Njira yoyamba yapaclitaxel padziko lonse lapansi idavomerezedwa ku China

Pa Seputembara 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. Evaluation (CDE) ya State Drug Administration.(Nambala yovomerezeka: JXHS2200082 dziko, JXHS2200083 dziko, JXHS2200084 dziko).

Ulamuliro

Gwero lachithunzi: State Drug Administration

Paclitaxelamagwiritsidwa ntchito kwambiri pochiza zotupa zosiyanasiyana zowopsa monga khansa ya m'mapapo, khansa ya m'mawere, khansa ya m'mawere, khansa ya mutu ndi khosi, komanso khansa ya m'mimba.Mapuloteni polymerization, microtubule msonkhano, kupewa depolymerization, potero kukhazikika microtubules ndi inhibiting mitosis wa maselo a khansa ndi kuyambitsa apoptosis, potero mogwira kupewa kuchulukana kwa maselo a khansa ndi kusewera odana ndi khansa kwenikweni.

Pakalipano, madera ambiri padziko lapansi amagwiritsa ntchito paclitaxel ngati jekeseni, yomwe imayenera kupangidwa ndi kuperekedwa ndi mtsempha wa mtsempha kuchipatala.Odwala amayenera kubwerera ku chipatala pafupipafupi, ndipo padzakhala zovuta pa malo opangira jakisoni.Chifukwa chake, chitukuko cha kukonzekera kwa paclitaxel pakamwa nthawi zonse kwakhala kotentha kwambiri pakufufuza kwamakampani..

RMX3001 ndi njira yopangira paclitaxel yopangidwa ndi Dahua Pharmaceutical kutengera luso lake laukadaulo lodzipangira lipid popereka mankhwala.Zavomerezedwa ndi Korea Food and Drug Administration mu Seputembala 2016 (dzina lamalonda Liporaxel), ndipo chizindikiritso ndi chithandizo chapamwamba kapena chachiwiri cha khansa ya m'mimba ya metastatic kapena khansa yam'mimba yobweranso kwanuko.Malinga ndi kutulutsidwa kwa atolankhani kuchokera ku Haihe Pharmaceuticals, Liporaxel ndiye chinthu choyamba pakamwa paclitaxel chomwe chapangidwa bwino ndikuvomerezedwa kuti chizigulitsidwa padziko lonse lapansi mpaka pano.Mu Seputembala 2017, Haihe Pharmaceutical idapeza R&D, kupanga ndi kugulitsa ufulu wa malonda ku China, Hong Kong, Taiwan ndi Thailand kuchokera ku Dahua Pharmaceuticals.

Kugwiritsa ntchito mndandanda wa RMX3001 ku China makamaka kumatengera mawonekedwe osasinthika, otseguka, owongolera, osagwirizana, osakhala otsika, mayesero azachipatala a Phase 3, omwe cholinga chake ndi kufananiza chithandizo chamzere wachiwiri wa paclitaxel oral solution RMX3001 ndi jakisoni wa paclitaxel (Taxol) Kuchita bwino komanso chitetezo kwa odwala omwe ali ndi khansa yapamwamba yam'mimba.Kafukufukuyu adachitidwa limodzi ndi Pulofesa Li Jin wa ku Shanghai Oriental Hospital ndi Pulofesa Qin Shukui wa ku Nanjing Jinling Hospital monga ofufuza wamkulu.

Dr. Ruiping Dong, Chief Executive Officer wa Haihe Pharmaceuticals, anati: "Kuvomerezedwa kwa ntchito ya paclitaxel oral solution (RMX3001) ndi chinthu china chofunika kwambiri cha Haihe Pharmaceuticals, ndipo ndikuthokoza kwambiri ofufuza ndi odwala omwe adagwira nawo ntchito yathu. mlandu.Khansara Yam'mimba Yapamwamba Pakufunikabe chithandizo chachikulu chomwe sichinakwaniritsidwe, ndipo tikuyembekeza kubweretsa chithandizo chamakono kwambiri padziko lonse lapansi kwa odwala ku China komanso padziko lonse lapansi posachedwa.

Yunnan Hande Biotechnology Co., Ltd. yakhala ikuyang'ana kwambiri pakupanga paclitaxel kwa zaka 28.Ndiwodzipangira yekha padziko lonse lapansi wopanga mankhwala oletsa khansa a paclitaxel omwe avomerezedwa ndi US FDA, European EDQM, Australian TGA, China CFDA, India, Japan ndi mabungwe ena olamulira dziko.bizinesi.Ngati mukufuna kugulaPaclitaxel API,chonde titumizireni pa intaneti.


Nthawi yotumiza: Sep-14-2022