创新药周报：SABCS 2023年会国产新药进展

www.hczq.com 证券研究报告 创新药周报20231203： SABCS2023年会国产新药进展 2023-12-3 证券分析师刘浩 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com @2021华创版权所有 本报告由华创证券有限责任公司编制 报告仅供华创证券有限责任公司的客户使用。本公司不会因接收人收到本报告而视其为客户。华创证券对这些信息的准确性和完整性不作任何保证。报告中的内容和意见仅供参考，并不构成本公司对所述证券买卖的出价或询价。本报告所载信息均为个人观点，并不构成对所涉及证券的个人投资建议。 请仔细阅读PPT后部分的分析师声明及免责声明。 01本周创新药重点关注 第一部分 02 03 国内创新药回顾全球新药速递 圣安东尼奥乳腺癌研讨会（SABCS） 证券研究报告 圣安东尼奥乳腺癌研讨会（SABCS）始于1977年，是乳腺癌领域规模最大，最具影响力的国际性会议。SABCS致力于提供有关乳腺癌研究的最新信息，包括实验生物学，病因，预防，诊断，和乳腺癌和癌前乳腺疾病的治疗知识，主要参与者包括医学、外科、妇科和放射肿瘤学领域从事乳腺癌研究的学术和私人医生和研究人员等，由得克萨斯大学圣安东尼奥健康科学中心梅斯癌症中心（UTHealthSanAntonio’sMaysCancerCenter）和美国癌症研究协会（AACR）共同主办。 第46届SABCS将于当地时间2023年12月5日至9日在美国得克萨斯州圣安东尼奥举行，约150项来自中国临床专家及创新药企的临床研究 及新药数据将公布。 资料来源：SABCS2023年会官网，华创证券 公司 药名 靶点 适应症 阶段 题目 百利天恒 BL-B01D1 EGFRxHER3ADC BC&其他实体瘤 I BL-B01D1,afirst-in-classEGFRxHER3bispecificantibody-drugconjugate,inpatientswithLocallyAdvancedorMetastaticBreastCancerandotherSolidTumor:Resultsfromaphase1study. 科伦博泰 SKB264 TROP2ADC 经治TNBC II UpdatedefficacyandsafetyofSKB264(MK-2870)forpreviouslytreatedmetastatictriplenegativebreastcancer(mTNBC)inPhase2study 来凯医药 afuresertib AKT 经治HR+HER2-BC Ib APhaseIbStudytoevaluatetheefficacyandsafetyofafuresertibplusfulvestrantinpatientswithlocallyadvancedormetastaticHR+/HER2-breastcancerwhofailedstandardofcaretherapies 先声药业 SIM0270 SERD ER+HER2-BC I Afirst-in-humanphase1studyofSIM0270,abrain-penetrantoralselectiveestrogenreceptordegrader(SERD),inpatientswithER+/HER2-locallyadvancedormetastaticbreastcancer 益方生物 D-0502 SERD ER+HER2-BC Ib APhaseⅠbStudyofD-0502asmonotherapyforadvancedormetastaticER-positiveandHER2-negativebreastcancer:Resultsfromthedose-expansionstage 开拓药业 普克鲁胺 AR HR+HER2-AR+BC Ic ProxalutamideplusEndocrineTherapiesinWomenwithHR+/HER2-/AR+MetastaticBreastCancer:APhaseIcStudy 百济神州/Zymeworks zanidatamab HER2双抗 HR+HER2+BC IIa Primaryresultsfromaphase2astudyofzanidatamab(zani)+palbociclib(palbo)+fulvestrant(fulv)inHER2+/HR+metastaticbreastcancer(mBC) 君实生物 特瑞普利单抗 PD-1 HER2-BC II EfficacyandsafetyoftoripalimabplusmetronomicchemotherapyinHER2negativemetastaticbreastcancer:amulticenterphaseIItrialbasedonaBayesianadaptiverandomizeddesign 药捷安康 tinengotinib FGFR HR+HER2-&TNBC TheefficacyandsafetyoftinengotinibinpatientswithadvancedormetastaticHR+/HER2-breastcancerorTNBC 百力司康 BB-1701 HER2ADC HER2loBC I Reportoncohortexpansionofphaseistudytoinvestigatethesafety,tolerability,pharmacokineticsandantitumoractivityofBB-1701inpatientswithlocallyadvanced/metastaticHER2lowbreastcancer 普米斯 PM8002 PD-L1xVEGF-A 