NgoSeptemba 13, 2022, iShanghai Haihe Pharmaceutical Research and Development Co., Ltd. kunye neDaehwa Pharmaceutical Co., Ltd. babhengeze ngokudibeneyo ukuba isisombululo somlomo se-paclitaxel (RMX3001) siphuhliswe ngokudibeneyo ngamaqela amabini samkelwe ngokusemthethweni liZiko leChiza. Uvavanyo (CDE) loLawulo lweZiyobisi lukaRhulumente.(Inombolo yokwamkelwa: JXHS2200082 ilizwe, JXHS2200083 ilizwe, JXHS2200084 ilizwe).
Umthombo womfanekiso: Ulawulo lweziyobisi lukaRhulumente
Paclitaxelisetyenziswa kakhulu kunyango lwamathumba ayingozi ahlukeneyo afana nomhlaza wemiphunga, umhlaza wamabele, umhlaza wesibeleko, umhlaza wentloko kunye nentamo, kunye nomhlaza wesisu.Iprotheyini ye-polymerization, i-microtubule assembly, ukuthintela ukuchithwa kwe-depolymerization, ngaloo ndlela kuzinzisa i-microtubules kunye nokuthintela i-mitosis yeeseli zomhlaza kunye nokubangela i-apoptosis, ngaloo ndlela ikhusela ngokufanelekileyo ukwanda kweeseli zomhlaza kunye nokudlala i-anti-cancer effect.
Okwangoku, iindawo ezininzi zehlabathi zisebenzisa i-paclitaxel ngendlela yokutofa, ekufuneka yenziwe kwaye ilawulwe nge-intravenous drip esibhedlele.Izigulane kufuneka zibuyele esibhedlele rhoqo, kwaye kuya kubakho ukusabela okungalunganga kwindawo yokutofa.Ngoko ke, ukuphuhliswa kwamalungiselelo e-paclitaxel yomlomo kuye kwaba yinto eshushu kuphando lweshishini..
I-RMX3001 luqulunqo lomlomo lwe-paclitaxel oluphuhliswe yi-Dahua Pharmaceutical ngokusekwe kubuchwephesha bayo bokusungula i-lipid self-emulsifying yokuhanjiswa kweziyobisi.Ivunyiwe yi-Korean Food and Drug Administration ngoSeptemba 2016 (igama lokurhweba i-Liporaxel), kwaye isalathisi sonyango oluphambili okanye lwesibini lomhlaza wesisu we-metastatic okanye umhlaza wesisu oqhelekileyo wendawo.Ngokutsho kwe-press release evela kwi-Haihe Pharmaceuticals, i-Liporaxel yimveliso yokuqala ye-paclitaxel yomlomo eye yaphuhliswa ngempumelelo kwaye yavunywa ukuba ithengiswe kwihlabathi ukuza kuthi ga ngoku.NgoSeptemba 2017, i-Haihe Pharmaceutical ifumene i-R & D, amalungelo okuvelisa kunye nokuthengisa imveliso kwilizwe laseChina, eHong Kong, eTaiwan naseThailand kwiDahua Pharmaceuticals.
Ukusetyenziswa koluhlu lwe-RMX3001 e-China ikakhulu isekelwe kwi-randomized, i-label evulekile, i-parallel-controlled, i-non-inferiority design, i-multi-center Phase 3 uvavanyo lwezonyango, olujolise ukuthelekisa unyango lwesibini lwe-paclitaxel isisombululo somlomo RMX3001 kunye inaliti ye-paclitaxel (i-Taxol) Ukusebenza kunye nokhuseleko kwizigulane ezinomhlaza wesisu esiphezulu.Uphononongo luqhutywe ngokubambisana nguNjingalwazi uLi Jin ovela kwiSibhedlele sase-Shanghai Oriental kunye noNjingalwazi uQin Shukui ovela kwiSibhedlele saseNanjing Jinling njengabaphandi abayintloko.
UDkt. Ruiping Dong, iGosa eliLawulayo le-Haihe Pharmaceuticals, uthe: "Ukwamkelwa kwesicelo se-paclitaxel isisombululo somlomo (RMX3001) yenye into ebalulekileyo kwi-Haihe Pharmaceuticals, kwaye ndiyabulela kakhulu kubaphandi bekliniki kunye nezigulane ezithatha inxaxheba kwi-Haihe Pharmaceuticals. ityala.Umhlaza wesisu okwinqanaba eliphezulu Kusekho imfuno enkulu yonyango engekafikelelwa, kwaye sinethemba lokuzisa olona nyango lukumgangatho ophezulu kwihlabathi kwizigulana zaseTshayina nakwihlabathi liphela ngokukhawuleza.”
I-Yunnan Hande Biotechnology Co., Ltd. sele igxile kwimveliso ye-paclitaxel iminyaka eyi-28.Ngumvelisi wokuqala ozimeleyo wehlabathi we-anticancer drug paclitaxel evunywe yi-US FDA, i-European EDQM, i-Australian TGA, i-China CFDA, i-Indiya, i-Japan kunye nezinye ii-arhente ezilawulayo zelizwe.ishishini.Ukuba ufuna ukuthengaPaclitaxel API,nceda uqhagamshelane nathi kwi-intanethi.
Ixesha lokuposa: Sep-14-2022