艾滋疫情激发新药渴求 20品种跻身畅销药500强
 来源： 医药经济报 作者：蔡德山 2010年12月10日16:18
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| 图示∶2010年12月即将出版的《中国特色医疗金鉴》登载的刘君主任及其机构 |
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我国累计报告艾滋病死亡病例6.8万余例，局部地区疫情严重。人们渴望抗HIV/AIDS疫苗诞生及疗效更好新药上市。
【慧聪制药工业网】12月1日是第23个世界艾滋病日。卫生部11月29日通报称，截至2010年10月底，累计报告艾滋病病毒感染者和病人37万余例，其中病人13万余例，死亡6.8万余例。
据世界卫生组织报道，自上世纪80年代初发现艾滋病后，在免疫缺陷病毒（HIV）感染扩散下，全球艾滋病患者群体逐年扩大。近两年，随着不同类别药物“鸡尾酒式”重新组合的临床推广，抗HIV市场正经历着跨越式的发展，但是部分药物专利期满后，销售额也在下降。
GBIResearch商业情报公司对抗HIV未来市场预测显示，到2015年，全球HIV治疗市场年复合增长率（CAGR）为3.7％。
20品种跻身畅销药500强
据IMS数据显示，近5年来，全球抗HIV药物市场年均增速13%。2009年，全球HIV治疗市场达到140亿美元，比上一年增长13.43%。其中，美国吉利德生物、英国葛兰素史克、美国百时美施贵宝的销售额占据抗HIV药物总额的80%以上。
近两年，全球领先的500强畅销药物中，抗HIV药物已有20个品种。其中，处于平稳增长的品种是恩曲他滨+替诺福韦酯、恩曲他滨+替诺福韦酯+依非韦伦、利托那韦+洛匹那韦、阿扎那韦、依非韦伦、阿巴卡韦+拉米夫定、恩夫韦肽、恩替卡韦、氨普那韦和奈韦拉平等10个药物，占总体市场的83%，同比上一年增长了24.96%。
分析表明，疗效较好的复方制剂逐渐主导市场；副作用较大、病人耐受性较差的药物已处于负增长态势。其中，去羟肌苷、司他夫定、替拉那韦和恩曲他滨是下滑较大的品种，已经跌出全球500强药品市场。据国外分析预测，到2017年，抗HIV药物市场将稳步达到150多亿美元的用药水平。
在我国，SFDA批准国内生产和进口的药物已有21个。2009年，我国将国家免费治疗的抗艾滋病药品和沙奎那韦、阿德福韦酯、齐多拉米双夫定、恩曲他滨、恩夫韦肽等药物全部收入《国家基本医疗保险、工伤保险和生育保险药品目录》，从而在抗HIV临床中发挥了重要作用。
我国实行抗艾滋病病毒药品定点生产、统一集中采购，纳入国家药品储备，统一分配、调拨，并通过全国疾病预防控制网络逐级分发。因此，国内抗HIV药物市场由两部分构成，一是医院使用；二是政府采购分配。目前，在医院接受治疗的患者很少，而政府采购是主体。
2009年，国内22个城市样本医院直接作用于病毒用药为8.88亿元，比上一年增长了28.02%。随着《艾滋病防治条例》的颁布，在卫生部抗艾滋病药物招标采购计划的推动下，样本医院使用的抗免疫缺陷病毒治疗药物已增加到12个品种，在单方传统核苷类逆转录酶抑制剂用药金额下降的影响下，预期增长率仍然超过20%。其中，拉米夫定、恩替卡韦占据了50%以上的份额。
据业内人士分析，抗HIV主要产品国产化后，每例患者每年使用的进口药和国产药直接费用仍在1万元左右。
国产拉米夫定、齐多夫定产量上扬
核苷类逆转录酶抑制剂（NRTIS）是最先问世、品种较多、应用较广的一类药物，临床证实对HIV复制具有很强的抑制作用。目前，临床使用的主要品种有齐多夫定、拉米夫定、司他夫定、去羟肌苷、阿巴卡韦、扎西他滨等，近年用于抗HIV的新品种是恩曲他滨、替诺福韦酯。