1LTNBC Ib/II APhaseIb/IIStudytoAssesstheSafetyandEfficacyofPM8002(Anti-PD-L1xVEGF-ABispecificAntibody)inCombinationwithNab-PaclitaxelforFirstLineTreatmentofLocallyAdvancedorMetastaticTriple-NegativeBreastCancer 公司 药名 靶点 适应症 阶段 题目 百利天恒 BL-M07D1 HER2ADC HER2+loBC I BL-M07D1,anantibody-drugconjugatedirectedtoHER2inpatientswithlocallyadvancedormetastaticBreastCancerwithHER2-positive/low-expressionandothersolidtumors:Resultsfromafirst-in-humanphase1study. 百济神州/Mirati sitravatinib 多激酶抑制剂 TNBC II PhaseIIstudyofsitravatinibplustislelizumabwithorwithoutnab-paclitaxelinpatientswithlocallyrecurrentormetastatictriplenegativebreastcancer. 恒瑞医药 达尔西利 CDK4/6 HR+HER2-BC Ib DalpiciclibandtucidinostatinpatientswithHR+/HER2-advancedbreastcancerandresistancetoCDK4/6inhibitors:AphaseIbtrial. 恒瑞医药 达尔西利 CDK4/6 HR+HER2-BC DalpiciclibcombinationwithletrozoleasneoadjuvanttherapyforHR-positiveHER2-negativebreastcancer:asingle-arm,prospectiveexploratoryclinicalstudy. 恒瑞医药 达尔西利 CDK4/6 HR+HER2-BC新辅助 CDK4/6inhibitordalpiciclibcombinedwithletrozoleasneoadjuvanttherapyinpostmenopausalpatientswithhormonereceptor-positive,HER2-negativestageII-IIIbreastcancer:asingle-armexploratorytrial. 恒瑞医药 吡咯替尼 HER2 HR+HER2loBC Ib PILHLE-001:neoadjuvantpyrotinibcombinedwithchemotherapyinHR-positive,HER2-low(IHC2+/FISH-negative)earlybreastcancer. 恒瑞医药 吡咯替尼 HER2 1LHER2+BC Efficacy,safetyandtranslationalstudyofpyrotinibcombinedwithalbumin-boundpaclitaxelasfirstlinetreatmentofHER-2positivemetastaticbreastcancer. 恒瑞医药 法米替尼 多激酶抑制剂 HR+HER2-BC Famitinib,amulti-targetedreceptortyrosinekinaseinhibitor,combinedwithdalpicilibandfulvestrantinadvancedHR-positiveandHER2-negativebreastcancer. 康宁杰瑞 KN026 HER2双抗 1LHER2+BC Twoandahalfyearsfollow-updataofHER2-targetedbispecificantibodyKN026combinedwithdocetaxelasfirst-linetreatmentforHER2-positiverecurrent/metastaticbreastcancer. 三生国健 伊尼妥单抗 HER2 HER2+BC InetetamabcombinedwithsirolimusandchemotherapyinHER2positivemetastaticbreastcancerpatientswithabnormalactivationofPi3k/Akt/mTORpathwayaftertrastuzumabtreatment. 三生国健 伊尼妥单抗 HER2 2L+HER2+BC Effectivenessandsafetyofinetetamab+pyrotinib+vinorelbinein≥second-linetreatmentofHER2-positivemetastaticbreastcancer. 三生国健 伊尼妥单抗 HER2 HER2+BC II UpdatedResultsofaPhaseIIStudy:NeoadjuvantInetetamabCombinedwithPertuzumab,PaclitaxelandCarboplatinforLocallyAdvancedHER2-PositiveBreastCancer. 扬厉医药 TFX06 SERD ER+HER2-BC I/II TFX06,anext-generationoralCERAN/SERD,showsfavorablesafetyandPKprofile,extracranialandintracranialefficacyinpatientswithER+/HER2-breast