长春高新获准艾滋病疫苗临床试验 分析师解读影响“中性”


长春高新获准艾滋病疫苗临床试验 分析师解读影响“中性”

 
 
 
 
 

长春高新获准艾滋病疫苗临床试验 分析师解读影响“中性”  
    2011年03月08日 06:15 来源:证券日报 作者:陈雅琼
    长春高新 (SZ:000661)最新价:56.30  1.1 1.92%行情走势 公司新闻 最新公告大单追踪 资金流向 持仓成本股票预警 优股预测 龙虎榜上周,长春高新[56.33 -1.86%](000661.SZ)子公司的治疗类艾滋病疫苗项目被批准进入I期临床试验,再次吸引了投资者对“抗艾”概念的关注。《证券日报》记者采访了相关分析师,目前,全球范围内预防性艾滋病疫苗和治疗性艾滋病疫苗研发的成功率极低,我国已经申报的艾滋病疫苗项目仅有3个。尽管这一项目被社会各界寄予了巨大的希望,但考虑到其研发难度非常大,该分析师认为其对上市公司的影响应解读为“中性”。

研发进展十分缓慢

    根据来自SFDA、中信证券[15.24 -0.20%]研究部的信息,国内在申报的艾滋病项目有邵一鸣团队、百克药业、奥克生物3家。其中,百克药业的技术有DNA/MAV载体艾滋病疫苗和艾滋病疫苗(核酸疫苗与重组疫苗联合使用);邵一鸣团队的技术为DNA-天坛痘苗复合型艾滋病疫苗;奥克生物的治疗性基因工程艾滋病疫苗目前尚无进展。

    作为唯一一家研发艾滋病疫苗的上市公司,长春高新今年3月3日公告,其控股60%的子公司长春百克药业有限责任公司(简称百克药业)申报的治疗类艾滋病疫苗项目已经正式收到国家食品药品监督管理局出具的《药物临床试验批件》,批准进入I期临床试验,受理号为:CXSB0900024。

    而百克药业是我国最早开发艾滋病疫苗的单位之一,2005年其预防性疫苗就已进入Ⅰ期临床,目前正处于Ⅱ期临床阶段。

世界范围内仅1例成功

    在一部分投资者印象中,实现艾滋病的预防似乎是天方夜谭。事实上,艾滋病疫苗的研究的确步履维艰。根据可查资料,世界范围内仅有1例艾滋病疫苗研发成功,并且在当年被美国《时代》周刊评为十大医学突破之一。

    2009年9月,研究人员结合两种老疫苗研发出新艾滋病疫苗,测试结果首次表明其可以使接种者的感染风险降低31.2%。整个实验有1.6万人参加,耗资1.05亿美元。一位学医出身、不愿透露姓名的分析师说:“31.2%实际是比较低的保护率,乙肝疫苗大约能达到85%-90%的保护效果,这才是疫苗保护率的正常水平。”

    “根据国外经验,预防性艾滋病疫苗的风险较大,治疗性艾滋病疫苗的成功性会高些,国内现在没有一个预防性艾滋病疫苗获得批文的,已获得的数据也没有表明其有效的。”该分析师还说。

未来10年疫苗都无法使用

    美国纽约洛克菲勒大学艾伦·戴蒙德艾滋病研究中心主任何大一在艾滋病研究方面建树颇丰,最为人熟知的是其发明的“鸡尾酒疗法”。虽然鸡尾酒疗法能使艾滋病患者的死亡率降低20%,但何大一对艾滋病疫苗依然持比较悲观的态度,他认为未来10年“预防艾滋病的疫苗仍然无法使用。”

    人们曾经对艾滋病疫苗研发充满信心,美国前总统克林顿就预言过2007年根治艾滋病的疫苗将研制成功。但是,由于无法攻克艾滋病病毒结构变异性强的特点,该预言不幸付诸东流。

    何大一指出,传统研发艾滋病疫苗的思路是,先用疫苗刺激人体免疫系统产生反应,然后再形成抗体。而他目前的新思路是,直接为人体装配上一套现成的抗体武器,疫苗进入体内,就能动员免疫系统立刻投入战斗。

