辉瑞投资基石药业2亿美元,获得PD-L1大陆**商业权利

2020-09-30 基石药业 基石药业

基石药业和辉瑞宣布建立战略合作关系,辉瑞将对基石药业进行2亿美元股权投资,获得基石药业9.90%的股份。辉瑞获得舒格利单抗(CS1001,PD-L1抗体)在中国大陆地区的独家商业化权利,基石药业继续主

基石药业和辉瑞宣布建立战略合作关系,辉瑞将对基石药业进行2亿美元股权投资,获得基石药业9.90%的股份。辉瑞获得舒格利单抗(CS1001,PD-L1抗体)在中国大陆地区的独家商业化权利,基石药业继续主导舒格利单抗围绕五个适应症的临床开发和注册战略。并有权获得最高可达2.8亿美元的舒格利单抗里程碑付款及额外的分级特许权使用费。基石药业保留在中国大陆以外地区开发和商业化舒格利单抗的所有权利。

双方还将共同选择处于后期研发阶段(已经过概念验证的)的肿瘤产品,并在大中华地区联合开发。这些产品可能来自辉瑞的管线,也可能双方联合从第三方引进。双方也可以选择性地在大中华地区联合引进其他肿瘤产品。

舒格利单抗是基石药业开发的、有望成为同类最优的一款PD-L1抗体,其潜在适应症涵盖肺癌、胃癌和食管癌等多个中国高发癌症类型。此项合作为基石药业进一步开发舒格利单抗提供了资金支持。与此同时,辉瑞获得基石药业的授权,在中国独家负责舒格利单抗的商业化经营,并将发挥其行业领先的商业化能力,让该创新疗法更快惠及中国更广大地区的医生和患者。合作还将使基石药业和辉瑞能在大中华地区开发和商业化更多创新肿瘤产品。

“辉瑞对基石药业的投资,不仅证明其对我们肿瘤PD-L1疗法的潜力充满信心,也是对我们的研发能力的认可。”基石药业董事长兼首席执行官江宁军博士表示。“通过与辉瑞携手,并借助其商业化能力,我们将确保中国更广大地区的患者能够更快地受益于我们高度差异化的PD-L1疗法。此外,在此次合作的基础上,基石药业将为中国患者加速开发及商业化全球创新的疗法,并进一步转型为一家具有全方位能力的生物制药企业。”

“辉瑞长期致力‘为患者带来改变其生活的突破创新’,并始终引以为豪。”辉瑞生物制药集团代理中国区总裁Pierre Gaudreault表示。“与基石药业的合作,让我们在这一历程上再添一笔,我们助力这一潜在同类最优的PD-L1产品的开发,并在其获批后进行商业化运营。与拥有出众临床开发能力的伙伴进行合作,帮助满足中国患者未被满足的肿瘤治疗需求。”

合作主要内容和财务条款 

  • 辉瑞获得舒格利单抗在中国大陆地区的独家商业化权利,基石药业继续主导舒格利单抗围绕五个适应症的临床开发和注册战略。
  • 基石药业有权获得最高可达2.8亿美元的舒格利单抗里程碑付款及额外的分级特许权使用费。
  • 基石药业保留在中国大陆以外地区开发和商业化舒格利单抗的所有权利。
  • 辉瑞将以每股1.725美元(约为每股13.37港元)的价格,总计2亿美元,认购115,928,803股基石药业股份。根据该等股权投资,辉瑞将持有基石药业9.90%的股份。
  • 基石药业和辉瑞将共同选择处于后期研发阶段(已经过概念验证的)的肿瘤产品,并在大中华地区联合开发。这些产品可能来自辉瑞的管线,也可能双方联合从第三方引进。
  • 基石药业和辉瑞也可以选择性地在大中华地区联合引进其他肿瘤产品。

此次交易已获双方公司的必要内部审批。交割无需获得基石药业股东的批准。

关于舒格利单抗

舒格利单抗是由基石药业开发的在研抗PD-L1单克隆抗体。舒格利单抗的开发基于由美国Ligand公司授权引进的OmniRat®转基因动物平台。该平台可一站式产生全人源抗体。作为一种全人源全长抗PD-L1单克隆抗体,舒格利单抗是一种最接近人体的天然G型免疫球蛋白4(IgG4)单抗药物。舒格利单抗在患者体内产生免疫原性及相关毒性的风险更低,这使得舒格利单抗与同类药物相比体现出潜在的独特优势。

舒格利单抗已在中国完成I期临床研究剂量爬坡。在Ia期和Ib期研究中,舒格利单抗在多个适应症中均表现出良好的抗肿瘤活性和耐受性。

目前,舒格利单抗正在进行多项临床研究,除了一项美国桥接性I期研究外,在中国,舒格利单抗正针对多个癌种开展一项多臂Ib期临床研究,一项针对淋巴瘤的II期注册临床研究,以及四项分别在三、四期非小细胞肺癌、胃癌和食管癌的III期注册临床研究。

