CPhI: Reg­u­la­to­ry changes have led to a CMO boom in Chi­na, but can that con­tin­ue?

Con­tract man­u­fac­tur­ing for do­mes­tic com­pa­nies un­til re­cent­ly didn’t ex­ist in Chi­na, thanks to some reg­u­la­to­ry re­stric­tions that re­quired de­vel­op­ers to be in charge of their own man­u­fac­tur­ing process. Now, the young busi­ness mod­el is be­ing test­ed with high­er de­mand and ex­treme­ly fast growth as the CPhi In­for­ma­Mar­kets re­port ex­pects CMO ser­vices to con­tin­ue to ex­pand in the com­ing years.

In 2013, just four IND ap­pli­ca­tions were sub­mit­ted in Chi­na. That num­ber sky­rock­et­ed to 99 in 2020, fol­lowed by 94 al­ready in 2021. Chi­na is now the home of four PD-1 mAb ther­a­peu­tics, with an­oth­er five in the NDA process.

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