New crest virus detection reagents out of the tide: more than a dozen listed companies grab the EU

Newcrestvirusdetectionreagentsoutofthetide:morethanadozenlistedcompaniesgrabtheEU “Accordingtoincompletestatistics,14newcoronavirusdetectionreagentsdevelopedby5universitiesincludingTsinghuaUniversityhaveobtainedEUCEcertificationandofficiallyobtainedthequalificationtoentertheEUmarket.”OnMarch17,theStateCouncilJointPreventionandControlMechanismPressConferencefoundthatacrosstheepidemicsituationabroad,thedemandforvirusdetectionhasincreasedsignificantly.Onthebasisoftheneedforvirusdetection,ourdetectionreagentshavegoneabroad.Infact,inadditiontothenewcoronavirusdetectionproductsthatcollegesanduniversitiesparticipateinresearchanddevelopment,domesticthird-partydetectioninstitutionsandresearchinstitutesalsofrequentlypublishnewsaboutthedeploymentofnewcoronavirusdetectionproductsinoverseasmarkets.AccordingtoincompletestatisticsofsaunaandYewang,currentlymorethantenlistedcompanieswithkitproductsaresuppliedwithKehuaBio,LepuMedical,SanuoBio,WanfuBio,OrientalBio,HuadaGene,XinbangPharmaceutical,DaanGene,etc.Intheplantodeployoverseas,someofthecompanieshaveobtainedEUmarketaccessconditions,andsomecompanieshavealreadyreceivedexportorders.Thedomestic”certified”kitshaveadailyproductioncapacityofmorethan3millioncopiesandstartoverseassupply.OnMarch16,theStateFoodandDrugAdministrationannouncedtheemergencyapprovalsituationagain.Twonewcoronavirus(2019-nCoV)IgM/IgGantibodydetectionkits(colloidalgoldmethod)fromBeadReagentCo.,Ltd.Thismeansthatthedomesticproductioncapacityof”certified”newcoronavirusdetectionreagentshasfurtherexpanded.AsofMarch16,theStateFoodandDrugAdministration’semergencyapprovalsystemhasapproved19newcrownvirusdetectionproducts.Relativelyoneday,theStateFoodandDrugAdministrationreleasednewsthatasofMarch11,theStateDrugAdministrationhadapprovedatotalof16newcoronavirusdetectionreagents,including10nucleicaciddetectionreagentsand6antibodydetectionreagents;nucleicaciddetectionThedailyproductioncapacityofreagentsisnearly2.6million,andthedailyproductioncapacityofantibodydetectionreagentsisnearly1million.Basically,therearealargenumberofnucleicaciddetectionreagentproductsthathavenotyetpassedemergencyapprovalinChina,whichcanbedonatedorsoldtodiseasecontrolcentersandotheralternativeresearch.Thedomesticepidemichaseased,buttheglobalepidemichasbeguntobegin.AccordingtoWHOstatistics,asof23:00onthe17th,Beijingtime,morethan180,000caseshavebeendiagnosedworldwide,and159countriesandregionshavereportedcases.Behindthisisahugegapinthedetectionreagentsfornewcoronarypneumonia.OntheeveningofMarch17th,Beijingtime,theUSFDAurgentlyissuedthelatestnewcoronavirusdetectionguidancepolicymentioningthatthenumberofnewcoronavirusinfectionsintheUnitedStatesisincreasing,andthereisanurgentneedtoexpandthedetectionofnewcoronavirusintheUnitedStatesinpublichealthemergencies.ability.OnMarch17,LeiChaozi,directoroftheScienceandTechnologyDepartmentoftheMinistryofEducation,saidthatthenewcoronavirusdetectionproductsdevelopedbyTsinghuaUniversityandotherfiveuniversitieshavenotbeendonatedwithalternativereagents,andhavealsobeenstartedinmorethan10countriessuchasItaly,theUnitedKingdom,andtheNetherlands.Fundinggoods.Priortothis,somenewcoronavirustestingandproductionenterprisesalsoreceivedforeignorders.OnFebruary27,inresponsetoaregulatoryinquiryletter,thelistedcompanyOrientBiostatedthatthethreenewcoronavirusdiagnosticproductsdevelopedbythecompanycanbesoldintheEuropeanUnion,andithasalreadycooperatedwithAustria,Croatia,Italy,GreeceandotherEUcountries.Anemergencysalesorderforthenewcrownvirusdiagnosticserieshasbeenissued.Inaddition,onMarch3,theChengduScienceandTechnologyBureautoldthemediathatMikeBio-newcoronavirussupportedbytheChengduEmergencyScienceandTechnologyResearchProject.The2019-nCoVnucleicaciddetectionkit(fluorescencePCRmethod)hasreceivedoverseasordersfromIranandothercountriesafterobtainingthe”MedicalDeviceRegistrationCertificate”submittedbytheStateFoodandDrugAdministration.TheEUmarkethaslowentrybarriersandquasi-biologicals.Itisnotdifficulttofindoutthatthemergedcompanyis“rushingtothebeach”andsortingoutthepublicinformation.Inthiswaveofkitkits,theEUhasbecomethefrontierfortheNuggets.OntheeveningofMarch17,thelistedcompanyKehuaBiologicalannouncedthatthecompanyreceivedtheEUmarketfreesalescertificatefornewcoronavirusdetectionrelatedproducts.ShortlyaftertheopeningonthemorningofMarch18,KehuaBiostockshadadailylimit.AccordingtothebasicproductinformationdisclosedbyKehuaBio,thecompany’snewcoronavirusnucleicacidreagent,IgM/IgGantibodydetectionkit,IgMantibodydetectionkit,IgGantibodydetectionkit4productshaveobtainedtheEUfreesalescertificate,andtheEUhasbeencompletedThecompetentauthorityhasregisteredandhasaccesstotheEUmarket.ThismeansthatinadditiontobeingmarketableintheEU,thesetestingproductsmustalsobesoldinothercountriesthathavearecognizedagreementwiththeEuropeanEconomicArea.OnMarch18th,SaunaandYewangcalledtheKehuaBiologicalSecuritiesOffice.Thestaffsaidthatthecompany’snationalmedicaldeviceproductexportsalescertificateisstillintheprocess.SomepeopleintheIVDindustrySongYu(pseudonym)toldreportersthatsomecompaniesintheindustryhadalreadypreparedfortheexportofvirusdetectionproductsinJanuarythisyear,”Somefeltthattheydidnotwanttoget(emergencyapproval),andtheyweredeployedoverseasinadvance.”