China's new 'new'

As a result of a revision to CFDA's definition of "new" small molecules, multinationals may want to partner with domestic companies to obtain exclusivity for products that are already approved outside China.

CFDA previously considered any drug not yet approved in China as a new drug that was eligible for exclusivity, whether or not it was approved elsewhere. Under changes adopted on March 4, CFDA has created two classes of small molecule drugs that are considered new and eligible for de facto exclusivity periods...