齐多夫定最早于1964年合成，在对化合物不断的筛选研制后，由英国威尔康公司开发上市，1987年3月获得美国FDA批准，是首次用于抗HIV/AIDS预防和治疗的口服胶囊剂，商品名为“立妥威”。上世纪已有近百个国家临床使用。
齐多夫定现已载入英、美等多国药典。上世纪末，齐多夫定进入中国市场。2002年，东北制药总厂研发的齐多夫定率先获得生产批件。2008年4月湖北朗欧药业齐多夫定注射用粉针剂获批时，SFDA已批准20家企业生产齐多夫定，主要有原料药、胶囊、片剂、注射液、注射用粉针和口服液。
拉米夫定是葛兰素史克公司开发的一种胞嘧啶核苷衍生物类口服制剂，1995年11月17日获FDA批准后上市，商品名“贺普丁”和“益平维”。该药是单方制剂，也是抗HIV“鸡尾酒组合疗法”主要方案中的重要组分。1998年，FDA批准贺普丁用于抗慢性乙肝病毒（CHB）感染的新适应症，从而扩大了市场份额。1998年，葛兰素史克将拉米夫定引入我国市场并获得行政保护。
2009年，葛兰素史克的拉米夫定全球性市场比上一年增长了5.81%。在抗HIV市场中，核苷类逆转录酶抑制剂是重要的组分之一，但是单方用药已呈下滑趋势，仅占总体市场的8%，而复方制剂已是发展方向。
随着贺普丁在我国行政保护结束，国内对拉米夫定的开发有了实质性进展，改变了进口药物一统天下的局面。2008年，SFDA批准上海迪赛诺化学制药有限公司生产拉米夫定原料药，尔后又批准北京万生药业、湖南千金湘江药业、福建广生堂药业、安徽贝克和美吉斯制药（厦门）生产。据中国化学制药工业协会数据显示：2009年，抗艾滋病药物拉米夫定在出口增长458%的拉动下，产量增长394%；齐多夫定出口量大增，占到品种产量三分之一，2009年产量增长119%。
尽管部分抗免疫缺陷病毒“鸡尾酒”复方制剂有一定的副作用，但是复方制剂仍是当前抗HIV的主推品种，也是拉动抗HIV药物市场的动力。从2009年世界市场分析，7个复方制剂的市场份额为86.65亿美元，比上一年增长了18.34%；占抗HIV总体市场的61.45%，比上一年提高了1.2个百分点。美国吉利德生物、英国葛兰素史克、美国百时美施贵宝、美国阿博特雅培、美国默沙东在复方制剂市场呈现出新的鼎足之势。
迄今为止，SFDA已批准了3个抗HIV复方制剂，分别是拉米夫定/齐多夫定片（双汰芝）、阿巴卡韦双夫定片（三协唯）、洛匹那韦+利托那韦软胶囊和片剂（克力芝）。2009年，样本医院抗HIV用药主要品种是进口药克力芝和双汰芝，两个复方制剂用药金额仅占全部用药的8%左右。
随着世界卫生组织对HIV/AIDS的全面重视和科学评价，免疫缺陷病毒感染人数统计数据已进一步透明，从而引起了全社会的高度关注。我国已将抗HIV基本药物载入2009版《国家基本医疗保险、工伤保险和生育保险药品目录》和《国家基本药物目录》，为临床使用开了绿灯。
抗HIV药品属于免疫缺陷病毒感染者终生用药，而药品的昂贵费用也决定了巨大的市场空间，吸引了制药厂商的激烈追逐。但是，目前获得合理规范治疗的人群覆盖率仍然较低，贫困和营养不足也加剧了并发症及严重机会性感染的发生。
许多地区的感染数难以得到有效遏制，人们更渴望抗HIV/AIDS疫苗的诞生及疗效更好的新药上市。
细胞学的发展历程是什么
| 1975年，英国人F.Sanger设计出DNA测序的双脱氧法，1980年获诺贝尔化学奖。此外Sanger还由于1953年测定了牛胰岛素的一级结构而获得1958年诺贝尔......
