中国上海，2021年6月24日-罗欣药业集团股份有限公司（以下简称“罗欣药业”）子公司山东罗欣药业集团股份有限公司（以下简称“山东罗欣”）宣布与韩国HKinno.NCorporation（原CJHealthCareCorporation公司，以下简称“HKinno.NCorporation”）在线签署合作协议，就引进HKinno.NCorporation公司的替戈拉生注射剂产品达成合作。山东罗欣将获得该产品在中国的独家开发、生产和商业化权利。目前，替戈拉生注射剂在全球范围内尚无产品上市。
Shanghai,China,June24,2021--ShandongLuoxinPharmaceuticalGroupStockCo.,Ltd.(ShandongLuoxin),asubsidiaryofLuoxinPharmaceuticalGroupStockCo.,Ltd.(LuoxinPharmaceutical)signedacooperationagreementwithSouthKorea-basedHKinno.NCorporation(formerlyCJHealthCareCorporation)wherebyShandongLuoxinwillgaintheexclusiverightsforthedevelopment,manufacture,andcommercializationofTegoprazaninjectionsinChina.Atpresent,Tegoprazaninjectionsarenotyetavailableanywhereworldwide.Thesigningeventtookplaceonline.
替戈拉生是钾离子竞争性酸阻滞剂类药物（Potassium-CompetitiveAcidBlockers，P-CAB），其抑制酸分泌的作用机制为竞争性结合壁细胞内H+/K+-ATP酶（质子泵）的钾离子结合部位。与传统质子泵抑制剂(PPI)不同，P-CAB可直接抑制H+/K+-ATP酶，而无需在强酸环境下活化。而且，无论H+/K+-ATP酶活化与否，P-CAB均可与之结合。替戈拉生注射剂主要用于治疗胃食管反流、上消化道出血和预防应激性胃黏膜损伤等，具有起效快、作用时间长、酸性条件下稳定、可同时抑制激活和静息状态质子泵等特点。
Tegoprazan,anovelpotassium-competitiveacidblocker(P-CAB),inhibitsgastricH+/K+-ATPase(protonpump)inapotassium-competitiveandreversiblemanner.Differentfromthetraditionalprotonpumpinhibitors(PPI),P-CABcandirectlyinhibitH+/K+-ATPasewithoutactivationinstrongacidenvironments.Moreover,P-CABcanbecombinedwithH+/K+-ATPasewhetheritisactivatedornot.Tegoprazaninjectionshavemainlybeendevelopedforthetreatmentofacid-relatedgastrointestinaldiseasessuchasgastroesophagealrefluxdisease(GERD)anduppergastrointestinalbleedingaswellasforthepreventionofstressgastricmucosainjury.Thedrughasmanyadvantages,includingfastonsetofaction,effectivenessoveraprolongedperiodandstabilityunderacidicconditionsthatcansimultaneouslyinhibitbothactivatedandrestingstateprotonpumps.
根据IQVIA数据，2020年中国质子泵抑制剂（PPI）药物市场规模约30亿美元，仅次于美国位居全球第二，其中注射剂市场规模约20亿美元，约128亿人民币，占PPI药物市场的60%。根据协议条款，山东罗欣将获得替戈拉生注射剂产品在中国的独家开发、生产和商业化权益，并将向HKinno.NCorporation支付总计不超过500万美元的首付款及销售里程碑付款。
StatisticsfromIQVIArevealthatChina’sPPImarketamountedtoaboutUS$3billionin2020,rankingsecondintheworldjustbehindtheU.S.ThemarketforinjectionsreachednearlyUS$2billion(approx.US$12.8billionyuan),accountingfor60percentofthetotalPPIdrugmarket.Undertheagreement,ShandongLuoxinwillreceivetheexclusivedevelopment,manufacture,andcommercialrightsofTegoprazaninjectionsinChina,andpayuptoUS$5millionintotaldownpaymentsandsalesmilestonepayments.
韩国HKinno.N代表理事
姜碩禧(KangSeok-hee)
罗欣药业作为我们钾离子竞争性酸阻滞剂类药物在中国的开发合作伙伴，具有消化领域强大竞争能力以及出色的商业能力。我很高兴双方可以达成进一步合作，增加Tegoprazan产品在中国市场价值。
AsthedevelopmentpartnerofourP-CABinChina,LuoxinPharmaceuticalhasstrongcompetitiveandexcellentbusinesscapabilitiesinthedigestionsector.IampleasedthatthetwosideshavebeenabletoenterintothiscooperationwiththeaimofincreasingthevalueofTegoprazanintheChinesemarket.
