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Sunday, June 3, 2012

南京江宁高新园: 一校一企一产业 !!


江宁高新园:创业创新活力迸发的国家大学科教创新园区 2012-06-01 新华日报(南京)方山脚下,秦淮之滨,一座国家级高新技术产业开发区崛起腾飞南京江宁高新园。江宁高新园的前身是江宁科学园,经过18年的发展,园区已经形成了高新技术产业区、江宁大学城、方山风景区联动发展的三大功能区域,确立了生命科学、高端装备制造和现代服务业为主导的现代产业发展格局。江宁区副区长、江宁高新园党工委书记周育刚介绍说,江宁科学园更名为江宁高新园,是区委、区政府发展高新技术产业、支撑江宁新一轮跨越发展、科学发展的战略布局,江宁要把高新园打造成为南京创新型经济发展的重要载体平台,成为与全国高新区同台竞争又一个重要引擎。目前,江宁高新园围绕“二次创业”,积极践行“三争一创”,全面落实创新驱动战略,壮大新兴产业支撑,优化环境服务配套,大力弘扬“诚实、创新、包容”的园区精神,全力打造长三角一流的大学科教创新园区,国际领先、国内一流的生命科学城,最具活力和竞争力的国家级高新区,建成创业创新活力迸发的国家级大学科技创新园区,奋力争当全区乃至全市“第二个率先”的先行军。
【科创篇】有载体有政策有公寓,科技特区成创业乐园江苏(江宁)大学科教创新园由南京市江宁区与江苏省教育厅、科技厅合作共建,包括南京紫金(方山)科技创业特别社区、生命科学城、秦淮源国际化品质生活社区、毕业企业创业园四个功能区,包含国际一流的孵化器、加速器、中试用房,以及总部研发中心、人才公寓等功能设施,建立健全公共技术、投融资、信息交流、中介服务和政府服务“五大平台”,构筑集特有功能、特殊政策、特色运作于一体的创业创新“小环境”。紫金(方山)科技创业特别社区:已全面开工建设各类创业载体50万平方米,启动人才公寓、生命科学产业中心(博览馆)、创业大道等配套设施建设,确保年内建成生命科学城活力智岛一期项目和生命科学产业中心。今年,将引进1-2家知名投资基金、2-3家科技小额贷款公司,目前已成立邦信科技贷款公司,注册资本3亿元。“十二五”期间,高新园将建成230万平方米孵化加速载体,全面构建江苏省医药动物实验基地、江苏省基因药物技术中心等专业技术支撑平台,孵化毕业200家企业,培育创新型企业100家,建成创业创新活力迸发的国家级大学科技创新区。
【人才篇】一年集聚5名“千人计划”人才,园区成引才“强磁场”过去的一年里,园区引进国家“千人计划”5人、省“双创”计划6人、市区人才计划近30人。目前,高新园已有近50位高端人才获得了中央千人、省双创、南京市321等人才引进计划资助。去年一季度,园区企业省建筑科学研究院缪昌文博士当选为中国工程院院士,今年一季度引进和培育国家“千人计划”2人,东南大学生命科学研究院院长谢维教授等6位高层次人才落户园区。在园区集聚的高端人才中,有以施一公教授、张丹博士、谢良志博士为首的生命科学领域的领军人物;有以章方良博士、赵子建博士、戴一凡博士等为代表的海归创业团队;有以郭宏新董事长、张杭董事长、陈依军董事长为代表的高校教授创业企业家。2012年,高新园将确保入选国家、省市人才引进计划64名。“十二五”期间内,园区将引进领军创业人才、科技创业家、国家“千人计划”专家分别占全区总量的1/4,力争1/3
【大学篇】大学城和园区展开“齿合式合作”,大学科技园遍地开花拥有15所高校、25万师生的江宁大学城已经成为江宁高新园的最大优势。园区推动高校重点实验室、研究生部、公共技术平台等创新资源迁入大学城。现在,正以每年不少于3家的速度引入省级以上重点实验室。园区瞄准产业链高端环节,加强与高校的齿合式合作:与高校实现“一校一企一产业”合作,组建一个运作公司、建设一个产业基地、培育一个新兴产业,走出一条园校利益一体、互惠双赢的政产学研合作之路。目前,园区与中国药科大学、南京医科大学、南京工程学院、江苏经贸学院、金陵科技学院合作的五个大学科技园加速推进。加快建立“孵化服务+创业投资+创业导师”的创业孵化体系,为高校师生创业提供从基础服务到投融资、市场拓展的全方位解决方案。“180”大学生创业广场,已经入驻100多家学生创办企业。大学城还将与10所高校展开合作,建成1-2个国家级科技企业孵化器,筹备成立大学城就业创业培训服务中心。
【产业篇】高端高质高新,大批优质项目产业集聚园区高新园一手抓主导产业,做强做优,一手抓新兴产业,培育引导,两手硬、两不误,主”“新”并举,加速转型升级。生命科学产业:集聚了金斯瑞生物科技、奥赛康研发中心、康缘生物医药科技园、先声药业抗体药物研究所及中试基地、美国异种器官移植医疗中心等一批领军项目以及合源医药创新团队、美国斯坦福大学终身教授王义斌等多个创新创业人才项目。致力打造国际领先、国内一流的生命科学城。高端装备产业:瞄准智能装备领域,南高齿入驻了蒂森克虏伯、舍弗勒、瑞拓、吉地亚、帕艾斯等一批重大项目,建成全国有影响的高端装备制造业基地。现代服务产业:以方山横岭旅游小镇、方山当代文化创意产业园、天景山动漫基地、杨柳湖文化创意园等为平台,发展总部经济、文化创意、动漫网游、软件及服务外包、金融信息等现代服务业,增强城市核心功能和竞争力。未来五年,园区将建成博士后工作站、院士工作站20家以上,培育一批百亿、十亿级以上的企业,累计上市公司突破20家。
【城建篇】高端配套加紧完善,建设幸福乐居新城示范区瞄准国际国内一流园区,以一流的基础设施和精品工程,迅速提升城市形态和整体形象,全面增强高新园对外吸引力。 南京医科大学明德医院、高星级酒店、潭桥小学、龙湖湾小学、加洲城小学等配套重点项目加速推进,园区在生活、医疗、教育等方面的配套将更加完善。方山作为高新园的后花园,成功申报为国家3A级旅游景区。方山当代创意产业园、方山风景区、秦淮湿地公园规划与资源进一步整合,方山横岭将被建设成旅游小镇,以方山当代创意产业园为核心的创意产业集群已经初步形成。建成区域实施“退二进三”,打造现代经济总部区、商务区等功能,争取趋势科技、硕文软件和中国电信呼叫中心等重大项目的落户建设。同时,园区内的拆迁工作和复建房正在稳步推进。高新园统筹城乡发展,建设和谐园区同步取得了新的进展。本版撰稿 孔永祥

