Fi­bro­Gen, As­traZeneca score Chi­na ap­proval for ane­mia drug ahead of piv­otal US da­ta

It may be the first time a multi­na­tion­al phar­ma­ceu­ti­cal com­pa­ny As­traZeneca $AZN could be­gin sell­ing a po­ten­tial block­buster med­i­cine in Chi­na, be­fore the Unit­ed States or Eu­rope. Fi­bro­Gen $FGEN and the British drug­mak­er have se­cured Chi­na ap­proval for their oral drug, rox­adu­s­tat, for ane­mic pa­tients with chron­ic kid­ney dis­ease who are de­pen­dent on dial­y­sis.

The drug, which stim­u­lates the pro­duc­tion of red blood cells by mim­ic­k­ing the ef­fect of high al­ti­tude in hu­mans, will be launched in the sec­ond half of next year un­der the Chi­nese brand name: ài ruì zhuó 爱瑞卓. While Fi­bro­Gen will take care of man­u­fac­tur­ing, As­traZeneca is in charge of com­mer­cial­iza­tion. Ap­proval for a larg­er pool of pa­tients — who are not de­pen­dent on dial­y­sis — is ex­pect­ed some­time in 2019, af­ter Chi­nese reg­u­la­tors com­plete an in­spec­tion of tri­al sites, the San Fran­cis­co-based com­pa­ny said on Mon­day.

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