作者：
Sang-Ki Rhee，韩国生命科学和生物技术研究所，前所长，高级研究员
Jeong-Seok Kim, 韩国生命科学和生物技术研究所，创新与研发政策研究组组长
译者：
中国科学技术信息研究所 封颖
2008-10
生物科技的不断发展，带来了崭新的产品和全新的治疗手段，改变着整个世界。更为重要的是，生物科技将故有产业赋予以全新面貌。OECD预测认为，到2020～2030年，生物制品很有可能变成人们须夷不可或缺的日常生活用品。
1982年，韩国科技部首次将生物科技纳入其国家研发规划之中，1983年《生物科技促进法》正式实施。随后，韩国生命科学和生物技术研究所于1985年正式成立。
进入1990年代之后，韩国的大学设立了生物科技院系和研究中心。随着生物科技在全球的迅猛发展，为满足培养韩国本土科学家的战略需求，韩国生物产业协会于1991年成立。
国家推动：从追赶到创新
1992年，韩国开始实施“国家生物科技研发计划”，又称HAN或G-7。随后，为将韩国本土的生物科技实力提升到能与世界各顶级科技强国相竞争的高水平，又实施了一项充满雄心的规划，即Biotech 2000规划（1994～2006）。
根据Biotech 2000规划，为发展关键技术，确保在如生物科技、IT科技、纳米科技等一些关键性的战略领域方面保持领先水平，韩国于2000年启动了“21世纪前沿研发项目”。
与此同时，韩国日益处于快速发展的中国和技术先进的日本这样一种“两面夹击”之中。为应对这种情况，韩国政府于2004年启动了“下一代增长引擎项目”，该计划精选出包括生物科技领域在内的10个产业领域进行密集型投资。
在Biotech 2000规划实施的1994年到2006年间，韩国政府对生物科技领域的研发经费投入达到43000亿韩元（约合43亿美元）。如表1所示，研发经费以年均23％的高速增长。
在第一框架计划实行期间，研发投资提升了韩国生物科技的竞争力。从发表的生物科技论文数量来看，SCIE论文从1994年的世界第29位（420篇论文）上升到了2005年的世界第13位（4089篇论文），年均增速为26％。（见表2）
尤其值得一提的是，韩国发表在如《自然》、《科学》、《细胞》这样的世界顶尖科学杂志上的论文数量也大为提升。从1994年到2005年的11年间，韩国在世界顶尖科学杂志上共发表了130篇论文，其中生物科技方面的论文有86篇，占全部论文总数的66％。仅2005年一年之中，韩国就在世界顶尖科学杂志上发表了23篇生物科技论文，占这11年中发表生物科技论文总数的四分之一之多。不过，与其它国家相比，尽管韩国生物科技发表论文在数量上已经足以平起平坐，但在论文的影响力上，韩国还尚待提高。
从专利数量来看，在第一框架计划期间（1994～1997年）进展不甚明显，情况在第二框架计划期间（1998～2001年）得到改观，此后保持了良好的发展势头。2002～2005年间，韩国在美国登记了207项生物科技方面的专利，比第一框架计划期间增长4.4倍，比第二框架计划期间增长1。2倍。
从技术指数来看，在第一框架计划期间（1994～1997年）韩国生物技术水平排名世界21位，在第二框架计划期间（1998～2001年）排名世界17位，在第三框架计划期间（2002～2005年）排名世界14位。从专利技术指数来看，韩国农业得到51.9分，医药得到36.0分，产业过程得到31.7分，基础技术得到14.7分。1998年以来，在韩国登记的专利中，一半以上的专利是由韩国人登记并拥有自主专利权的。
表1: 1994年到2006年间韩国政府对生物科技的研发经费投入
表2: 1994到2005年间韩国发表SCIE论文数量
Bio-Vision 2016：韩国第二项推动生物科技的国家计划
韩国政府推动生物科技发展的政策已经发生改变。2000年以来，韩国政府及其各个所属部门对生物科技日益重视，提升各部门之间的协调显得日益必要。
韩国政府于2004年成立了科技创新办公室（于2008年2月关闭），专门从事有效分配研发经费、避免各部门的重复投资。在变化了的形势下，韩国政府、产业界和学界认为应该设计新的生物科技政策，做为对生物科技第一框架计划即Biotech 2000规划的补充和完善。
2006年11月，在充分吸取了Biotech 2000规划的经验和教训的基础之上，由韩国教育部、科技部牵头，联合其它的六个政府部门，宣布了一项雄心勃勃的Bio-Vision 2016规划（2006~2016），Bio-Vision 2016规划是对Biotech 2000规划的继承和创新，是在2006~2016年指导和推动韩国生物科技发展的国家规划。
Bio-Vision 2016规划的核心战略包括如下几项：韩国国家生物科技创新体系、增大研发投入经费力度、推动韩国生物产业的发展并使其走向世界、制度改革以及增大韩国民众对生物科技的认可度。（见图3）
按照Bio-Vision 2016规划设立的目标，在2006~2016年间，韩国将对生物科技投资总额将达143亿美元，生物产业市场份额将达600亿美元；截至2016年，韩国应成为世界生物科技七强之一。Bio-Vision 2016规划的战略重点是：发展生物科技的核心技术，发展生物科技的平台技术，增强基础设施建设以便将韩国的生物产业做大做强。
