.Methods:A total of 1 110 compounds with hepatotoxic adverse reactions were collected from the SIDER database(SIDER 4.1,released on October,2015)and LiverTox(updated on March,2025)as positive datasets,and 312 compounds that do not cause liver damage from DILIrank(updated on September,2023)as negative datasets.Stone MIND Collector software was used to convert the collected compound molecule images into SMILES format,and then a hepatotoxicity model was constructed using Inno QSAR on the DrugFlow platform.The accuracy and robustness of the QSAR hepatotoxicity model were verified using 5-fold cross validation.Then,72 compounds contained in Ginkgo biloba and 25 compounds contained in Polygonum multiflorum were collected and integrated from the TCMSP(Version 2.3,updated on May,2014)database and Yaozhiwang database(updated on quarter 3rd)for screening.The QSAR hepatotoxicity model was used to predict and evaluate the hepatotoxicity of the two medicinal substances.Results:The fitting evaluation of the constructed QSAR hepatotoxicity model showed an ACC of 0.809,ROC-AUC of 0.757,close to 1.The F1 score value was 0.888,indicating that the model has high accuracy and precision,good model performance,and high predictability.The prediction results showed that both Ginkgo biloba and Polygonum multiflorum are substances that may cause liver toxicity.The hepatotoxicity caused by Ginkgo biloba is most likely related to the compounds cardanol(C21 H34 O),amentoflavone(C30 H18 O10),ginkgolide B(C20 H24 O10),and ginkgolide J(C20 H24 O10).The hepatotoxicity caused by Polygonum multiflorum is most likely related to the compounds pyrogallol(C6H6O3),2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside(C20 H22 O9),and citreorosein(C15 H10 O6).Conclusion:The QSAR liver toxicity prediction and evaluation method for MFH substances established in this study aims to explore and evaluate the liver toxicity of food and drug substances more deeply and finely,providing data reference for early identification and warning.

Abstract:Reference standards serve as a critical material foundation for drug quality control,and the lawful distribution of the national drug reference standards is one of the core functions of National Institutes for Food and Drug Control(NIFDC).As a driving force for new-quality productivity,big data has improved the precision and intelligence of reference standard distribution management.To improve the efficiency of reference standard management,this study analyzes user demand data,examines distribution workflows,and summarizes pratical applications of big data technologies.This findings indicate that big data technology has a wide range of applications in building a continuous cycle system,optimizing distribution models for specific varieties,sorting out the characteristics of distribution methods,integrating packaging and transportation processes,etc.Based on these insights,recommendations are proposed,including establishing an intelligent user feedback system,linking and sharing data between reference substances and drug standards,and optimizing workload allocation.These suggestions provide a reference for further enhancing the efficiency of reference substance management.

Abstract:Alopecia areata is a prevalent chronic tissue-specific autoimmune disorder characterized by the destruction of hair follicles and unpredictable hair loss on the scalp and other body areas.Studies have shown that Janus kinase(JAK)acts as a key factor in immune activation in the pathogenesis of alopecia areata.Deuruxolitinib(LEQSELVI),a novel deuterated JAK1/2 inhibitor,was approved by the US FDA on July25,2024,for the treatment of severe alopecia areata in adults.Several clinical trials have demonstrated hair regrowth in patients with severe alopecia areata following deuruxolitinib treatment,with an overall favorable safety and tolerability profile.This article introduces its pharmacological effects,pharmacokinetics,clinical research,safety and drug use in special populations.

