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抗肿瘤植物药现状及趋势分析

日期:2020-8-6   浏览: 次

关(guan)键词:植物药,抗肿瘤药,植物碱,紫(zi)杉醇类


癌症一直以来是严重威胁人类健康的一类常见疾病近年来,全球抗肿瘤药物市场一直都在持续增长中。调查数据显示,2010年我国抗肿瘤药物市场规模达到491.26亿元,同比增长21.30%。在医院用药排名中,抗肿瘤药物已从2002年的第4位跃升至2010年的第2位,仅次于抗感染用药,在医院用药市场份额中达到17.6%,比五年前提高了5个百分点。近几年的数据显示植物药抗肿瘤一直处于走高的趋势,但发展缓慢。市场主导的明星产品发展趋缓,只有个别单品出现了快速增长的局面,未来的植物药发展又会有怎样的瓶颈和机遇?

根据(ju)中(zhong)(zhong)国(guo)市(shi)(shi)场(chang)调查中(zhong)(zhong)心的(de)数据(ju)显(xian)示(shi),在(zai)(zai)众多(duo)(duo)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)中(zhong)(zhong),植(zhi)(zhi)物(wu)类(lei)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)的(de)用(yong)(yong)药(yao)(yao)(yao)份额一直处于(yu)各(ge)类(lei)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)之(zhi)首,最新数据(ju)显(xian)示(shi),2010年其(qi)市(shi)(shi)场(chang)份额已(yi)增长(zhang)到37.14%。在(zai)(zai)中(zhong)(zhong)国(guo)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)市(shi)(shi)场(chang)上,销售较好的(de)植(zhi)(zhi)物(wu)生物(wu)碱(jian)和(he)其(qi)他(ta)天然药(yao)(yao)(yao)是紫杉(shan)醇(chun)、羟喜树碱(jian)、长(zhang)春(chun)瑞滨、多(duo)(duo)西他(ta)赛(sai)等。这(zhei)类(lei)药(yao)(yao)(yao)物(wu)不但在(zai)(zai)干(gan)扰癌(ai)(ai)细(xi)胞(bao)的(de)微蛋白(bai)合(he)成中(zhong)(zhong)发挥(hui)主(zhu)(zhu)要作用(yong)(yong),而且还具有(you)诱导细(xi)胞(bao)凋亡、抗(kang)血管(guan)形成的(de)积(ji)极作用(yong)(yong),在(zai)(zai)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)物(wu)中(zhong)(zhong)有(you)不可(ke)替代地位(wei)。该类(lei)药(yao)(yao)(yao)物(wu)临(lin)床需求的(de)走高(gao),推动了(le)其(qi)上游原料药(yao)(yao)(yao)市(shi)(shi)场(chang)的(de)火爆(bao)。与此同时(shi),新的(de)产品(pin)也(ye)崭露头(tou)角,据(ju)中(zhong)(zhong)国(guo)医(yi)(yi)(yi)药(yao)(yao)(yao)工业(ye)信息中(zhong)(zhong)心数据(ju)显(xian)示(shi)2011年抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)植(zhi)(zhi)物(wu)药(yao)(yao)(yao)销售金额放缓(huan),各(ge)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)植(zhi)(zhi)物(wu)药(yao)(yao)(yao)的(de)增长(zhang)高(gao)低各(ge)不同,除了(le)明星产品(pin)外,到底哪些产品(pin)具有(you)新的(de)市(shi)(shi)场(chang)抗(kang)癌(ai)(ai)价值?从进(jin)出(chu)(chu)口数据(ju)的(de)分析到国(guo)内外市(shi)(shi)场(chang)的(de)现状(zhuang)分析和(he)发展(zhan)趋(qu)势,生物(wu)谷邀(yao)请中(zhong)(zhong)国(guo)医(yi)(yi)(yi)药(yao)(yao)(yao)保(bao)健品(pin)进(jin)出(chu)(chu)口商会副主(zhu)(zhu)任张中(zhong)(zhong)朋,上海医(yi)(yi)(yi)药(yao)(yao)(yao)工业(ye)研究院的(de)市(shi)(shi)场(chang)分析师范淮平一同座客2012抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)植(zhi)(zhi)物(wu)药(yao)(yao)(yao)产业(ye)发展(zhan)论坛,针对(dui)我国(guo)植(zhi)(zhi)物(wu)类(lei)抗(kang)肿(zhong)(zhong)(zhong)(zhong)瘤(liu)(liu)药(yao)(yao)(yao)物(wu)的(de)市(shi)(shi)场(chang)状(zhuang)况做出(chu)(chu)了(le)分析。

