近日,华尔街日报登载了一篇名为《apollobio: drug approvals at same time in u.s.and china 》(阿波罗计划:让药物审批在中国与美国同步)的文章,以下为华尔街日报报道原文:
▲图:东方略阿波罗计划 刊登在《华尔街日报》b叠4d版
译文
《中国日报·华尔街日报china watch》专访英译中文本
东方略:让药物审批在中国与美国同步
——记一家奋战在癌症、心脑血管及肝脏疾病的最前线的中国公司 中国日报记者郝楠报道
东方略公司(430187)坚信自己的阿波罗计划可以减少药品在中国的审批时间,从而使新药落地中国时间从八年缩短到基本与国外同步。
这家已在业内知名的公司有个大气的名子:“东方略”。
“东方略正在打通一条快速通道使得美国生物医学公司进入中国市场,帮助中国患者获得更快和更有效的治疗,这一行动,我们将其命名为‘阿波罗计划’”该公司的董事长仇思念说。
公司启动了这个项目,愿其就像美国阿波罗太空计划,将帮助开启一个新时代,所不同的是,这一次,计划不是在太空,而是将在医学领域,仇说。
由于长时间的临床试验审批流程,海外药物获得在中国销售的许可通常需要8年时间。
阿波罗计划也旨在创建一个中美两国制药公司合作的典型。仇进一步表述道:该项目的目标为在纳斯达克上市的美国公司在第三阶段的临床试验药物,以控制投资风险。
根据2011年发表在《自然化学生物学》杂志上的“医药研发目标的实现”一文预测,大约53%的药物在第三阶段极有可能会得到美国食品和药物管理局的批准。
为什么阿波罗计划把其关注重点放在癌症、心血管疾病及肝脏疾病三项上?
“那是因为许多中国人都在遭受这三种疾病折磨,并且迫切的需要更好的药物,”仇说。
在广州的一家名为pico的,中国权威的医药市场研究机构的调查显示:在中国大陆至少有1.3亿乙肝病毒携带者,2.6亿心血管疾病患者以及3000万肿瘤患者。
为能医治这么庞大的患者群,仇和他的阿波罗计划目标明确,路径简单:公司购买美国研发的药品专利并且获得独家许可。公司与美国生物制药公司签订独家许可协议并且获得在中国独家开发,制造和商业化推广该药品的权利。
公司目前正在与四家美国生物医药公司谈判,一旦达成协议,公司将申请这些药物在中国的临床试验。
仇不是单枪匹马,他有强大的后盾……
陈明键,仇的导师、东方略聘请的融资顾问公司东方高圣的创始人,协助东方略的发展做了高远的战略规划:“致力于汇集来自美国最好的技术,中国最好的资金与市场机会,创建一个更大更好的公司。”
而东方高圣是一家中国投资银行,早于18年前创立。
中国大陆政府相关部门,也有与仇一致的认识和措施:去年晚些时候,中国食品药品监督管理局就采取了一系列旨在改革药品审查和批准系统的措施。
该管理局负责人就曾表示:如果中国大陆申请人“已经在美国或欧盟提交了相同的申请并被批准”,其在大陆申报的新药临床实验的审批程序的处理速度将获提前。特别是,对于有重要的临床价值并且没有在中国销售的新药, 中国食品药品监督管理局将给予外国制药公司优先地位。其它同样受到优先处理的药物还包括:艾滋病、恶性肿瘤、的药物、罕见病和传染病预防和治疗的药物。
另一个受到鼓舞的例证是:今年二月,东方略宣布,计划为项目筹集5亿美元的投资。目前已筹集了约8亿元人民币(合1.233亿美元)。
当然,仇和他的团队也清醒地意识到:许多美国生物医药公司,虽然对阿波罗计划感兴趣,但是并不确定阿波罗项目是否能够真正将他们的药品在中国落地,并取得商业回报。
为消除这些疑惑,仇在其导师及其投资公司的支持下,已经与中国三家顶级医药行业的研究、生产、销售投资公司建立了合作关系。仇如数家珍地介绍道:“海口vti将成为研发平台,未来还将与金城医药和九州通合作,打开中国医药生产和销售网络。自去年以来,得益于中国新兴资本市场,新三板将为筹集资金和吸引研发公司提供很好机会。公司还通过与香港晨兴创投合作,选择美国的药品项目。晨兴创投有足够的国外生物医药公司投资经验,他们已经邀请了几位顶级专家和科学家加入委员会,包括风险投资先锋pitch johnson,项目发起人陈明键,以及两位肝脏疾病方面的关键意见领袖。”
可谓“人才济济,名流云集”。仇兴奋地说。
海内海外和业内业外,对阿波罗计划也予以了积极的肯定。
业内专家johnson表示:全球,包括癌症治疗在内的医药拓展的未来在于基因治疗。阿波罗计划正在创造足够的机会,包括商业机会,将未来变为现实。他预祝也相信中国和美国同行将通过阿波罗项目建立互信和合作。
仇和他的东方略,已经开始了阿波罗计划的进程:
