context: Over the past 30 years, the biopharma industry in China, especially in Shanghai, has experienced rapid growth. The ‘Shanghai International Express’ in biopharma has connected China with the world, taking the lead in aligning with global standards and promoting Shanghai's biopharma industry to grow from a total output value of less than C¥5 bn to nearly C¥200 bn.
A seires of policies on the development of the biopharma industry was announced by the Shanghai Municipal Government during the 2023 Shanghai International Biopharmaceutical Industry Week.
The ‘Shanghai action plan for accelerating the innovation of synthetic biology and building a high-end biomanufacturing industry cluster (2023-25)’ specifies three key aspects of market development
- accelerating the innovation of synthetic biotechnology
- enhancing infrastructure and laboratory capabilities, establishing new research and development institutions
- promoting the conglomeration and development of the high-end biomanufacturing industry
- creating a spatial layout with ‘one core and two wings’ to drive the implementation of industry projects and reinforce the collaborative development of the industry supply chain
- creating a world-class industrial ecosystem
- strengthening diversified financial support, exploring innovative regulatory policies and enhancing talent recruitment and training
The ‘2022 China Biotechnology Industry Observations’ report highlights that going global is a crucial strategy for the success of innovative pharma. It suggests that, in addition to the US, attention should also be given to other overseas markets. Currently, expanding into the US remains the top choice for Chinese biotech companies, as their free-market pricing system offers significant pricing advantages with a free-market pricing system for pharmaceuticals.
The US is the world's largest market for innovative drugs. Apart from traditional Western markets, the Gulf Arab countries, especially Saudi Arabia, represent an untapped market, offering another overseas market option for Chinese biotechnology companies.
Analysts argue that although international expansion has become a vital strategy for Chinese biotech companies, venturing into the global market demands a comprehensive understanding of the regulatory authorities, regulatory requirements, pathways and contract research organisations resources in different countries. Conducting international multi-centre clinical trials involves significant differences in clinical resources, cross-border costs, collaboration models and timelines compared to domestic operations.