天(tian)然药(yao)(yao)(yao)无(wu)论在(zai)减轻(qing)临(lin)床(chuang)症状(zhuang)、提高生(sheng)存质量、防止复发(fa)(fa)转移、延长(zhang)生(sheng)存期(qi),还是(shi)在(zai)与放化(hua)疗配(pei)合(he)、增效减毒(du)等方面(mian)都有很好的效果(guo)。全球所(suo)应用(yong)175种抗癌药(yao)(yao)(yao)物(wu)中(zhong)(zhong),有57%直接或间接来源于天(tian)然产物(wu)。但是(shi)仅6%做过生(sheng)物(wu)活(huo)性筛选,15%经过植物(wu)化(hua)学的评价,不(bu)到(dao)10%的药(yao)(yao)(yao)用(yong)植物(wu)经过详细(xi)的药(yao)(yao)(yao)理研(yan)究(jiu)。所(suo)以,天(tian)然产物(wu)研(yan)发(fa)(fa)创新药(yao)(yao)(yao)物(wu)的潜(qian)能(neng)十分巨大。结合(he)西药(yao)(yao)(yao)的联(lian)合(he)用(yong)药(yao)(yao)(yao),临(lin)床(chuang)效果(guo)也有明显提高,无(wu)论是(shi)从药(yao)(yao)(yao)品的活(huo)性筛选,临(lin)床(chuang)安全评估还是(shi)到(dao)欧盟注(zhu)册审批都离不(bu)开临(lin)床(chuang),由(you)中(zhong)(zhong)科院上海(hai)药(yao)(yao)(yao)物(wu)研(yan)究(jiu)所(suo)俞强教授、赛诺菲临(lin)床(chuang)研(yan)发(fa)(fa)总(zong)监杨毅(yi)、中(zhong)(zhong)国中(zhong)(zhong)医科学院叶祖光及中(zhong)(zhong)国药(yao)(yao)(yao)科大学教授梁毅(yi)等研(yan)究(jiu)员分别就(jiu)以上相关信息将(jiang)做详细(xi)讲解。

紫杉醇和(he)多西(xi)他(ta)赛领衔植物类(lei)抗肿(zhong)瘤药

紫杉醇是(shi)一(yi)种天然(ran)植物(wu)(wu)类抗肿瘤(liu)新药,于(yu)(yu)20世纪(ji)60 年(nian)代末由美国(guo)国(guo)立癌(ai)症(zheng)研究所(suo)(NCI)从太平洋短叶紫杉的(de)树(shu)皮中提取(qu),分离后得到(dao)具有紫杉烯环的(de)二萜类化(hua)合(he)物(wu)(wu)。经NCI 与施贵宝公(gong)司30多(duo)年(nian)的(de)开(kai)发,1992 年(nian)12 月获(huo)得FDA 批准上市,商品(pin)(pin)名(ming)为泰素,现(xian)已在世界50多(duo)个国(guo)家上市,主要(yao)用于(yu)(yu)治疗卵(luan)巢癌(ai)、乳腺癌(ai)和(he)非小(xiao)细(xi)胞(bao)肺癌(ai)和(he)卡波络(luo)式恶性肿瘤(liu)。多(duo)西(xi)他赛属(shu)于(yu)(yu)微管(guan)解聚抑制剂(ji)(ji),并不是(shi)一(yi)种天然(ran)物(wu)(wu)质(zhi),必(bi)须以半合(he)成的(de)方式来(lai)生(sheng)产(chan),该(gai)产(chan)品(pin)(pin)由法国(guo)罗纳(na)普(pu)朗克乐安公(gong)司开(kai)发的(de)一(yi)个半合(he)成紫杉醇衍生(sheng)物(wu)(wu),该(gai)品(pin)(pin)以注(zhu)射剂(ji)(ji)为主,辅以粉针和(he)胶(jiao)囊剂(ji)(ji),是(shi)用于(yu)(yu)乳腺癌(ai)、非小(xiao)细(xi)胞(bao)肺癌(ai)的(de)化(hua)疗药物(wu)(wu)。