1、1839年，捷克人J.E.Pukinye用protoplasm这一术语描述细胞物质，“Protoplast”为神学用语，指人类始祖亚当。
2、1879年，德国人W.Flemming观察了蝾螈细胞的有丝分裂，于1882年提出了mitosis这一术语。德国人E.Strasburger(1876~80)在植物细胞中发现有丝分裂。
3、1883年，人E.vanBeneden发现马蛔虫Ascarismegalocephala的减数分裂现象。
4、1871年，德国人F.Miescher从脓细胞中分离出核酸。
5、1928年，英国微生物学家F.Griffith于发表了著名的肺炎双球菌转化试验。
线粒体
6、1944年，美国人O.Avery，C.Macleod和M.McCarthy等人通过微生物转化试验证明DNA是遗传物质。
7、1953年，美国人J.D.Watson和英国人F.H.C.Crick提出DNA双螺旋模型。
8、1956年，蒋有兴(美籍华人)利用徐道觉发明的低渗处理技术证实了人的2n为46条，而不是48条。
9、1961年，英国人P.Mitchell提出线粒体氧化磷酸化偶联的化学渗透学说，获1978年诺贝尔化学奖。
10、1961~64年，美国人M.W.Nirenberg破译DNA遗传密码。
11、1968年，瑞士人WernerArber从细菌中发现DNA限制性内切酶。
12、1970年，美国人D.Baltimore、R.Dulco和H.Temin由于发现逆转录酶而共享诺贝尔生理医学奖。
13、1973年，美国人S.Cohen和H.Boyer将外源基因拼接在质粒中，在大肠杆菌中表达，揭开基因工程的序幕。
14、1975年，英国人F.Sanger设计出DNA测序的双脱氧法，1980年获诺贝尔化学奖。此外Sanger还由于1953年测定了牛胰岛素的一级结构而获得1958年诺贝尔化学奖。
15、1975年，德国人G.J.F.Kohler、阿根廷C.Milstein和丹麦科学家N.K.Jerne发展了单克隆抗体技术，荣获1984年度诺贝尔生理医学奖。
16、1981年，美国首次发现艾滋病，1983年，法国巴斯德研究所的LucMontagbier发现AIDS病毒。艾滋病的全称为AcquiredImmunoDeficiencySyndrome，由人类免疫缺陷病毒HIV引起。20年来全球共有约5800万人受到艾滋病病毒感染，2200万人死于艾滋病。我国于1985年发现。
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Stimulate HIV epidemic among drug-selling drug craving 20 500 species
Source: Medicine Economic News Analysis: Choy Hill at 16:18 on December 10th, 2010
China reported a total of 6.8 million cases of AIDS deaths in some areas the epidemic is serious. People want anti-HIV / AIDS vaccine and efficacy of the birth of more new drugs.
【Network】 HC pharmaceutical industry is the December 1 World AIDS Day 23. Ministry of Health, November 29 informed that, as of the end of October 2010, the cumulative reported HIV infection and the patient more than 37 cases, of which 13 million cases of patients, the death of 6.8 million cases.
The World Health Organization reported that since the early 80s of last century after the discovery of AIDS in the immunodeficiency virus (HIV) infection spreads, the global AIDS community has expanded each year. The past two years, with the different types of drugs "cocktail" re-combination of clinical, anti-HIV market is experiencing the development by leaps and bounds, but some of the drugs after patent expiry, sales have been declining.
GBIResearch business intelligence company forecast future market against HIV by 2015, global HIV treatment market compound annual growth rate (CAGR) of 3.7%.
Details of HIV drug market
20 species among the 500 best-selling drug
According to IMS data, the past 5 years, the global anti-HIV drug market, the average annual growth rate of 13%. In 2009, global HIV treatment market of 140 million U.S. dollars, up 13.43% over the previous year. Among them, the U.S. Gilead Biology, GlaxoSmithKline UK, the U.S. Bristol-Myers Squibb's sales of anti-HIV drugs account for 80% of the total.
Past two years, the world's leading top 500 best-selling drugs, anti-HIV drugs for more than 20 varieties. Which, in the steady growth of the species is emtricitabine + tenofovir ester, emtricitabine + tenofovir + efavirenz ester, ritonavir + lopinavir, ritonavir Azar, efavirenz, abacavir + lamivudine, En Fuwei peptide, entecavir, ammonia & P Equal ritonavir and nevirapine 10 drugs accounted for 83% of the overall market, an increase of 24.96% the previous year.
Analysis showed that the compound effect of better gradually dominate the market; side effects, poor patient tolerance of drugs already in negative growth. Among them, didanosine, stavudine, and ritonavir for the pull-emtricitabine is a decline in larger species, has dropped out of the top 500 pharmaceutical market. According to foreign analysis and forecast that by 2017, anti-HIV drug market will steadily to reach 150 billion dollars in medication.
