Chi­nese reg­u­la­tors green light Mer­ck­'s Keytru­da in record time; As­traZeneca takes the price-freeze pledge

→ Chi­na’s drug reg­u­la­tors have ap­proved Mer­ck’s Keytru­da for ad­vanced melanoma in record time. The phar­ma gi­ant said that the Chi­na Na­tion­al Drug Ad­min­is­tra­tion of­fered the OK on a Phase Ib study af­ter pro­vid­ing pri­or­i­ty re­view sta­tus, “cre­at­ing an in­dus­try lead­ing ap­proval turn­around time for im­port­ed can­cer med­i­cine in Chi­na.”

Mer­ck’s $MRK Roy Baynes thanked the Chi­nese reg­u­la­tors for the speedy work, say­ing: “The ap­proval of Keytru­da in Chi­na, for this first in­di­ca­tion, was made pos­si­ble through ex­ten­sive col­lab­o­ra­tive ef­fort with the Chi­nese pa­tients and in­ves­ti­ga­tors who par­tic­i­pat­ed in KEYNOTE-151, as well as the reg­u­la­to­ry and gov­ern­ment au­thor­i­ties who pri­or­i­tized this fil­ing.”

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