罗氏的ALK抑制剂Rozlytrek获得FDA批准治疗NTRK基因融合实体瘤和ROS1阳性NSCLC

2019-08-16 不详 MedSci原创

罗氏Genentech宣布,FDA批准其ALK 抑制剂Rozlytrek(entrectinib),用于治疗12岁以上、无治疗方法、NTRK基因融合的实体肿瘤儿童和成人患者。该机构还批准Rozlytrek治疗ROS1阳性的转移性非小细胞肺癌(NSCLC)成人患者。

罗氏Genentech宣布,FDA批准其ALK 抑制剂Rozlytrek(entrectinib),用于治疗12岁以上、无治疗方法、NTRK基因融合的实体肿瘤儿童和成人患者。该机构还批准Rozlytrek治疗ROS1阳性的转移性非小细胞肺癌NSCLC)成人患者。

美国食品和药物管理局表示,就NTRK融合阳性疾病而言,57%的患者观察到肿瘤明显缩小,其中7.4%达到肿瘤完全消失。此外,在31名肿瘤缩小的患者中,61%的患者在9个月或更长时间内得以保持萎缩。对于ROS1阳性的NSCLC患者,该机构表示总体反应率为78%,其中5.9%的患者完全消失了癌症。此外,在40名肿瘤缩小的患者中,55%的患者出现了至少持续12个月的萎缩。

罗氏首席医疗官兼全球产品开发主管Sandra Horning评论道:"Rozlytrek对两种罕见癌症的批准是对患者的一项重大进步,该药物是FDA批准的第一种选择性针对ROS1和NTRK融合的治疗方法。"

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    2019-10-22 bugit
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topicList=[TopicDto(id=15634, encryptionId=9b3e156346e, topicName=ROS1阳性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=83fc34405672, createdName=124987a0m77(暂无昵称), createdTime=Thu Dec 05 18:01:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839710, encodeId=c4e91839e108c, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Oct 22 00:01:00 CST 2019, time=2019-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852093, encodeId=b44018520934e, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 21 11:01:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668422, encodeId=b4d016684220e, content=<a href='/topic/show?id=fcde4188421' target=_blank style='color:#2F92EE;'>#基因融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41884, encryptionId=fcde4188421, topicName=基因融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b07026292028, createdName=lvygwyt2790, createdTime=Thu May 07 08:01:00 CST 2020, time=2020-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364517, encodeId=6c69136451ed2, content=<a href='/topic/show?id=7c5615628ad' target=_blank style='color:#2F92EE;'>#ROS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15628, encryptionId=7c5615628ad, topicName=ROS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442710, encodeId=de5c1442e1013, content=<a href='/topic/show?id=d6bc231956' target=_blank style='color:#2F92EE;'>#ALK抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2319, encryptionId=d6bc231956, topicName=ALK抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68704968601, createdName=12498cf9m36(暂无昵称), createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525516, encodeId=296815255164a, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533960, encodeId=cb7415339605f, content=<a href='/topic/show?id=0717156309a' target=_blank style='color:#2F92EE;'>#ROS1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15630, encryptionId=0717156309a, topicName=ROS1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573338, encodeId=97f615e333835, content=<a href='/topic/show?id=6bbc15655cc' target=_blank style='color:#2F92EE;'>#Rozlytrek#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15655, encryptionId=6bbc15655cc, topicName=Rozlytrek)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b70f15850841, createdName=lanyan20020091, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1816345, encodeId=17c7181634589, content=<a href='/topic/show?id=28dd9e5029b' target=_blank style='color:#2F92EE;'>#阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97502, encryptionId=28dd9e5029b, topicName=阳性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/XhttJCp4Aq9gKA5n4v9elclQlVQTDenMiaEiadlI5D3gtmfSiaicoIY4ZsuibrQKLibDdxBKVY8oS6B2FicqJlT93clow/132, createdBy=03202500144, createdName=ms7258648636991762, createdTime=Sat Aug 31 15:01:00 CST 2019, time=2019-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738258, encodeId=d0011e3825839, content=<a href='/topic/show?id=9b3e156346e' target=_blank style='color:#2F92EE;'>#ROS1阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15634, encryptionId=9b3e156346e, topicName=ROS1阳性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=83fc34405672, createdName=124987a0m77(暂无昵称), createdTime=Thu Dec 05 18:01:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839710, encodeId=c4e91839e108c, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Oct 22 00:01:00 CST 2019, time=2019-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852093, encodeId=b44018520934e, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 21 11:01:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668422, encodeId=b4d016684220e, content=<a href='/topic/show?id=fcde4188421' target=_blank style='color:#2F92EE;'>#基因融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41884, encryptionId=fcde4188421, topicName=基因融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b07026292028, createdName=lvygwyt2790, createdTime=Thu May 07 08:01:00 CST 2020, time=2020-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364517, encodeId=6c69136451ed2, content=<a href='/topic/show?id=7c5615628ad' target=_blank style='color:#2F92EE;'>#ROS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15628, encryptionId=7c5615628ad, topicName=ROS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442710, encodeId=de5c1442e1013, content=<a href='/topic/show?id=d6bc231956' target=_blank style='color:#2F92EE;'>#ALK抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2319, encryptionId=d6bc231956, topicName=ALK抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68704968601, createdName=12498cf9m36(暂无昵称), createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525516, encodeId=296815255164a, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533960, encodeId=cb7415339605f, content=<a href='/topic/show?id=0717156309a' target=_blank style='color:#2F92EE;'>#ROS1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15630, encryptionId=0717156309a, topicName=ROS1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573338, encodeId=97f615e333835, content=<a href='/topic/show?id=6bbc15655cc' target=_blank style='color:#2F92EE;'>#Rozlytrek#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15655, encryptionId=6bbc15655cc, topicName=Rozlytrek)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b70f15850841, createdName=lanyan20020091, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1816345, encodeId=17c7181634589, content=<a href='/topic/show?id=28dd9e5029b' target=_blank style='color:#2F92EE;'>#阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97502, encryptionId=28dd9e5029b, topicName=阳性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/XhttJCp4Aq9gKA5n4v9elclQlVQTDenMiaEiadlI5D3gtmfSiaicoIY4ZsuibrQKLibDdxBKVY8oS6B2FicqJlT93clow/132, createdBy=03202500144, createdName=ms7258648636991762, createdTime=Sat Aug 31 15:01:00 CST 2019, time=2019-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738258, encodeId=d0011e3825839, content=<a href='/topic/show?id=9b3e156346e' target=_blank style='color:#2F92EE;'>#ROS1阳性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Thu Nov 21 11:01:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1668422, encodeId=b4d016684220e, content=<a href='/topic/show?id=fcde4188421' target=_blank style='color:#2F92EE;'>#基因融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=41884, encryptionId=fcde4188421, topicName=基因融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b07026292028, createdName=lvygwyt2790, createdTime=Thu May 07 08:01:00 CST 2020, time=2020-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1364517, encodeId=6c69136451ed2, content=<a href='/topic/show?id=7c5615628ad' target=_blank style='color:#2F92EE;'>#ROS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15628, encryptionId=7c5615628ad, topicName=ROS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442710, encodeId=de5c1442e1013, content=<a href='/topic/show?id=d6bc231956' target=_blank style='color:#2F92EE;'>#ALK抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2319, encryptionId=d6bc231956, topicName=ALK抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=68704968601, createdName=12498cf9m36(暂无昵称), createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525516, encodeId=296815255164a, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533960, encodeId=cb7415339605f, content=<a href='/topic/show?id=0717156309a' target=_blank style='color:#2F92EE;'>#ROS1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15630, encryptionId=0717156309a, topicName=ROS1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573338, encodeId=97f615e333835, content=<a href='/topic/show?id=6bbc15655cc' target=_blank style='color:#2F92EE;'>#Rozlytrek#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15655, encryptionId=6bbc15655cc, topicName=Rozlytrek)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b70f15850841, createdName=lanyan20020091, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=)]
    2019-08-18 医者仁心
  7. 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05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525516, encodeId=296815255164a, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533960, encodeId=cb7415339605f, content=<a href='/topic/show?id=0717156309a' target=_blank style='color:#2F92EE;'>#ROS1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15630, encryptionId=0717156309a, topicName=ROS1)], 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  8. 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05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525516, encodeId=296815255164a, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Sun Aug 18 05:01:00 CST 2019, time=2019-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533960, encodeId=cb7415339605f, content=<a href='/topic/show?id=0717156309a' target=_blank style='color:#2F92EE;'>#ROS1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15630, encryptionId=0717156309a, topicName=ROS1)], 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    2019-08-18 licz0427
  9. 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罗氏的Genentech部门与Skyhawk Therapeutics公司签订了独家许可协议,以开发和商业化调控RNA剪接的小分子。Skyhawk指出将利用其SkySTAR技术平台开发针对某些肿瘤和神经疾病的治疗方法。

