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我国全球基金艾滋病项目启动 国产抗艾药低价开路
www.ebiotrade.com 时间：2010年3月8日 来源： 医药经济报
摘要： 有市场人士乐观地表示，抗艾仿制药或将成为中国药企的新财路，因为价格低廉的国产抗艾药可能成为未来市场的主流。
有市场人士乐观地表示，抗艾仿制药或将成为中国药企的新财路，因为价格低廉的国产抗艾药可能成为未来市场的主流。
日前，整合了正在我国实施的全球基金艾滋病多轮项目的新的中国全球基金艾滋病项目宣布正式启动。此项目为去年11月我国与全球抗击艾滋病、结核病和疟疾基金（以下简称全球基金）签订协议，将正在执行的第三轮、第四轮、第五轮、第六轮和第八轮中国全球基金艾滋病项目整合。这是迄今世界范围内向全球基金申请的、以应对艾滋病需求国家策略并全面整合资源为主旨的最大项目。
“这对我国的艾滋病疫苗研究人员来说，不光是研究方向的重要调整点，还是推进更大规模国内联合合作的契机。”中国疾病预防控制中心艾滋病防控首席专家邵一鸣表示，对于艾滋病疫苗这样的世纪性科学难题，百家争鸣和联合攻关同等重要。
据悉，全球基金艾滋病项目将由中国疾病预防控制中心（CDC）主要负责具体实施工作。该项目为期6年，总经费达5.1亿美元，覆盖全国31个省、区、市。目前，其中一期项目工作计划已经获得批准，总经费为1.94亿美元，于2010年1月正式启动。项目总目标是扩大中国艾滋病预防、治疗和关怀服务，促进高危人群及艾滋病病毒感染者、艾滋病病人对艾滋病综合防治服务的全面可及。
“事实上，我们对于艾滋病患的治疗才刚刚起步。”一位业界人士向记者表示，虽然卫生部曾多次举办过大规模的临床培训，但实际上目前中国能够治疗艾滋病的专家级医生只有几十位，而且大多数艾滋病患目前只能依靠国家提供的免费药物来维持治疗，抗艾药市场仍是“政府采购”独撑的局面。
抗艾药排队待审
目前，全球已上市的抗艾药物约有20种，国内的上海迪赛诺、浙江华海、东北制药和厦门迈克4家企业已获得其中5种药物的生产批文。2009年10月，东北制药厂宣布其治疗艾滋病的新仿制药——司他夫定（D4T）获得国家食品药品监督管理局（SFDA）的新药证书和生产批号。加上此前该厂获批的仿制药齐多夫定和上海迪赛诺生物制药公司获批的去羟肌苷、地丹诺莘，我国已有多种逆转录酶抑制剂类艾滋病药实现了本地仿制生产。
据记者了解，目前仍有不少厂家希望涉足艾滋病药物，据SFDA药品注册司负责人介绍，目前尚有奈维那平等同类仿制药等待批准。据天方药业披露，公司就曾上报申请生产齐多夫定的有关手续，目前已经由河南省药监局批复，并已经上报SFDA待批。
“根据WHO推荐的最新版‘艾滋病治疗指南’，以及我国‘中国艾滋病病人抗病毒治疗研究’的成果，国家食品药品监管局也批准了国产奈韦拉平、齐多夫定和拉米夫定等联合用药的研究申请。这对阻断艾滋病的母婴传播以及临床治疗耐药都具有重要意义。”SFDA药品注册司司长张伟日前公开表示，在去年批准的1464个品种的药品中即包括治疗HIV感染方面的药品。而目前用于治疗HIV感染的鸡尾酒疗法的主要药品已在我国批准上市，其中大部分药品也已经国产化。
然而，虽然国家已经开始布置在艾滋病教育、检测筛查等配套的前期工作，但有药企仍表示离抗艾药物在中国市场赚钱的日子还非常遥远。上海迪赛诺生物医药有限公司北京分公司产品经理郑红表示，迪赛诺公司是国内第一批定点生产抗艾药物的企业，目前已经获得4种抗艾药物的生产批文，是目前国内企业中最多的，但还不能谈到利润。
“现在抗艾药招标基本都是成本价采购，企业没有什么利润，但如果没有政府采购这一项，中国抗艾市场的统计数字会更难看。”浙江华海药业一位人士认为，政府采购将是相当长时期内支撑中国抗艾市场的主要力量。
总体投入仍显不足
事实上，不仅抗艾药物生产企业仍谈不到“赚钱”，国家针对艾滋病预防、治疗和关怀服务方面的投入在艾滋病患的巨大群体需求面前亦显得捉襟见肘。
按照官方统计数据显示，截至2009年10月31日，中国累计报告艾滋病患者和感染者近32万例，其中艾滋病病人10万余例。此外，报告的评估结果显示，到2009年年底，中国存活的艾滋病感染者和病人总数估计将达74万人。部分国际专家的看法则是感染人数正处于快速增长期，实际感染人数还要高得多，“2010年将达到1000万人”。与此相对应的是，目前中国艾滋病人群的治疗条件匮乏——去年通过政府采购药物接受治疗的艾滋病患者为5000人，抗艾药物在医院的使用量更是少到可以忽略不计；国内开设艾滋病治疗项目的医院只有几家。
实际上，我国目前对于艾滋病防治的资金投入，从2005年开始才自原来的1500万元大幅增加至1亿元人民币，而根据全球基金中国抗艾项目的5.1亿美元来看，仍距联合国艾滋病规划署中2002年就应该达到20亿美元的标准相去甚远。
全国政协委员邵一鸣亦呼吁，新药临床试验审批应有所改革，从以往不利于创新性研究的“严进宽出”改成利于创新性研究的“宽进严出”。“因为临床研究一直是疫苗和药物研究中最长的阶段，建立鼓励团队研究尽早进入临床研究阶段的新药审评政策，直接关系到我国开展的研究能否能在激烈的国际竞争中夺得先机。”
国产药或成主流
有业界人士指出，使用国产药品以最快速度抑制艾滋病治疗药物价格已成为涉及中国国家安全的战略问题。而东北制药厂新闻发言人勾希连透露，该厂生产的艾滋病治疗药物已进入北京、河南等地医院，若以国外每位患者年花费8万人民币价格计算，使用该厂生产的齐多夫定只是这一价位的5%～7%。
