China National Medical Products Administration approval summary:anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy

Background:On May 8,2018,the China National Medical Products Administration(NMPA)approved anlotinib,an orally administered anti-angiogenesis inhibitor,for the treatment of patients with advanced non-small cell lung can-cer(NSCLC)who have progressed after treatment with two or more lines of prior systemic chemotherapy.Main body of the abstract:China NMPA reviewed and inspected a regional double-blinded,placebo-controlled,Phase III trial comparing the overall survival(OS)of NSCLC patients between the anlotinib and placebo arms.A total of 437 patients were randomized(2:1)to receive either anlotinib(n=294)or placebo(n=143)once daily on a 2-week on and 1-week off schedule.Patients with epidermal growth factor receptor(EGFR)or activating anaplastic lymphoma kinase(ALK)genomic tumor aberrations should have disease progression on NMPA-approved therapy.Anlotinib is the first NMPA-approved drug for patients with advanced NSCLC who have progressed on at least two lines of prior systemic chemotherapies in China.The approval was based on a statistically and clinically significant improvement in median OS with anlotinib(9.46 months)compared with placebo[6.37 months;hazard ratio(HR])=0.70,95%confidence interval(CI)=0.55-0.89;two-sided log-rank P=0.002].The confirmed objective response rate(ORR)was 9.2%in the anlotinib arm and 0.7%in the placebo arm.The median duration of response(DoR)was 4.83 months,with a 95%CI of 3.31-6.97 months.The toxicity profile of anlotinib was consistent with that of known anti-angiogenesis inhibitors.Common adverse drug reactions(ADRs)in anlotinib-treated patients included hypertension(67.4%),hand-foot syndrome(43.9%),hemoptysis(14.0%),thyroid stimulating hormone(TSH)elevation(46.6%),and corrected QT interval(QTc)prolongation(26.2%).Short conclusion:Anlotinib demonstrated a clinically significant OS prolongation as a novel therapeutic option for advanced or metastatic NSCLC following at least two lines of chemotherapy.

Transfer film effects induced by 3D-printed polyether-ether-ketone with excellent tribological properties for joint prosthesis

Based on the building principle of additive manufacturing,printing orientation mainly determines the tribological properties of joint prostheses.In this study,we created a polyether-ether-ketone(PEEK)joint prosthesis using fused filament fabrication and investigated the effects of printing orientation on its tribological properties using a pin-on-plate tribometer in 25% newborn calf serum.An ultrahigh molecular weight polyethylene transfer film is formed on the surface of PEEK due to the mechanical capture of wear debris by the 3D-printed groove morphology,which is significantly impacted by the printing orientation of PEEK.When the printing orientation was parallel to the sliding direction of friction,the number and size of the transfer film increased due to higher steady stress.This transfer film protected the matrix and reduced the friction coefficient and wear rate of friction pairs by 39.13%and 74.33%,respectively.Furthermore,our findings provide a novel perspective regarding the role of printing orientation in designing knee prostheses,facilitating its practical applications.

Effects of high-dose glucose-insulin-potassium on acute coronary syndrome patients receiving reperfusion therapy:a meta-analysis

