Merck’s Keytruda: First imported drug approved for use under a pilot program on the resort island of Hainan

BEIJING— Merck MRK & Co.’s immunotherapy cancer drug Keytruda is finding its way into China as the first imported drug approved for use under a pilot program on the resort island of Hainan intended to boost medical tourism.

The fast-track entry for Keytruda into China, albeit limited, is likely to give Merck an advantage in competing with Bristol-Myers Squibb Co. BMY, which is also seeking approval in China for its rival drug Opdivo. Both companies had faced a lengthy approval process required by Chinese regulators.

An institution affiliated with Hainan Health and Family Planning Committee announced on its account on the WeChat messaging platform late Thursday that Keytruda will be the first imported drug used in a cancer hospital in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.

Set up in 2013, the zone sets special rules on foreign investment, such as 100% foreign ownership in hospitals and fast-track approvals for new drugs and medical devices. The hospital gained approval from the China Food and Drug Administration to import Keytruda this March, and will import more foreign cancer drugs based on patients’ need, according to the announcement.

Source: http://www.wsj.com

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