More than Just Generics: International Partnerships Make China the Biologics Hotspot

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The report concludes that the chief driving force behind rising standards within the Chinese market – and therefore its export potential – has paradoxically been an increased awareness amongst domestic consumers and the desire for more tightly regulated, higher-quality drugs.

Chinese companies are increasingly investing for the future, with 21% investing in cold chain storage technology, 16% in ADC development, 43% commercial and scale-up facilities and perhaps most interestingly, 27% in continuous processing.

Continuous processing remains at the cutting edge of the industry and is predicted to revolutionise pharma manufacturing over the next decade. However, its initial set-up costs and new learning’s are high, implying a significant change in approach from Chinese companies.

Two major challenges were identified as potential drag factors. Firstly, finished drug supply of solid dose forms is not showing the accelerated pace of development that the biologics sector is experiencing, and the report postulates that ‘too much ground has been ceded to Western and Indian manufacturers’ who lead this sector internationally. Secondly, as China’s overall pharma economy expands, the CFDA is experiencing greater backlogs and regulatory bottlenecks.

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The domestic industry strongly supports the implementation of a US-style GDUFA system to alleviate these pressures and an overwhelming 94% stating that the ‘CFDA must grow rapidly to a comparable size to the US FDA if it is to properly regulate its industry’.

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