.SongYusaidthattheEUimplementsafilingsystem,anditisrelativelysimpletoobtainEUmarketaccessqualification,aslongasitisCEcertified,buttheUnitedStatesisspecialandrequiresFDAcertification.ThereporternoticedthatattheendofFebruary,OrientalBiosciencedisclosedtheprocessofobtainingEUaccessqualificationindetailinresponsetotheinquiryletteroftheShanghaiStockExchange-theCEcertificationofthenewcoronavirusdiagnosticseriesproducts,madeadeclarationofconformityandsubmittedittotheEUcompetentauthorityAftercompletion,youcanaffixtheCEmarkontheproduct.OrientBiobegantoprovidethecorrespondingmaterialsasrequiredonJanuary28,andcompletedtheCEcertificationinFebruary.Withtherapidspreadoftheepidemicaroundtheworld,intensiveofficialsoflistedcompanieshaveannouncedtheEUmarketinrecentyears.OnMarch2,BGIannouncedthatitswholly-ownedsubsidiary,EuropeanMedicine,hasobtainedafreesalescertificateforEUinvitrodiagnosticmedicaldevicessubmittedbytheDanishMedicalAdministration.OnMarch6,WanfuBiosaidthatthecompany’sthreenewcoronavirusdetectionproductsobtainedtheCEcertificationentrustedbytheEuropeanUnion,whichhasbecomeanentryconditionfortheEUmarket.About10dayslater,SanuoBioandSinbonPharmaceuticalsdisclosedtothepublicthatrelevantproductshavesubmittedCEproductnotificationstotheEUcompetentauthorities,becomingEUmarketaccessconditions.LepuMedical,Da’anGeneclaimstoobtainEUCEaccessorcertification,andobtainEUmarketaccessqualification.Initially,atpresent,nodomesticlistedcompanyhasannouncedthatanewcoronavirustestproducthasobtainedUSFDAcertification.ThemostrecentnewsisthatonMarch18th,ShanghaiMindiBiomedicalTechnologyCo.,Ltd.announcedthatanewcoronavirusnucleicaciddetectionsystemhassubmittedanapplicationtotheFDAandhasofficiallyenteredthestageofreviewandapproval.Thecurrentstatusofkitmanufacturingcompanies:Onlymorecompaniesarewaitingforemergencyapprovaltopassmultiplelistedcompaniestosprinttheoverseasnewcoronavirustestingmarket,buttherearecompaniesthatarewaitingforemergencyapprovalfromSINOPHARMregulators.Forexample,KehuaBiology,whichhaspassedthepreliminaryCEcertification,hasnotyetpassedtheregistrationapprovaloftheStateFoodandDrugAdministration.AirForceKehuaBiosaidpubliclythatthecompany’snewcoronavirusnucleicaciddetectionreagentsarebeingsuppliedtodiseasecontrolcentersaroundtheworld,butareintheprocessofregistrationapproval.OnMarch18th,SaunaandYewangaskedKehuaBiotounderstandtheprogressofthecompany’sinternalregistrationandapprovalofvirusdetectionproductsandwhetherclinicaltrialshavebeencompleted.Thestaffsaidthattheydidnotknowthedetails.SongYuAirForcetoldthesaunaandYewangthataccordingtotherequirementsoftheStateFoodandDrugAdministration,newcoronavirusdetectionreagentsthathavenotpassedtheregistrationapprovalcannotbedirectlysoldtothehospital.”ManylistedcompaniessupplyCDCswithoutaregistrationcertificate.”Butifyousupplyittothehospitalforclinicaluse,itneedstobesoldtothehospital.”SongYutoldreportersthatundernormalcircumstances,anucleicaciddetectionkitneedstobecarriedoutinvariouslocallaboratories,afteridentification,tothehospitalforclinicalcomparison,follow-upon-siteverificationandotherwork.”Theapprovaltimeismorethan18months,andtwoyearsisrelativelynormal.””OnMarch18th,SaunaandYewanglearnedfromtherelevantstaffoftheStateFoodandDrugAdministrationthatthelatestsubmissionofnewcoronarypneumoniavirustestingandapprovalcanonlybereviewedinaccordancewiththenormalprocess,andyoucantakethe”prioritychannel”,butyouhavenoway”EmergencyApproval”.Atpresent,therearestillmanynewcrestvirusdetectionreagentproductsinChinaawaitingemergencyapproval.AsearlyasFebruary13,FosunPharmastatedontheinvestorinteractionplatformthatthenewcoronavirusnucleicaciddetectionkitdevelopedbytheholdingsubsidiaryFosunLongMarchisactivelyapplyingforemergencyapprovalbytheStateFoodandDrugAdministrationinaccordancewithrelevantnationalregulations.Inaddition,MikeBioandLivzonGroupbothsaidinFebruarythatrelatedproductsenteredthenationalemergencyapprovalchannel.InMarch,YangpuMedical,MeikangBiologyandSTEastOceanhavesuccessivelyrevealedtheprogressoftheregistration-relatedwork.OnMarch18,SaunaandYewanglearnedfromthelistedcompanyRundaMedicalthattheaccountingreagentsjointlydevelopedbytheexistingcompanyanditspartnersarestillunderreviewandapprovalandare“alreadyintheclinicalsummarystage”.Sauna,YeWangLiYunqieditorWangJinyuproofreadingLiMing

