信达生物与赛诺菲战略合作-条款梳理&会议纪要

信达生物与赛诺菲达成战略合作–条款梳理及会议纪要20220805内部资料，切勿转载；如有错漏，敬请谅解合作内容梳理：2022年8月4 日，信达生物公告与赛诺菲达成关于抗肿瘤药物SAR408701及SAR444245两款产品在中国的临床开发及商业化合作。 SAR408701（TusamitamabRavtansine；抗CEACAM5ADC）□信达无需支付任何首付款。信达主导中国的临床开发和商业化。 赛诺菲将有权获得累计最高达80百万欧元的开发里程碑付款，以及NDA获批后基于该产品在中国净销售额的特许权使用费。 □SAR408701靶向CEACAM5，在全球范围内（包括中国）开展二线非小细胞肺癌的III期临床研究，以及一线非小细胞肺癌、胃癌和其他实体肿瘤的全球II期临床。 SAR444245（非α偏向性IL-2）□信达主导中国的临床开发，赛诺菲将负责中国商业化。 □信达无需支付任何首付款。 信达将有权获得累计最高达60百万欧元的开发里程碑付款，以及于NDA获批后基于该产品在中国净销售额的特许权使用费。 □SAR444245(IL-2)目前正在皮肤癌、胃肠癌、非小细胞肺癌╱间皮瘤、头颈癌和淋巴瘤等适应症上开展全球临床II期研究。同时，赛诺菲将分两批次认购信达股份。 □第一批次每股认购价42.42港元，认购金额3亿欧元（约24.17亿港元）。 认购价格为股份发行协议日期（即2022年8月3日）前30个交易日信达平均收市价溢价20%的股价。信达将向赛诺菲发行合共56，975，670股股份，占发行后总股本的3.73%。 相关股份上市后的禁售期为两年。 □第二批次在双方达成独立书面协议后进行，拟定认购金额同样为3亿欧元，每股价格将在未来按紧接第二批次相关股份发行协议日期前30个交易日的平均收市价溢价20%厘定，且该价格不得较基准价折让20%或以上。 若双方同意第二批次交割，交割将最晚不迟于2025年6月30日。 o注：基准价为股份发行协议日期的收市价及其紧接该协议日期前5个交易日的平均收市价两者中的较高者。溢价股权投资表明赛诺菲认可信达作为中国领先生物制药公司的长期增长潜力。 首次交割后收取的所得款项将为信达提供额外的资本支持。 电话会议纪要：Q&AQ：Sanofi’smotivationforthispartnershipwithInnovent？Sanofitohaveaboardseat？ A：SanofirecognizesInnoventasastrongbiotechcompanyinChina.TheyarealwayslookingforstrongpartnershipsinChina.(1)TheyseeInnoventhasastrongmarketingteam.(2)TheyareimpressedthatInnoventhasanefficientclinicaldevelopmentteam–within10yearswe’vemarketedmorethan5products，particularlyPD-1.(3)Withatleasttwotimesofsitevisits，Sanofi’steamisimpressedwithourCMCandmanufacturingcapacitiesandquality.(4)Wehaverobustpipelines，especiallyadeepandcomprehensivepipelineinantibodybiologics.SanofiwillnothaveaboardseatinInnovent.Q：InnoventhasotherIL-2assetsinpipeline，withtheadditionofSanofi’sIL-2，howtoprioritize？ OverallplanforIL-2development？ A：IL-2hasbeenatargetforI/O30yearsago.ThefirstIL-2drugcandidatewasverytoxic.TheefficacyofthesecondIL-2drugcandidatewasnotthatimpressive，butdefinitelyafewpatientshavecancerscuredbyIL-2.Sincethen，thecomplexbiologyofIL-2hasbeenreviewed.ManycompaniesaremakingthenextgenerationIL-2.Sanofi’sIL-2waslicensedfromSynthorx.Synthorxhasinventedanewtechnologythancaninsertnon-naturalaminoacidsatprecisesitestoallowtheproductionofmodifiedmolecule.ThistechnologyallowsprecisecalculationofIL-2Rαchainbindingsites.Thismolecule(SAR444245)sincethebeginningrepresentsthepotentialbestinclassinbetaIL-2binding.JohnReed，headofSanofiR&DandYongjunLiuwereinvolvedinthelicenseinofthismolecule.Thismoleculehasprogressedtophase2.WebelievethismoleculepotentiallywillbetheFICIL-2.IntermsofourinternalIL-2assetsdevelopedin-house，therearetwodimensions.OneisontheIL-2specificityandpotency.OurIL-2isdifferentiated.Wehavedifferenttechnologyforspecificityandpotency，particularlywesignificantlyreducethepotencyofIL-2，becausethiswillleadtotoxicity.TheotherdimensioniswefusesIL-2withourothertherapeuticantibodies.OurIL-2willbecombinedwithanotherantibodytobedeliveredtothespecifictarget.Q：HowdoyouseethevalueofthecommercialtermswithSanofi？ A：ThetwoassetsfromSanofiwillbeincombowithourPD-1.ForCEACAM5ADC，InnoventwillberesponsibleforclinicaldevelopmentandforexclusivecommercializationinChina.ForIL-2，InnoventwillleadtheChinaclinicaldevelopment，whileSanofiwillberesponsibleforthecommercializationofthisassetinChina.Forbothassets，therearenoupfrontpayment required.Q：Besidesthesetwoassets，anyplantoexpandthepartnershipwithSanofitoincludeotherassets？ A：Thiscollaborationrepresentsthebeginningofaboardandlong-termcollaborationwithSanofi.CEOandtheheadofR&DofSanofibothhaveintereststodeepenthecollaborationinthreeareas，discovery，clinicaldevelopment，andcommercialization.Thetwocompanieshavestrongrespectandtrusttoeachother.YongjunLiuleftSanofitwoyearsago.Q：ClinicaldevelopmentplanofthesetwoassetsinChina？ A：TheCEACAM5ADCisunderaphase3studyfor2LNSCLCtreatment，andthisstudyalsoinvolvesChina.Sanofiwillstillleadthisphase3trialinChina.Webelieve1LNSCLCand1LGCarethekeyindicationsforfurtherdevelopment.Innoventwillleadbothindicationsandwewillstartfromarandomizedphase3studywithdifferentregimensin1LNSCLCand1LGCasaPoC，andthendecidethenextstepsasapivotalstudy.WewillfocusonlungandGIcancerandthecombinationwithPD-1.Q：ResponsibilityofR&Dcostforthetwodrugs？ A：BothsideshaveagreedtheclinicaldevelopmentplansandthearrangementsontheR&Dcosts.Bothsideshaveagreednottodisclosethedetails.BothsideswillcontributetotheR&DcostinChina.Q：EliLilyreportedthe2QresultsofPD-1sales，andInnovent’scommercialheadwillleave.Anycomments？ A：EliLilyreleasedtheir2Qrevenue，includingthePD-1sintilimab.Ourproductsalesin2QwasoverRMB1bn，lowerthanourexpectation.Covid-19relatedlockdownsincertainareasimpactedtheoverallsales.Themajorimpactalsorelatedtoourcommercialorganizationreconstructionwhichstartedearlythisyear.Wedecidedtoestablishaproductlinekindofcommercialorganization，whichwenameasbusinessunit.Startingfromthisyear，wemadesomechangestocommercialteam.OriginallyPD-1andbiosimilarwerecommercializedbythesameorganization.Byseparatingtheproductsandhavingspecificdedicatedteam，wewillbemoreefficientintermsofcommercialization.Wemadeteamchangesincertainhospitalsorcities，andatthebeginning，thereweresomeimpactsoncommercialactivities.Peoplewhooriginallydedicatedf