楚天科技:水剂类制药装备提供商 !!


 2012-05-31 17:16:00 来源: 中国经济网(北京) 楚天科技主营业务为水剂类制药装备的研发、设计、生产、销售和服务。水剂类制药装备是制药企业生产小容量注射剂、粉针剂、冻干粉针剂、口服液剂、大容量注射剂等药品的关键设备,按生产药品剂型不同可分为安瓿瓶联动线、西林瓶联动线、口服液联动线、大输液联动线等。上述联动线通常由洗、烘、灌、封等系列单机和药物在线称重设备、灯检机等辅助设备组成,广泛用于化学药品制剂、中药制剂、疫苗、血液制品、保健品、兽药等的生产领域。楚天科技自成立以来一直专注于水剂类制药装备的研发和生产,致力于为制药企业提供专业化、个性化的制药装备解决方案。经过多年积累,楚天科技已成为国内领先的水剂类制药装备提供商,主要产品覆盖国内制药工业百强中的64家企业(注:根据南方医药经济研究所和《医药经济报》发布的“第五届(2009)中国制药工业百强”名单统计),典型客户包括国药集团、中生集团、哈药集团、石药集团、上药集团、修正药业、扬子江药业、广药集团、天津医药、华北制药、东北制药、步长集团、双鹤集团、华东医药、浙江医药、三九医药、齐鲁制药、太极集团、东北制药、科伦药业、丽珠医药、云南白药、神威药业、康恩贝、正大天晴、太原制药、亚宝药业、人福科技、无限极(原南方李锦记)、科兴生物、沃森生物等国内著名制药企业。

中國人海智財外包 !!


