Sebtembar 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. iyo Daehwa Pharmaceutical Co., Ltd. waxay si wadajir ah ugu dhawaaqeen in xalinta afka paclitaxel (RMX3001) ay si wadajir ah u soo saareen labada dhinac ay si rasmi ah u ansixisay Xarunta Daroogada Qiimaynta (CDE) ee Maamulka Dawooyinka ee Gobolka.(Lambarka aqbalaadda: dalka JXHS2200082, dalka JXHS2200083, dalka JXHS2200084).
Isha sawirka: Maamulka Dawooyinka ee Gobolka
Paclitaxelwaxaa si weyn loogu isticmaalaa daawaynta burooyinka halista ah ee kala duwan sida kansarka sambabada, kansarka naasaha, kansarka ugxansidaha, kansarka madaxa iyo qoorta, iyo kansarka caloosha.Polymerization Protein, isu-ururinta microtubule, ka hortagga depolymerization, sidaas darteed xasilinta microtubules iyo joojinta mitosis ee unugyada kansarka iyo kicinta apoptosis, si wax ku ool ah looga hortago faafitaanka unugyada kansarka iyo ciyaarista saameynta kansarka ka hortagga.
Waqtigan xaadirka ah, inta badan adduunka ayaa isticmaala paclitaxel qaab cirbad ah, taas oo u baahan in la sameeyo oo lagu maamulo faleebo xididada ah ee isbitaalka.Bukaan-socodka waxay u baahan yihiin inay si joogto ah ugu soo laabtaan cisbitaalka, waxaana jiri doona fal-celin xun oo ka imanaysa goobta la duray.Sidaa darteed, horumarinta diyaarinta paclitaxel ee afka ayaa had iyo jeer ahayd meel kulul ee cilmi-baarista warshadaha..
RMX3001 waa qaab afka laga sameeyo oo paclitaxel ah oo ay soo saartay Dahua Pharmaceutical oo ku salaysan tignoolajiyada gudbinta dawooyinka dufanka leh ee is-ku-jiidaya.Waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka ee Kuuriya Sebtembar 2016 (magaca ganacsiga Liporaxel), iyo tilmaamuhu waa daawaynta sare ama labaad ee daaweynta kansarka caloosha ee metastatic ama kansarka caloosha oo soo noqnoqda.Sida lagu sheegay war-saxaafadeed ka soo baxay Haihe Pharmaceuticals, Liporaxel waa badeecada paclitaxel-ka ee ugu horreysa ee si guul leh loo horumariyo loona oggolaaday suuqgeynta adduunka illaa hadda.Bishii Sebtembar 2017, Haihe Pharmaceutical waxay ka heshay R&D, xuquuqaha wax soo saarka iyo iibinta badeecadaha ee dhul weynaha Shiinaha, Hong Kong, Taiwan iyo Thailand oo ka yimid Dahua Pharmaceuticals.
Codsiga liiska ee RMX3001 ee Shiinaha ayaa inta badan ku salaysan randomized, calaamad-furan, isbarbar-control, design aan hooseeyo, multi-xarunta ah Wajiga 3 tijaabo caafimaad, kaas oo ujeedadiisu tahay in la barbardhigo daaweynta-labaad ee paclitaxel xal afka RMX3001 iyo cirbadeynta paclitaxel (Taxol) Waxtarka iyo badbaadada bukaanada qaba kansarka caloosha ee sareeyo.Daraasadda waxaa si wadajir ah u sameeyay Professor Li Jin oo ka socda Isbitaalka Oriental Shanghai iyo Professor Qin Shukui oo ka socda Isbitaalka Nanjing Jinling oo ah baarayaasha maamulaha.
Dr. Ruiping Dong, oo ah madaxa fulinta ee Haihe Pharmaceuticals, ayaa yiri: "Aqbalaada codsiga paclitaxel afka laga qaato (RMX3001) waa guul kale oo muhiim u ah Haihe Pharmaceuticals, waxaan aad ugu mahadcelinayaa baarayaasha kiliinikada iyo bukaanada ka qaybqaatay our maxkamadayn.Kansarka caloosha ee sareeyo Wali waxaa jirta baahi caafimaad oo aad u weyn oo aan la daboolin, waxaana rajeyneynaa inaan sida ugu dhaqsaha badan ugu keeno daawaynta ugu casrisan adduunka uguna habboon bukaannada ku nool Shiinaha iyo adduunka oo dhan."
Yunnan Hande Biotechnology Co., Ltd. waxa ay diiradda saareysay soo saarista paclitaxel muddo 28 sano ah.Waa saaraha ugu horreeya ee madax-bannaan ee adduunka ee daawada paclitaxel ee ka hortagga kansarka ee ay ansixisay US FDA, European EDQM, Australian TGA, China CFDA, India, Japan iyo hay'adaha kale ee sharciyeynta qaranka.ganacsi.Haddii aad rabto inaad iibsatoPaclitaxel API,fadlan online nagala soo xidhiidh.
Waqtiga boostada: Seb-14-2022