据悉，目前在北京两家权威治疗艾滋病的医院——北京地坛医院和佑安医院尚未使用任何国产抗艾药物。同时，据卫生部性病艾滋病预防控制中心专家指出，艾滋病综合治疗需多种药物联用，包括核苷类非核苷类及蛋白酶抑制类药物，其中最著名的“鸡尾酒”疗法费用较高，国内艾滋病患者只有200余人能够享有“鸡尾酒”联合药物治疗，其中有近一半还是获赞助得治。因此，目前我国及发展中国家获准生产的艾滋病治疗新药，则主要集中在价格低廉的逆转录酶抑制剂类药物上。
而随着全球基金艾滋病项目的正式启动，以及药企抗艾仿制药纷纷排队待审，亦有市场人士乐观地表示，抗艾仿制药或将成为中国药企的新财路，因为价格低廉的国产抗艾药可能成为未来市场的主流，而国际专利药企业“如果拘泥于专利技术而形成艾滋病药品的垄断，那么，治疗这一顽症将远无定期”。（记者 王海洋）
我國全球基金艾滋病項目啟動國產抗艾藥低價開路
www.ebiotrade.com 時間：2010年3月8日來源： 醫藥經濟報
摘要： 有市場人士樂觀地表示，抗艾仿製藥或將成為中國藥企的新財路，因為價格低廉的國產抗艾藥可能成為未來市場的主流。
有市場人士樂觀地表示，抗艾仿製藥或將成為中國藥企的新財路，因為價格低廉的國產抗艾藥可能成為未來市場的主流。
日前，整合了正在我國實施的全球基金艾滋病多輪項目的新的中國全球基金艾滋病項目宣布正式啟動。此項目為去年11月我國與全球抗擊艾滋病、結核病和瘧疾基金（以下簡稱全球基金）簽訂協議，將正在執行的第三輪、第四輪、第五輪、第六輪和第八輪中國全球基金艾滋病項目整合。這是迄今世界範圍內向全球基金申請的、以應對艾滋病需求國家策略並全面整合資源為主旨的最大項目。
“這對我國的艾滋病疫苗研究人員來說，不光是研究方向的重要調整點，還是推進更大規模國內聯合合作的契機。”中國疾病預防控制中心艾滋病防控首席專家邵一鳴表示，對於艾滋病疫苗這樣的世紀性科學難題，百家爭鳴和聯合攻關同等重要。
據悉，全球基金艾滋病項目將由中國疾病預防控制中心（CDC）主要負責具體實施工作。該項目為期6年，總經費達5.1億美元，覆蓋全國31個省、區、市。目前，其中一期項目工作計劃已經獲得批准，總經費為1.94億美元，於2010年1月正式啟動。項目總目標是擴大中國艾滋病預防、治療和關懷服務，促進高危人群及艾滋病病毒感染者、艾滋病病人對艾滋病綜合防治服務的全面可及。
“事實上，我們對於艾滋病患的治療才剛剛起步。”一位業界人士向記者表示，雖然衛生部曾多次舉辦過大規模的臨床培訓，但實際上目前中國能夠治療艾滋病的專家級醫生只有幾十位，而且大多數艾滋病患目前只能依靠國家提供的免費藥物來維持治療，抗艾藥市場仍是“政府採購”獨撐的局面。
抗艾藥排隊待審
目前，全球已上市的抗艾藥物約有20種，國內的上海迪賽諾、浙江華海、東北製藥和廈門邁克4家企業已獲得其中5種藥物的生產批文。 2009年10月，東北製藥廠宣布其治療艾滋病的新仿製藥——司他夫定（D4T）獲得國家食品藥品監督管理局（SFDA）的新藥證書和生產批號。加上此前該廠獲批的仿製藥齊多夫定和上海迪賽諾生物製藥公司獲批的去羥肌苷、地丹諾莘，我國已有多種逆轉錄酶抑製劑類艾滋病藥實現了本地仿製生產。
據記者了解，目前仍有不少廠家希望涉足艾滋病藥物，據SFDA藥品註冊司負責人介紹，目前尚有奈維那平等同類仿製藥等待批准。據天方藥業披露，公司就曾上報申請生產齊多夫定的有關手續，目前已經由河南省藥監局批复，並已經上報SFDA待批。
“根據WHO推薦的最新版'艾滋病治療指南'，以及我國'中國艾滋病病人抗病毒治療研究'的成果，國家食品藥品監管局也批准了國產奈韋拉平、齊多夫定和拉米夫定等聯合用藥的研究申請。這對阻斷艾滋病的母嬰傳播以及臨床治療耐藥都具有重要意義。”SFDA藥品註冊司司長張偉日前公開表示，在去年批准的1464個品種的藥品中即包括治療HIV感染方面的藥品。而目前用於治療HIV感染的雞尾酒療法的主要藥品已在我國批准上市，其中大部分藥品也已經國產化。
然而，雖然國家已經開始佈置在艾滋病教育、檢測篩查等配套的前期工作，但有藥企仍表示離抗艾藥物在中國市場賺錢的日子還非常遙遠。上海迪賽諾生物醫藥有限公司北京分公司產品經理鄭紅表示，迪賽諾公司是國內第一批定點生產抗艾藥物的企業，目前已經獲得4種抗艾藥物的生產批文，是目前國內企業中最多的，但還不能談到利潤。
“現在抗艾藥招標基本都是成本價採購，企業沒有什麼利潤，但如果沒有政府採購這一項，中國抗艾市場的統計數字會更難看。”浙江華海藥業一位人士認為，政府採購將是相當長時期內支撐中國抗艾市場的主要力量。
總體投入仍顯不足
事實上，不僅抗艾藥物生產企業仍談不到“賺錢”，國家針對艾滋病預防、治療和關懷服務方面的投入在艾滋病患的巨大群體需求面前亦顯得捉襟見肘。
按照官方統計數據顯示，截至2009年10月31日，中國累計報告艾滋病患者和感染者近32萬例，其中艾滋病病人10萬餘例。此外，報告的評估結果顯示，到2009年年底，中國存活的艾滋病感染者和病人總數估計將達74萬人。部分國際專家的看法則是感染人數正處於快速增長期，實際感染人數還要高得多，“2010年將達到1000萬人”。與此相對應的是，目前中國艾滋病人群的治療條件匱乏——去年通過政府採購藥物接受治療的艾滋病患者為5000人，抗艾藥物在醫院的使用量更是少到可以忽略不計；國內開設艾滋病治療項目的醫院只有幾家。
實際上，我國目前對於艾滋病防治的資金投入，從2005年開始才自原來的1500萬元大幅增加至1億元人民幣，而根據全球基金中國抗艾項目的5.1億美元來看，仍距聯合國艾滋病規劃署中2002年就應該達到20億美元的標準相去甚遠。