Abstract:Objective:To establish a method for detecting target gene profiles of herbal-derived microRNAs(miRNAs)in mice lung tissue and to apply this method to analyze the target gene profile and biological functions of miR-320 contained in Qingfei Paidu Decoction(QFPD),thereby providing miR-level mechanistic insights into its therapeutic effects against viral pneumonia.Methods:Second-generation high-throughput sequencing was used to quantify the expression of the target miRNA(miR-320)in QFPD.The"Capturing and Sequencing of miRNA-target Complex Technology(CSCT)"was employed to preliminarily identify its target gene profile in mice lung tissue,followed by validation using AlphaFold3.The overlapping results were identified as the definitive target gene profile of miR-320.Functional enrichment analysis was performed to elucidate the regulatory role of QFPD mediated by miR-320 in mice lung tissue.The detection results were compared with TargetScan predictions to evaluate the advantages of the proposed sequential detecntion method(CSCT+AlphaFold3).Results:High-throughput sequencing revealed abundant miR-320 in QFPD,with its expression level ranked among the top 50 miRNAs.In mice lung tissues,miR-320 targeted 26 gene classes,including 19 annotated genes(18 mRNAs and 1 transcriptional enhancer).Through canonical miRNA-mRNA recognition,miR-320 exhibits strong base complementarity with all 26 targets,with minimum free energy values ranging from-35.8 to-21.8 kcal·mol-1.AlphaFold3 predictions yielded a minimum combined ipTM+pTM score of 1.1(within the high-confidence range),providing complete validation(100%)of the CSCT(Computational Small RNA Target Identification)results.This confirms these 26 gene classes as the functional spectrum of miR-320.Compared with TargetScan,the"CSCT+AlphaFold3 Sequential Detection Method"developed in this study demonstrated superior accuracy.Functional analysis revealed that the target genes are mainly enriched in interleukin mediated immune signaling pathways,involved in antigen processing and presentation,immune factor/cell mediated apoptosis,and lymphocyte proliferation/activation.Conclusion:miR-320 from QFPD predominantly regulates immune-related pathways in mice lung tissue,which may represent one of the miRNA mediated mechanisms underlying QFPD's efficacy against viral pneumonia.The developed"CSCT+AlphaFold3"method exhibits high reliability and accuracy for detecting miRNA-target interaction profiles and can serve as a robust technique for studying miRNA mediated regulation in traditional Chinese medicine decoctions.

Abstract:Objective:To provide suggestions for optimizing the marketing registration pathway for over-the-counter traditional Chinese medicines(OTC TCMs)in China.Methods:A comparative analysis was conducted on the simplified registration system for traditional herbal medicines in the European Union,OTC Kampo preparations in Japan,and TCM marketing in China.The comparison focused on review agencies,regulatory frameworks,classification and simplified registration pathways,and documentation requirements.Based on international experience,suggestions for improving China's simplified registration management for OTC TCMs were proposed.Results:Regulatory authorities in Japan and the EU have established production standards for traditional medicines based on traditional use experience and specific literature as substantial evidence of safety and efficacy.For products meeting these standards,non-clinical or clinical trial requirements may be exempted to avoid unnecessary duplication of testing.Conclusions:China should further clarify the categories of TCMs eligible for direct OTC registeration,establish OTC TCM production standards,and appropriately simplify the listing and declaration requirements for TCMs expedite market entry and promote innovation in OTC TCMs.

Abstract:The implementation of China's drug patent linkage system has established a crucial platform for the early resolution of patent disputes between originator and generic drugcompanies.This article systematically reviews the patent declaration information of generic drugs registered on the China Listed Drug Patent Information Registration Platform,the drug-related cases published by the China National Intellectual Property Administration,and the judgments published on the China Judgements Online.Focusing on typical cases since the implementation of the drug patent linkage system,the article analyzes the patent declaration strategies employed by generic drug companies,as well as the common defense strategies used in drug patent linkage cases from the perspective of generic drug companies.The study aims to provide practical insights to assist generic drug companies in making more informed and strategic decisions regarding patent declarations within the complex landscape of pharmaceutical patents.

Abstract:Objective:To evaluate the bioequivalence of clarithromycin tablets in healthy Chinese subjects.Methods:Two separate studies were conducted—a fasting study and a fed study—each involving 52 healthy subjects.Both studies employed a two-period,complete repetition,and self-crossover design.Subjects received a single oral dose(0.25 g)of either the test or reference clarithromycin tablet.The plasma concentrations of clarithromycin were determined using Liquid chromatography-mass spectrometry(LC-MS).Pharmacokinetic parameters and relative bioavailability were calculated with WinNonlin8.1 software to assess bioequivalence between the two preparations.Results:Under fasting conditions,the main pharmacokinetics parameters(mean±SD)for the test and reference preparations were as follows:Cmax(1 219.26±446.14)vs(1 179.41±473.28)ng·mL-1;AUC0-t(6 285.38±2 021.53)vs(6 311.37±2 212.95)h·ng·mL-1;AUC0-∞(6 453.49±2 041.59)vs(6619.14±2335.67)h·ng·mL-1.Under fed conditions,the corresponding values were:Cmax(1 587.32±628.76)vs(1492.28±573.62)ng·mL-1;AUC0-t(7053.24±2436.54)vs(6714.95±2193.32)h·ng·mL-1;AUC0-∞(7 253.08±2 510.36)vs(6 959.44±2 206.17)h·ng·mL-1.The 90%confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ for both fasting and fed studies fell entirely within theaccepted bioequivalence range of 80.00%～125.00%.Conclusion:The test and reference clarithromycin tablets are bioequivalent in healthy Chinese subjects under fasting and fed conditions.

