I te Hepetema 13, 2022, ko Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. me Daehwa Pharmaceutical Co., Ltd. i panui tahi ko te otinga waha paclitaxel (RMX3001) i hangaia tahitia e nga taha e rua kua whakamanahia e te Center for Drug Aromātai (CDE) o te Whakahaere Taakaro State.(Tau whakaae: JXHS2200082 whenua, JXHS2200083 whenua, JXHS2200084 whenua).
Puna whakaahua: State Drug Administration
PaclitaxelKei te whakamahia nuitia ki te maimoatanga o nga momo pukupuku kino penei i te mate pukupuku o te huhu, te mate pukupuku o te uma, te mate pukupuku ovarian, te mate pukupuku o te upoko me te kaki, me te mate pukupuku puku.Te polymerization pūmua, te huihuinga microtubule, te aukati i te depolymerization, na reira ka whakapumau i nga microtubules me te aukati i te mitosis o nga pūtau mate pukupuku me te whakaoho i te apoptosis, na reira ka taea te aukati i te tipu o nga pūtau mate pukupuku me te takaro i te paanga anti-mate pukupuku.
I tenei wa, ko te nuinga o nga waahi o te ao e whakamahi ana i te paclitaxel i roto i te ahua o te werohanga, e tika ana kia hangaia me te whakahaere ma te whakaheke toto i roto i te hohipera.Me hoki mai nga turoro ki te hohipera i nga wa katoa, a ka puta he kino ki te waahi werohanga.Na reira, ko te whakawhanaketanga o nga whakaritenga paclitaxel-waha he waahi wera i roto i nga rangahau ahumahi..
Ko te RMX3001 he hanga a-waha o te paclitaxel i hangaia e Dahua Pharmaceutical i runga i tana hangarau hou whakaemulsifying lipid-whaiaro tuku tarukino.Kua whakaaetia e te Korean Food and Drug Administration i te marama o Hepetema 2016 (te ingoa hokohoko ko Liporaxel), a ko te tohu he tohu whakamua, tuarua ranei mo te maimoatanga o te mate pukupuku pekitia metastatic, te mate pukupuku puku o te rohe ranei.E ai ki te panui a Haihe Pharmaceuticals, ko Liporaxel te hua paclitaxel waha tuatahi kua oti pai te whakawhanake me te whakaaetia mo te hokohoko i te ao i tenei wa.I te marama o Hepetema 2017, i whiwhi a Haihe Pharmaceutical i te R&D, te whakaputa me nga mana hoko o te hua i te tuawhenua o Haina, Hong Kong, Taiwana me Thailand mai i Dahua Pharmaceuticals.
Ko te tono whakarārangitanga o RMX3001 i Haina ko te nuinga i runga i te matapōkeretia, tapanga tuwhera, whakarara-whakahaere, hoahoa kore-iti, maha-pokapū Wāhanga 3 whakamātautau haumanu, e whai ana ki te whakataurite i te maimoatanga rarangi tuarua o te otinga waha paclitaxel RMX3001 me te werohanga paclitaxel (Taxol) Te kaha me te haumaru ki nga turoro me te mate pukupuku puku.I whakahaerehia nga rangahau e Ahorangi Li Jin mai i te hohipera o Shanghai Oriental me Ahorangi Qin Shukui mai i te hohipera o Nanjing Jinling hei kaitirotiro matua.
I kii a Takuta Ruiping Dong, Tumuaki Kaiwhakahaere o Haihe Pharmaceuticals: “Ko te whakaaetanga o te tono mo te otinga waha paclitaxel (RMX3001) tetahi atu tohu nui mo Haihe Pharmaceuticals, a ka nui taku mihi ki nga kaitirotiro haumanu me nga turoro i uru mai ki a maatau. whakawakanga.Ko te mate pukupuku puku nui He nui tonu te matea haumanu kare i tutuki mo te rongoa, a ko te tumanako ka kawea mai e matou nga maimoatanga hou me te watea o te ao ki nga turoro i Haina me te ao i te wa e taea ai.
Kua 28 tau a Yunnan Hande Biotechnology Co., Ltd. e aro ana ki te hanga paclitaxel.Koia te kaihanga motuhake tuatahi o te ao o te paclitaxel tarukino anticancer tipu kua whakamanahia e te US FDA, European EDQM, Australian TGA, China CFDA, India, Japan me etahi atu tari whakahaere a-motu.hinonga.Ki te hiahia koe ki te hokoAPI Paclitaxel,tena koa whakapā mai ki runga ipurangi.
Te wa tuku: Sep-14-2022