    实验表明,新思路研发出的药物在艾滋病晚期病人身上能清除血液中90%的病毒。这也许能说明,为什么治疗性疫苗能后来居上,在研发进度上超过预防性疫苗。

研发周期长消耗大

    中国疾病预防控制中心性病艾滋病预防控制中心病毒与免疫研究室主任、艾滋病首席专家邵一鸣3月5日政协会议时接受采访表示,目前,其已着手启动第二代和第三代疫苗的申报试验工作,第二代最早有望于今年年底和明年上半年进入试验。同时,一代艾滋病疫苗在顺利通过Ⅰ期试验后,也将于近期申报进行Ⅱ期试验。

    根据我国新药申报的程序,艾滋病疫苗的研发要经过Ⅰ、Ⅱ、Ⅲ期临床研究,每个周期超过5年。前述分析师对《证券日报》记者表示:“根据以前的经验,每期艾滋病疫苗研发不花3000-5000万元是做不出来的,不过,国家大力扶持这一项目,有一定的补贴。”

    以长春高新为例,根据定期报告信息,2009年,长春高新获得政府补助的百克药业艾滋病疫苗专项资金187.22万元;2010年上半年,再次获政府补助39.13万元。如果以分析师估计的费用来计算,企业的负担依然不是一笔小数目。

我国每年6.8万人死于艾滋

    去年12月1日是第23个世界艾滋病日。根据2010年11月29日卫生部通报的中国艾滋病疫情及防治工作情况,截至2010年10月底,累计报告艾滋病病毒感染者和病人370393例,其中病人132440例;死亡68315例。同日召开的国务院常务会议明确指出,预防和控制艾滋病,关系到人民群众身体健康和经济社会发展,关系到民族兴衰和国家存亡。

    在这样的背景下,艾滋病疫苗的市场前景广阔,政府支持也将不遗余力。“企业研究疫苗主要看两个问题:能不能做出来、效果怎么样。”业内人士表示。尽管预防性艾滋病疫苗不被看好,但如果治疗性艾滋病疫苗能研发成功,对企业来说将是巨大的利好消息。

艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复 艾滋病不治会早死,早治才康复

 
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 
 
 

慢性艾滋病早期中医药治疗保障生命论证

红津液饮料面世 或将能预防艾滋病

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Changchun High-tech analysts be allowed to interpret clinical trials of HIV vaccine effects "neutral"
    
At 06:15 on March 8, 2011 Source: Securities Daily Author: Chen Yaqiong
    
Changchun High-tech (SZ: 000661) New price: 56.30 1.1 1.92% market trends company news bulletin large single-track positions in the cost of equity capital flows, superior stock forecasts Billboard warning last week, the Changchun High-tech [56.33 -1.86%] (000661.SZ ) a subsidiary of the treatment of type AIDS vaccine project was approved to enter Phase I clinical trial, once again attracting investors to the "anti-AIDS" concept of concern. "Securities Daily" interview the relevant analysts, at present, global preventive AIDS vaccine and therapeutic AIDS vaccine research and development of very low success rate, China has reported only three AIDS vaccine projects. Although this project is the community has placed great hope, but considering the difficulty of its R & D is very large, the analysts believe that its impact on the listed company should be interpreted as "neutral."

Very slow development

    
According from the SFDA, CITIC Securities [15.24 -0.20%] of the Ministry of Information and domestic projects in the declaration of the AIDS team Shao Yiming, one hundred grams medicine, Oak bio 3. Among them, one hundred grams medicine technology has DNA / MAV AIDS vaccine and AIDS vaccine vector (DNA vaccine and recombinant vaccine use); Shao Yiming technology team vaccinia virus DNA-Temple of Heaven compound AIDS vaccine; Oak therapeutic genetic engineering of biological There is no progress in AIDS vaccine.

    
AIDS vaccine research and development as the only listed company, Changchun High-tech announcement on March 3 this year, 60% subsidiary of its holding in Changchun Sparks Pharmaceutical Co., Ltd. (hereinafter referred to one hundred grams medicine) reported the treatment of type AIDS vaccine project has been officially received the State Food and Drug Administration issued a "drug clinical trial this document", approved to enter Phase I clinical trials, the admissibility number: CXSB0900024.

    
The one hundred grams of the earliest development of medicine is one of the units of AIDS vaccine, a preventive vaccine in 2005 had entered the phase Ⅰ clinical, currently in Phase Ⅱ clinical stage.