In China, SFDA approved drug of domestic production and imports have been 21. In 2009, China's free treatment for the country's anti-AIDS drugs and saquinavir, adefovir dipivoxil, Qiduolami double Telbivudine, emtricitabine, En Fuwei peptide drugs such as total income "national basic medical insurance, injury insurance and maternity insurance medicine directory ", which in clinical anti-HIV play an important role.
China's fixed-point implementation of anti-HIV drugs production, centralized purchasing, in the national medical stores, uniform distribution, allocation, and the national disease prevention and control through the gradual distribution. Thus, the domestic anti-HIV drug market consists of two parts, one hospitals; Second, the government procurement and distribution. Currently, patients receiving treatment in hospitals is small, and is the subject of government procurement.
In 2009, the national sample of hospitals in 22 cities directly on the virus drugs 8.88 billion, an increase of 28.02% the previous year. With the "AIDS Prevention and Control Act," the promulgation of anti-AIDS drugs in the Ministry of Health procurement plan under the impetus of the tender, the sample hospitals of anti-HIV drugs has been increased to 12 species, in the unilateral traditional nucleoside reverse transcriptase inhibitor agent under the influence of drugs decreased the amount of expected growth is still over 20%. Among them, lamivudine, entecavir occupy more than 50% of the share.
According to industry analysts, the main anti-HIV product localization, each patient used in each of the imported drugs and medicines made about the direct costs are still 1 million.
Domestic lamivudine, zidovudine production rose
Nucleoside reverse transcriptase inhibitors (NRTIS) was the first to come out, more varieties, a wider application of a class of drugs, clinically proven replication of HIV has a strong inhibitory effect. Currently, the clinical use of the main varieties of zidovudine, lamivudine, stavudine, didanosine, abacavir, Tashi gemcitabine, etc., in recent years, new varieties for resistance to HIV is a boon song He Bin, tenofovir esters.
AZT was first synthesized in 1964, continued screening of compounds in development, the development of listed companies by the British Wellcome, in March 1987 the U.S. FDA approval is the first time for the anti HIV / AIDS prevention and treatment oral capsules, trade name "Wei Li properly." The last century, nearly one hundred countries have clinical use.
Zidovudine has been included British, American and other multi-national pharmacopoeia. The last century, zidovudine into the Chinese market. In 2002, the Northeast Pharmaceutical Factory R & D received the first production of zidovudine approval document. April 2008 Hubei Pharmaceutical zidovudine Langou powder for injection upon approval, SFDA has approved 20 enterprises producing zidovudine, mainly bulk drugs, capsules, tablets, injection, injectable powder for injection and oral solution.
GlaxoSmithKline Lamivudine is a cytosine nucleoside derivatives developed class of oral agents, 17 November 1995 after approval by the FDA listing, trade name "lamivudine" and "Yi Ping-dimensional." The drug is prescribed preparations, but also anti-HIV "cocktail combination therapy" an important component in the main program. In 1998, FDA approval of lamivudine for chronic hepatitis B virus resistant (CHB) infection of the new indication, thereby expanding the market share. In 1998, the introduction of lamivudine GlaxoSmithKline will market and access to executive protection.
In 2009, GlaxoSmithKline's lamivudine global market growth over the previous year 5.81%. Market in the anti-HIV nucleoside reverse transcriptase inhibitors is one of the important components, but the drug has shown a declining trend of unilateral, only 8% of the overall market, while the compound is the direction of development.
With the end of lamivudine administrative protection in China, the domestic development of lamivudine has been substantial progress, changing the dominance of imported drugs. In 2008, SFDA approved the Chemical & Pharmaceutical Co., Ltd. on the production of lamivudine Haidisainuo API, and later approved by Beijing million Pharma, Hunan thousands of Jinxiang Jiang medicine, Kwong Sang Tong Medicine, Fujian, Anhui, Kyrgyz and U.S. system of Baker drugs (Xiamen) production. According to the China Chemical Pharmaceutical Industry Association data show that: In 2009, the AIDS drug lamivudine in the export growth driven by 458 percent, production increased by 394%; zidovudine sharp rise in exports, accounting for one third of yield First, the 2009 annual growth of 119%.