4月12日,东方略联手中国大陆领先的远程医疗服务公司──beijing remote horizon group,以及世界上最大的肝病医生的联盟──亚太肝脏疾病联盟,发起了一个战胜乙肝病毒的项目。三方表示将在中国找到治愈乙肝的方法。
这个活动被誉为中国版的翡翠丝带项目──一个由亚洲肝病中心和斯坦福大学医学院于2001年发起的活动。
海内海外和业内业外,对阿波罗计划的未来,同样也予以了美好的憧憬:
“10年前,美国开始采用专门针对孩子肺炎的疫苗,但我们仍然需要从美国进口。我们期待有一款疫苗可以同时帮助中美两国的孩子。这就是我为什么会欣赏阿波罗项目。如果项目成功了,它可以造福一代又一代人。一个伟大的项目需要大投资者以及高水平的研究机构。”吕亦晨,前哈佛大学公共卫生学院艾滋病研究所资深研究员,海口vti生物研究院主席如此展望。
“阿波罗项目给我留下了深刻的印象。它可以大大改善肝炎在中国的治疗情况。该项目在研发上投资的500万美元将有望加速新药研究与开发。”成军,北京地坛医院副院长则认识的更实际。
▲图:东方略董事长仇思念在阿波罗计划发布会上作演讲
原文
apollobio: drug approvals at same time in u.s. and china
——cancer and heart and liver diseases in thefiring line, hao nan reports.
abiomedicalinvestment company in beijing says it believes it can cut the waiting time fora pharmaceutical
drugapproved in the united states to make its chinese mainland debut from eightyears to none at all.
“apollobiois developing a fast track for u.s. biomedicine companies to enter chinesemarkets and helping chinese patients receive faster and more efficient medicaltreatment,” said qiu sinian, the company’s chairman.
thecompany launched the project, called by the same name, this year that, like theu.s. apollo space programs, will help launch a new era, this time in medicine,he said.
it normally takes eight years for overseas medications to receive clearance to be sold in china because of lengthy clinical trials and approval processes.
theproject also aims to create a model for collaboration between chinese and u.s.pharmaceutical companies, he said. the project will target nasdaq-listed u.s.companies that have drugs in the third phase of clinical trials in order tolimit investment risks. according to “getting pharmaceutical r&d back ontarget”, published in the nature chemical biology journal in 2011, about 53 percent of drugs in the third phase will likely be approved by the u.s. food anddrug administration.
drugsin three fields — cancers and cardiovascular and liver diseases — will be thefocus of the apollobio project.