BACKGROUND:This meta-analysis aimed to assess the efficacy of high-dose glucose-insulinpotassium(GIK) therapy on clinical outcomes in acute coronary syndrome(ACS) patients receiving reperfusion therapy.METHODS:We searched the PubMed,Web of Science,MEDLINE,Embase,and Cochrane Library databases from inception to April 26,2022,for randomized controlled trials(RCTs) that compared high-dose GIK and placebos in ACS patients receiving reperfusion therapy.The primary endpoint was major adverse cardiovascular events(MACEs).RESULTS:Eleven RCTs with 884 patients were ultimately included.Compared with placebos,high-dose GIK markedly reduced MACEs(risk ratio [RR] 0.57,95% confidence interval [95% CI]:0.35 to 0.94,P=0.03) and the risk of heart failure(RR 0.48,95% CI:0.25 to 0.95,P=0.04) and improved the left ventricular ejection fraction(LVEF)(mean difference [MD] 2.12,95% CI:0.40 to 3.92,P=0.02) at 6 months.However,no difference was observed in all-cause mortality at 30 d or 1 year.Additionally,high-dose GIK was significantly associated with increased incidences of phlebitis(RR 4.78,95% CI:1.36 to 16.76,P=0.01),hyperglycemia(RR 9.06,95% CI:1.74 to 47.29,P=0.009) and hypoglycemia(RR 6.50,95% CI:1.28 to 33.01,P=0.02) but not reinfarction,hyperkalemia or secondary reperfusion.In terms of oxidative stress-lowering function,high-dose GIK markedly reduced superoxide dismutase(SOD) activity but not glutathione peroxidase(GSH-Px) or catalase(CAT) activity.CONCLUSION:Patients with ACS receiving reperfusion therapy exhibited a reduction in MACEs and good oxidative stress-lowering eflcacy in response to high-dose GIK.Moreover,with a higher incidence of complications such as phlebitis,hyperglycemia,and hypoglycemia.Furthermore,there were no observed survival benefits associated with high-dose GIK.More trials with long-term follow-up are still needed.

Comprehensive prognostic and immune analysis of sterol Oacyltransferase 1 in patients with hepatocellular carcinoma

BACKGROUND Sterol O-acyltransferase 1(SOAT1)is an important target in the diagnosis and treatment of liver cancer.However,the prognostic value of SOAT1 in patients with hepatocellular carcinoma(HCC)is still not clear.AIM To investigate the correlation of SOAT1 expression with HCC,using RNA-seq and gene expression data of The Cancer Genome Atlas(TCGA)-liver hepatocellular carcinoma(LIHC)and pan-cancer.METHODS The correlation between SOAT1 expression and HCC was analyzed.Cox hazard regression models were conducted to investigate the prognostic value of SOAT1 in HCC.Overall survival and disease-specific survival were explored based on TCGA-LIHC data.Biological processes and functional pathways mediated by SOAT1 were characterized by gene ontology(GO)analysis and the Kyoto Encyclopedia of Genes and Genomes(KEGG)analysis of differentially expressed genes.In addition,the protein-protein interaction network and co-expression analyses of SOAT1 in HCC were performed to better understand the regulatory mechanisms of SOAT1 in this malignancy.RESULTS SOAT1 and SOAT2 were highly expressed in unpaired samples,while only SOAT1 was highly expressed in paired samples.The area under the receiver operating characteristic curve of SOAT1 expression in tumor samples from LIHC patients compared with para-carcinoma tissues was 0.748,while the area under the curve of SOAT1 expression in tumor samples from LIHC patients compared with GTEx was 0.676.Patients with higher SOAT1 expression had lower survival rates.Results from GO/KEGG and gene set enrichment analyses suggested that the PI3K/AKT signaling pathway,the IL-18 signaling pathway,the calcium signaling pathway,secreted factors,the Wnt signaling pathway,the Jak/STAT signaling pathway,the MAPK family signaling pathway,and cell–cell communication were involved in such association.SOAT1 expression was positively associated with the abundance of macrophages,Th2 cells,T helper cells,CD56bright natural killer cells,and Th1 cells,and negatively linked to the abundance of Th17 cells,dendritic cells,and cytotoxic cells.CONCLUSION Our findings demonstrate that SOAT1 may serve as a novel target for HCC treatment,which is helpful for the development of new strategies for immunotherapy and metabolic therapy.