全國政協委員邵一鳴亦呼籲，新藥臨床試驗審批應有所改革，從以往不利於創新性研究的“嚴進寬出”改成利於創新性研究的“寬進嚴出”。 “因為臨床研究一直是疫苗和藥物研究中最長的階段，建立鼓勵團隊研究儘早進入臨床研究階段的新藥審評政策，直接關係到我國開展的研究能否能在激烈的國際競爭中奪得先機。”
國產藥或成主流
有業界人士指出，使用國產藥品以最快速度抑制艾滋病治療藥物價格已成為涉及中國國家安全的戰略問題。而東北製藥廠新聞發言人勾希連透露，該廠生產的艾滋病治療藥物已進入北京、河南等地醫院，若以國外每位患者年花費8萬人民幣價格計算，使用該廠生產的齊多夫定只是這一價位的5%～7%。
據悉，目前在北京兩家權威治療艾滋病的醫院——北京地壇醫院和佑安醫院尚未使用任何國產抗艾藥物。同時，據衛生部性病艾滋病預防控制中心專家指出，艾滋病綜合治療需多種藥物聯用，包括核苷類非核苷類及蛋白酶抑制類藥物，其中最著名的“雞尾酒”療法費用較高，國內艾滋病患者只有200餘人能夠享有“雞尾酒”聯合藥物治療，其中有近一半還是獲贊助得治。因此，目前我國及發展中國家獲准生產的艾滋病治療新藥，則主要集中在價格低廉的逆轉錄酶抑製劑類藥物上。
而隨著全球基金艾滋病項目的正式啟動，以及藥企抗艾仿製藥紛紛排隊待審，亦有市場人士樂觀地表示，抗艾仿製藥或將成為中國藥企的新財路，因為價格低廉的國產抗艾藥可能成為未來市場的主流，而國際專利藥企業“如果拘泥於專利技術而形成艾滋病藥品的壟斷，那麼，治療這一頑症將遠無定期”。 （記者 王海洋）
China Global Fund AIDS project launched low-cost Chinese-made established classes open
www.ebiotrade.com Time: March 8, 2010 Source: Medicine Economic News
Abstract: In some market participants expressed optimism that anti-Ai generic drug or pharmaceutical companies will become the new sources of revenue, as low-cost Chinese-made established classes could become the future market mainstream.
Some market participants expressed optimism that anti-Ai generic drug or pharmaceutical companies will become the new sources of revenue, because low-cost Chinese-made established classes could become the future market mainstream.
Recently, the integration is being implemented in China after many rounds of the Global Fund AIDS Project New China Global Fund AIDS project announced the official launch. This project in November last year China and the Global Fund to Fight AIDS, Tuberculosis and Malaria Fund (hereinafter referred to as the Global Fund) signed an agreement being implemented in the third round, fourth round, fifth round, sixth round, and the eighth round of the China Global Fund to AIDS Project Integration. This is by far the world-wide application within the Global Fund to address the needs of the national AIDS strategies and resources to fully integrate the maximum thrust of the project.
"This is our country's AIDS vaccine researchers, not only an important research direction set point, or to promote joint cooperation on a larger scale of domestic opportunity." Chinese Center for Disease Control and Prevention of AIDS prevention and control, said Shao Yiming, chief expert for the AIDS vaccine that century scientific challenges, competition and joint research are equally important.