“many chinese people suffer from these three kinds of diseases and urgently need better medicine,” mr. qiu said.
china has at least 130 million carriers of hepatitis b, 260 million patients with acardiovascular disease and 30 million tumor patients, according to guangzhoupico, one of china’s leading pharmaceutical market research institutes.
the apollobio project is simple: the company buys the patents of the u.s.-madedrugs and acquires the exclusive license. the company enters exclusive license agreements with u.s. bio-pharmaceutical companies and obtains exclusive rightsto develop, make and commercialize their drugs in china.
the company is now negotiating with four u.s. biomedical companies, and when agreement is reached, apollobio will apply for clinical trials of those drugsin china.
chen mingjian, founder of hollyhigh, financial adviser company of apollobio,speaking of the company’s strategy, said: “the aim is to bring together thebest technology from the u.s. and the best capital and market opportunities inchina to create a bigger and better company.”
hollyhigh is a chinese investment bank that was founded 18 years ago. late last year thechina food and drug administration adopted aseries of measures aimed at overhauling the drug review and approval system.
the cfda said investigational new drugs will be handled faster if the chineseapplicant “has filed the same application in the united states or in theeuropean union and the application was approved”.
for new drugs believed to have significant clinical value and that have not beensold in china, the cfda will grant the foreign drugmaker priority status. otherdrugs that receive the same priority include drugs for preventing and treatinghiv/aids, malignant tumors, rare diseases and severe infectious diseases.
in february, apollobio announced that it had gained a listing on china’s nationalequities exchange and quotations, the neeq, also known as the new third board.it plans to raise $500 million in investment for the project. it has raised 800million yuan ($123.3 million) so far.
manyu.s. biomedical companies, though interested in the project, are unsure whetherapollobio is capable of commercializing their drugs in china. apollobio hascollaborative relationships with three chinese industrial investors inresearch, production and marketing, mr. qiu said.
“shandong jincheng pharmaceutical will be responsible for making drugs, and join town pharmaceutical group has china’s largest marketing and logistics networks in the industry,” he said. haikouvaccine technology inc will be the research and development platform.
the neeq will provide opportunities to raise funds and draw r&d companies thathave benefited from china’s emerging capital market since last year, mr. qiusaid.
thecompany is also working with hong kong morningside ventures, which gives adviceon choosing drug projects in the u.s.
“morningsidehas ample experience in investing in foreign biomedicine companies,” qiu said.“we have invited several top experts and scientists to join the committee,including venture capital pioneer pitch johnson, project initiator chenmingjian and two key opinion leaders in liver diseases.”
theapollobio project is expected to build stronger ties between china and u.s. intheir partnership in the biomedical sector, including hepatology, insiders say.
johnsonsaid the future of global pharmaceutical lies in gene treatment. cancertreatment is creating ample business opportunities. he expects chinese andtheir u.s. counterparts to build mutual trust through the apollobio project.
onapril 12 apollobio teamed up with beijing remote horizon group, the country’sleading remote medical service firm, and the asia- pacific alliance of liverdiseases, the world’s largest liver diseases doctor’s alliance, to launch aproject called defeat hbv. the three have said they will find a cure forhepatitis b in china.
thecampaign is touted as the chinese version of the jade ribbon project, an eventinitiated by the asia liver center and the school of medicine at stanforduniversity in 2001.
itused the chinese character ren as a symbol, aiming to raise awareness amongasians, of hepatitis b.what they say
chineseresearchers in medicine talk about apollobio’s ambitious move to acquire theexclusive distribution rights to u.s.-made pharmaceutical drugs.
“aspecial vaccine for children’s pneumonia was adopted in the united states 10years ago but we still need to import it from the country.we expect a vaccineto help both chinese and u.s. children simultaneously. that’s why i appreciatethe apollobio project. if it succeeds, it could benefit generations upongenerations. a grand project needs big-picture investors and high-levelresearch organs.”
luyichen, former principal research scientist at harvardt.h.chan school of public health, and president of haikou vti biologicalinstitute in haikou, hainan province
“i was impressed by the apollobio project. it could significantly benefit thetreatment of hepatitis in china. the $5 million investment in research for theproject is expected to accelerate new drug research and development.”
chengjun, deputy dean of beijing ditan hospital
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