按照Bio-Vision 2016规划，韩国政府将聚焦并全力推动少数几个领域的发展，包括生物科技、ICT（信息科技和通信科技）、纳米科技，并将大力推动韩国公众对这几个领域的认知程度和支持力度。韩国政府还将致全力于推动本土科学家在这几个领域的发展和成长，还将加强参与这几个领域的政府部门的跨部门合作程度和协调水平。
除此而外，韩国政府还制定了数项国家科技政策和科技规划来推动韩国科技的发展。如，2006年韩国颁布了“国家技术路线图”，2008年韩国颁布了“第三次韩国远景规划”，致力于发展核心技术和面向未来的技术。
图3: Bio-Vision 2016规划的远景和目标
韩国生物产业：逐步迈向亚洲称雄
韩国的生物技术发展总体水平良好，在诸如发酵技术、抗生素、诊断技术、疫苗技术等方面达到了较高水平。在此基础上，韩国生物产业逐步迈向亚洲称雄。
2007年6月，世界最大的制药企业辉瑞公司与韩国政府达成一项协议，辉瑞将与韩国政府在未来5年中联合投资3亿美元开发新药。辉瑞公司总裁Jeffrey B. Kindler表示，“辉瑞对韩国高水平的制药业和韩国研发经费投入力度之高留下了深刻印象”。辉瑞还对韩国生命科学和生物技术研究所进行研发经费的资助，并将其视为辉瑞的全球研发拍挡之一，两家还共同开展了一些新药研制项目。
全球制药和消费者保健行业居领先位置的跨国公司瑞士诺华公司下属的诺华风险基金近来进入了韩国产权投资市场，以扩大其在韩国生物产业发展中的影响度。
随着韩国生物科技研发经费投入力度的猛增，韩国生物产业的规模迅速扩大，从2000年以来每年增幅都高于20％。据预测，到2010年，韩国生物产业产值将达到65亿美元。
韩国生物制药、生物环境、生物化工、生物能源和生物食品的产品与服务的销售额，从1994年的1.74亿美元增长到了2005年的27亿美元，其中，生物制药和生物食品的销售额占到了总销售额的80％。1994年到2005年，韩国生物产业销售额的年均增长速度为27.7％。预计到2016年，韩国生物产业的市场规模将增长到600亿美元。
韩国拥有一批自主研发、享誉世界的生物制品。如，韩国Cheiljedang公司生产的“CJ-lysine”和“CJ-tide”，其产量和产品的多样化程度都在不断提高。在第一框架计划期间（1994～1997年），韩国能够自主生产的生物制品还是一个都没有，处于空白状态；在第二框架计划期间（1998～2001年），韩国就可以自主研发并生产2种生物制品了；在第三框架计划期间（2002～2005年），韩国自主研发并生产的生物制品达到了14种。初期，大多数韩国自主研发并生产的生物制品都是功能性食品；如今，逐渐出现了生物医药类和生物诊疗类制品。
韩国SK公司率先成功推出了一种新药，名为Sunpla，随后韩国又制成并生产了12种新药。韩国首个获得国际认可的新药是Factive，它于2003年获得美国食品与药品管理局的认可。此后，许多韩国新药已经研发成功并投入生产，它们都希望被国际上认可，均已申请美国食品与药品管理局认可程序，目前处于等待批准状态。2005年，5种韩国新药申请了美国食品与药品管理局认可。由跨国制药公司研发、在韩国开展临床试验的药品数量从2000年的33种增长到2005年的146种，增加了4.4倍。
韩国生物技术企业数量为亚洲第二多，其公司数目仅次于日本。2005年，韩国约有640家生物技术公司，其中30％为生物制药企业，25％为生物食品企业。韩国每年都涌现出许多成功的生物技术企业。2005年，韩国“高斯达克”创业板市场上，有42家生物科技企业。
韩国政府积极采取措施，推动建立一批能够适应创新型市场环境的韩国生物产业集群，这些措施包括刺激年轻人的创新性、在全国推动创新型生物科技企业的建立以及吸引外国一流研发实体机构的投资。（见图4）
图4: 韩国立志成为一个亚洲生物产业“大拿”，图为其密集发展的生物产业集群
说明：该图摘自Bio-Vision 2016规划，该规划由韩国八个政府部委联合制定，于2006年11月正式颁布。
结论：面临的挑战
生物科技是21世纪全球经济一个极为重要的组成部分，同时也是推动韩国经济增长的关键性平台。
然而，韩国要想实现其生物技术未来发展的远景目标，还必须迎接许多挑战。尤其是在世界各国都将生物科技视为最重要科技领域、并都极力推动本国生物科技发展的情况下，韩国就需要大力增强灵活度，这样才能适应日趋激烈、不断变化的竞争性环境。韩国还应根据本国国情和优势，选择好应全力发展的战略领域和竞争方向，并摸索出一条发展上述领域和方向的道路。
与此同时，韩国和中国做为东亚国家，拥有很多共同的区域性和国际性利益，两国互惠互补的关系应该继续加强。在科技领域加强合作和交流，对两国都大有裨益。虽然两国科技交流与合作已经开展得有声有色，但在生物科技领域等领域的交流与合作还是可以进一步深入推动下去，这样对增强韩中两国的生物科技竞争力都很有好处。
（生物技术世界,2008年第10期）
附英文原文:
Biotechnology in Korea: Current Status and Challenges Ahead