IP Considerations for Firms Doing Business in China and India   Legal Affairs: Jun 1, 2012 (Vol. 32, No. 11) Ningling Wang , Mukta Jhalani  Intellectual Property Issues to Contemplate Before Making the Move With low labor costs, deep talent pools, and large populations, China and India have become attractive emerging markets for many western companies in the life science industry. In recent years, we have seen a trend for western biotech and pharmaceutical companies to establish their R&D centers or set up operations in China and India. Some western biotech and pharmaceutical companies have also formed joint ventures or research collaborations with domestic companies in China and India. In the life science industry, in addition to business and scientific considerations, IP protection and enforcement can be critical to success. Strong patent protection worldwide gives a patent owner leverage in negotiating deals. Patent protection in China should be obtained, although many people are still skeptical about enforcement of patent rights in China. Without patent protection, inventors in the life sciences lose the option of enforcing their proprietary rights. At the same time, publication of such inventions elsewhere makes them prior art. And a prior art defense has become an effective way for infringers to avoid infringement liability in China. With strong patent protection, a patentee can enforce its rights against potential infringers to exclude them from the market. In such enforcement proceedings, more and more potential infringers consider and challenge the validity of the patents as a counter defense to infringement. In China, the Patent Reexamination Board (PRB) of the SIPO is the sole jurisdiction for challenging the validity of a patent. If one of the parties does not agree with the PRB’s decision, that party can appeal only to the Beijing No. 1 Intermediate People’s Court. The decision by Beijing No. 1 Intermediate People’s Court can be appealed only to the Beijing High People’s Court. Any further appeal is not a matter of right since the People Supreme Court in China has discretion in taking cases from High People’s Courts. The invalidity proceeding can be long and the potential infringer can allege invalidity challenges on different grounds. The common grounds for invalidity in life science include a lack of sufficient support in the specification for the patented claim scope and a lack of inventive step. Accordingly, when preparing and prosecuting a patent application, it is important to envision potential invalidation grounds and make the issued patent as strong as possible in defense of invalidity challenges.
Lack of Patent Linkage In comparison with the U.S., China is not an ideal place for patent litigation, especially for biotech and pharmaceutical companies. One important reason is that, different from the U.S., there is no patent linkage in China. Specifically, in the U.S., the Hatch-Waxman Act requires a branded drug manufacturer to list its patent numbers and expiration dates in the Orange Book with the FDA. The FDA cannot approve a generic drug if that generic drug would infringe a brand manufacturer’s patent listed in the Orange Book. However, there is no Orange Book listing with the State Food and Drug Administration in China (SFDA), and SFDA does not probe into whether a generic drug would infringe a branded manufacturer’s patent as a condition precedent for SFDA approval of the generic drug. It is up to the branded drug manufacturer to sue the generic drug company for patent infringement once the generic drug gets into the market. China is currently considering setting up patent linkage between the SIPO and SFDA. In addition, China does not offer data exclusivity to branded drug manufacturers. This is another risk innovative companies need to consider before moving to China.
Ownership Issues Additional IP issues that have been troublesome in China include ownership and trade secret protection. These issues occur often in deals such as licensing and joint research collaborations. Due diligence by the suitor should be conducted to ascertain the real owner of the IP prior to any deals in China. Individual inventors normally do not have patent rights if they are employed by an entity in China because such rights by default belong to employers under the employment contract. Even for professors who claim to be “independent” from the university, it is important to review their employment contract to ascertain ownership of any inventions made by the professor. In addition, talent in the life science area often moves from one company to another, especially in big cities. Therefore, it is advisable to carefully review all relevant employment contracts to ascertain who truly owns the patent rights of the invention(s) under consideration. We have also seen companies’ valuable trade secrets disclosed in a form of, for example, a patent application by a key scientist in the company who later left to join another company. The publication of the patent application makes the trade secret lose its value. Therefore, we suggest carefully drafting the employment contract and internal policies to implement strict procedures to prevent disclosure of trade secrets.
 India  Only recently has India provided patent production for pharmaceuticals. It is important to understand the boundaries of patentable subject matter, however, as defined by the 2005 amendments to the Indian Patent Act. Under section 3(d) of the Act, “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not considered a patentable invention. Application of this section requires an understanding of the term “efficacy.” A much-publicized dispute involving the interpretation of section 3(d) involves Novartis and its anticancer drug imatinib mesylate. Novartis attempted to patent a new version of its previously known imatinib mesylate, but the Indian Patent Office rejected the patent application under section 3(d). The Indian Patent Office initially rejected Novartis’ patent application on the basis that the drug did not meet the novelty and efficacy requirements of the Patent Act. After failed attempts at appealing the rejection of its patent application, Novartis ultimately appealed to the Indian Supreme Court, and it remains to be seen how the Supreme Court interprets “efficacy” as used in section 3(d).
Compulsory License Another important aspect of the Indian Patent Act, which up until recently did not get as much attention, relates to a compulsory licensing provision. The Act allows for grant of a compulsory license three years after the grant of a patent where (1) reasonable requirements of the public have not been met, (2) the invention is not publicly available at a reasonably affordable price, and (3) the invention was not worked on in India. A few months ago, the Indian Patent Office granted a compulsory license to an Indian pharmaceutical company for Bayer’s anticancer drug Nexavar on the grounds that the drug was not meeting the reasonable requirements of the public, was not reasonably affordable, and was not locally manufactured. The fate of Nexavar in India raises several concerns for innovative pharmaceutical companies regarding the availability, pricing, and manufacturing of patented drugs in India. It is particularly crucial to have a strategy on “working” the invention in India, for instance, by manufacturing in India, collaborating with an Indian company, or taking advantage of India’s investment treaties, as applicable. Any pharmaceutical company considering operations in India should consider that India does not offer data exclusivity for pharmaceuticals. In other words, a generic manufacturer can rely on the technical data generated by an innovative company because, in India, that data does not enjoy a period of exclusivity. Typically, a generic manufacturer relies on the innovator’s data with a showing of bio-equivalency between the generic and the innovative drug. In the presence of data exclusivity, an innovator can prevent others from relying on its clinical data. As a result, a period of data exclusivity can provide patent-like protection to prevent generic manufacturers from relying on the clinical data generated by the innovator. But India does not offer such data exclusivity protection. Thus, a pharmaceutical company setting up operations in India would need to consider the possibility of not having exclusivity for data that it generates in India.

新興國家比的是 國家整體戰略 ! Steven Burrill...Innovation in Emerging Markets !!!!


