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With a concerted effort by the government, academia and businesses, Taiwan is translating its biotech discoveries into commercial opportunities. The early returns look positive, as Taiwan’s PharmaEssentia Corp. and TaiMedBiologics Inc. recently reported heartening news about trials for their biotechnology products. In November 2009, PharmaEssentia announced commencement of the phase I clinical trial in Canada for a drug designed to treat both hepatitis B and C. The drug has shown promise because it is particularly long-acting, so patients would not have to take it as often as other drugs in the interferon class currently on the world market. A month later, TaiMed revealed that its drug for treating preexisting Over the past few decades, Taiwan has concentrated on developing its high-tech industries, and is now a world leader in the production of electronic, information technology, computer and semiconductor products. Today, with the growing interest in biotechnology by the government, academia and related businesses, hopes are high in Taiwan that this sector can also achieve the same success. The definition of “biotechnology” varies from place to place. Generally speaking, the term encompasses a vast range of life sciences and medical disciplines as well as all related technologies. In the West, it primarily refers to the use of biological systems in manufacturing drugs or other products. According to the 2009 White Paper on the Biotechnology Industry in Taiwan published by the Industrial Development Bureau of the Ministry of Economic Affairs (MOEA), it is defined as “the knowledge (e.g. molecular biology, cell biology, immunology, genetics and proteomics) and technologies (e.g. genetic engineering, protein engineering, cell engineering and tissue engineering) that fall within the scope of life sciences, employed to develop and manufacture products to improve the quality of human life.” Regardless of its precise definition, biotechnology has emerged as one of the most promising mainstream medical industries in the 21st century. With the human lifespan lengthening, the quest is on to improve health throughout the life cycle. Biotech products are an increasing part of this pursuit and promise to bring significant business opportunities in the near future. In an article entitled “Bottlenecks and Visions in Taiwan’s Biotech Industry” published in the local China Times newspaper on March 3 this year, Wong Chi-huey, president of Academia Sinica, Taiwan’s foremost academic and research institute, writes that with the “arrival of an aging population worldwide, focus has shifted to preventative medicine and individualized healthcare as opposed to treatment of diseases.” Aggressive Efforts The biotech plan consists of four main pillars: strengthening the industrial value chain in the commercialization process, establishing a biotechnology venture capital (BVC) fund, founding the Food and Drug Administration (FDA) and creating an integrated biotech incubation center. The Executive Yuan’s Science and Technology Advisory Group (STAG) is coordinating the biotech action plan, with the MOEA, National Science Council (NSC) and Department of Health (DOH) assuming crucial administrative roles. “This plan calls for moving forward with basic research in areas that demonstrate high potential, and then for commercializing these achievements,” explains Lee Chong-chou, director of the Biotechnology Office under STAG. “On the whole, it is expected to speed up the growth of Taiwan’s biotech sector and lay a firm foundation for biotech to become Taiwan’s next star industry.” With strong support from the government, Lee hopes that the output value of the biotech industry will double over a four-year period, thereby turning biotech into a trillion-dollar industry. To strengthen food and drug oversight and better link the standards of the local biotech and medical industries with those of the international market, the Organic Act of the Food and Drug Administration under the Department of Health was passed in May 2009, leading to the establishment of the FDA on January 1 this year. The FDA integrates the operations of several existing agencies to improve screening efficiency of food and drugs, as well as oversee the safety of food, drugs, medical devices and cosmetics to better serve public health. “Operations in the past were dispersed under different units, lengthening the whole processing time,” STAG’s Lee says. “Under the new FDA framework, the transparency of the entire inspection processes is strengthened, and this simplified A further government effort to boost the biotech sector is the BioTaiwan trade show, which has been sponsored by ITRI and organized by the Taiwan Bio Industry Organization since 2000. The BioTaiwan 2010 exhibition is scheduled for July 22−25 at the Taipei World Trade Center and will showcase the newest developments in the field as well as biotech products from Taiwan and abroad. In conjunction with the show, the BioBusiness Asia 2010 forum is scheduled for July 20−21 in Taipei. Under the theme “Energizing BioBusiness in Asia,” the forum will bring together biotechnology corporate executives and academics from around Asia to discuss current development trends and potential business opportunities.