Read more

[Can watermelon aphrodisiac?】 _Zhuyang_function

銆 愯 タ 鐡 滆 兹 澹  槼 撼 楋 銆 慱 锷 ╅ 槼 瑗跨摐鏄汉浠渶鐔熺煡鐨勬按鏋滀簡锛岃繖鏄竴绉嶆爣鍑嗙殑瀵掓€ф按鏋滐紝鎵€浠ョ壒鍒€傚悎鍦ㄥ澶╃殑鏃跺€欏悆锛屽澶╁悆瑗跨摐鍙互琛ュ厖澶ч噺鐨勬按鍒嗭紝灏ゅ叾鍥犱负鐐庣儹澶╂皵瀵艰嚧鐑﹁It ‘s a bit of a chain, and it…

Read more

[Do you know that it is poisonous if the beans are fried?]

銆愯彍璞嗙倰涓嶇啛鏈夋瘨鍚椼€慱鍋氫笉鐔焈鍗卞 鍦ㄥ啲澶╃殑鏃跺€欙紝铏界劧闈掕彍姣旇緝灏戯紝浣嗘槸瀹跺鎴锋埛杩樻槸绂讳笉寮€闈掕彍鐨勶紝鍥犱负缁What is the difference between the stubble and the stubble?紝浣嗘槸瀹冪殑鍚冩硶纭疄鍜岃眴瑙掍笉涓€鏍风殑锛屽畠鍙堣绉颁綔涓哄洓瀛h眴锛屽悆璧锋潵鍙f劅鏄潪甯稿ソ鐨勶紝鍙互鐐掕彍鍚冿紝閭d箞鑿滆眴鐐掍笉鐔熸湁姣掑悧?Do you have a sorrow and a sorrow and a sorrow?鐜 岃  鐨 哨…

Read more