Although some anti-HIV "cocktail" compound has some side effects, but the compound is still pushing the current varieties of the main anti-HIV, anti-HIV drug market is driving the momentum. Analysis of the world market from 2009, 7 compound with a market share $ 8,665,000,000, an increase over the previous year 18.34%; anti-HIV overall market share 61.45%, over the previous year by 1.2 percentage points. U.S. Gilead Biology, GlaxoSmithKline UK, the U.S. Bristol-Myers Squibb, the U.S. 阿博特雅培, Merck in the U.S. market presents a new compound of the tripartite balance of forces.
So far, SFDA has approved three anti-HIV compound, namely lamivudine / zidovudine tablets (Combivir), Abaka Wei Shuangfu stator (three co-CD), lopinavir + benefits care ritonavir soft capsules and tablets (CHRIS Chi). In 2009, anti-HIV drug sample hospitals are the main varieties of chocolate imported drugs Combivir Chicago and two the amount of compound drugs only about 8% of all drugs.
With the World Health Organization HIV / AIDS seriously and the comprehensive scientific evaluation of the number of HIV infections has been further transparency of statistical data, which caused great concern in society. Essential drugs against HIV in China has been loaded 2009 edition of "national basic medical insurance, industrial injury insurance and maternity insurance medicine directory" and "National Essential Drugs List", a green light for clinical use.
Anti-HIV drugs are life-long HIV-infected drug, and the high cost of drugs has also decided a huge market space, has attracted the intense pursuit of the pharmaceutical manufacturers. However, there are people a reasonable standard treatment coverage remains low, poverty and malnutrition have exacerbated the complications and the incidence of serious opportunistic infections.
The number of infections is difficult in many areas has been effectively curbed, people are more eager to anti-HIV / AIDS vaccine and efficacy of the birth of new drugs and better.
What course of development of cytology
December 11, 2010 House of Love Medical Medical Network
In 1975, the British design F. Sanger dideoxy DNA sequencing, was awarded the Nobel Prize in Chemistry in 1980. Also in 1953, Sanger also determined the primary structure of bovine insulin obtained the Nobel in 1958 ......
1,1839, the Czech JEPukinye with the protoplasm of the term describes the cellular material, "Protoplast" as the theological term referring to the first man Adam.
2,1879, the Germans W. Flemming observed in the salamander cell mitosis, in 1882 proposed the term mitosis. German E. Strasburger (1876 ~ 80) found in plant cell mitosis.
3,1883, the people E.vanBeneden found that the meiotic horse roundworm Ascarismegalocephala phenomenon.
4,1871, the German F. Miescher isolated DNA from the pus.
5,1928, the British microbiologist F. Griffith made famous in pneumococcal transformation experiment.
Mitochondria
6,1944, Americans O. Avery, C. Macleod, and M. McCarthy, who proved by microbial transformation test is the genetic material DNA.
7,1953, the Americans and the British FHCCrick JDWatson DNA double helix model proposed.
8,1956, the Jiangyou Xing (Chinese Americans) invented by Xu Tao feel confirmed hypotonic treatment technology for the 46 people 2n, instead of 48.
9,1961, the British P. Mitchell coupling of mitochondrial oxidative phosphorylation proposed by the chemiosmotic theory, was the 1978 Nobel Prize in Chemistry.
10,1961 ~ 64 years, Americans MWNirenberg deciphering the genetic code DNA.
11,1968, the Swiss WernerArber DNA from bacteria found in restriction enzymes.
12,1970, the American D. Baltimore, R. Dulco and H. Temin shared the discovery of reverse transcriptase and the Nobel Prize in Physiology or Medicine.
13,1973, the American S. Cohen and H. Boyer splicing foreign genes in the plasmid and expressed in E. coli, and open a prelude to genetic engineering.
14,1975, the British design F. Sanger dideoxy DNA sequencing, was awarded the Nobel Prize in Chemistry in 1980. Also in 1953, Sanger also determined the primary structure of bovine insulin obtained the Nobel Prize in Chemistry in 1958.
15,1975, the German GJFKohler, Argentina NKJerne C. Milstein, and Danish scientists have developed monoclonal antibody technology, won the 1984 Nobel Prize in Physiology or Medicine.
16,1981, the United States, AIDS was first discovered in 1983, the French Pasteur Institute discovered LucMontagbier AIDS virus. The full name of AIDS AcquiredImmunoDeficiencySyndrome, by the human immunodeficiency virus HIV causes. 20 years, about 5800 million people worldwide are infected with HIV, 2200 people died of AIDS. Discovered in China in 1985. |
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