Abstract:Ophthalmic drug delivery has long faced many challenges due to the complex physiological barriers and rapid clearance mechanisms of the eye,which leads to low bioavailability,frequent adverse reactions,and poor patient compliance with conventional ophthalmic formulations.In order to overcome these limitations,researchers have developed a variety of new ophthalmic drug delivery systems in recent years,aiming at prolonging drug retention time on the ocular surface,enhancing intraocular penetration,and increasing the drug concentration in the target tissue.This review systematically summarizes the research progress of new ophthalmic drug delivery systems,including both marketed products and those under clinical investigation.It elaborates in detail on their formulation design,mechanism of action,and therapeutic efficacy.According to the different routes of administration,the review highlights representative strategies such as ocular surface delivery systems(e.g.,nano-drug delivery systems,non-aqueous solvent delivery systems,ophthalmic gels,drug-eluting contact lenses,and lacrimal canaliculus implants),periocular delivery systems(e.g.,subconjunctival and suprachoroidal administration),intraocular delivery systems(e.g.,implants in the anterior chamber and vitreous body),as well as nasal mucosa delivery system and drug-mechanical combined delivery systems.Finally,the future development of the new ophthalmic drug delivery system is prospected.

Abstract:Objective:To compare the efficacy and safety of vunakizumab with other IL-17A inhibitors currently approved for plaque psoriasis in China.Methods:Three IL-17A inhibitors,secukinumab,ixekizumab and xeligekimab,were selected as the reference drugs in this study.A matching-adjusted indirect comparison(MAIC)approach was used to compare the efficacy and safety of vunakizumab with the reference drugs.Results:In terms of efficacy,vunakizumab demonstrated a faster onset of action compared to secukinumab,with significantly higher PASI 75 response rates at week 4 and higher PASI 100 response rates at week 12(34.23%vs 32.90%,P=0.574).However,PASI 75 and PASI 90 response rates at week 12 were lower than those for secukinumab(both P<0.001).Compared to ixekizumab and secukinumab,vunakizumab demonstrated higher PASI 75 and PASI 100 response rates at week 12(88.91%vs 85.80%;33.40%vs 33.00%,85.72%vs 82.10%,P=0.104;36.06%vs 30.20%,P<0.05).In terms of safety,the incidence of adverse events such as upper respiratory tract infections,injection site reactions,and tinea pedis was significantly lower or showed no difference(all P<0.001).Conclusion:Vunakizumab exhibits a faster onset of actin within 4 weeks,achieves a higher PASI 100 response rate at week 12,and higher PASI 75 than that of ixekizumab and xeligekimab,along with a favorable safety profile.

Abstract:Objective:To mine and analyze risk signals of adverse drug reactions associated with hypotension in older patients within the US FDA adverse event reporting system(FAERS)database,providing evidence to guide safe medication use in elderly adults.Methods:Reports of hypotension in elderly patients(aged≥60 years)from the FAERS database between Q12004 and Q42024 were collected.Disproportionality analysis methods,including the reporting odds ratio(ROR)and proportional reporting ratio(PRR),were used to detect safety signals for drugs implicated in hypotension among this population.Results:After data cleaning,82 048 elderly patients with hypotension were identified,encompassing 82 844 reports.A total of 272 drugs exhibited positive safety signals,34 of which lacked documented hypotension risk in their labeling.The majority of signal-positive drugs fell into cardiovascular agents and nervous system agents.Conclusion:Many drugs are associated with hypo-tension risk in elderly patients.The risk level of drug-induced hypotension should be considered to optimize drug therapy in clinical practice.