Inspired by novel radiopharmaceuticals:Rush hour of nuclear medicine

Nuclear medicine plays an irreplaceable role in the diagnosis and treatment of tumors.Radiopharmaceuticals are important components of nuclear medicine.Among the radiopharmaceuticals approved by the Food and Drug Administration(FDA),radio-tracers targeting prostate-specific membrane antigen(PSMA)and somatostatin receptor(SSTR)have held essential positions in the diagnosis and treatment of prostate cancers and neuroendocrine neoplasms,respectively.In recent years,FDA-approved serials of immune-therapy and targeted therapy drugs targeting programmed death 1(PD-1)/programmed death ligand 1(PD-L1),human epidermal growth factor receptor 2(HER2),and nectin cell adhesion molecule 4(Nectin 4).How to screen patients suitable for these treatments and monitor the therapy?Nuclear medicine with specific radiopharmaceuticals can visualize the expression level of those targets in systemic lesions and evaluate the efficacy of treatment.In addition to radiopharmaceuticals,imaging equipment is also a key step for nuclear medicine.Advanced equipment including total-body positron emission tomography/computed tomography(PET/CT)and positron emission tomography/magnetic resonance imaging(PET/MRI)has been developed,which contribute to the diagnosis and treatment of tumors,as well as the development of new radiopharmaceuticals.Here,we conclude most recently advances of radiopharmaceuticals in nuclear medicine,and they substantially increase the“arsenal”of clinicians for tumor therapy.

Single-arm trials for domestic oncology drug approvals in China

The urgent need for effective cancer treatments,particularly for advanced and relapsed cases in which standard therapies are inadequate,has spurred the development of innovative therapeutic drugs1,2.Among the strategies to expedite drug development,the use of single-arm trials(SATs)is emerging as a promising avenue with substantial potential to shorten drug approval timelines and accelerate market entry.

Exploration of Related Issues on PK/PD Studies and Bioanalytical Characteristics of Peptides

Peptides play multiple functions in cellular processes and are considered an attractive paradigm for the development of novel drugs and therapeutic approaches. However, the complexity of their pharmacokinetics/pharmacodynamics and physicochemical properties presents challenges in their development. Currently, there is no single analytical method that fully meets the requirements for studying peptide drug pharmacokinetics. Interdisciplinary teams and multiple technical platforms are required to address these challenges. This article explores the pharmacokinetics, bioanalytical methods, challenges, and strategies in the development of peptide drugs. As our understanding of peptide drug pharmacokinetics and bioanalytical characteristics deepens, it will facilitate their development and provide scientific evidence for rational clinical use.

Selection of suitable internal controls for gene expression normalization in rats with spinal cord injury

There is a lack of systematic research on the expression of internal control genes used for gene expression normalization in real-time reverse transcription polymerase chain reaction in spinal cord injury research.In this study,we used rat models of spinal cord hemisection to analyze the expression stability of 13 commonly applied reference genes:Actb,Ankrd27,CypA,Gapdh,Hprt1,Mrpl10,Pgk1,Rictor,Rn18s,Tbp,Ubc,Ubxn11,and Ywhaz.Our results show that the expression of Ankrd27,Ubc,and Tbp were stable after spinal cord injury,while Actb was the most unstable internal control gene.Ankrd27,Ubc,Tbp,and Actb were consequently used to investigate the effects of internal control genes with differing stabilities on the normalization of target gene expression.Target gene expression levels and changes over time were similar when Ankrd27,Ubc,and Tbp were used as internal controls but different when Actb was used as an internal control.We recommend that Ankrd27,Ubc,and Tbp are used as internal control genes for real-time reverse transcription polymerase chain reaction in spinal cord injury research.This study was approved by the Administration Committee of Experimental Animals,Jiangsu Province,China(approval No.20180304-008)on March 4,2018.

Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China

Regulatory science is a discipline that uses comprehensive methods of natural science,social science,and humanities to provide support for administrative decision-making through the development of new tools,standards,and approaches to assess the safety,efficacy,quality,and performance of regulated products.During the pandemics induced by infectious diseases,such as H1N1 flu,severe acute respiratory syndrome(SARS),and Middle East respiratory syndrome(MERS),regulatory science strongly supported the development of drugs and vaccines to respond to the viruses.In particular,with the support of research on drug regulatory science,vaccines have played a major role in the prevention and control of coronavirus disease 2019(COVID-19).This review summarizes the overall state of the vaccine industry,research and development(R&D)of COVID-19 vaccines in China,and the general state of regulatory science and supervision for vaccines in China.Further,this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines,with analyses from the aspects of nationallevel planning,relevant laws and regulations,technical guidelines,quality control platforms,and postmarketing supervision.Ultimately,this review provides a reference for the formulation of a vaccine development strategy in response to the current pandemic and the field of vaccine development in the post-pandemic era,as well as guidance on how to better respond to emerging and recurring infectious diseases that may occur in the future.

Bacterial outer membrane vesicle-based cancer nanovaccines

Tumor vaccines,a type of personalized tumor immunotherapy,have developed rapidly in recent decades.These vaccines evoke tumor antigen-specific T cells to achieve immune recognition and killing of tumor cells.Because the immunogenicity of tumor antigens alone is insufficient,immune adjuvants and nanocarriers are often required to enhance anti-tumor immune responses.At present,vaccine carrier development often integrates nanocarriers and immune adjuvants.Among them,outer membrane vesicles(OMVs)are receiving increasing attention as a delivery platform for tumor vaccines.OMVs are natural nanovesicles derived from Gramnegative bacteria,which have adjuvant function because they contain pathogen associated molecular patterns.Importantly,OMVs can be functionally modified by genetic engineering of bacteria,thus laying a foundation for applications as a delivery platform for tumor nanovaccines.This review summarizes 5 aspects of recent progress in,and future development of,OMV-based tumor nanovaccines:strain selection,heterogeneity,tumor antigen loading,immunogenicity and safety,and mass production of OMVs.

Clinical review considerations of class I PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation

Several phosphoinositide 3-kinase(PI3 K) inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide, and many drugs that have the same target are in the clinical research stage. In March 2022,duvelisib became the first PI3 K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases. Meanwhile, linperlisib and copanlisib have almost completed the technical review of the clinical specialty. The Center for Drug Evaluation(CDE) of the China National Medical Products Administration(NMPA) found that class I PI3 K inhibitors can cause various degrees of immune-related adverse events, which are associated with action mechanisms, affecting the benefit-risk assessment of the drugs. On April 21, 2021, the United States Food and Drug Administration(FDA) convened the Oncologic Drugs Advisory Committee(ODAC)meeting to discuss the safety of PI3 K inhibitors indicated for hematolymphatic malignancies and their related risk of death. The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3 K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma.

Postoperative radiotherapy for thymus salivary gland carcinoma:A case report

BACKGROUND Salivary gland cancer is a rare disease in which cancer cells form in the tissues of the salivary glands.It mostly occurs in the glands that have secretion functions,such as the parotid gland,sublingual gland and submandibular gland.This is very rare when it occurs in other nonsecreting glands.Here,we report one case of salivary gland carcinoma occurring in the thymus and discuss related diagnoses and treatment progress.CASE SUMMARY One 33-year-old middle-aged man presented with a thymus mass without any clinical symptoms when he underwent regular physical examination.Later,the patient was admitted to the hospital for further examination.Computed tomography(CT)showed that there was a mass of 3 cm×2.8 cm×1.5 cm in the thymus area.The patient had no symptom of discomfort or tumor-related medical history before.After completing the preoperative examinations,it was confirmed that the patient had indications for surgery.The surgeon performed a transthoracoscope"thymectomy+pleural mucostomy"for him.During the operation,the tumor tissue was quickly frozen,and the symptomatic section showed a malignant tumor.The final pathological result suggested thymus salivary gland carcinoma-mucoepidermoid carcinoma(MEC).In the second month after surgery,we performed local area radiotherapy for the patient,with a total radiation dose of 50.4 Gy/28Fx.After 12 mo of surgery,the patient underwent positron emission tomography-CT examination,which indicated that there was no sign of tumor recurrence or metastasis.After 16 mo of operation,CT scan re-examination showed that there was no sign of tumor recurrence or metastasis.As of the time of publication,the patient was followed up for one and a half years.He had no sign of tumor recurrence and continued to survive.CONCLUSION The incidence of MEC in the thymus is low,and its diagnosis needs to be combined with clinical features and imaging methods.Histopathological analysis plays a key role in the diagnosis of the disease.Patients with early-stage disease have a good prognosis and long survival period.In contrast,patients with advanced-stage disease have a poor prognosis and short survival period.Combining radiotherapy and chemotherapy in inoperable patients may prolong survival.