Emerging Markets Turn to Innovation  Feature Articles: Jun 1, 2012 (Vol. 32, No. 11) G. Steven Burrill  Governments Increasingly Seek to Build Their Economies through Life Science Investments In April 2011, Ascletis launched with $100 million in backing from a Chinese billionaire to discover and develop new treatments for cancer and infectious diseases in China. The company’s management team, based in Chapel Hill, NC, is made up of seasoned pharmaceutical industry veterans, but most of its staff is based in the company’s Hangzhou, China, offices. Ascletis is not the first company attempting to marry U.S. expertise in drug development with affordable talent in China. But the company hopes to seize opportunities created by cultural differences between the two countries that may allow it to in-license promising products that have been shelved by pharmaceutical companies because they were seen as undesirable products for developed markets. For example, Americans want once-a-day pills instead of injections, whereas people in China are more concerned about pricing, efficacy, and safety rather than convenience. Ascletis reflects not only the new global marketplace—single, flat, interconnected, and increasingly borderless—but the opportunity life science companies have today to exploit the availability of capital and the differing value assets from one country to another. It also points to a harsher reality of which the pharmaceutical industry has taken note. After decades in which the U.S., Europe, and Japan were the principal drivers of global economic growth, the tide has shifted to developing nations in Asia, Latin America, and other parts of the world where a rising middle class is fueling an economic boom. These emerging markets—China, India, Brazil, Russia, South Korea, Indonesia, and Turkey, among others—are becoming the new economic heavyweights. China surpassed Japan as the world’s second-largest economy in 2011 and is projected to overtake the U.S. by 2020. India is expected to become the third largest economy within the next couple of years. And Brazil and Russia’s GDP is higher than any European country with the exception of Germany. Within Brazil, Russia, India, and China, the middle class is expanding rapidly—growing at 21% a year to reach 1.8 billion people by 2014. The increased affluence is creating a greater demand for healthcare, in part because with changing lifestyles have come a growing incidence of chronic disease. India and China will make up nearly one-third of the world’s total patients with type 2 diabetes in 2030, with more than 150 million people afflicted with the disease by then.The pharmaceutical industry has targeted these emerging markets as a primary source of sales growth in the coming years. With many products facing patent expirations and slowing sales growth in developed countries, big pharma sees emerging markets providing an opportunity to extend product life after loss of exclusivity in established markets. These markets have a high regard for brands, giving the originator a leg up over generic competitors. Big Pharma is also investing in research and development around the world to take advantage of low-cost talent, local expertise, and proximity to new markets. For example, Merck in 2011 said it would commit $1.5 billion to expand its research and development activities in China. Every multinational pharmaceutical company now is establishing a presence in the major emerging markets countries. And it’s not just traditional big pharma, but biotechs as well. Amgen has been steadily diversifying into emerging markets, entering Brazil in a big way with its $215 million buy of Bergamo, and establishing a foothold in the Middle East with the $700 million acquisition of privately held Turkish pharmaceutical firm Mustafa Nevzat.
New Focus Once viewed solely as a source of inexpensive labor, these emerging markets are becoming sources of innovation. This is seen in the rapid increase in their contributions to scientific articles being published in peer-reviewed journals and patent applications being filed with the World Intellectual Property Organization. China is closing ranks with the U.S. as the top filer of patents applications and is expected to surpass it by 2015. One striking example of this innovation shift is the rapid rise of BGI, formerly the Beijing Genomics Institute, to become the world’s leading sequencer of genomes. Backed by $1.5 billion in government funding, BGI has established partnerships and collaborations with leading academic and government research institutions throughout the world, as well as global biotechnology and pharmaceutical companies. In February BGI teamed up with the Asia Cancer Research Group (ACRG) to conduct genomic research on lung cancer and liver cancer. ACRG was established in 2010 as an independent, not-for-profit company by Lilly, Merck, and Pfizer to accelerate research and, ultimately, improve treatment for patients affected with the most commonly diagnosed cancers in Asia by freely sharing the resulting data with the scientific community. We are also seeing a global movement of scientists, who often come to the U.S. and Europe for education and business-management training. Unlike the recent past when they would remain and work in their adopted countries, they are returning to their native countries to take advantage of the growing opportunities available to them in their homelands.
Shifting to High-Value Industries  Perhaps the clearest sign of these countries as emerging sources of innovation is the concerted investment their governments are making to move their economies to high-value industries from a dependence on low-value commodities and manufacturing. They see biotechnology and other medical technologies as important drivers of economic growth and are investing heavily in education, infrastructure, and healthcare to develop homegrown industries to serve the needs of their people and fuel further growth of their economies. Russia may be the leader in this trend, leveraging its financial strength to gain industry expertise. Government-backed investment funds have been making significant bets in innovative Western life science companies that are willing to set up drug development and manufacturing facilities in Russia. Rusnano, backed by $10 billion in government money, has entered into a $760 million partnership with U.S. venture capital firm Domain Associates to back up to 20 companies willing to develop their compounds in Russia. China’s current economic plan calls for doubling biomedical R&D innovation funding from the previous plan to $300 billion. It seeks to make China the second-largest pharmaceutical market by 2020. South Korea has pledged increased funding for stem cell research, describing it as a “new growth engine.” Its drug agency approved the first therapeutic using allogeneic stem cells in January, developed by Seoul-based Medipost to regenerate knee cartilage using stem cells derived from umbilical cord blood.
Win-Win Opportunities  Life science companies facing a difficult funding environment in the U.S. are finding that one cost-effective way to develop their drugs is through partners in emerging markets. They can gain access to capital to fund development while retaining rights to their products throughout most of the world. For example, Harbor Biosciences granted Sinopharm subsidiary China State Institute of Pharmaceutical Industry (CIPI) exclusive rights in China to three of its products in exchange for the Chinese government-owned pharmaceutical’s agreement to develop them. CIPI will finance all product development in China to two mid-stage compounds and one preclinical compound for major indications including diabetes, cancer, inflammation, and infectious disease. Besides being eligible for milestone payments and royalties for sales in China, Harbor retains all rights outside China and can use the clinical data generated by CIPI to seek marketing approval elsewhere. Harbor advances its products through development without having to provide any financial support to do so. By leveraging the needs in emerging markets, companies such as Harbor can obtain access to nondilutive financing, reduce development risk, and develop multiple compounds at once. For the emerging markets, these deals provide a way for these countries to build their economies, decrease their dependence on drugs produced outside their borders, and increase the high-value skills and technical skills of their workers as they address the health needs of their populations. Such agreements take on varying forms. Rusnano, for example, often ties its investment in Western biotechs with agreements to develop their compounds and commercialize them first in Russia. Its investment in two Massachusetts-based biotechs, Bind Biosciences and Selecta Biosciences, include providing each company with $25 million to set up wholly owned subsidiaries in Russia to advance the clinical development of their pipeline candidates. They expect Rusnano’s commitment to help them in their partnering efforts, as well as help them access global sources of funding. In other cases, deals take on the form of more traditional partnering arrangements. Maxwell Biotech Venture Fund, partially backed by the Russian government, licensed Maryland-based Sequella’s experimental antibiotic for the treatment of tuberculosis, which is an epidemic in Russia. Maxwell gains rights to the drug in Russia and neighboring Commonwealth of Independent States countries, where it will assume responsibility for further clinical development and regulatory approval. Sequella gets a partner that can navigate the product through the local regulatory agencies, an equity investment, clinical supply purchase, and milestone payments worth up to $50 million, as well as royalties. Plus, Sequella retains all rights to the drug in the U.S. and the rest of the world. In this way, companies can leverage an asset they may be ill-prepared to commercialize in an emerging market, and leverage the needs in those countries to accelerate development, cut costs, and reduce the risk of bringing those products to market in developed countries. At the same time, this global movement of technology and innovation can help boost the economies of the emerging countries and address unmet medical needs of their populations.
Challenges Ahead This is not to say that doing business in emerging markets will be easy. Other than their economic potential, emerging markets have little in common. Their demographics, governments, regulatory policies, economic structures, healthcare systems, and cultures are quite disparate and must be taken into account when devising an emerging markets strategy. Just as in developed countries, governments in emerging markets face increased pressure to rein in healthcare costs. In most of these countries, government regulations and policy are designed to benefit local companies, and demand that foreign companies wishing to do business in their markets establish local subsidiaries and partner with local firms. Their regulatory bureaucracies can be difficult to navigate, and businesses are often hampered by a lack of managerial expertise. Markets are often fragmented with many small players competing to get their products on official government lists of essential drugs. The potential market is huge, however, and governments see the importance of investing in the life sciences to build innovation-based economies that can provide high-quality jobs. They see innovation as the way to transform their societies for the better, especially amidst the austere economic conditions and global challenges facing the world today. The challenge for innovative companies is to understand and be able to take advantage of global opportunities when and wherever they may arise. Those that succeed are posed to reap huge rewards.

