Prevenar 13 Gains China OK But Challenges Remain
In a step that may boost flagging global sales, Pfizer’s big-selling pneumococcal vaccine Prevenar 13 has finally been approved in China, but the US giant still faces more than regulatory hurdles to get the product out into the market and accessible to patients.
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Frank Zhang, co-founder and chair of the Hong Kong-listed Chinese biotech Genscript, parent of Nasdaq-listed cell therapy star, Legend Biotech, has been detained by Chinese authorities, along with four employees.
China releases technical requirements for foreign drug makers to register their chemical drugs in the country, and issues patent linkage details, which a legal expert says needs to be closely examined.