1. Inkqubela yomsebenzi yamva nje:
Isibhengezo esilawulayo se-paclitaxel yendalo:
● China CDE:
NgoDisemba 13, 2021, isicelo esongezelelweyo seCDE sigqityiwe (isimo seCDE samva nje siboniswe kumfanekiso).kwaye i-Hande yamkela i-GMP yokuhlola ukuthotyelwa kwendawo yeYunnan kwiPhondo lokuTya kunye noLawulo lweZiyobisi ngoJanuwari 18-20, 2022. Ekubeni iCDE ayisayi kukhupha nawaphi na amaxwebhu okuvuma ukubhaliswa kwe-API kunye nokuguqulwa kokutshintsha, ayiyi kukhupha nawaphi na amaxwebhu axhasayo. ixesha likhona, kodwa sele linokubhekiswa ngamalungiselelo kunye nezixhobo.Ngokwemvume yeCDE, nceda ubhekisele kwi-imeyile yesaziso sotshintsho kwinkqubo ehambelanayo kunye notshintsho oluqhelekileyo..
Emva kokuhlolwa kwendawo, uYunnan Hande uya kuphinda aqalise ngokusemthethweni ukuthengisa kwimarike yaseTshayina.Inkampani yakho inokusebenzisa iimveliso ze-Hande kuphando kunye nophuhliso, uvavanyo oluncinci, uvavanyo lokulinga kunye nokusetyenziswa kwekliniki ngokweemfuno zakho.Izixhobo zesicelo zinokucaphula ngokuthe ngqo izixhobo ze-CDE ze-Hande.
● EU EDQM:
U-Hande ufumene isatifikethi se-CEP kunye "noXwebhu lweSatifikethi sokuThunyelelwa ngaphandle kwee-APIs kwi-EU" ("WC"), kwaye imarike ye-EU iqalise kwakhona ukuthengisa ngokusemthethweni kwezorhwebo.Ukuba inkampani yakho idinga isatifikethi se-CEP kunye neleta yogunyaziso okanye iimveliso, nceda uqhagamshelane nathi ngexesha.
● I-FDA yase-US:
Ulwazi lotshintsho lweDMF lungenisiwe.
● Amanye amazwe okanye imimandla:
ERashiya: Abathengi abakhoyo baqalise ukubhalisa;
EIndiya: Idatha yeDMF ifakiwe;
IBrazil: Ukulungiswa kwedatha yeDMF;
EJapan: Izixhobo zokubhalisa zingenisiwe;
I-Australian TGA: Kumalungiselelo;
I-EU GMP: ekulungiseleleni;
Amanye amazwe aza kusebenzisa ngaxeshanye.Kwixesha elizayo, i-Hande iya kunceda inkampani yakho ukuba yandise imarike yeqhinga lamazwe ngamazwe.
2. Umgca wemveliso we-10-DAB semi-synthetic paclitaxel:
Imveliso yokulinga iphelile kwaye uvavanyo lugqityiwe.Ngoku yenza uphando olusemgangathweni kunye nokuhlolwa kozinzo.Isicwangciso soveliso sebhetshi yokuqinisekiswa kweebhetshi ezi-3 siya kuqala ngoJanuwari 2022 emva kokufakwa kunye nokugunyaziswa kwezixhobo kugqityiwe.
Isicwangciso solawulo se-10-DAB semi-synthetic paclitaxel:
● I-CDE yaseChina: Inombolo yoxwebhu: Y20210000685, kucetywa ukuqalisa isicelo kwikota yesibini ye-2022;
● I-EDQM kunye ne-FDA: Cwangcisa ukufaka ifayile kwikota yesine ye-2022.
3. Umgca wokuqhubela phambili:
Ngokusetyenziswa kweenkcukacha-manani kwindawo kunye novavanyo lwesampulu yeziseko ezininzi zokutyala i-yew, isicwangciso sonyaka sokuthengwa kwempahla siphunyeziwe ngeziseko ezi-3 zokutyala ezinkulu zokuqinisekisa unikezelo lwemathiriyeli ekrwada eyaneleyo yesixa esisebenzayo se-paclitaxel.Imveliso yonyaka ye-10-DAB yi-2000kg / ngonyaka, kunye nomgangatho ozinzile kunye nokunikezelwa kwexesha elide.
● 10-DAB III yokufayilisha yolawulo:
I-DMF: Inombolo ye-DMF ifunyenwe.
2. Olunye ulwazi
1. Sichatshazelwe ngulo bhubhani, iHande ayisayi kuphinda ithathe inxaxheba kumboniso weCPHI.Ukuze sisebenze ngcono inkampani yakho, siya kuqhubeka nokundwendwela abathengi kwaye sisebenzisane nomsebenzi wophuhliso lwentengiso yenkampani yakho ngeenkonzo ezingcono.
Ixesha lokuposa: Feb-18-2022