U.S. regulators are poised to tap the brakes on approving dozens of cancer drugs and other new medicines developed in China.
The regulators have expressed concerns about the quality of studies largely conducted in China and whether the results can apply to patients in the U.S.
The shift threatens to halt the plans of Western drugmakers, including
& Co. and
Novartis AG
, who were eyeing billions of dollars in sales from bringing the Chinese medicines to the U.S. It could also raise a new source of tension between the two countries.
Lilly this year was aiming to roll out a lung-cancer immunotherapy developed in China and sell it at a lower price than similar drugs already on the market.
The Food and Drug…