Tissue Engineering and Regulatory Science

Tissue engineering has successfully evolved from its original concept[1]into medical products with a rapid pace of develop-ment and a multi-billion dollar market[2].Compared with tradi-tional medical products,tissue-engineered medical products(TEMPs)have distinct characteristics that provide unique benefits for the repair and regeneration of damaged or diseased tissues or organs[1,2].

Research progress on the role of gut microbiota dysregulation in the pathogenesis of diabetic nephropathy

There are about over 100 trillion microbial cells in human gut,which affect the nutritional,metabolic,physiological and immune functions of the host.This paper reviews the differences in gut microbiota between patients with diabetic nephropathy(DN)and healthy people.These differences lead to the disorder of symbiotic relationship,which may have induced the progression of DN,as well as targeted interventions to reconstruct the symbiotic relationship.Recent studies have found that endotoxin from intestinal bacteria and a large number of toxic metabolites were produced by fermentation of gut microbiota,such as trimethylamine-N-oxide,indoxyl sulfate and p-cresol sulfate,leading to the disruption of intestinal barrier function.Endotoxin and bacterial metabolites,entering the systemic circulation,were involved in DN progression by mediating inflammatory responses,renin-angiotensin-system and vascular injury.The reduction of some beneficial bacterial metabolites in DN patients,such as short-chain fatty acids,would weak body energy metabolism and destroy glucose homeostasis.In addition,gut microbiota is essential for the conversion of bile acids,and plays an important role in the development of DN by synthesizing secondary bile acids and regulating glucose and metabolic balance through foresaid X receptor(FXR)and G protein-coupled bile acid receptor(TGR5).Animal and clinical studies have revealed that probiotics,prebiotics,fecal microbiota transplantation,and Chinese medicine intervention may have potential therapeutic effects in maintaining a metabolically balanced gut microbiota to reduce the progression of DN,end-stage renal disease and cardiovascular complications.

Overview of Type 2 Diabetes Drugs on the Market

Type 2 Diabetes Mellitus (T2DM) is a systemic metabolic disorder with complex pathogenesis. In recent years, a variety of new T2DM drugs have emerged, such as sodium-dependent glucose transporters 2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors. As traditional medicines, insulin also has developed kinds of formulations such as quick-acting or premixed insulin. In addition, new treatment schedules combining multiple drugs are also fully explored. The efficacy, the administration, the mechanism, the safety and the price of these drugs are all different, providing patients with multiple options. This paper reviews the main types of type 2 diabetes drugs on the market and describes the mechanism of action. The representative type 2 diabetes treatment drugs are listed, and the advantages and disadvantages of these representative drugs are preliminarily evaluated. This information is reviewed to help doctors with clinical medication.

Key considerations on the development of biodegradable biomaterials for clinical translation of medical devices:With cartilage repair products as an example

With the interdisciplinary convergence of biology,medicine and materials science,both research and clinical translation of biomaterials are progressing at a rapid pace.However,there is still a huge gap between applied basic research on biomaterials and their translational products-medical devices,where two significantly different perspectives and mindsets often work independently and non-synergistically,which in turn significantly increases financial costs and research effort.Although this gap is well-known and often criticized in the biopharmaceutical industry,it is gradually widening.In this article,we critically examine the developmental pipeline of biodegradable biomaterials and biomaterial-based medical device products.Then based on clinical needs,market analysis,and relevant regulations,some ideas are proposed to integrate the two different mindsets to guide applied basic research and translation of biomaterial-based products,from the material and technical perspectives.Cartilage repair substitutes are discussed here as an example.Hopefully,this will lay a strong foundation for biomaterial research and clinical translation,while reducing the amount of extra research effort and funding required due to the dissonance between innovative basic research and commercialization pipeline.

