Musi waGunyana 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. uye Daehwa Pharmaceutical Co., Ltd. vakazivisa pamwe chete kuti paclitaxel oral solution (RMX3001) yakagadziridzwa nemapato maviri aya yakabvumidzwa zviri pamutemo neCentre for Drug. Kuongorora (CDE) yeHurumende Drug Administration.(Nhamba yekugamuchira: JXHS2200082 nyika, JXHS2200083 nyika, JXHS2200084 nyika).
Mufananidzo kunobva: State Drug Administration
Paclitaxelrinoshandiswa zvakanyanya mukurapa mamota akasiyana akashata akadai sekenza yemapapu, kenza yemazamu, kenza yeovarian, kenza yemusoro nemutsipa, uye kenza yemudumbu.Protein polymerization, microtubule musangano, kudzivirira depolymerization, nokudaro kudzikamisa microtubules uye inhibiting mitosis yekenza masero uye kukonzeresa apoptosis, nokudaro zvinobudirira kudzivirira kuwanda kwekenza maseru uye kutamba anti-cancer mhedzisiro.
Parizvino, nzvimbo zhinji dzepasirese dzinoshandisa paclitaxel nenzira yejekiseni, inoda kugadzirwa uye kupihwa intravenous drip muchipatara.Varwere vanofanira kudzokera kuchipatara nguva nenguva, uye pachava nemigumisiro yakaipa panzvimbo yejekiseni.Naizvozvo, kuvandudzwa kweoral paclitaxel gadziriro yagara iri nzvimbo inopisa mukutsvaga kwemaindasitiri..
RMX3001 inogadzirwa nemuromo ye paclitaxel yakagadziridzwa neDahua Pharmaceutical zvichibva pane yayo itsva lipid self-emulsifying dhizaini tekinoroji.Yakatenderwa neKorea Chikafu neDrug Administration munaGunyana 2016 (zita rekutengesa Liporaxel), uye chiratidzo chiri chepamusoro kana chechipiri-mutsara kurapwa kwemetastatic gastric cancer kana yemuno inodzokororwa cancer yemudumbu.Zvinoenderana nekuburitswa kwenhau kubva kuHaihe Pharmaceuticals, Liporaxel ndiyo yekutanga oral paclitaxel chigadzirwa chakabudirira kugadzirwa uye kubvumidzwa kushambadzira munyika kusvika parizvino.MunaGunyana 2017, Haihe Pharmaceutical yakawana iyo R&D, kugadzira uye kutengesa kodzero dzechigadzirwa mu mainland China, Hong Kong, Taiwan neThailand kubva kuDahua Pharmaceuticals.
Rondedzero yekushandiswa kweRMX3001 muChina inonyanya kuenderana nerandomized, yakavhurika-label, parallel-controlled, isiri-yakaderera dhizaini, multi-center Phase 3 kliniki yekuedza, iyo ine chinangwa chekuenzanisa yechipiri-mutsara kurapwa kwepaclitaxel oral solution RMX3001 uye. paclitaxel jekiseni (Taxol) Kushanda uye kuchengeteka mune varwere vane advanced gastric cancer.Chidzidzo ichi chakaitwa pamwe chete naProfessor Li Jin vekuShanghai Oriental Hospital naProfessor Qin Shukui vekuNanjing Jinling Hospital sevaongorori vakuru.
Dr. Ruiping Dong, Chief Executive Officer weHaihe Pharmaceuticals, akati: "Kugamuchirwa kwechikumbiro che paclitaxel oral solution (RMX3001) chimwe chiitiko chakakosha cheHaihe Pharmaceuticals, uye ndinotenda zvikuru kune vaongorori vekiriniki nevarwere vakapinda muchirongwa chedu. kutongwa.Gomarara remudumbu repamusoro Pachine chido chikuru chisati chazadziswa chekurapwa, uye tinotarisira kuunza kurapa kwepamusoro-soro uye kuri nyore pasi rose kuvarwere muChina nepasirese nekukasika.
Yunnan Hande Biotechnology Co., Ltd yanga yakatarisana nekugadzirwa kwepaclitaxel kwemakore makumi maviri nemasere.Ndiyo yekutanga yakazvimirira kugadzira pasi rose-yakagadzirwa anticancer drug paclitaxel iyo yakatenderwa neUS FDA, European EDQM, Australian TGA, China CFDA, India, Japan nemamwe masangano anodzora nyika.enterprise.Kana uchida kutengaPurogiramu inonzi Paclitaxel,ndapota taura nesu online.
Nguva yekutumira: Sep-14-2022