Big pharma 不得不的中國佈局 !


跨国药企的“中国企图” !!  剑指中国市场将研发及行政总部等“大脑”部门移至中国,背后是跨国药企的“中国企图”。2007年,两大外资药企罗氏与葛兰素史克(GSK)先后入驻上海张江。2009年,拜耳医药在京成立全球研发中心。201010月,辉瑞在武汉设立研发中心,对上海研发中心进行补充。而记者获悉,继礼来之后,6月下旬另一家知名外资药企也将把公司亚太区总部迁至上海。严伦博向本报记者表示,此研发中心的投资金额不便透露,但可以说“意义重大,且有望多次追加投资”。而未来研发出的药品,也可服务于中国外的其他市场。常见病用药向来是大型药企的“兵家必争之地”。上海市卫生局局长徐建光介绍,目前全国范围内20周岁以上,仅显性糖尿病(已被诊断)患者就占总人口的9.7%,显性与隐性糖尿病(糖尿病前期)患者更是超过25%,仅上海市一地的显性糖尿病患者便占当地总人口的15.8%在中国糖尿病用药的细分市场中,礼来与拜耳、赛诺菲、诺和几家鼎足而立,竞争激烈。据预测,未来5年中我国口服糖尿病用药的市场销售额将超过6亿美元。礼来中国研究副总裁、礼来中国研发中心总经理章蓓透露,“中国的糖尿病患者人数多于世界上其他国家,其中多达四分之三的患者尚未能有效地控制疾病。礼来中国研发中心将探索应对这一未被满足的患者需求的创新解决方案,从而实现开发具有突破性的治疗药物的目标”。
合作补益过去两年中,跨国药企在商业领域频频与国内企业联姻。在礼来和科文斯中国合作之前,默克已结盟先声药业,辉瑞则牵手海正药业,并作为上药登陆H股基础投资者之一。然而,上述这些例子均是偏重于在商业运作。徐小星说,罗氏现在一半是在支持商务,一半是在研发。不过,最为关键是如何找到有共同愿景又有互补能力的合作伙伴,这往往是可遇不可求的。“最容易开始的一类是国外已有新药,且被证明十分有效的,那么国内公司加紧研发做出类似的化学药。其次,是国内外在这一技术上都有研究,国外更胜一筹,这时外资药企作为合作方就应帮助国内企业把既有的产品做得更强。”徐小星说。事实上,201110月,在肿瘤药领域领跑市场的罗氏就与苏州生物纳米园、哈佛大学三方达成了合作协议,初期专注于为癌症治疗开发自噬体抑制剂。徐小星指出,在这样的合作中合作方都出钱出力,“一起冒这个险投资,进行非常前沿的创新。”礼来中国总裁艾博来(Eric Baclet)则表示,礼来风投基金在过去五年中已斥资6000万完成了8项投资,并强调现阶段许多风投和外资公司还是集中于研发后期的项目,其实未来各大公司和风投应当进一步关注中小企业药物研发早期的能力。