罗氏推出体外针对ROS1突变非小细胞肺癌的诊断测试

罗氏诊断公司(Roche Diagnostics)推出了首个针对ROS1阳性肺癌的体外诊断测试VENTANA ROS1(SP384)抗体。该抗体是市场上第一个也是唯一一个在体外通过免疫组化检测ROS1方法,很可能作为一种经济有效的方法来鉴定癌症中ROS1蛋白表达的升高。

罗氏、吉利德、默沙东……跨国公司高管大变动

又到了年底换帅高峰期时,谁将接替吉利德科学 CEO John Milligan的悬念终于被揭晓。

罗氏以43亿美元收购基因治疗公司Spark Therapeutics

罗氏以每股114.50美元,总计43亿美元现金收购基因疗法公司Spark Therapeutics,该交易预计将在第二季度完成。

罗氏的PD-L1单抗Tecentriq 治疗三阴性乳腺癌即将获得FDA批准

罗氏的PD-L1单抗Tecentriq(atezolizumab)与化疗药(Abraxane,nab-paclitaxel)联合,用于PD-L1阳性的、无法切除的局部晚期或转移性三阴性乳腺癌(TNBC)患者,通过了FDA的批准测试。

全新抗癌药来了,罗氏全球第三大战略中心明年上海竣工

进博会现场,罗氏制药带来的一款治疗ALK阳性局部晚期或转移性非小细胞肺癌新药——安圣莎,引发了场内外关注。这款新药在美国获批后的9个月便迅速在国内获批,基本实现与欧美同步上市。获批后短短46天,国内第一批经处方开出的安圣莎开始造福患者。“这恰恰生动见证了不断深化改革开放的中国加速度。”上海罗氏制药有限公司总经理周虹在接受文汇报记者专访时这样注解。此次参与首届中国国际进口博览会,罗氏制药高度重视,