德国模式+张江制造:跨国药企在华生物制药商业化合同生产(CMO)服务平台亮相进博会

2019-11-06 佚名 MedSci

2019年11月6日,第二届中国国际进口博览会医药馆,肿瘤免疫治疗、靶向药物等生物创新药大放异彩。在它们的背后,一种全新的生物制药创新商业模式正在崛起,成为加快国产生物制药技术研发和转换的“关键撬动点”! 勃林格殷格翰生物药业(中国)有限公司今天在进博会上宣布:德国技术+张江制造,跨国药企在华首个生物制药商业化合同生产(CMO)服务平台已经准备就绪,正蓄势待发——今后创新企业只需专注于研发

2019年11月6日,第二届中国国际进口博览会医药馆,肿瘤免疫治疗、靶向药物等生物创新药大放异彩。在它们的背后,一种全新的生物制药创新商业模式正在崛起,成为加快国产生物制药技术研发和转换的“关键撬动点”!



勃林格殷格翰生物药业(中国)有限公司今天在进博会上宣布:德国技术+张江制造,跨国药企在华首个生物制药商业化合同生产(CMO)服务平台已经准备就绪,正蓄势待发——今后创新企业只需专注于研发,商业化生产可交由平台。这意味着,未来将有更多的中国生物医药新产品从这个平台源源不断下线,造福中国患者,助力上海和全国生物医药产业腾飞!

中国生物新药@张江制造

生物制剂结构一般几百倍于化学药,生产工艺复杂。以单克隆抗体为例,这是一种先进的肿瘤免疫疗法,无论是单药和组合疗法,都有望为不同癌种的患者带来福音,但其稳定质量产出和商业化生产十分不易,取决于严密的过程管理、高水平的生产设施、生产工艺和人才的丰富经验。

在药品上市许可人制度试点前,企业在研发的同时,需要再单独建立一条生产线或建一个工厂用于生产临床和上市后的商业化生产。这对创新型企业几乎是不可能完成的任务。张江地区汇聚着近300家生物医药企业,其中90%以上都是以新药研发为主的创新型企业。以往,这些企业通常只有一条路:把研发成果廉价卖掉,也就是俗称的“卖青苗”。

现在,勃林格殷格翰将国际化的质量标准、平台技术和卓越的运营模式带到中国,并积极参与推动药品上市许可持有人制度的试点。“这意味着以往‘单打独斗’的小企业可以通过委托生物制药合同生产平台(CMO)进行生产,更专注于研发新药,这不仅鼓励了科研人员的创新积极性,又极大地缓解了研发企业在投资建厂,募集资金及运营生产方面所面临的巨大压力,从而为中国患者带来更多一流、可负担的生物制药。” 勃林格殷格翰生物药业(中国)有限公司罗家立博士说。

通过这个生物制药商业化合同生产(CMO)服务平台,将原本生物制药产业链中的“生产瓶颈”变成“服务平台”,帮助在研新药实现产业化和价值最大化。根据上海统计局发布的数据,2019年上半年上海工业战略性新兴产业中,生物医药产业产值比去年同期增长7.6%。勃林格殷格翰生物制药商业化合同生产(CMO)服务平台的建成,则有望使上海生物制药引擎进一步加速。
德国药企首创中国生物制药创新商业模式

“目前全球一半以上已经上市的生物药是以委托生产的方式由勃林格殷格翰生产制造的!“罗家立博士介绍,勃林格殷格翰不仅是一家德国百年制药企业,更是全球生物制药领域的先行者。公司旗下BioXcellence™帮助全球业内合作伙伴生产并上市了超过三十种生物制药产品,包括用于肿瘤和免疫学的单克隆抗体、干扰素和其他靶向治疗。

2013年,勃林格殷格翰做出了一个极具远见的战略决策:在上海张江投资建设一座世界级的生物制药生产基地。由此,中国上海与德国比伯拉赫、奥地利维也纳、美国加利福尼亚一起,成为勃林格殷格翰全球四大生物制药基地之一。

作为跨国药企在华建立的第一个且唯一具有国际标准的生物制药基地,勃林格殷格翰生物药业(中国)有限公司于2017年5月正式落成投产,并于2019年初进行产能扩建,包括新增一个2000L一次性生物反应器和用于支持两条2000L生物反应器生产线进行GMP生产所需的全部基础设施设备。

比生产基地更重要的是,勃林格殷格翰在中国创立了生物制药合同生产这一创新的商业模式:为国内外生物制药企业提供服务,帮助它们生产和上市创新的生物制药产品,同时还包揽“一条龙”服务:从生产工艺开发、新药注册,临床和商业化药物生产到申请上市许可等。2016年,勃林格殷格翰成为中国药品上市许可持有人制度试点中唯一的生物制药试点企业,开展生物制药合同生产业务试点。

“就在今年国庆前夕,勃林格殷格翰生物药业(中国)有限公司被评选为上海自贸区十大创新经典样本企业,证明了试点和这个创新商业模式在中国是成功可行的。“罗家立强调,上海基地的使命是立足中国、服务全球!“勃林格殷格翰始终致力于在中国的持续发展,尤其支持上海建设成为一流的生物医药产业基地,以及全球科技创新中心的目标,并愿意贡献出我们的一份力量!”

