New ane­mia drug gets China ap­proval

China Daily (Canada) - - BUSINESS -

ZHENG YIRAN Roxadu­s­tat, a do­mes­ti­cally de­vel­oped Class 1 medicine, re­ceived mar­ket­ing ap­proval from the Na­tional Med­i­cal Prod­ucts Ad­min­is­tra­tion on Tues­day, a mile­stone for China’s bio­phar­ma­ceu­ti­cal re­search and de­vel­op­ment in­dus­try.

As­traZeneca China and Fi­broGen China de­vel­oped and in­cu­bated this first-of-its-kind oral medicine for ane­mia.

“Roxadu­s­tat’s ap­proval in China demon­strates the de­ter­mi­na­tion of the Chi­nese gov­ern­ment to ac­cel­er­ate the availability of ur­gently needed new clin­i­cal drugs to Chi­nese pa­tients, and to sup­port phar­ma­ceu­ti­cal in­no­va­tion,” said Leon Wang, ex­ec­u­tive vice-pres­i­dent in­ter­na­tional and China pres­i­dent at As­traZeneca.

Roxadu­s­tat is de­signed to treat ane­mia caused by chronic kid­ney dis­ease in pa­tients who are dial­y­sis-de­pen­dent. As­traZeneca and Fi­broGen an­nounced they ex­pect to launch the prod­uct in China in the second half of 2019.

“In the fu­ture, As­traZeneca will work closely with the gov­ern­ment to in­crease the ac­ces­si­bil­ity of roxadu­s­tat in China, and to use the drug to ben­e­fit more Chi­nese pa­tients. At the same time, in re­sponse to the Chi­nese gov­ern­ment’s call for phar­ma­ceu­ti­cal in­no­va­tion, we will build a lo­cal in­cu­ba­tion plat­form to make more new drugs that ben­e­fit

China first, and open up China’s phar­ma­ceu­ti­cal in­no­va­tions to the world,” Leon said.

Chen Nan, lead prin­ci­pal in­ves­ti­ga­tor in the Phase-III clin­i­cal trial of roxadu­s­tat in China and pro­fes­sor of Shang­hai Jiao Tong Univer­sity School of Medicine, said: “Thanks to the im­prove­ment of China’s phar­ma­ceu­ti­cal in­no­va­tion at­mos­phere, do­mes­tic in­ves­ti­ga­tors now have much bet­ter op­por­tu­ni­ties to show their ex­cel­lence, along­side their in­ter­na­tional peers, in the global clin­i­cal de­vel­op­ment of first-in-class in­no­va­tive drugs.”

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