礼来在沪建研发中心 分羹中国市场蛋糕


20120601世纪经济报道外资药企云集的张江药谷又迎来一家大企业。531,美国礼来制药在上海宣布,其中国研发中心正式投入运营,专攻糖尿病药物开发。不仅如此,礼来还与科文斯中国(Covance China)宣布签署合作伙伴关系协议,后者将为礼来中国研发中心提供一系列药理学领域的服务。礼来制药全球执行副总裁、礼来研究院总裁严伦博(Dr.Jan Lundberg)表示:“礼来中国研发中心的成立,说明我们是以非常严肃认真的态度,致力于探索和开发中国糖尿病患者迫切需要的具有突破性的药物。”罗氏全球授权业务总监徐小星向本报记者表示,利用国内外的公司的不同强处,强强联合,能够打造出来同时具备对中国市场有利,又对国际有利的新颖制药。

F-康聯代理GSK抗生素開賣


【經濟日報╱記者黃文奇/即時報導】2012.05.08 生技族群4月報喜,F-康聯(4144)等多家生技股7日公布4月營收,其中F-康聯、懷特上月營運年成長三成;精華光、台耀也有年增近一成表現;F-康聯第2季起主力產品「葛蘭素」(GSK)抗生素針劑「力百汀」開賣,下半年營運旺。

越南等鄰近國家 腸病毒拉警報


2012/06/03 聯合報】越南今年腸病毒疫情提早出現,單是5月通報病例就超過65百例。越南新住民、台商、華僑多,衛生署疾病管制局提醒,返鄉、旅遊民眾應多注意,特別是隨行幼童,應勤洗手、保持警覺。 今年台灣腸病毒疫情也來勢洶洶,疾管局指出,鄰近國家中國大陸、港澳、馬來西亞、新加坡及泰國,也有同樣趨勢,病例數皆較去年同期高出許多。

