西安杨森两款艾滋病创新药物恩临和普泽力宣布在华上市

2018-11-23 美通社 美通社

强生公司在华制药子公司西安杨森制药有限公司今日宣布上市两款药物:恩临®和普泽力®,与其他抗HIV药物联合使用,用于治疗成年1型人类免疫缺陷病毒(HIV-1)感染。 恩临®,即利匹韦林片,适用于治疗开始时1型人类免疫缺陷病毒核糖核酸(HIV-1 RNA)低于或等于100,000拷贝/mL的1型人类免疫缺陷病毒(HIV-1)感染的初治患者(12岁及以上)。普泽力®,即达芦那韦考比司他片,适用于抗逆转录

强生公司在华制药子公司西安杨森制药有限公司今日宣布上市两款药物:恩临®和普泽力®,与其他抗HIV药物联合使用,用于治疗成年1型人类免疫缺陷病毒(HIV-1)感染。 恩临®,即利匹韦林片,适用于治疗开始时1型人类免疫缺陷病毒核糖核酸(HIV-1 RNA)低于或等于100,000拷贝/mL的1型人类免疫缺陷病毒(HIV-1)感染的初治患者(12岁及以上)。普泽力®,即达芦那韦考比司他片,适用于抗逆转录病毒药物初治成年患者,以及未出现达芦那韦耐药相关突变的既往接受抗逆转录病毒药物治疗的成年患者。

西安杨森抗HIV新药普泽力、恩临正式在华上市
西安杨森抗HIV新药普泽力、恩临正式在华上市

强生公司在华制药子公司西安杨森制药有限公司今日宣布上市两款药物:恩临 和普泽力 ,与其他抗 HIV 药物联合使用,用于治疗成年 1 型人类免疫缺陷病毒 (HIV-1) 感染。

恩临®是世界上体积最小(25mg)的抗逆转录病毒药物,具有疗效确切、安全性与耐受性良好的特点[1]。恩临®获批后,西安杨森公司即与中国疾病预防控制中心签署了捐赠项目,为500名静脉注射吸毒的HIV患者提供相关治疗。2017年,恩临®被列入国家医保乙类目录,成为唯一进入此次医保目录的非核苷类反转录酶抑制剂。普泽力®由HIV蛋白酶抑制剂达芦那韦(800 mg)和药代动力学增效剂考比司他(150 mg)固定剂量组成[2]。作为在中国首个获批的由考比司他作为增效剂的蛋白酶抑制剂,普泽力®具有较高的基因耐药屏障,有助于降低耐药发生风险。恩临®和普泽力®的服药剂量均为每日一片,用法更加简便,有助于减轻患者服药负担,并提高依从性。西安杨森医学事务部副总裁李滨表示:“最新版艾滋病诊疗指南中将恩临®和普泽力®均列为一线推荐用药[3]。我们相信,恩临®和普泽力®凭借各自的药物特性将满足不同患者的用药需求,带来个性化治疗方案。”

艾滋病是一种严重的由HIV病毒感染导致的传染性疾病。2017年全球有940,000人死于艾滋相关病症[4]。在中国,报告感染病例呈持续上升趋势。2017年,中国新增报告HIV感染病例/AIDS病人134,512例,较2006年报告感染病例数上升3倍之多[5],[6]。

北京协和医院感染科主任李太生教授致辞
北京协和医院感染科主任李太生教授致辞

迄今为止,HIV病毒感染/艾滋病仍然是全球公共卫生领域最严峻的挑战之一,中国在抗击艾滋病领域成绩有目共睹,但挑战仍然存在。“尽管尚不可治愈,时至今日,罹患艾滋病已不再意味着“被宣判死刑”,北京协和医院感染科主任李太生教授解释道,“凭借先进的抗逆转录病毒疗法,艾滋病已经转变为一种慢性疾病。坚持长期治疗,患者可以过上长久并相对健康的生活。”  