根(gen)BioInsight数据显示,在(zai)(zai)单品排(pai)名前10位的(de)抗(kang)肿瘤(liu)药(yao)中(zhong)(zhong),紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)和(he)多(duo)(duo)西(xi)他赛占据了前两位的(de)席位。国(guo)际(ji)市场上(shang)有(you)2种(zhong)(zhong)(zhong)(zhong)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)原料药(yao):一(yi)种(zhong)(zhong)(zhong)(zhong)来自各(ge)种(zhong)(zhong)(zhong)(zhong)红豆(dou)杉(shan)(shan)(shan)(shan)(shan)树(shu)皮;另一(yi)种(zhong)(zhong)(zhong)(zhong)是从欧洲(zhou)观(guan)赏紫(zi)杉(shan)(shan)(shan)(shan)(shan)枝条里提取(qu)出10-浆(jiang)果赤霉碱,然(ran)后再经半(ban)合成(cheng)(cheng)而成(cheng)(cheng),即多(duo)(duo)西(xi)他赛(多(duo)(duo)烯紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun))和(he)卡巴他赛。红豆(dou)杉(shan)(shan)(shan)(shan)(shan)是一(yi)种(zhong)(zhong)(zhong)(zhong)具有(you)很高经济、生(sheng)态(tai)和(he)科(ke)研价(jia)(jia)值的(de)植(zhi)(zhi)物(wu)(wu),其(qi)(qi)野生(sheng)资源十分(fen)珍(zhen)贵(gui),随着人(ren)(ren)工培(pei)(pei)育红豆(dou)杉(shan)(shan)(shan)(shan)(shan)技(ji)术的(de)成(cheng)(cheng)熟,我国(guo)人(ren)(ren)工红豆(dou)杉(shan)(shan)(shan)(shan)(shan)种(zhong)(zhong)(zhong)(zhong)植(zhi)(zhi)规(gui)模日益扩大(da),但市场种(zhong)(zhong)(zhong)(zhong)植(zhi)(zhi)领(ling)域也出现了不同(tong)程度的(de)弊端(duan),怎样(yang)合理规(gui)划(hua)种(zhong)(zhong)(zhong)(zhong)植(zhi)(zhi)和(he)生(sheng)产规(gui)范,期待大(da)家(jia)共同(tong)关注(zhu)和(he)探讨。目(mu)前,人(ren)(ren)类获得(de)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)的(de)方法(fa)有(you):天(tian)然(ran)提取(qu)、人(ren)(ren)工合成(cheng)(cheng)、人(ren)(ren)工半(ban)合成(cheng)(cheng)、生(sheng)物(wu)(wu)发(fa)(fa)(fa)酵和(he)细胞(bao)培(pei)(pei)养。其(qi)(qi)中(zhong)(zhong)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)的(de)人(ren)(ren)工半(ban)合成(cheng)(cheng)技(ji)术已非(fei)常成(cheng)(cheng)熟,占据其(qi)(qi)产量的(de)绝(jue)大(da)部分(fen)。但目(mu)前国(guo)内(nei)外合成(cheng)(cheng)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)和(he)多(duo)(duo)烯紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)一(yi)般(ban)都采用(yong)(yong)(yong)不对(dui)称催化(hua)反(fan)应或(huo)手(shou)性(xing)源合成(cheng)(cheng),但由于(yu)所用(yong)(yong)(yong)的(de)手(shou)性(xing)催化(hua)剂价(jia)(jia)格(ge)昂贵(gui)或(huo)者反(fan)应步(bu)骤太长,其(qi)(qi)生(sheng)产成(cheng)(cheng)本高。第四军医大(da)学中(zhong)(zhong)国(guo)工程院(yuan)院(yuan)士张生(sheng)勇与中(zhong)(zhong)国(guo)科(ke)学院(yuan)上(shang)海药(yao)物(wu)(wu)研究(jiu)所李亚平研究(jiu)员将在(zai)(zai)2012抗(kang)肿瘤(liu)植(zhi)(zhi)物(wu)(wu)药(yao)产业发(fa)(fa)(fa)展论坛(tan)上(shang),就(jiu)紫(zi)杉(shan)(shan)(shan)(shan)(shan)烷人(ren)(ren)工半(ban)合成(cheng)(cheng)和(he)新剂型的(de)开发(fa)(fa)(fa)发(fa)(fa)(fa)表演(yan)讲。国(guo)内(nei)的(de)一(yi)些(xie)厂(chang)商目(mu)前也已成(cheng)(cheng)功开发(fa)(fa)(fa)利用(yong)(yong)(yong)细胞(bao)培(pei)(pei)养法(fa)在(zai)(zai)工厂(chang)里成(cheng)(cheng)批培(pei)(pei)养紫(zi)杉(shan)(shan)(shan)(shan)(shan)树(shu)皮细胞(bao)生(sheng)产紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)的(de)工作。随着技(ji)术的(de)不断改(gai)进,相(xiang)信(xin)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)产量将会(hui)进一(yi)步(bu)扩大(da)。而以(yi)往的(de)传(chuan)统植(zhi)(zhi)物(wu)(wu)类抗(kang)肿瘤(liu)药(yao)除了用(yong)(yong)(yong)于(yu)治疗癌症,在(zai)(zai)其(qi)(qi)他适应症上(shang)也得(de)到了研究(jiu),例(li)如紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)在(zai)(zai)治疗风湿性(xing)关节(jie)炎和(he)紫(zi)杉(shan)(shan)(shan)(shan)(shan)醇(chun)洗脱(tuo)型药(yao)物(wu)(wu)支架(jia)上(shang)的(de)应用(yong)(yong)(yong)等。2012抗(kang)肿瘤(liu)植(zhi)(zhi)物(wu)(wu)药(yao)产业发(fa)(fa)(fa)展论坛(tan)组委会(hui)就(jiu)濒临灭绝(jue)的(de)植(zhi)(zhi)物(wu)(wu)大(da)熊猫――红豆(dou)杉(shan)(shan)(shan)(shan)(shan),做专题讨论,来自植(zhi)(zhi)物(wu)(wu)所的(de)专家(jia)将针对(dui)人(ren)(ren)工种(zhong)(zhong)(zhong)(zhong)植(zhi)(zhi)的(de)领(ling)域开发(fa)(fa)(fa)和(he)利用(yong)(yong)(yong)等环节(jie)做相(xiang)关的(de)指导和(he)评(ping)价(jia)(jia)。