海富通基金干细胞概念 豪砸1.5亿


20120602世纪经济报在基金独门股中,中源协和是不多进入基金重仓股的股票。海富通精选基金一季报显示,海富通精选基金持有中源协和超过600万股,持股市值超1.69亿元,占基金资产净值比例为1.94%,位居基金重仓股的第十位。对比海富通精选的其余重仓股可以发现,其余九只皆是清一色的金融、地产、机械等传统行业的基金重仓股。在这些股票之中,中源协和轻盈的身影与生物医药概念显得格外突出。海富通持有中源协和的股份比例在中源协和的流通股股东中也颇有地位,中源协和2012年一季报显示,海富通精选基金是中源协和十大流通股股东中唯一一家公募基金,其持有流通股比例为1.86%,是仅次于大股东的第二大流通股股东。
“恋上”干细胞  记者查阅公司和基金季报发现,海富通精选是在2011年四季度进入中源协和,当季度中源协和的加权平均股价为24.84元,这意味着,海富通精选的建仓成本市值可能近1.5亿元。而这些引来海富通独门关注的产品,则涉及到了一个重要的概念——干细胞。干细胞是一类具有自我复制和多向分化能力的细胞,是肌体的起源细胞,是形成人体各种组织器官的祖宗细胞。因此,它对人体发育、衰老和疾病的治疗有着巨大的作用,因此干细胞技术也是医学领域的研究热点之一。而作为国内唯一干细胞题材的已上市公司——中源协和,也由于这个神秘却又充满了可能性的小物体,得到了机构的青睐。中源协和的前身是主营纺织的望春花,从2001年开始进军干细胞产业。至2011年,重整后的中源协和的纺织部分资产早已剥离,主业彻底转为干细胞的研究和应用。“上市公司现在实际上是控股公司,有20多个人员。主要的资产是旗下的子公司。”中源协和公司一位高管告诉记者。中源协和此时的重心实际为主要子公司——协和干细胞基因工程有限公司(简称“协和公司”),中源协和与中国医学科学院血液病医院(血液学研究所)分别持有协和干细胞57%43%的股权。协和公司的主营业务为干细胞资源的检测与存储业务、基因检测业务、单克隆抗体试剂的生产与销售业务。协和公司同时控股和参股8家子公司。协和公司2011年度实现营业收入为2.47亿元,实现归属于协和母公司所有者的净利润为5635.54万元。除了协和公司外,中源协和另外一块颇具吸引力的资产是持有和泽生物科技有限公司(下文简称“和泽生物”)51%的股权。和泽生物现有的财务数据一般,截至2011930,和泽生物收入3745万元,净利润为负的1105万元。但是和泽生物的前景诱人。中源协和看中的或是和泽生物手中的干细胞库,和泽生物已与黑龙江、上海、江苏、安徽、江西、河南、山西、吉林、辽宁、河北、陕西、海南、云南、甘肃、内蒙古等15个省市卫生系统具有重要影响力的机构签订了建设地方干细胞库的合作协议或达成合作意向。根据华宝证券的研究报告显示,截至20111229,已有八家先期投入。和泽生物背后蕴含的巨大想象空间,激发了市场的热情。2011年初,中源协和公布增发收购和泽生物股权的方案复牌后,中源协和的股价出现连续7个涨停,在短短一个半月的时间里,中源协和的股价上涨超过120%。市场的热烈反应,某种程度上印证了这一收购的价值,但是2011年初的增发方案最终宣告失败,这并不妨碍中源协和继续收购的步伐。20123月份,中源协和以自有资金收购和泽生物51%的股权,获得和泽生物控股权。与此同时,中源协和宣布向大股东定向增发募集资金收购和泽生物余下49%股权的增发方案。
新药诱惑  在剥离了纺织资产和收购和泽生物后,中源协和已经是国内名副其实的唯一干细胞题材的上市公司。协和公司副总裁黄家学告诉记者,目前中源协和已经形成了七大产业发展板块,分别是生物组织库(干细胞组织库)、干细胞治疗、基因诊断与检测试剂、抗衰老与美容保健、药物和高端医疗器械。其中,除了生物组织库已经为市场所熟知之外,其余的各大板块其实仍是较少人知悉。干细胞治疗方面,黄家学对记者介绍指出,目前已与军事科学院等合作,为其提供优质细胞治疗用干细胞培养服务。其透露,这种临床治疗的应用,已获得了解放军后总卫生部系统批文。事实上,基因诊断与检测试剂则是更为陌生的领域。中源协和的基因检测已经在3月份推向市场黄家学告诉记者,现阶段推出的主要是儿童基因检测套餐。记者从该基因检测项目的销售渠道方面了解到整个3月份大约已经做出30多份、4月份上涨到100份左右,5月份估计达到了250份。“基因检测很有可能成为上市公司的第二大利润增长点。”黄家学告诉记者。此外,检测试剂则是更为市场忽视的细分领域。华宝证券的研究显示,公司CD系列单克隆抗体体外诊断试剂有望成为公司新的利润增长点。CD系列单克隆抗体体外诊断试剂主要应用于了解细胞的分化和T细胞亚群的数量和质量变化,对多种疾病诊断具有参考意义。目前国内同类的体外试剂,主要是国外产品的市场,国内并无此类试剂。据业内人士估计,这个细分市场的容量大约在四五十亿左右,主要客户是医院和研究机构。据了解,目前中源协和已经建立成符合GMP标准的质量区间,正在国家药监局申报,一旦拿到行政许可,就有望投入生产销售。据记者从业内人士处了解的情况显示,由于检测试剂申报属于国家第三类体外试剂范围,跟药物不一样,如检测的结果准确可靠,在拿到批文后就可以投入生产销售。“体外试剂已经有大量的数据做了测试基础。” 黄家学告诉记者。“其他方面虽然也发展不错,但是我们判读现在处于市场的培养期,对公司的利润贡献暂时不明显,我们最为看重的其实是公司的新药研发进展。”有对中源协和持续关注的上海私募机构人士告诉记者。中源协和曾经公告称,和泽生物旗下的“脐带间充质干细胞抗肝纤维化注射液”(治疗肝硬化新药)已经上报国家药监局。记者查阅国家食品药品监督管理局药品审评中心,该项受理号为CXSL1000057、由和泽生物科技有限公司申报的药品申报进度显示,中心已经结束该项技术评审工作,于201238报送国家食品医药监督管理局进行审批。记者查阅国家食品医药监督管理局的行政许可进度时发现,该项受理号为CXSL1000057的药品,于2012425开始办理,目前办理状态为“制证完毕-已发批件”。而在国家食品医药监督管理局的网站上显示“制证完毕-已发批件”的结果意味着“批件已发给相应省级食品药品监督管理局注册处或进口药品申请人”,但同时有标注:“本进度查询结果仅供药品注册申请人了解其申报品种的注册进度等,不作为信息发布或任何证明使用。药品批准文号等信息仅供参考,以正式下发批件为准。”而据记者从公司方面了解的信息显示,目前正在研发的均为市场想象空间巨大的新药,主要涉及到肿瘤、糖尿病、肝病、类风湿等应用,其中有两个药品已经进入了临床一期阶段,一个已经计入临床二期阶段,有两个正在进行临床前研究。此外,在抗衰老与美容保健方面,主要产品已经获得了卫生许可、生产许可,正在等待上市销售许可。而抗衰老中心,则还在争取获得资质。“都要在获得许可后,才会投入生产,保证合法经营。”上述公司高管指出。
干细胞政策疑云虽然,一切有关干细胞的展望,都看起来很美好,但是,聚集在这个行业上端的最大阴影,则是政策的不明朗。20111024,卫生部发布《关于加强脐带血造血干细胞管理工作的通知》要求,对脐带血造血干细胞采集和应用采取多个措施。此后在201216,卫生部再度发文指出,将在71前停止在治疗和临床试验中试用任何未经批准使用的干细胞,并停止接受新的干细胞项目申请。同时要求有关部门抓紧研究并提出制度性文件草案和相关技术标准、规范,探索建立监管模式和长效机制。这使得中源协和也遭到了市场对其所在行业的政策存在重大不确定性的质疑。事实上,悬在整个行业头上的,并不是简单的禁止与通行的问题,而是整体导向缺乏统一监管安排的问题。事实上,在973863和国家“十二五”医药工业规划中,干细胞都是重要扶持发展的项目,而在最新下发的国务院办公厅《关于加强战略性新兴产业知识产权工作的若干意见》,再度提出支持七大新兴产业,其中干细胞正是生物产业六个子行业中的一家。虽然干细胞的研究在衔枚疾进,但是由于担心行业发展混乱,干细胞的应用却一直没有放开。这或许也是在新兴产业概念投资大行其道的时候,干细胞领域却鲜有基金关注的主因。
实际上,已经进驻的私募机构对此也有分歧。追逐干细胞的巨大诱惑而来的不但有海富通,还有私募名人蔡明旗下的民森A号和徐翔旗下的泽熙瑞金1号、龙信基金通1。民森A号早在2011年一季报已经现身,持有509万股,其后虽然略有减仓,但是至今年一季度持股数量仍高达344万股,对该股的未来明显看好。但徐翔旗下的泽熙瑞金1号和龙信基金通1号则同在2011年四季度进驻,合计持股高达710万股。但旋即在今年一季度减仓,至一季报公布已经淡出十大流通股股东。可见对于行业未来尚有疑虑。“规范化管理对上市公司这种规范发展的企业而言实际上是好事。我们正在积极开展干细胞治疗的规范与标准研究项目,积极配合参与国家相关行业政策标准的制定。”上述中源协和高管指出。据黄家学介绍,目前中源协和旗下的干细胞等组织资源库,合共拥有两个卫生部的批文、12个卫生厅的批件和7个科技厅的批件。而真正的决定性时刻或在71之后,届时卫生部将重新接受干细胞临床治疗申请。中源协和上述高层告诉记者,“只要是干细胞应用放开,中源协和肯定能最先受益。”中源协和所倚仗的或者是其堪称“豪华”的专家技术团队以及这个团队背后的影响力。中源协和的高管中就有多位行业专家,其中董事陈晓红现任301医院副院长,独立董事刘晓程曾任中国医学科学院副校长。和泽生物的专家技术团队则由中国军事医科科学院前院长、中国科学院院士、实验血液学家吴祖泽领衔。