The worldwide success of only 1 case

    
Impression in the part of investors, implement AIDS prevention seems to be fantasy. In fact, the AIDS vaccine research is truly struggling. Root documented information, the worldwide only 1 case of AIDS vaccine research and development success, and in that year by the U.S. "Time" magazine as one of the top ten medical breakthroughs.

    
September 2009, researchers combined two old HIV vaccine research and development of new vaccines, test results for the first time that it can reduce the risk of infection in vaccinated 31.2%. 1.6 million people participated in the experiment, a cost of 105 million. A medical school background, analyst of anonymity, said: "31.2% effective rate of protection is relatively low, about hepatitis B vaccine to achieve 85% -90% of the protective effect, this is the normal level of vaccine protection rate. "

    
"According to foreign experience, greater risk of preventive AIDS vaccine, therapeutic success of an AIDS vaccine will be higher, the domestic do not have to obtain approval of a preventive AIDS vaccine, and has obtained the data did not show that its effective." The analysts said.

The next 10 years are not available vaccines

    
New York, Rockefeller University David Ho, Aaron Diamond AIDS Research Center, appreciable achievements in AIDS research, is best known for his invention of the "cocktail therapy." Although HAART can reduce the mortality rate in patients with AIDS, 20%, but David Ho of the AIDS vaccine is still holding more pessimistic attitude, he believes the next 10 years, "the prevention of AIDS vaccine is still not available."

    
It had been confident of AIDS vaccine research and development, former U.S. President Bill Clinton predicted in 2007 to cure AIDS vaccine will be developed. However, because HIV can not overcome the strong variation of the characteristics of the structure, the prophecy unfortunately wasted.

    
Ho pointed out that the traditional idea is to develop an AIDS vaccine, the first vaccine to stimulate the immune system reacts, and then the formation of antibodies. At present he is the new idea is assembled directly on the body of a ready-made antibodies weapons, vaccines into the body, able to mobilize the immune system into action immediately.

    
Experiments show that the new ideas developed in patients with advanced AIDS drugs in the blood can eliminate 90% of the virus. This might explain why therapeutic vaccines can come from behind, on the progress in research and development than preventive vaccine.

Large consumption long development cycle

    
Chinese Center for Disease Control and Prevention Center for STD and AIDS Prevention and Control Research Office and the immune virus, AIDS, Shao Yiming, chief expert CPPCC session on March 5 when the interview said that at present, it has to initiate and launch the second generation and third generation vaccines reported experimental work The second generation is expected early next year at the end of this year and into the test. Meanwhile, the generation of AIDS vaccine in phase Ⅰ test passed, it will soon return to Ⅱ trial.

    
According to China's new drug reporting procedures, AIDS vaccine research and development to go through the Ⅰ, Ⅱ, Ⅲ clinical studies, each cycle over 5 years. Above analysts "Securities Daily" told reporters: "According to past experience, each AIDS vaccine R & D spending 3000-5000 million is not usually do, but, the state strongly support this project, a certain amount of subsidy."

    
Changchun High-tech, for example, periodic reports based on information, 2009, the Changchun High-tech access to government subsidies Sparks Pharmaceutical 1.8722 million yuan special funds for AIDS vaccine; first half of 2010, again received 391,300 yuan government subsidy. If the analyst to calculate the estimated cost, the burden on businesses is still not a small sum.

6.8 million people die of AIDS each year

    
December 1 last year, is the first of 23 World AIDS Day. According to November 29, 2010 the Chinese Ministry of Health and the AIDS epidemic prevention and control work, as at the end of October 2010, the cumulative reported HIV infections and 370,393 cases of patients, of which 132,440 cases of patients; killed 68,315 cases. With the State Council executive meeting held clear that prevention and control of AIDS related to the health of the people and the economic and social development, related to national prosperity and national survival.

    
In this context, the AIDS vaccine market prospects, the Government will spare no effort to support. "Business of the vaccine depends primarily on two questions: Can you do it and how to effect." Industry source said. Although preventive AIDS vaccine is not good, but if the treatment of AIDS vaccine research and development success of the enterprise will be a great good news.

 
 
 
 
 

[ 作者:佚名    转贴自:本站原创    点击数:196    更新时间:2011-3-9    文章录入:nnb ]