Abstract:Objective:To develop a method for simultaneous determination of 17 saponin components in Huoxue Zhitong Capsules by ultra-high performance liquid chromatography tandem mass spectrometry(UHPLC-MS/MS),coupled with multivariate statistical analysis for quality evaluation of different batches.Methods:A Thermo Fisher Scientific Accucore Phenyl Hexyl column(100 mm×2.1 mm,2.6 μm)was used,with mobile phase consisting of 0.1%formic acid aqueous solution-acetonitrile for gradient elution,at a flow rate of 0.4 mL·min-1,and the column temperature was set at 35℃.Mass spectrometry employed a heated electrospray ionization source(HESI),operating in negative ion mode with multiple reaction monitoring(MRM)scanning.Agglomerative hierarchical clustering analysis,principal component analysis(PCA),and boxplot analysis were used to comprehensively evaluate the differences between Huoxue Zhitong Capsules from different manufacturers.Results:The 17 saponin components showed good linear relationships within the linear range(r≥0.9968),with precision,repeatability,and stability RSD all less than 5.00%.The average recoveries ranged from 93.2%to 108.0%,with RSD of 1.01%to 5.67%.The contents of the 17 saponins in 10 batches of Huoxue Zhitong Capsules,including notoginsenoside R1,Fa,ginsenoside Re,Rg1,Rf,F3,Rg2,Rb1,Rc,F1,Rb2,Rb3,Rd,F2,Rg5,20(S)-ginsenoside Rg3 and 20(R)-ginsenoside Rg3 were 346.2976～730.3066,59.1678～125.9001,189.4788～391.8343,1696.3028～2078.3066,2.4021～3.1435,40.31299～71.5728,37.1285～57.8093,968.6498～1 784.8576,4.5467～6.2157,4.3753～10.1749,10.1996～22.9377,7.5306～12.3707,337.7592～686.3070,4.3891～9.4875,0.0000～11.5466,6.321 1～9.623 1,and 0.000 0～1.426 2 μg·g-1,respectively.Multivariate statistical analysis revealed differences in saponin components among Huoxue Zhitong Capsules produced by different manu-facturers.Even for products from the same manufacturer but different batches,there were certain degrees of variation in the contents of 17 kinds of saponins.Conclusion:The developed analytical method demonstrates good separation efficiency and sensitivity,enabling efficiently quantification of 17 saponin components in Huoxue Zhitong Capsules,providing a scientific basis for quality control optimization and standard improvement.

Abstract:Objective:To establish an artificial intelligence image recognition and data analysis method to efficiently and accurately distinguish different specifications of black beans,confused wild soybeans,and common counterfeit black kidney beans,thus to achieve intelligent upgrading of traditional Chinese medicine trait identification.Methods:Digital image samples of black bean traits were collected to create a dataset.Deep learning methods were used to learn the dataset to obtain the ability to distinguish various types of black beans and their counterfeits.Sample expansion methods and metric learning methods were used to improve model performance and obtain better discriminative ability.Results:The method showed accuracy of 99.8%,recall of 100.0%,mean average precision(mAP)of 99.9%,and mAP@0.5:0.95 of 99.8%on the black bean dataset.The trained model could effectively distinguish various types of black beans and their counterfeits,and visually display their detection results.Conclusion:This study takes black beans and related varieties as an example,providing references for the intelligent upgrading of traditional Chinese medicine trait identification,aiming to improve the efficiency and accuracy of the identification,perfect the quality standard system,empower the digital transformation of the entire industry chain,and provide technical support for regulation and market circulation of traditional Chinese medicine.

Abstract: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.

Abstract: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.

Abstract: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/PIdual 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<0.0001],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=0.0004).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<0.0001).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.

Abstract: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 18716.48 units·mg-1 to 21723.22 units·mg-1 and a mean content of 0.9765 mg(potency)·mg-1(anhydrous basis)with a 95%confidence interval of 0.9565 mg(potency)·mg-1 to 0.9966 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.

Abstract:Objective:To evaluate the real-world treatment patterns and economic burden among patients with moderate to severe psoriasis treated with biologics in China.Methods:Adult psoriasis patients who initiated biologics between 2019 and 2023 were identified from the hospital information system database of tertiary hospitals and secondary hospitals in Tianjin.Biologics treatment patterns were assessed by persistence,adherence,swithching and trends in the selection of different lines of biological agents over time,and the economic burden of patients was assessed.Results:A total of 1 646 patients were included,with a mean age of(43.7±14.0)years,and male patients accounted for a larger proportion(67.0%).The proportion of patients who continuously used biologics in the first year of follow-up was 33.1%,with a proportion of days covered by prescriptions of(0.4±0.3).Only 3.0%of patients switched to second-line biologics.In 2020 and 2021,adalimumab and secukinumab were the primary first-line treatment drugs,with usage rates of 79.0%and 91.1%,respectively.92.8%of patients had outpatient visits related to psoriasis,with an average of(7.4±5.1)visits per year.The annual direct medical costs associated with psoriasis were(19 506±12 877)Yuan,with medication costs comprising the largest portion(83.2%,16 223 Yuan).Conclusion:Patients with moderate to severe psoriasis exhibited poor adherence in taking biologics,with a low proportion switching biologics,medication costs represented the primary economic burden for patients.Biologics adherence among patients should be further improved,and treatment strategies need to be optimized to achieve the goal of long-term stable control of psoriasis.