Sang-Ki Rhee, Senior Fellow, Korea Research Institute of Bioscience and Biotechnology (KRIBB)
Jeong-Seok Kim, Team Leader, Innovation and R&D Policy Team, Korea Research Institute of Bioscience and Biotechnology (KRIBB)
With the success stories from consumer electronics in the 1960s to heavy industry a decade later to information technology during the 1990s, Korea is now hedging its bet on biotechnology with the highest priority as a next economic growth engine.
With its traditionally sound basis of biotechnology and the government’s strong commitment to promote related industries, Korea is now emerging as a rising bioindustry powerhouse of Asia.
Scientific discoveries in biotechnology are changing the world with new products and medical treatments, and more importantly, shaping existing industries into entirely new ones. OECD predicts that twenty or thirty years from now, bio-applications may well become part of everyday life.
In recognition that biotechnology would emerge as a key discipline for the nation’s economic growth, the Korean government started to support biotechnology as far back as the early 1980s, when genetic engineering and new biotechnology emerged worldwide.
The Ministry of Science and Technology (MOST) included biotechnology in the national R&D projects in 1982 for the first time, followed by the enactment of the Biotechnology Promotion Law in 1983. Under this law, the Korea Research Institute of Bioscience and Biotechnology (KRIBB) was established in 1985.
Entering the 1990s, universities opened new departments related to biotechnology, and established biotechnology research centers. As the world’s biotechnology market grew bigger, the need to nurture the domestic bioindustry led the birth of the Bioindustry Association of Korea (BAK) in 1991.
National Drives: from catch-up to innovation
The first national biotechnology R&D program, the Highly Advanced National (HAN or G-7) Project, was launched in 1992, followed by the audacious umbrella plan, called Biotech 2000 (1994-2006) to place Korea’s biotechnological capabilities at competitive levels with those of world’s leading countries and build an indigenous bioindustry.