关于基石药业

基石药业是一家生物制药公司,专注于开发及商业化创新肿瘤免疫治疗及精准治疗药物,以满足中国和全球癌症患者的殷切医疗需求。成立于2015年底,基石药业已集结了一支在新药研发、临床研究以及商业化方面拥有丰富经验的世界级管理团队。公司以肿瘤免疫治疗联合疗法为核心,建立了一条15种肿瘤候选药物组成的丰富产品管线,其中5款后期候选药物正处于关键性临床试验或注册阶段。凭借经验丰富的管理团队、丰富的管线、专注于临床开发的业务模式和充裕资金,基石药业的愿景是通过为全球癌症患者带来创新肿瘤疗法,成为全球知名的中国领先生物制药公司。如需了解有关基石药业的更多信息,请访问:www.cstonepharma.com

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    2020-10-02 smartjoy
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    2020-09-30 Jessica

    辉瑞与基石药业

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1771818, encodeId=57de1e71818aa, content=<a href='/topic/show?id=62754005931' target=_blank style='color:#2F92EE;'>#商业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40059, encryptionId=62754005931, topicName=商业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd6238344589, createdName=zhangxingru, createdTime=Fri Nov 13 04:57:20 CST 2020, time=2020-11-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1255092, encodeId=97a51255092b9, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Fri Oct 02 11:57:20 CST 2020, time=2020-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889506, encodeId=1cda88950610, content=辉瑞与基石药业, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Sep 30 22:09:08 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889501, encodeId=709588950142, content=阅读, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3282551952, createdName=12543f43m99暂无昵称, createdTime=Wed Sep 30 21:40:49 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889498, encodeId=ad85889498d4, content=<a href='/topic/show?id=952e93e2512' target=_blank style='color:#2F92EE;'>#辉瑞#</a>作为老牌制药公司,在肿瘤领域都是经典的老药,在创新药方面全面落伍,不管是靶向治疗还是免疫治疗时代,都没有抓住机会。这次与<a href='/topic/show?id=e95742114c0' target=_blank style='color:#2F92EE;'>#基石药业#</a>合作的PD-L1单抗<a href='/topic/show?id=9e52103953a4' target=_blank style='color:#2F92EE;'>#舒格利单抗#</a>,应该是辉瑞在中国的一个契机, beContent=null, objectType=article, channel=null, level=null, likeNumber=426, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93725, encryptionId=952e93e2512, topicName=辉瑞), TopicDto(id=42114, encryptionId=e95742114c0, topicName=基石药业), TopicDto(id=103953, encryptionId=9e52103953a4, topicName=舒格利单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Sep 30 21:20:18 CST 2020, time=2020-09-30, status=1, ipAttribution=)]
    2020-09-30 12543f43m99暂无昵称

    阅读

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1771818, encodeId=57de1e71818aa, content=<a href='/topic/show?id=62754005931' target=_blank style='color:#2F92EE;'>#商业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40059, encryptionId=62754005931, topicName=商业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fd6238344589, createdName=zhangxingru, createdTime=Fri Nov 13 04:57:20 CST 2020, time=2020-11-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1255092, encodeId=97a51255092b9, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Fri Oct 02 11:57:20 CST 2020, time=2020-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889506, encodeId=1cda88950610, content=辉瑞与基石药业, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211019/df01a4bfb64246379ddfef3370d04115/e1274c8eb5e440918f56f83bcfea9031.jpg, createdBy=3a345397082, createdName=Jessica, createdTime=Wed Sep 30 22:09:08 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889501, encodeId=709588950142, content=阅读, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3282551952, createdName=12543f43m99暂无昵称, createdTime=Wed Sep 30 21:40:49 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889498, encodeId=ad85889498d4, content=<a href='/topic/show?id=952e93e2512' target=_blank style='color:#2F92EE;'>#辉瑞#</a>作为老牌制药公司,在肿瘤领域都是经典的老药,在创新药方面全面落伍,不管是靶向治疗还是免疫治疗时代,都没有抓住机会。这次与<a href='/topic/show?id=e95742114c0' target=_blank style='color:#2F92EE;'>#基石药业#</a>合作的PD-L1单抗<a href='/topic/show?id=9e52103953a4' target=_blank style='color:#2F92EE;'>#舒格利单抗#</a>,应该是辉瑞在中国的一个契机, beContent=null, objectType=article, channel=null, level=null, likeNumber=426, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93725, encryptionId=952e93e2512, topicName=辉瑞), TopicDto(id=42114, encryptionId=e95742114c0, topicName=基石药业), TopicDto(id=103953, encryptionId=9e52103953a4, topicName=舒格利单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Sep 30 21:20:18 CST 2020, time=2020-09-30, status=1, ipAttribution=)]
    2020-09-30 lovetcm

    #辉瑞#作为老牌制药公司,在肿瘤领域都是经典的老药,在创新药方面全面落伍,不管是靶向治疗还是免疫治疗时代,都没有抓住机会。这次与#基石药业#合作的PD-L1单抗#舒格利单抗#,应该是辉瑞在中国的一个契机

    0

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