和黄中国在美国启动呋喹替尼（Fruquintinib）一期临床试验

和黄中国医药科技有限公司在美国启动了呋喹替尼(Fruquintinib)一期临床试验。呋喹替尼是一种高选择性强效口服血管内皮生长因子受体(VEGFR)1,2及3的抑制剂,已经在中国进行了一些II期和III期临床试验,用于治疗结直肠癌、肺癌和胃癌,试验达到主要终点。美国的临床研究是一项多中心、开放性I期临床研究,用于评估呋喹替尼在美国晚期实体瘤患者中的安全性、耐受性和药代动力学。本月早些时候已开始第一个剂量的给药。关于这项研究的其他细节可以在clinicaltrials.gov上找到,代号NCT03251378。

欢迎欣赏新闻稿！Chi-MedInitiatesFruquintinibU.S.ClinicalTrials

December15,201702:00AMEasternStandardTime

LONDON--(BUSINESSWIRE)--HutchisonChinaMediTechLimited(“Chi-Med”)(AIM/Nasdaq:HCM)hasinitiatedtheUnitedStatesPhaseIbridgingclinicaltrialoffruquintinib.Fruquintinibisahighlyselectiveandpotentoralinhibitorofvascularendothelialgrowthfactorreceptors(“VEGFR”)1,2and3,thathasmetitsprimaryendpointinseveralPhaseIIandIIIclinicaltrialsinChinaforthetreatmentofcolorectal,lungandgastriccancers.TheclinicalstudyintheU.S.isamulti-center,open-label,PhaseIclinicalstudytoevaluatethesafety,tolerabilityandpharmacokineticsoffruquintinibinU.S.patientswithadvancedsolidtumors.Thefirstdrugdosewasadministeredearlierthismonth.Additionaldetailsaboutthisstudymaybefoundatclinicaltrials.gov,usingidentifierNCT03251378.

AboutFruquintinibDevelopmentinChina

Colorectalcancer:TheChinaFoodandDrugAdministration(“CFDA”)acknowledgedacceptanceoftheNewDrugApplication(“NDA”)forfruquintinibforthetreatmentofpatientswithadvancedcolorectalcancer(“CRC”)inJune2017.Fruquintinibwassubsequentlyawardedpriorityreviewstatusinviewofitssignificantclinicalvalue,accordingtoaCFDAannouncementinSeptember2017.TheNDAissupportedbydatafromthesuccessfulFRESCOstudy,aPhaseIIIpivotalregistrationtrialoffruquintinibin416patientswithCRCinChina,whichwashighlightedinanoralpresentationattheAmericanSocietyofClinicalOncologyAnnualMeetingheldonJune5,2017(clinicaltrials.govidentifierNCT02314819).TheFRESCOstudyfollowedaninitialPhaseItrialin40solidtumorpatients,aPhaseIbstudyin62CRCpatients,andaPhaseIIclinicaltrialin71CRCpatients.

Lungcancer:FruquintinibisbeingstudiedinaPhaseIIIpivotaltrialinapproximately520third-linenon-smallcelllungcancer(“NSCLC”)patients,knownastheFALUCAstudy(clinicaltrials.govidentifierNCT02691299),followingaPhaseIIclinicaltrialin91third-lineNSCLCpatients.FruquintinibisconcurrentlybeingstudiedinaPhaseIIstudyincombinationwithIressa®(gefitinib)infirst-linesettingforpatientswithadvancedormetastaticNSCLC(clinicaltrials.govidentifierNCT02976116).

Gastriccancer:InOctober2017,Chi-MedinitiatedapivotalPhaseIIIclinicaltrialoffruquintinibincombinationwithTaxol®(paclitaxel),knownastheFRUTIGAstudy,forthetreatmentofover500patientswithadvancedgastricorgastroesophagealjunction(GEJ)adenocarcinoma(clinicaltrials.govidentifierNCT03223376).

InChina,fruquintinibisjointlydevelopedwithEliLillyandCompany.

AboutFruquintinib

Fruquintinib(HMPL-013)isahighlyselectivesmallmoleculedrugcandidatethathasbeenshowntoinhibitVEGFR24hoursadayviaanoraldose,withloweroff-targettoxicitiescomparedtoothertargetedtherapies.Itstolerability,alongwithitscleandrug-druginteractionprofiledemonstratedtodate,mayenablerationalcombinationwithothercancertherapiessuchaschemotherapyandothertargetedtherapies,whicharebeingstudiedinourongoingclinicaltrialsoffruquintinib.

Atanadvancedstage,tumorssecretelargeamountsofvascularendothelialgrowthfactor(“VEGF”),aproteinligand,tostimulateformationofexcessivevasculature(angiogenesis)aroundthetumortoprovidegreaterbloodflow,oxygen,andnutrientstothetumor.VEGFandVEGFRplaypivotalrolesintumor-relatedangiogenesis,andfruquintinibinhibitstheVEGF/VEGFRpathway.Thisrepresentsanimportanttherapeuticstrategyinblockingthedevelopmentofnewbloodvesselsessentialfortumorstogrowandinvade.

AboutChi-Med

Chi-Medisaninnovativebiopharmaceuticalcompanywhichresearches,develops,manufacturesandsellspharmaceuticalsandhealthcareproducts.ItsInnovationPlatform,HutchisonMediPharmaLimited,focusesondiscoveringanddevelopinginnovativetherapeuticsinoncologyandautoimmunediseasesfortheglobalmarket.ItsCommercialPlatformmanufactures,markets,anddistributesprescriptiondrugsandconsumerhealthproductsinChina.