It is reported that the Global Fund AIDS project will be China Center for Disease Control and Prevention (CDC) is mainly responsible for the specific implementation. The project period of 6 years, the total funding by 5.1 billion U.S. dollars, covering the country's 31 provinces, autonomous regions and municipalities. At present, one phase of the project work plan has been approved, with a total funding of 194 million U.S. dollars, was officially launched in January 2010. The general objective is to expand China's AIDS prevention, treatment and care services, and promote high-risk populations and HIV infection, AIDS comprehensive prevention and treatment services for AIDS patients in the overall accessibility.
"In fact, our treatment of AIDS patients is only just beginning." An industry spokesman told reporters that, although the Ministry of Health has repeatedly held large-scale clinical training, but in fact China to treat AIDS expert-level doctors only dozens, and most AIDS patients now rely on state-provided drugs free of charge to maintenance treatment, established classes the market is still "government procurement" has to support the situation.
Established classes pending queue
At present, the world has been listed established classes of about 20 species, the domestic Shanghai Desano, Zhejiang Huahai, Northeast Pharmaceutical and Xiamen Mike four companies have access to these five kinds of drug production approval. In October 2009, the Northeast Pharmaceutical Factory announced that its new generic drug to treat AIDS - stavudine (D4T) won the State Food and Drug Administration (SFDA) of the new drug certificate and production batch number. Prior to the plant together with the approved generic drug zidovudine and Shanghai Desano Bio-pharmaceutical companies, approved didanosine, ground Dunlop Xin, China has a variety of reverse transcriptase inhibitor class of AIDS drugs to achieve a local imitation of production.
This reporter has learned that there are still many manufacturers want to set foot in AIDS drugs, according to SFDA Drug Registration Department person in charge, there are the Navier That kind of equality for approval of generic drugs. Fang Pharmaceutical, according to the disclosure of days, the company reported a production once the relevant procedures zidovudine has now been approved by the Food and Drug Administration of Henan Province, and has submitted to SFDA pending.