Under the Biotech 2000, the 21st Century Frontier R&D Program was kicked off in 2000 to develop core technologies and to secure leading-edge technologies in key strategic areas like biotechnology, IT technology, nanotechnology by 2010. Among the total of 21 projects that run for 10 years with an average budget of $100 million per project, 8 projects are biotechnology related, covering various areas from microbial research to plant biodiversity and new drug development.
In the meantime, facing uncertainty and challenges in a “nut-shell” situation sandwiched by fast-growing China and technologically advanced Japan, the Korean government launched ‘The Next-Generation Growth Engine Program’ in 2004, which was to intensively support 10 selective industries including biotechnology.
Between 1994 and 2006, the period covered by Biotech 2000, governmental R&D expenditures in biotechnology totaled KRW 4.3 trillion (about US $4.3 billion). As shown in Fig. 1, the annual average investment has increased at a hefty rate of 23%.
The competitiveness of Korean biotechnology was increased by investment during the First Framework Plan. In terms of the number of biotechnology papers published, SCIE papers ranked 29th (420 papers) in 1994 and 13th (4089 papers) in 2005, showing an annual increase of 26% (Fig. 2).
In particular, more Korean papers are being published in prominent science journals such as Nature, Science, and Cell. More specifically, from 1994 to 2005, among the 130 papers published in prominent science journals, 86 were biotechnology papers, accounting for 66% over this period. In 2005, the ratio of biotechnology papers was 25% (23 papers), indicating a rapid rise in recent times. Although Korea can compete with other countries in terms of the number of papers published, there is still a gap in terms of their impacts.
As for the number of patents, things did not improve much during the first phase of the First Framework Plan (1994?-1997), but the number started to increase during the second phase (1998?-2001), and this positive trend is still on-going. Considering the number of patents registered in the US, 207 were registered during the third phase (2002?-2005), representing a 4.4-fold rise over that in the first phase and a 1.2-fold rise compared to the second phase.
With regard to the technology index, Korea's technology level ranked 21st in the first phase (1994?-1997), 17th in the second phase (1998?-2001), and 14th in the third phase (2002?-2005) [13]. Regarding the patent technology index, Korea achieved 51.9 for agriculture, 36.0 for medicine, 31.7 for industrial processes, and 14.7 for basic technology. Since 1998, in terms of domestic patents in Korea, the number of registered Korean patents has outstripped that of foreign patents.
Fig.1: Governmental R&D Expenditures
Fig. 2: Number of SCIE Papers
Bio-Vision 2016: the 2nd national plan for biotechnology promotion
There has been a change in the policy of the Korean government regarding the development of biotechnology. Various governmental agencies have been paying more attention to biotechnology since 2000, and the need for cooperation between agencies has increased.
In this connection, to avoid duplicated investment in the same or similar projects by different agencies and to allocate the research budget efficiently, the Office of Science and Technology Innovation (closed in February 2008) was established in 2004 in the government. In the face of such changes, the government, industry and academia have demanded a new biotechnology policy to complement the First Framework Plan for Biotechnology Promotion.
In November 2006, based on the success factors and the lessons learned from Biotech 2000, the 6 governmental agencies, led by the Ministry of Education, Science and Technology (MEST, formerly MOST), announced an ambitious 10-year plan, called “Bio-Vision 2016”, which is a follow-up from Biotech 2000.
The core strategies of Bio-Vision 2016 include the national biotechnology innovation system, expansion of R&D infrastructure, development of bioindustry and its globalization, regulatory/institutional reform and enhancement of public acceptance (Fig. 3).
They plan to invest a total of US $14.3 billion and create a US$60 billion market over the next 10 years, in order for Korea to become one of the top seven biotechnology powerhouses in the world by 2016. It puts priority on the acquisition of core and platform technologies and the expansion of infrastructure that will help local bioindustry in full bloom.
According to this plan, the government is concentrating on convergent technologies involving biotechnology, ICT and nanotechnology, and promoting public awareness and trust on biotechnology. It also pays more attention to increase the ethnical standards of scientists, and strengthen inter-ministerial coordination among participating ministries.
The government also worked out several national S&T policies and plans including the "National Technology Roadmap” in 2006, the 3rd Korean Foresight Exercise in 2008 to develop core and future-oriented technologies.
