Thaum lub Cuaj Hlis 13, 2022, Shanghai Haihe Pharmaceutical Research thiab Development Co., Ltd. thiab Daehwa Pharmaceutical Co., Ltd. tau sib koom tshaj tawm tias cov tshuaj paclitaxel qhov ncauj (RMX3001) sib koom ua ke tsim los ntawm ob tog tau raug pom zoo los ntawm Lub Chaw Saib Xyuas Tshuaj. Kev Ntsuam Xyuas (CDE) ntawm Lub Xeev Kev Tswj Xyuas Tshuaj.(Tus naj npawb lees paub: JXHS2200082 lub tebchaws, JXHS2200083 lub tebchaws, JXHS2200084 lub tebchaws).
Yees duab Source: State Drug Administration
Paclitaxelyog dav siv nyob rau hauv kev kho mob ntawm ntau yam malignant qog xws li mob ntsws cancer, cancer ntawm lub mis, cancer ntawm zes qe menyuam, mob taub hau thiab caj dab, thiab gastric cancer.Protein polymerization, microtubule los ua ke, tiv thaiv depolymerization, yog li stabilizing microtubules thiab inhibiting lub mitosis ntawm cov qog nqaij hlav cancer thiab ua rau apoptosis, yog li zoo tiv thaiv kev loj hlob ntawm cov qog nqaij hlav cancer thiab ua si tiv thaiv qog noj ntshav.
Tam sim no, feem ntau ntawm lub ntiaj teb no siv paclitaxel nyob rau hauv daim ntawv ntawm kev txhaj tshuaj, uas yuav tsum tau tsim thiab muab tso rau hauv cov hlab ntsha nyob rau hauv lub tsev kho mob.Cov neeg mob yuav tsum tau rov qab mus rau tsev kho mob ntau zaus, thiab yuav muaj kev cuam tshuam tsis zoo ntawm qhov chaw txhaj tshuaj.Yog li ntawd, kev txhim kho ntawm qhov ncauj paclitaxel npaj tau ib txwm yog qhov chaw kub hauv kev tshawb fawb kev lag luam..
RMX3001 yog ib qho kev qhia qhov ncauj ntawm paclitaxel tsim los ntawm Dahua Pharmaceutical raws li nws cov lipid tus kheej-emulsifying tshuaj xa technology.Nws tau raug pom zoo los ntawm Korean Food and Drug Administration nyob rau lub Cuaj Hli Ntuj 2016 (lub npe lag luam Liporaxel), thiab qhov qhia tau yog qib siab lossis thib ob-kab kho mob qog noj ntshav hauv plab lossis mob qog noj ntshav hauv zos.Raws li kev tshaj tawm xov xwm los ntawm Haihe Pharmaceuticals, Liporaxel yog thawj qhov ncauj paclitaxel cov khoom lag luam uas tau tsim ua tiav thiab pom zoo rau kev lag luam hauv ntiaj teb txog tam sim no.Thaum lub Cuaj Hlis 2017, Haihe Pharmaceutical tau txais R & D, tsim khoom thiab muag cov cai ntawm cov khoom hauv Suav teb av loj, Hong Kong, Taiwan thiab Thaib teb los ntawm Dahua Pharmaceuticals.
Daim ntawv teev npe ntawm RMX3001 hauv Suav teb feem ntau yog ua raws li kev sib tw, qhib-daim ntawv sau npe, sib npaug-tswj, tsis muaj kev tsim qauv, ntau qhov chaw kho mob Phase 3, uas yog lub hom phiaj los sib piv cov kab thib ob ntawm kev kho paclitaxel qhov ncauj tshuaj RMX3001 thiab Kev txhaj tshuaj paclitaxel (Taxol) Kev ua tau zoo thiab kev nyab xeeb hauv cov neeg mob uas mob qog noj ntshav siab.Txoj kev tshawb no tau koom ua ke los ntawm xibfwb Li Jin los ntawm Shanghai Oriental Tsev Kho Mob thiab Xib Fwb Qin Shukui los ntawm Nanjing Jinling Tsev Kho Mob ua tus thawj saib xyuas.
Dr. Ruiping Dong, Tus Thawj Coj ntawm Haihe Pharmaceuticals, tau hais tias: "Kev lees txais ntawm daim ntawv thov rau paclitaxel qhov ncauj tshuaj (RMX3001) yog lwm qhov tseem ceeb rau Haihe Pharmaceuticals, thiab kuv zoo siab heev rau cov kws tshawb fawb soj ntsuam thiab cov neeg mob uas tau koom nrog peb. kev sim.Kev mob qog noj ntshav siab tseem tseem muaj qhov xav tau kev kho mob loj heev rau kev kho mob, thiab peb cia siab tias yuav coj lub ntiaj teb kev hloov kho tshiab thiab yooj yim tshaj plaws rau cov neeg mob hauv Suav teb thiab thoob ntiaj teb kom sai li sai tau. "
Yunnan Hande Biotechnology Co., Ltd. tau tsom mus rau kev tsim cov paclitaxel rau 28 xyoo.Nws yog lub ntiaj teb thawj tus neeg ua haujlwm ywj pheej ntawm cov nroj tsuag-derived anticancer tshuaj paclitaxel uas tau pom zoo los ntawm US FDA, European EDQM, Australian TGA, Tuam Tshoj CFDA, Is Nrias teb, Nyiv thiab lwm lub tebchaws tswj hwm.kev lag luam.Yog xav yuavPaclitaxel API,thov hu rau peb hauv online.
Post lub sij hawm: Sep-14-2022