Ngo-Okthoba 13, abantu abangaphezu kwe-180 abavela embonini yocwaningo nentuthuko yokugomela amasosha omzimba babuthana e-Chengdu Hall e-Shanghai Hope Hotel.Othisha abayishumi abavela embonini yocwaningo nokuthuthukiswa kwezidakamizwa ezilwa namagciwane kanye nezikhungo zocwaningo lwesayensi nabo balethe ukwabelana okumangalisayo.
Kusukela emcabangweni nasekusetshenzisweni kwamasosha omzimba, uDkt. Zhang Aihua uxoxe ngokuhlukaniswa kanye nokuqanjwa kwamagama kwemithi elwa namasosha omzimba.Ethatha i-CD47 njengesibonelo, uDkt. Zhang wachaza ngendlela yokwenza kanye nokusetshenziswa komtholampilo kwemithi elwa namasosha omzimba.Njengamanje, ucwaningo nokuthuthukiswa kwamasosha omzimba we-monoclonal kushisa kakhulu.Enqubweni yokuthuthukiswa, kufanele sehlukanise umehluko phakathi kokuthuthukiswa kwamasosha omzimba aqanjwe kabusha kanye nokulawulwa kwekhwalithi ye-Biosimilar.Ekuthuthukisweni kwemithi emisha, ucwaningo lwekhwalithi eyanele kufanele lwenziwe ngokuhambisana nomqondo wokuthuthuka wekhwalithi evela kumklamo (QbD) kanye nomgomo wokuphepha, ukusebenza kahle, nokuba nekhwalithi elawulekayo.
UDkt. Wang Gang, usosayensi omkhulu, ubenomthwalo wemfanelo wokuthobela imithetho nokuhlolwa esikhungweni sokubukeza izidakamizwa se-CFDA (CDE).Wethule uhlaka lwe-State Drug Administration of China, okuwuhlelo lwezomthetho olunezigaba ezintathu zemithetho, imithethonqubo, nemihlahlandlela yezobuchwepheshe ye-State Drug Administration.Uphinde wethula izinqubo zokubhaliswa nokugunyazwa kweSicelo Selayisense Yemikhiqizo Yezinto Eziphilayo yase-China (i-BLA) kanye Nesicelo Esisha Sezidakamizwa (i-NDA).Uqinisekisile ukuthi ukuguqulwa kwezinqubo zokuphatha, umthetho, kanye nokugunyazwa kwezidakamizwa ze-State Drug Administration kuzothuthukisa kakhulu ukuthuthukiswa kwezidakamizwa ezintsha e-China, futhi kuqhathanise uhlelo lokubuyekeza lokuphatha lwe-Food and Drug Administration of Europe kanye ne-United States.Ekugcineni, ukhombise imibono yakhe mayelana nezinguquko zesikhathi esizayo zohlelo lokulawulwa kwemithi lwaseChina.UDkt. Wang usiholele ukuthi sibuyekeze ukulawulwa okuqondile kwezichibiyelo zoMthetho Wokuphathwa Kwezidakamizwa we-People's Republic of China kanye neMithethonqubo Yokubhaliswa Nokuphathwa Kwezidakamizwa, kanye nomthelela wazo ofinyelela kude embonini ye-R&D yezemithi eminyakeni yamuva.
I-Counttar Rigel eyakhiwe yi-ALIT Life Sciences ilungele umcimbi wobungcweti nosagolide njengalona.I-Countstar Altair yakhelwe ngokukhethekile lo mkhakha.Ukuphathwa kwayo kwedatha nokusebenza kokulawula kuvumelana ngokugcwele ne-FDA 21 CFR Ingxenye11.Iyakwazi futhi ukuhlinzeka ngezinsizakalo zokuqinisekisa ze-3Q zezinhlobonhlobo zamagranule okuqinisekisa ajwayelekile.Ixazulula ngokuphelele izinkathazo zamakhasimende ezimboni mayelana nokulawulwa kwekhwalithi.
Esizeni somhlangano, ochwepheshe abaningi bemboni beza ukuzoxhumana futhi baxoxe, futhi wonke umuntu ukuqinisekisile ngazwi linye ukusebenza nokuthobela kukaRigel.I-Countstar izoqhubeka nokusekela isimo sengqondo sesayensi esiqinile nesicophelelayo, ithuthuke njalo, futhi isize imboni yamasosha omzimba ibe nentuthuko engcono.
I-Countstar Altair inikeza insizakalo yesilingo yesibonelo, futhi yamukela wonke umuntu ukuthi afake isicelo!
