2015年1月20日讯 /生物谷BIOON/ --最近新加坡国家癌症研究中心报告了由美国FDA和新加坡卫生科学局联合研发的新型肿瘤疫苗的相关研究细节。新加坡系统借此机会能够跻身世界医学研究中心之列，打造一个集生物医药研发、生产为一体的中心。
美国MicroVAX公司于2014年8月份宣布开始进行这一项目并与新加坡有关部门进行合作开展临床研究。研究人员系统通过靶向多种癌症通用标记物来治疗包括乳腺癌、胰腺癌、大肠癌、卵巢癌和肺癌在内的多种疾病。其实质仍然是通过激活人体免疫系统，使其提高识别肿瘤细胞的能力，进而治疗癌症。这也是首个获得美国FDA和新加坡卫生科学局共同批准的临床项目。
尽管这一疗法在近年来出现的肿瘤免疫疗法大潮中显得没有那么独特，但是这折射出新加坡当局和产业界决定借此机会在当今生物医药产业有所作为。事实上近五年来，新加坡已经和包括诺华公司、艾伯维公司和安进公司等多家世界生物医药巨头进行了广泛的合作。同时，新加坡还在近几年大力发展药物加工业产业。
不过，新加坡想要在亚洲医药产业领域一枝独秀，还需要面临不小的挑战。除了日本这种传统市场之外，中国台湾地区、韩国等地因为其药物审批周期短，相关机制健全也成为吸引国际医药企业的热点地区之一。
这也为中国生物医药产业提出了拷问：中国在充当"世界加工厂"长达三十年之久后的今天，在生物医药研发如火如荼的时候，我们在这个庞大的市场中究竟是要继续扮演加工厂的角色还是转型成为竞争者和世界各大医药巨头一决雌雄？这值得每一个生物医药产业人士深思。
详细英文报道：
SINGAPORE--The National Cancer Centre Singapore will brief on the status of a first-in-human clinical trial using an adenovirus under a protocol endorsed by the U.S. Food and Drug Administration (FDA) and Singapore's Health Sciences Authority (HSA), highlighting the wealthy city-state's push to be a leader in early stage clinical trials in Asia.
MicroVAX, a biotech company located in Manassas, VA, announced in August last year it would start Phase I clinical trials for a proprietary vaccine platform that allows under the provisions of an FDA IND entry of patients with cancers of the breast, prostate, colon, ovary and lung, that have relapsed after initial salvage therapy.
The August statement noted the trials are sponsored by the Singapore Clinical Research Institute, and conducted by Dr. Toh Han Chong, senior consultant and deputy director at the National Cancer Centre Singapore.
"Our main objective is to assess the safety and benefit of this unique vaccine, which aims to target a common protein on many of the commonest cancers such as colon cancer, breast cancer and ovarian cancer, and provide a specific extra boost to the immune system against cancer at the same time," Dr. Toh was quoted as saying in August. "We will also assess how potent this vaccine can stimulate a meaningful immune response against the cancers."
Singapore has moved to build a vast biomedical complex for treatment aimed at patients from home and abroad, clinical research and manufacturing in the past five years that includes the DUKE NUS Graduate Medical School, the Biopolis cluster of research facilities, the Agency for Science Technology and Research, or A*Star, and new state-of-the-art manufacturing plants in biologics by AbbVie ($ABBV), Amgen ($AMGN) and Novartis ($NVS) in the past two years among others. Companies like Bayer Healthcare have made it a regional cancer research hub.
The push on clinical trials faces competition from South Korea and Taiwan, both of which have shortened regulatory review periods along with Singapore to attract research as well as moves to attract industry clusters in biotech.
"Foreign patient among those undergoing this trial--so far shows promising results," according to an invite to a Jan. 21 press conference to update on the trials.
"The Phase I clinical trial also scores another first for Singapore as it is endorsed by both US FDA and our HSA. The trial is sponsored by Singapore Clinical Research Institute."