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Despite a challenging business environment, entrepreneurial health biotech companies in South Africa are finding ways to succeed.

Brazil boasts world-class biomedical science, but tension between the public and private sectors hinders progress in health biotech innovation.

Chinese government support and 'sea turtles' are spurring the sector, but investors lack exits. Supplementary information The online version of this article (doi:10.1038/nbt0108-37) contains supplementary material, which is available to authorized users.

India's home-grown biotech companies must strike a balance between domestic and international markets.

outstanding achievements in health biotechnology are a source of inspiration for the developing world. They are all the more impressive considering that the island is a small, relatively poor country that has suffered serious economic difficulties for more than a decade. These eco- nomic problems arose in the wake of the Soviet Union's disintegration and the political changes in Eastern Europe in the early 1990s, resulting in the collapse of Cuba's export markets, and the imposition since 1961 of a US trade embargo against Cuba, which has limited opportunities for the country's agri- culturally based economy. Despite these diffi- culties, Cuba's strong and continued emphasis on science since shortly after the 1959 revolution has resulted in a highly devel- oped health biotechnology sector. includes research on recombinant Dengue vaccine, preventative and therapeutic AIDS vaccines, cholera vaccine and a cancer therapeutic vaccine. The sector has also suc- cessfully produced diagnostic tests and therapeutics, as can be seen in Tab le 1 .I n addition, Cuba is devel- oping natural products based on the island's flora. An example is the natural anticholes- terol drug policosanol (PPG), an 8-alcohol extract derived from the wax of one of the country's main crops, sugarcane. Cuba began development of its health biotechnology sector by imitating products developed elsewhere, such as interferon-α 2b (IFN-α ), but in recent years greater empha- sis has been placed on innovation from within Cuba. The perception that innova- tion is increasing is supported by biotech- nology experts, such as James Larrick, an entrepreneur in Palo Alto, CA, who says: "Their pipeline is very, very deep now.… It's gone into an adolescence and it's looking pretty good." 1 Indeed, researchers in Cuba have filed about 500 patent applications in the health biotechnology sector based on more than 200 inventions (according to an analysis of the European Patent Office's (Munich, Germany) database, the European Network of Patent Databases, May 2003, http://www.european-patent-office.org/). These have been filed in several countries throughout the world, including the United States, Europe, Brazil, India, China and South Korea. Cuba exports biotechnology products to more than 50 countries, mainly in Latin America, Eastern Europe and Asia. Cuba's hepatitis B vaccine has been certified by the World Health Organization (Geneva, Switzerland) and is prequalified for use by United Nations purchasing agencies. The primary focus of Cuba's health biotechnology has been on developing products, rather than basic

showcased its capability in genomics and its intent to become one of the world’s leading contributors to the field of biotechnology. The country quickly set up major institutions in genomics, the Beijing Genomics Institute and the Chinese National Human Genome Center (with branches in Beijing and Shanghai), equipped with state of the art sequencing facilities and computers. Even though they entered the project relatively late, Chinese researchers successfully sequenced 1% of the human genome with an accuracy rate of 99%. They have continued to demonstrate their strength in the field, and in 2002 sequenced the rice genome of the most widely cultivated subspecies in China 1 . The country’s participation in the Human Genome Project is indicative of how rapidly China has reached world standards in sequencing, and this in turn reflects its general advanced state of development in health biotechnology. Since China initiated research in the field in the late 1980s, it has approved several vaccines and diagnostics and thera

Nat. Biotechnol. 30, 38–40 (2012); published online 9 January 2012 In the version of this article published in print, the affiliations were omitted. The error was corrected before online publication in the HTML and PDF versions of the article.

As health biotech enterprises in emerging economies move from imitation to innovation, will they become less relevant to local global health priorities?

A survey of entrepreneurial collaborations among health biotech firms in developing countries reveals a surprisingly high level of collaboration but a lack of emphasis on new or improved health biotech products and processes.

A survey of Canadian biotech firms reveals that their biotech collaborations with developing countries are not only significant but also increasingly reciprocal in terms of the exchange of financial resources and technological know-how.

term ‘health biotechnology’ evokes images of research-intensive universities such as Stanford University and the Massachusetts Institute of Technology (MIT), as well as initial public offerings on NASDAQ. Ty pically, we don’t think about biotechnology in connection with health solutions for poor people in developing countries. Still, as has been demonstrated in a technology foresight exercise, biotechnology can potentially be applied to a wide spectrum of health problems all over the world 1 .S uccessful research and development in health biotechnology is taking place in several countries that typically are classified as lower income countries or developing countries. With a view to understanding these successes and reproducing them more widely in the developing world, we have undertaken a detailed study of health biotechnology development in seven countries. This supplement reports the results of a 3-year study of health biotechnology innovation systems in Brazil, China, Cuba, Egypt, India, South Africa and South Korea. When compared with industrially advanced nations, the seven countries in this study are each at a different stage of economic development, but they can generally be considered ‘innovating developing countries’ (IDCs) 2 . Our objective was to identify and analyze the conditions encouraging successful development of health biotechnologies in developing countries. Ultimately, we want to identify lessons on how these countries have been able to build up capacity in health biotechnology. These lessons can potentially be put to use in other developing countries that so far have not succeeded in promoting biotechnology development, but may also be of relevance to industrially advanced nations. This

has a relatively long history of science and technology, and the current leftist government of President Luiz Inacio Lula da Silva continues to prioritize scientific and technological development in the country. Successes in the agricultural, energy and engineering (e.g., aeronautics) sectors reflect its scientific strength. Brazil’s terrestrial biodiversity, with numerous diverse biomes including the Cerrado, Amazon rainforest, Pantanal wetlands, Caatinga region, and Araucaria and Atlantic forests, is also unrivaled in the South American continent and probably elsewhere. This combination of natural and scientific resources gives the country great potential to promote health biotechnology. In 2004, a DNA bank was established at the Jardim Botânico (Botanical Garden) in Rio de Janeiro to preserve the genetic material of endangered plant life. With an expected 1,000 specimens to be collected per year, researchers at the two laboratories at the Jardim Botânico are currently involved in both plant conservation and development of plant-based medicines and treatments 1 .

Nat. Biotechnol. 28, 407–416 (2010); published online 7 May 2010; corrected after print 7 December 2010 In the version of this article initially published, a line was missing connecting India and China in Figure 3. The error has been corrected in the HTML and PDF versions of the article.

By focusing on an unmet medical need, providing a cost-efficient solution and reinvesting the resulting revenues into R&D and state-of-the-art manufacturing, Shantha Biotechnics was able to build one of India's first biotech successes.