植物类(lei)抗肿(zhong)瘤药研究新成果不断

面(mian)对(dui)植物(wu)药(yao)这所宝(bao)库(ku),国(guo)内(nei)外科学(xue)(xue)家们一直(zhi)都在研究探索。近年来(lai)(lai)(lai),科学(xue)(xue)家们已经陆(lu)续(xu)从香茶菜(cai)、水(shui)飞蓟(ji)、鹰嘴豆、雷公藤甲素、黄花(hua)蒿,榄香烯等多种植物(wu)中分离提取出了有(you)效的抗肿(zhong)瘤成分。未来(lai)(lai)(lai)的抗肿(zhong)瘤明星(xing)产(chan)品(pin)(pin)不断出新,面(mian)对(dui)新的市(shi)(shi)场(chang)导向和相关专利的到(dao)期,新产(chan)品(pin)(pin)的问(wen)世又(you)将给传统产(chan)品(pin)(pin)带(dai)来(lai)(lai)(lai)怎(zen)样的冲击?面(mian)对(dui)海外市(shi)(shi)场(chang)的出口形式我(wo)国(guo)内(nei)现有(you)的资源又(you)将面(mian)临怎(zen)样的考(kao)验?对(dui)于国(guo)内(nei)原料的市(shi)(shi)场(chang)供应(ying)短缺和价格规范等一系列问(wen)题(ti),又(you)该如何解(jie)决?新型的抗癌品(pin)(pin)种又(you)会给企业(ye)带(dai)来(lai)(lai)(lai)哪些商机和挑(tiao)战?来(lai)(lai)(lai)自上海交通大学(xue)(xue)医学(xue)(xue)院(yuan)院(yuan)长陈(chen)国(guo)强(qiang),厦门大学(xue)(xue)药(yao)学(xue)(xue)院(yuan)副(fu)院(yuan)长曾(ceng)锦章以及大连(lian)华立金港药(yao)业(ye)公司(si)董事谢恬就此进(jin)一步与大家一同(tong)探讨!

2012年9月26-27日,由生物(wu)(wu)谷(gu)主办的(de)(de)"2012抗(kang)肿瘤(liu)植(zhi)(zhi)物(wu)(wu)药(yao)(yao)产(chan)业发展论坛"将在上海召开,会议(yi)将围绕"植(zhi)(zhi)物(wu)(wu)类抗(kang)肿瘤(liu)药(yao)(yao)品原料和制剂市场(chang)分(fen)(fen)析及(ji)未来预测"、"医改新政对(dui)抗(kang)肿瘤(liu)药(yao)(yao)物(wu)(wu)市场(chang)的(de)(de)发展分(fen)(fen)析"、"植(zhi)(zhi)物(wu)(wu)类抗(kang)肿瘤(liu)药(yao)(yao)物(wu)(wu)的(de)(de)资(zi)源利用(yong)与(yu)发展"、"传(chuan)统(tong)植(zhi)(zhi)物(wu)(wu)药(yao)(yao)欧洲审批和质量标准策略"、"抗(kang)肿瘤(liu)植(zhi)(zhi)物(wu)(wu)药(yao)(yao)最新药(yao)(yao)物(wu)(wu)研(yan)(yan)发进(jin)展概况"等主题,邀请(qing)行(xing)业协会/学会、植(zhi)(zhi)物(wu)(wu)药(yao)(yao)生产(chan)企(qi)业(上下游产(chan)业链(lian))、医疗(liao)及(ji)临床(chuang)检(jian)验和检(jian)测机构、科研(yan)(yan)院所(suo)、仪(yi)器设备(bei)供应商、法律咨询机构等国内外同行(xing),共同交流行(xing)业经验、分(fen)(fen)享最新资(zi)讯、探讨(tao)传(chuan)统(tong)植(zhi)(zhi)物(wu)(wu)药(yao)(yao)抗(kang)肿瘤(liu)领域面(mian)临的(de)(de)机遇和挑战。

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