I-Active Pharmaceutical Ingredients (APIs) idlala indima ebalulekile embonini yezemithi futhi iyisisekelo esiyinhloko sokwenziwa kwayo yonke imithi.
Ubukhulu bemakethe bemboni yezemithi yaseJapan bukleliswe endaweni yesibili e-Asia.Ngokunyuka kwezindleko ze-R&D embonini yezemithi nezinye izizathu, kulindeleke ukuthi imakethe yama-API aseJapan izokhula ngenani eliphakeme kakhulu lika-7% kuya ku-8% ngo-2025. Phakathi kwazo, izinkampani zemithi ezidlale indima ebalulekile zihlanganisa I-Sun Pharmaceutical, i-Teva, i-Novartis International AG, i-Piramal Enterprises, ne-Aurobindo.
Ukuthuthukiswa kwemboni yemithi ejwayelekile yase-Japan nakho kubhekene nesithiyo sokungatholakali okwanele okuzimele kwezinto zokusetshenziswa.Cishe u-50% wemikhiqizo yawo yasekhaya yama-API asetshenziselwa ukukhiqizwa kwemithi ejwayelekile, futhi abahlinzeki abakhulu bamazwe ngamazwe bavela emazweni ase-Asia nase-Europe njenge-India, China, South Korea, Italy, Spain, Hungary kanye neJalimane.Ukuze kwehliswe ukuncika kuma-API angenisiwe, i-Japan igxile ekwenziweni kwasendaweni kwama-API.
I-Sumitomo Pharmaceuticals, inkampani yokuqala e-Japan ukukhiqiza izidakamizwa zamakhemikhali isebenzisa ubuchwepheshe obuthuthukisiwe be-organic synthesis, ihlela ukwakha i-molecule encane yezidakamizwa ze-APIs kanye nefektri ephakathi e-Oita City, e-Oita Prefecture.Umgomo oyinhloko wephrojekthi ukukhulisa amandla okukhiqiza i-API yenkampani ukuze kuhlangatshezwane nesidingo esikhulayo sama-API wekhwalithi ephezulu kanye nabaphakathi.
Imboni entsha ihlelelwe ukuthi iqale ukusebenza ngoSepthemba 2024. Umnyango wayo wokuthuthukiswa kwezinkontileka kanye nokukhiqiza (CDMO) usebenzisa ubuchwepheshe obuyingqayizivele ukuze ukhiqize futhi unikeze ama-molecule amancane ama-API kanye nabaphakathi ezinkampanini ezikhiqizayo, futhi uthole ukuthengiswa kwezentengiselwano kwangaphandle.Ngenxa yesidingo esinamandla samaphrojekthi amasha okuthuthukisa izidakamizwa, imakethe yomhlaba wonke ye-CDMO yezemithi ilondoloze ukukhula okuqhubekayo.Kulinganiselwa ukuthi inani lamanje lezohwebo lomhlaba wonke lomuthi we-CDMO lingaba amaRandi ayizigidi eziyizinkulungwane ezingama-81, okulingana nama-yen ayizigidi eziyizinkulungwane eziyi-10.
Ithembele ohlelweni lwayo oluhle kakhulu lokuqinisekisa ikhwalithi kanye nezinzuzo zokuphathwa kokuthengwa kwempahla emhlabeni wonke, i-Sumitomo Pharmaceuticals kancane kancane iye yakhulisa ibhizinisi layo le-CDMO phakathi neminyaka edlule futhi isisungule isikhundla esiphambili e-Japan.Izitshalo zayo e-Gifu nase-Okayama zinamandla amancane okukhiqiza.Amandla okukhiqiza aqinile ama-API kanye nezimaphakathi ezidingekayo emithini yokwelapha yamangqamuzana.Umkhiqizi wenkontileka yezemithi wase-Japan i-Bushu Corporation yafinyelela esivumelwaneni sokubambisana ne-Suzuken Pharmaceutical Company ngo-April 2021 ukuze inikeze ukusekelwa okusha kokuthuthukiswa komkhiqizo ezinkampanini zemithi ezingochwepheshe ezihlose ukungena emakethe yase-Japan.UBushu uthemba ukwenza isivumelwano sokubambisana sokukhiqizwa okuqondile kwasekhaya kwama-API, ngokusebenzisana kwezinkampani ezimbili zemithi, ukuhlinzeka ngezinsizakalo zokulawula indawo eyodwa ngesidingo semithi ekhethekile, okuhlanganisa ukukhuthazwa kwabaphethe ukugunyazwa/abaphethe izidakamizwa ukubonisana nokudlulisa, ukungenisa, ukuhlolwa kwemakethe, Ukukhiqiza nokuhlinzeka, ukugcinwa nokuthutha okuphathisiwe, ukuhlolwa kokuphromotha kanye nosizo lwesiguli kanye nezinye izinsiza.
Ngesikhathi esifanayo, iBushu Pharmaceuticals ingaletha izidakamizwa ngokuphephile ezigulini kuyo yonke inqubo ngokusebenzisa uhlelo olukhethekile lokuqapha iketango lezidakamizwa ezibandayo (Cubixx) olwakhiwe yi-Suzuken Co., Ltd. Ngaphezu kwalokho, i-Astellas Pharmaceutical Company yase-Japan idalule lokho ngoko uhlelo lwesithathu lokunwetshwa kokukhiqiza, isisekelo se-API sokukhiqizwa kwemithi esebenza engaguquki eyasungulwa e-Toyama, e-Japan ngoJanuwari 2020 izosetshenziselwa ukwakha i-tacrolimus hydrate API yokuqala ye-Astellas Prograf.
I-Tacrolimus umuthi ovimbela futhi welaphe ukwenqatshwa kwesitho ezigulini ezikhulile nezezingane ezithole ukufakelwa kwesibindi, izinso, inhliziyo (kanye namaphaphu okusha kwe-FDA ngo-2021).
Isikhathi sokuthumela: Jun-03-2019