"According to the latest version of WHO recommended 'HIV treatment guidelines', as well as our 'China anti-viral therapy for AIDS patients' results, the State Food and Drug Administration has approved domestic nevirapine, zidovudine and lamivudine combination therapy, etc. research applications. This block mother to child transmission of AIDS, as well as clinical treatment of drug resistance is of great significance. "SFDA drug registration Secretary Zhang has publicly stated that last year's ratification of the 1464 varieties of drugs which includes the treatment of HIV infection drugs. At present, for the treatment of HIV infection cocktail of essential drugs has been approved in China market, most of which have also been made of drugs.
However, while the countries have begun deployed in AIDS education, testing and other supporting pre-screening work, but there are pharmaceutical companies that are still away from the established classes in the Chinese market is still very distant day to make money. Shanghai Desano Bio-pharmaceutical Co., Ltd. Beijing Branch Zheng, product manager, said Dissais Solutia Inc. is the first fixed-point production enterprise established classes, there have been four kinds of established classes of production approval, is the domestic enterprises up to, but still can not talk about profit.
"Now established classes are basically the cost of the tender price of procurement, enterprises do not have any profits, but without government procurement this one, the Chinese anti-Ai market statistics will be more ugly." Zhejiang Huahai one believe that government procurement would be quite a long time to support the Chinese market, the main force against Ai.
Overall investment is still insufficient
In fact, not only established classes of production enterprises still can not talk about "making money", the state aimed at AIDS prevention, treatment and care services into the great groups of AIDS patients before the demand seems to be too stretched.
According to official statistics show that as at October 31, 2009, China has reported AIDS patients and infected nearly 32 million cases of which 10 thousand cases of AIDS patients. In addition, the report's findings show that by the end of 2009 China's survival and the total number of patients living with HIV is estimated at 740,000 people. Some international experts view that it is the number of infections is in rapid growth period, the actual number of infections is much higher, "in 2010 will reach 10 million people." Correspondingly, the current conditions of China's AIDS treatment for poor people - passed last year, government procurement of drugs for treatment of AIDS patients to 5,000 people, established classes in the hospital is the use of as little as to be negligible; domestic set up AIDS the hospital only a few treatment programs.
In fact, China's current capital investment for AIDS prevention and control, starting in 2005 before the original 15 million yuan from the substantial increase to 1 billion yuan in China, according to the Global Fund against Ai project 510 million U.S. dollars of view, is still away from the United Nations AIDS The Planning Department in 2002 to reach 2 billion U.S. dollars should be a far cry from the standards.
CPPCC National Committee member SHAO Yi also called for approval of clinical trials of new drugs should be some reform, from the past is not conducive to innovative research, "Yan easy out" conducive to innovative research into the "lenient entry, stringent exit." "Because clinical studies of vaccines and drug research has been the longest stage of team building to encourage research into the clinical research stage as soon as possible new drug review policy, is directly related to our ability to be able to research carried out in the fierce international competition, won the first machine. "
Domestic drug or into the mainstream of
Those in the industry have pointed out that the use of domestic medicines to suppress HIV treatment as quickly as drug prices have become involved in China's national security strategy. Hook, spokesman for the Northeast Greek pharmaceutical company said the production of AIDS treatment plant has entered Beijing, Henan and other places the hospital, if the foreign per patient cost of 80,000 yuan year prices, using the factory produced more than Qi Cardiff is the price set for 5% ~ 7%.
It is reported that the authority is currently in Beijing, two hospitals to treat AIDS - Beijing Ditan Hospital and You'an Hospital has not yet use any of homemade established classes. At the same time, according to the Ministry of Health STD and AIDS Prevention and Control Center experts pointed out that the need of multi-drug combination therapies for HIV in conjunction with, including nucleoside and protease inhibitor non-nucleoside drugs, most notably the "cocktail" therapy high cost, the domestic AIDS Only patients with more than 200 people can enjoy "cocktail" combination drug therapy, in which nearly half were sponsored or government. Therefore, the current production of China and developing countries be allowed to AIDS treatment drugs, mainly concentrated in low-cost reverse transcriptase inhibitor drugs.
With the Global Fund for AIDS, the official launch of the project, as well as generic pharmaceutical companies have been lining up against Ai awaiting trial, some market players expressed optimism that anti-Ai generic drug or pharmaceutical companies will become the new sources of revenue, because low-cost Domestic established classes could become the mainstream of the future market, while the international patent medicine business, "If rigidly adhere to the formation of AIDS drugs patented technology monopoly, then the treatment of this chronic disease will be far from free on a regular basis." (Xinhua, Wang marine)
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