订单排到三年后

据悉,由勃林格殷格翰生物制药生产基地受托生产的首个产品是一个单克隆抗体抗肿瘤免疫药物。目前,该药物已进入国家药品监督管理局上市最终审批的最后冲刺阶段,一旦获批,勃林格殷格翰可即刻开始大规模商业化生产,造福癌症患者。“我们已经做好充分准备!”罗家立说。
目前,勃林格殷格翰合同生产业务管线中还有着相当数量的处于临床研究阶段的高质量药物。

“上海基地的生产能力从实验室小规模级别和中试临床级别,直到可达2000立升的大规模市场化供应,能帮助医药创新产品更快更好地进入国内和国际市场。”罗家立说,由此,我们更看到了中国持续的创新,以及对世界一流生物制药生产能力的持续需求!

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    2020-06-17 zhangbaojun
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createdName=仁者大医, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535078, encodeId=1cd715350e84e, content=<a href='/topic/show?id=3df58e521e9' target=_blank style='color:#2F92EE;'>#药商#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87521, encryptionId=3df58e521e9, topicName=药商)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c72d12584423, createdName=soongzhihua, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568535, encodeId=f5d11568535b6, content=<a href='/topic/show?id=94789308131' target=_blank style='color:#2F92EE;'>#跨国药企#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93081, encryptionId=94789308131, topicName=跨国药企)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569715387953, createdName=医生2399, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1755645, encodeId=77fd1e5564566, content=<a href='/topic/show?id=85294906ef' target=_blank style='color:#2F92EE;'>#CMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4906, encryptionId=85294906ef, topicName=CMO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5e4136982125, createdName=zhangbaojun, createdTime=Wed Jun 17 07:18:00 CST 2020, time=2020-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1771802, encodeId=11af1e7180217, content=<a href='/topic/show?id=62754005931' target=_blank style='color:#2F92EE;'>#商业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40059, encryptionId=62754005931, topicName=商业)], attachment=null, authenticateStatus=null, createdAvatar=null, 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GetPortalCommentsPageByObjectIdResponse(id=1506762, encodeId=c7271506e6269, content=<a href='/topic/show?id=afce40064d1' target=_blank style='color:#2F92EE;'>#商业化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40064, encryptionId=afce40064d1, topicName=商业化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b549798360, createdName=yeaweam, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517814, encodeId=58d8151e8145e, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535078, encodeId=1cd715350e84e, content=<a href='/topic/show?id=3df58e521e9' target=_blank style='color:#2F92EE;'>#药商#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87521, encryptionId=3df58e521e9, topicName=药商)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c72d12584423, createdName=soongzhihua, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568535, encodeId=f5d11568535b6, content=<a href='/topic/show?id=94789308131' target=_blank style='color:#2F92EE;'>#跨国药企#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93081, encryptionId=94789308131, topicName=跨国药企)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569715387953, createdName=医生2399, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1755645, encodeId=77fd1e5564566, content=<a href='/topic/show?id=85294906ef' target=_blank style='color:#2F92EE;'>#CMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4906, encryptionId=85294906ef, topicName=CMO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5e4136982125, createdName=zhangbaojun, createdTime=Wed Jun 17 07:18:00 CST 2020, time=2020-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1771802, encodeId=11af1e7180217, content=<a href='/topic/show?id=62754005931' target=_blank style='color:#2F92EE;'>#商业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40059, encryptionId=62754005931, topicName=商业)], attachment=null, authenticateStatus=null, createdAvatar=null, 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GetPortalCommentsPageByObjectIdResponse(id=1506762, encodeId=c7271506e6269, content=<a href='/topic/show?id=afce40064d1' target=_blank style='color:#2F92EE;'>#商业化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40064, encryptionId=afce40064d1, topicName=商业化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b549798360, createdName=yeaweam, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517814, encodeId=58d8151e8145e, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, 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encryptionId=94789308131, topicName=跨国药企)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569715387953, createdName=医生2399, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
  6. 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GetPortalCommentsPageByObjectIdResponse(id=1506762, encodeId=c7271506e6269, content=<a href='/topic/show?id=afce40064d1' target=_blank style='color:#2F92EE;'>#商业化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40064, encryptionId=afce40064d1, topicName=商业化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b549798360, createdName=yeaweam, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517814, encodeId=58d8151e8145e, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1535078, encodeId=1cd715350e84e, content=<a href='/topic/show?id=3df58e521e9' target=_blank style='color:#2F92EE;'>#药商#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87521, encryptionId=3df58e521e9, topicName=药商)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c72d12584423, createdName=soongzhihua, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568535, encodeId=f5d11568535b6, content=<a href='/topic/show?id=94789308131' target=_blank style='color:#2F92EE;'>#跨国药企#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93081, encryptionId=94789308131, topicName=跨国药企)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569715387953, createdName=医生2399, createdTime=Fri Nov 08 04:18:00 CST 2019, time=2019-11-08, status=1, ipAttribution=)]
    2019-11-08 yeaweam
  7. 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  8. 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  9. 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