Hengrui Medicine (01276) Receives Full Response Letter on Injection of Carrelizumab

Zhtng Cijng APP News, Hng Ru Yyo (01276) fb gnggo, jnr, Jings Hng Ru Yyo Gfn Yuxin Gngs (yxi jinchng gngs) shudo Migu Shpn Yofngun Ly Gunl J (yxi jinchng FDA) guny zhsh yng kru zh dn kng linh ji sun p tn pin yng y b k qi chng zhhun yng l x zhngi de yxin zhlio de shngw zhpn xk shnqng (Biologics License Application) de wnzhng huf xn (Complete Response Letter, yxi jinchng CRL)Cc shnp fnyn zhyo y p tn xinggun shngchn chngd de CGMP jinch gunch xing yugun, gi chngd y 2026 nin 4 yu jishu le FDA CGMP jin d jinch, gngs y zhn du jin gun jgu tch de fnku yjin jnxng xingxng pngg, bng zhushu zhdng xingyng de gijn cushBnc shnbo shzh de xinggun chngd zi 2025 nin tnggule uzh de jinchCc CRL wi shj du chnpn lnchng ynji shj, nqun xng j yuxio xng fngmin de wnt. Gngs jing jj y FDA j hzu hubn Elevar Therapeutics jnxng mqi gutng, y mngqu hux de shnbo jhu.