尽管有证据显示,接受抗逆转录病毒疗法治疗的患者平均寿命已接近正常人群7,艾滋病药物的可及性仍然是公共卫生领域的重中之重。正如上海市公共卫生临床中心党委书记卢洪洲教授所说:“相信恩临®和普泽力®的到来可以进一步壮大中国HIV治疗一线用药的队伍,通过帮助改善治疗感受和降低耐药风险,为中国患者带来新的治疗选择”。

西安杨森制药有限公司一直致力于携手公共卫生机构等合作伙伴共同推动抗击艾滋病和HIV防治进程,为艾滋病预防、检测和治疗等工作提供支持,并开展艾滋病防治公众教育等工作。2014年起,西安杨森开始支持艾滋病全国性学术会议,并于2015年推出了HIV病毒感染相关知识的线上培训项目,为参与治疗和护理的医务人员提供专业教育服务。2018年,西安杨森又支持了中国首个艾滋病综合防治服务平台“i卫士”项目, 通过公开课、直播等方式提供在线艾滋病教育内容,使得更多的医生、患者和公众受益于这一平台。

西安杨森总裁Asgar Rangoonwala致辞
西安杨森总裁Asgar Rangoonwala致辞

“过去十年中,我们已经在全球范围内推出8种获批的艾滋病药物,并不断简化治疗方案,提升疗效和耐受性。未来,我们将推出艾滋病长效注射药物,相较于目前每日服药治疗的方法,患者使用长效针剂只需每月进行一次注射。从长远来看,我们的最终目标是研发出可以预防和阻止病毒传播的HIV疫苗”,西安杨森总裁Asgar Rangoonwala表示,“在中国,我们致力于与多方密切合作,携手创新。我们坚信,通过我们的共同努力,HIV终将被彻底消除,而恩临®和普泽力®就是实现这一目标的关键一步。”

参考文献:

[1] Edurant (rilpivirine). Prescribing Information.

[2] Prezcobix(darunavir and cobicistat). Prescribing Information.

[3] 中华医学会感染病学分会艾滋病丙型肝炎学组/中国疾病预防控制中心. 中国艾滋病诊疗指南(2018版). 中华内科杂志.2018(57) 12:882-867

[4] http://www.unaids.org/en/resources/fact-sheet

[5] 中国疾病预防控制中心性病艾滋病预防控制中心性病控制中心. 中国艾滋病性病. 2018(24) 2:111

[6] 秦倩倩等. 2006年全国艾滋病网络直报部分内容报告质量分析. 疾病监测. 2007(22) 11:769-772

[7] https://www.eurekalert.org/pub_releases/2017-05/tl-tlh050917.php

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    2018-11-25 陆成振
  5. [GetPortalCommentsPageByObjectIdResponse(id=1923614, encodeId=ad2b192361430, content=<a href='/topic/show?id=f9f25864447' target=_blank style='color:#2F92EE;'>#新药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58644, encryptionId=f9f25864447, topicName=新药物)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIuNQXObUwZmFG3VcZa2uhFq27sY7vfTowUhQCgRj2bj1odUibMF4sFXpuRLf6IE5t5yGVDSiaOoOcQ/132, createdBy=1e622500088, createdName=ms1065684921169360, createdTime=Wed Jul 03 19:45:00 CST 2019, time=2019-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285673, encodeId=facf12856e363, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Sun Nov 25 08:45:00 CST 2018, time=2018-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1424972, encodeId=654b14249e231, content=<a href='/topic/show?id=d42b90494af' target=_blank style='color:#2F92EE;'>#西安杨森#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=90494, encryptionId=d42b90494af, topicName=西安杨森)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f7a73942387, createdName=qindq, createdTime=Sun Nov 25 08:45:00 CST 2018, time=2018-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1543217, encodeId=89c9154321ef4, content=<a href='/topic/show?id=f2be61592eb' target=_blank style='color:#2F92EE;'>#杨森#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61592, encryptionId=f2be61592eb, topicName=杨森)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=421413558235, createdName=陆成振, createdTime=Sun Nov 25 08:45:00 CST 2018, time=2018-11-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353469, encodeId=92ac353469e5, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Nov 23 18:24:41 CST 2018, time=2018-11-23, status=1, ipAttribution=)]
    2018-11-23 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0