Fig. 3: Vision and Objectives of Bio-Vision 2016
Bioindustry: a rising powerhouse of Asia
Based on its traditionally sound basis of biotechnology and its related technologies such as fermentation technology, antibiotics, diagnostics and vaccines, Korea is now emerging as a rising powerhouse of Asian bioindustry.
Pfizer, the world's largest pharmaceutical company, forged a deal with the Korean government in June 2007 to invest US$300 million in the joint R&D for new drugs over the next five years. Jeffrey B. Kindler, Chairman and CEO of Pfizer said that “Pfizer has been impressed by Korea's high level of medical expertise and R&D capability.” The company also has been investing to the Korea Research Institute of Bioscience and Biotechnology (KRIBB) for joint research projects in developing new drugs as a global R&D partner.
Novartis Venture Fund (NVF) recently entered the Korean equity market as a stepping stone to widen involvement in the Korean bioindustry.
With domestic biotechnology R&D prowess growing by leaps and bounds, the size of bioindustry in Korea has grown rapidly, up more than 20% annually since 2000. It is forecast to reach US$ 6.5 billion by 2010.
The sales of biopharmaceutical, bioenvironmental, biochemical, bioenergy and biofood products and services have grown from US $174 million in 1994 to US $2.7 billion in 2005 with biopharmaceuticals and biofoods accounting for more than 80%. The average annual growth was 27.7 percent over the period. The market size of bioindustry is forecast to reach US $60 billion by 2016.
The number of world-class products such as “"CJ-lysine”" and “"CJ-tide”" produced by Cheiljedang Corporation is increasing and diversifying. In the first phase (1994?-1997), there was no single bio-product, but in the second phase (1998?-2001) two bio-products were produced, and in the third phase (2002?2005) 14 were produced. Initially, most of the bio-products were functional foods, but since then bio-products for medical diagnosis and treatment have begun to appear.
Since SK Pharm Co. succeeded in developing Sunpla as a new drug, 12 new medicines have been registered as new drugs. Ever since Korea’s first global new drug, Factive, was approved by the US FDA in 2003, many new medicines have been lined up for US FDA approval. As of 2005, six Korean medicines had applied for the US FDA’s approval. The number of clinical trials performed in Korea by multi-national drug companies increased 4.4-fold from 33 in 2000 to 146 in 2005.
Korea is home to more biotech companies than any other country in Asia, except Japan. There are about 640 companies active in biotechnology as of 2005. Thirty percent of the companies were in the biopharmaceutical sector, followed by 25% of in biofood sector. Successful bioventures have been increasing gradually. The number of KOSDAQ-listed bioventures amounted to 42 as of 2005.
The government of Korea is taking active steps on creating bioclusters conducive to market-driven innovative environment by stimulating the creation of young, innovative biotech companies throughout the country and enhancing efforts to attract foreign top-tier R&D entities for investment (Fig. 4).
The country has 18 regional bioindustry promotion centers and 10 bioventure incubating centers in operation across the nation. These centers are grouped into three regional clusters to form a regional innovation system (RIS).
Fig. 4: Korea as a One Big Biocluster
Conclusion: challenges ahead
Biotechnology is expected to become a major integral part of global economy in the 21st century and is also a key platform to accelerate the national economic growth in Korea.
There are, however, many challenges ahead that Korea must overcome to realize its vision of future biotechnology development. In particular, when other countries have similar strategies and are doing similar things, Korea needs to have the utmost flexibility in adapting to the constantly evolving competitive environment. The country also needs to create unique solutions of her own for focused strategies and competitive niches based on her own particular strengths.
Meanwhile, there are only a few countries with a more complementary relationship than that between Korea and China which share many regional and international interests. Two countries can both benefit greatly from improved co-operation in the fields of science and technology. Much has already been achieved particularly in the fields of biotechnology, although more are yet be done. To boost competitiveness of Korea as well as China in the world’s biotechnology arena, increasing co-operation must be continued to build on many good achievements by two countries.
References:
[1] Sang-Ki Rhee, Korea’s Biotech R&D and Bioindustry, Korea Investment Forum in US (2007)
[2] Bio-Vision 2016 (2006)
[3]Sang-Ki Rhee, Challenges and Opportunities for Biotechnology Development; Korean Experiences, Institute of Southeast Asian Studies (2004)