“The purpose of the BioBusiness Asia conference is to serve as a platform for discovering Asian biotech business opportunities,” Johnsee Lee, ITRI’s president, writes on the event’s official website. “We are privileged to present keynote speeches that address topics on emerging international biotech trends, business models and strategies to leverage global resources and maximize biobusiness value.” Meanwhile, to foster industrial clusters, spark the development of peripheral industries and facilitate the creation of new biotech products, the government has either established, or is planning, large-scale science parks focusing on biotechnology manufacturing and research. One plan is aimed at forming two large-scale biotech clusters: one in the Southern Taiwan Science Park (STSP), which is located near the city of Kaohsiung, and the other in the Hsinchu Biomedical Science Park (HBSP) in northern Taiwan. “Local drug makers and producers of medical equipment and The STSP is already open, with 17 biotech companies operating as of March this year.The park is home to companies that focus on vaccines, bio-agriculture, biomedical inspection and floriculture, as well as to businesses that manufacture medical equipment and devices. Last October saw the beginning of factory construction at the HBSP, which will be the first major park dedicated solely to biotech in Taiwan. As required by the Biotech and New Pharmaceutical Industry Development Act, which was promulgated in July 2007, the HBSP only accepts firms that “engage in the research, development and manufacture of new drugs and high-risk medical devices used for human beings, animals and plants.” Once construction is completed, the park is expected to host around 30 manufacturers. Incubation Center Academia Sinica is also located in Nangang, which will aid research. “The park will facilitate academic-industry cooperation and consolidate the research resources of Academia Sinica and many medical centers and hospitals in the Taipei area, thereby creating a cluster effect and copying the success of biotech parks like those in Boston,San Francisco and San Diego of the United States,” Academia Sinica’s Wong Chi-huey says. In the private sector, the encouraging successes of PharmaEssentia and TaiMed can be largely attributed to distinguished ethnic Chinese researchers who gained critical experience abroad. PharmaEssentia president Lin Ko-chung is one of a number of bioscientists who have returned to Taiwan with knowledge and experience gained in the West. “It’s exciting to come back to Taiwan with the technical know-how and experience I’ve gained in the West,” says Lin, who is also the chief executive officer of PharmaEssentia.
The company utilizes a novel technology that combines protein engineering and chemistry to create new products for better drug treatments for diseases such as hepatitis B and C. PharmaEssentia’s drugs are designed to increase a therapeutic protein’s efficacy and slow the rate at which it is eliminated from the body. In June 2009, PharmaEssentia received Investigational New Drug (IND) approval in the United States for P1101, a third-generation interferon drug candidate, marking the first time a locally developed protein drug has been so approved. One month later, the drug received IND approval in Canada, leading to the phase I clinical trial conducted “We expect that a patient undergoing hepatitis treatment will have to take our drug just once every two weeks or even once a month,” Lin says. “Taking it less frequently should also make it more cost-effective and ensure better patient compliance. That’s a blessing for patients, and it’s going to redefine the whole field of hepatitis treatment.” TaiMed Biologics follows a different approach—that of licensing. “Given limited financial and manpower resources, you can’t expect a small biotech company like ours to compete in every leg of a race,” says Jack Chen, TaiMed’s financial controller.“Our focus is on evaluating and licensing new drugs with great market potential, then working to improve their efficacy.” TaiMed was established in 2007 with the aim of creating a world-class, innovation-based biotechnology company in Taiwan that would satisfy the unmet medical needs of patients around the world. One of the company’s founders is David Ho, a leading Taiwanese-American AIDS researcher. With financial support from the National Development Fund, shortly after its formation TaiMed purchased the patent for Ibalizumab, an anti-HIV drug also known as TMB-355, from Genentech, Inc. of the United States. TaiMed has now taken over development of TMB-355, which is the For its work on the prophylactic properties of TMB-355, TaiMed received a two-year, US$3 million grant late last year from the Bill and Melinda Gates Foundation through the Aaron Diamond AIDS Research Center in the United States, which is also led by David Ho. TaiMed is the first Taiwanese company to have won such an honor. If and when the drug succeeds in completing all of its clinical trials, TaiMed plans to offer TMB-355 to Third World countries at cost. Series of Challenges The biggest problem, however, is the increasing need for trained personnel. As MED’s general director Shau Yio-wha
According to statistics from the Ministry of Education, the number of university undergraduate and graduate students obtaining degrees in biotech-related fields in Taiwan has grown steadily, reaching 53,283 in 2008, with 12,660 having obtained masters or Ph.D. degrees. This is indeed providing a constant pool of highly trained talent to the industry, but it will take time for the new scientists to gain the experience needed to help local companies become more competitive internationally. With a shortage of senior talent at home, it appears increasingly vital for Taiwan’s biotech sector to emulate Singapore’s example by recruiting high-end talent from abroad. Fortunately for Taiwan, the overseas ethnic Chinese community has a well-established track record in bioscience. Prominent examples include Academia Sinica’s Wong Chi-huey, who served as a board member for the US National Research Council on Chemical Sciences and Technology from 2000 to 2003, TaiMed’s David Ho, PharmaEssentia’s Lin Ko-chung and former Academia Sinica The need to recruit more of such experienced, talented researchers, whether ethnic Chinese or otherwise, may be slowing Taiwan’s endeavor to become a biotech powerhouse, but it has far from stopped it. With the firm commitment of the government to support its growth, Taiwan’s biotech industry is more focused than ever on moving from research discoveries to concrete products targeting some of the most pernicious diseases afflicting mankind. HIV/AIDS has been a deadly scourge for humanity for some 30 years, while the World Hepatitis Alliance estimates that one out of every 12 people worldwide suffers from chronic hepatitis B or C, which can cause permanent liver damage. Today PharmaEssentia and TaiMed may not be as well known as international biotech giants in Europe and the United States, but if the clinical trials being run by such local companies ultimately prove successful, their names will take a rightful place on the top tier of the global industry.
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