罗欣药业董事长兼CEO
刘振腾
我们与HKinno.NCorporation公司一直保持良好的合作伙伴关系，愿双方共同探索创新药物的努力早日取得成果，为全球病患提供更有价值的创新疗法，也期待在未来拓展更多合作空间。
WehavemaintainedagoodpartnershipwithHKinno.NCorporationandhopethejointeffortstoexploreinnovativedrugscanpayoffassoonaspossibleandprovidemoreeffectivetherapiestopatientsworldwide.Wearelookingforwardtofurtherexpansionofthecooperationinthefuture.
罗欣药业与HKinno.NCorporation（原CJHealthCareCorporation）合作始于2015年，双方就替戈拉生片在中国境内独家开发、生产及商业化权益达成协议。2017年6月该项目获得临床试验批件，2019年首个III期临床研究结果达到主要疗效终点。目前，替戈拉生片上市申请已获CDE受理。
ThecollaborationbetweenLuoxinPharmaceuticalandHKinno.NCorporation(formerlyCJHealthCareCorporation)beganin2015,whentheyreachedanagreementontheexclusivedevelopment,productionandcommercialrightsofTegoprazaninChina.ClinicaltrialapprovalwasobtainedinJune2017,whilethefirstphaseIIIclinicalstudyresultsreachedthemainefficacyendpointin2019.Atpresent,themarketingauthorizationapplicationforTegoprazanhasbeenacceptedbyChina'sCenterforDrugEvaluation(CDE).
关于韩国HKinno.NCorporation
HKinno.NCorporation公司是一家即将在韩国交易所上市的集团公司，已向韩国交易所递交上市申请。自1984年成立以来，凭借其处方药，如肠胃药、抗癌药、循环系统药、糖尿病药及肾药，及非处方药品组合，于韩国药品市场独占鳌头。公司于2018年2月18日被韩国KolmarKoreaCo.,Ltd收购，并于2020年2月6日完成官方注册名称变更，从原CJHealthCareCorporation正式更名为HKinno.NCorporation。
HKinno.NCorporationisabiotechnologyandpharmaceuticalcompanythatistheprocessofapplyingtolaunchanIPOontheKoreaStockExchange.Sinceinceptionin1984,thefirmhasdominatedtheSouthKoreandrugmarketwithitslineupofprescriptiondrugsforthetreatmentofgastrointestinal,kidneyandcirculatoryalimentsaswellascanceranddiabetes,alongsideanover-the-counterdrugportfolio.ThecompanywasacquiredbyKolmarKoreaCo.,LtdonFebruary18,2018,andcompleteditsofficialregistrationforanamechangeonFebruary6,2020,fromtheoriginalCJHealthCareCorporationtoHKinno.NCorporation.
关于罗欣药业
罗欣药业集团股份有限公司（以下简称“罗欣药业”）是集药品研发、生产、贸易及医疗健康服务为一体的大型医药企业集团。跻身发展速度领先的中国制药企业方阵，罗欣药业致力于为客户提供高品质原料药、多剂型药物（片剂、胶囊剂、注射剂等）和医疗健康服务。
罗欣药业连续多年位列中国制药工业百强企业榜单，且多次被评为“制药企业研发实力20强”，已于2019年登陆中国A股市场，股票代码002793。
LuoxinPharmaceuticalGroup(LuoxinPharmaceutical)isahealthcareconglomeratethatisengagedinhealthservicesaswellastheR&D,manufactureandsalesofpharmaceuticals.Asoneofthefastest-growingandleadingpharmaceuticalcompaniesinChina,LuoxinPharmaceuticaliscommittedtoprovidingcustomerswithhigh-qualityAPI,multi-agentdrugs(tablets,capsulesandinjections)andhealthcareservices.
LuoxiPharmaceuticalhasbeenincludedinthelistofChina’stop100pharmaceuticalproducersforseveralconsecutiveyearsandbeennamedamongtheTop20PharmaceuticalCompaniesByR&DStrengthmultipletimes.ItsshareswerelistedonChina’sA-sharemarketin2019,withthestockcode002793.
