| Summary/Abstract |
Biologics are one of the fastest growing fields in the biomedical industry. Producing these innovative drugs has proven both technologically and politically challenging, however. Traditional strategies of technological catch-up employed by East Asian countries have remained remarkably ineffective at catalyzing their biotechnological development. Consequently, biopharmaceutical innovation has historically been concentrated in the hands of a few developed countries. After decades of stagnation, China's biopharmaceutical industry began experiencing marked growth in the 2010s. This article analyzes the institutional evolution of China's biopharmaceutical industry from the early market reform era to 2020 to explain the roots of China's surge in biological innovation. Specifically, we argue that biopharmaceutical innovation is highly dependent not only on scientific capacity and the existence of academia-industry ties, but also on the presence of regulatory regimes that are harmonized with global standards and capable of incentivizing innovation while protecting patients' needs. Consequently, our findings contrast with the previous research drawing on India's experience to argue that intellectual property regime harmonization damages domestic innovation capacity. Ultimately, this study suggests that biopharmaceuticals may present a unique window of opportunity for latecomers to biotechnology and offers lessons on fostering science-based high-tech innovation for developing countries.
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