CPhI: Regulatory changes have led to a CMO boom in China, but can that continue?
Contract manufacturing for domestic companies until recently didn’t exist in China, thanks to some regulatory restrictions that required developers to be in charge of their own manufacturing process. Now, the young business model is being tested with higher demand and extremely fast growth as the CPhi InformaMarkets report expects CMO services to continue to expand in the coming years.
In 2013, just four IND applications were submitted in China. That number skyrocketed to 99 in 2020, followed by 94 already in 2021. China is now the home of four PD-1 mAb therapeutics, with another five in the NDA process.
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