加速 !药用辅料 规范



 作者: 来源:中国证券网 2012-05-30 08:34:39  事件:国家药监局日前通报了铬超标胶囊剂药品最终情况,截至524,各级药品检验机构共抽验胶囊剂药品11,561批次,铬含量超标的不合格产品669批次,5.8%。存在铬超标药品问题的生产企业254,占全部胶囊剂药品生产企业的12.7%  

医药:政策转向推动行业整合  评论: 问题胶囊事件将加速招标政策转向:“唯低价是取”的“安徽模式”成为药品市场“劣币驱逐良币”深层原因。今年3月国务院《医改工作十二五规划》明确提出“质量优先、价格合理”,已公布12年非基药中标结果的青海、甘肃、新疆、陕西看,招标结果好于市场预期。药品招标政策已开始有转向,问题胶囊事件将加速这一政策的执行。2012年是非基药招标大年,基药的政策方向也将传导到非基药招标中,招标政策逐渐趋于良性。问题胶囊事件推动辅料行业规范化、标准化升温。目前我国药用辅料品种符合药用标准的只占不到三成,《药用辅料管理办法(征求意见稿)》并未正式实施,问题胶囊事件充分暴露出辅料监管存在盲点,将会促使国家进一步重视药用辅料行业,引导市场规范化、标准化升温。专业药用辅料企业生产的符合药用标准、经过严格检验的药用辅料产品将成为药物制剂企业唯一的选择,尔康制药等龙头企业有望迎来历史性发展机会。问题胶囊事件不会改变行业增速回升态势。根据南方所数据,胶囊剂型占整个制药业收入约17%,问题胶囊事件短期会影响市场对胶囊剂型的消费,但对整个医药行业的收入增长影响不大。尤其在招标政策转向推动行业触底回升,同时11年中期开始的抗生素限量政策造成去年同期基数较低,该事件不会改变医药行业增速回升的态势。上市公司影响面小,优质龙头企业获得长期竞争优势:除少数公司外,此次通报结果对上市公司的整体影响不大。长期看,小企业将在药品质量控制成本的压力下面临淘汰,优质制药企业将凭借质量、资源优势受益于行业集中度的提升。建议关注辅料行业整合+政策转向预期+优质成长中坚。问题胶囊事件将推动政策转向和行业整合集中,有利于医药行业长期的健康发展。在挑战和机遇中,优质企业将迎来更大的发展空间。我们重点推荐药用辅料行业的整合者尔康制药;同时,在政策转向预期中推荐国药股份、国药一致、华润双鹤;继续关注通过创新和国际化路线穿越政策迷雾的成长中坚:恒瑞医药、华东医药、莱美药业、天士力。(国泰君安 李秋实)