Regulation Progress of Traditional Medicines in China

Let me introduce Chinese medicines. I will speak in Chinese, and I will express myself more clearly. Just now I listened carefully to Professor Werner Knoess, the doctor's report, giving me a deep feeling. As long as it is the medicine, modern or traditional, the general requirements to conform with, are the same, namely, safe, efficient and quality control. We cannot say that because these are traditional medicines.

Recombinant adeno-associated virus 8 vector in gene therapy:Opportunities and challenges

In recent years,significant breakthroughs have been made in the field of gene ther-apy.Adeno-associated virus(AAV)is one of the most promising gene therapy vectors and a powerful tool for delivering the gene of interest.Among the AAV vectors,AAV serotype 8(AAv8)has attracted much attention for its efficient and stable gene transfection into specific tissues.Currently,recombinant AAv8 has been widely used in gene therapy research on a va-riety of diseases,including genetic diseases,cancers,autoimmune diseases,and viral diseases.

Effectiveness of Acupoint Application in Patients with Pharyngeal Pain: Evidence from CHUNBO, A Prospective Real-World Study

Objective: To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application. Methods: Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching(PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain(within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events. Results: Of 7,699 enrolled participants, 6,693(86.9%) received acupoint application and 1,450(21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group(AG) and non-application group(NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG(P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG(logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41–1.63). The median age of effective cases was 4 years, mainly 3–6 years old(40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG(P<0.05). The commonly used acupoints for the effective cases were Tiantu(RN 22), Shenque(RN 8) and Dazhui(DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently(support 84.39%). A total of 1,324(17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups(P<0.05). All AEs reported were the first grade, and the average regression time of AEs was 2.8 days. Conclusions: Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3–6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, herbs of Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used in the treatment of pharyngeal pain.

Rapid and sensitive detection of Epstein-Barr virus antibodies in nasopharyngeal carcinoma by chemiluminescence strips based on iron-porphyrin single atom nanozyme

The correlation between Epstein-Barr virus(EBV)infection and nasopharyngeal carcinoma(NPC)risk has been extensively researched.The continual monitoring of EBV-IgAs provides a promising approach of NPC screening in its early stage.In this study,we successfully synthesized a single-atom nanozyme(SANzyme)through the application of iron-porphyrin based metal organic framework(MOF-FeP).The MOF-FeP possesses precisely-defined electronic and geometric structures that accurately mimic highly-evolved catalytic site of natural peroxidase.The peroxidase-like activity of MOF-FeP enables it to catalyze the chemiluminescence of luminol substrate.By integrating MOF-FeP into a traditional strip,we created a rapid and highly-sensitive evaluation tool for detecting EBV-IgAs.Importantly,the MOF-FeP strip enables the simultaneous detection of three EBV-IgAs,greatly improving the accuracy of EBV-associated NPC screening.The sensitivities of the MOF-FeP strip(75.56%–93.30%)surpass those of current enzyme-linked immunosorbent assay(ELISA)methods(64.44%–82.22%).This test takes only 16 min to perform as opposed to the customary 1–2 h required for standard ELISA.Additionally,the MOF-FeP strip is suitable for whole blood samples,thereby significantly simplifying the sample preparation and detection process.In conclusion,the MOF-FeP strip combines the simplicity of traditional strip with the high catalytic activity of SANzyme.Our innovative MOF-FeP strip offers a new point-of-care strategy for EBV-IgAs detection,which is expected to markedly facilitate early screening for EBV-associated diseases.