Pa Okutobala 13, anthu opitilira 180 ochokera kumakampani ofufuza ndi chitukuko cha katemera wa antibody adasonkhana ku Chengdu Hall ku Shanghai Hope Hotel.Aphunzitsi khumi ochokera m'makampani ofufuza ndi chitukuko cha antibody-drug ndi mabungwe ofufuza asayansi adabweretsanso kugawana kodabwitsa.
Kuyambira pa lingaliro ndi kugwiritsa ntchito ma antibodies, Dr. Zhang Aihua adakambilana za magulu ndi mayina a mankhwala a antibody.Potengera CD47 mwachitsanzo, Dr. Zhang adafotokoza za momwe amagwirira ntchito komanso kagwiritsidwe ntchito ka mankhwala a antibody.Pakalipano, kafukufuku ndi chitukuko cha ma antibodies a monoclonal ndi otentha kwambiri.M'kati mwachitukuko, tiyenera kusiyanitsa kusiyana pakati pa chitukuko cha ma antibodies atsopano ndi kulamulira khalidwe la Biosimilar.Popanga mankhwala opangidwa mwaluso, kafukufuku wokwanira wokwanira ayenera kuchitidwa molingana ndi lingaliro lachitukuko la khalidwe lochokera ku mapangidwe (QbD) ndi mfundo yokhala otetezeka, yogwira ntchito, ndikukhala ndi khalidwe labwino.
Dr. Wang Gang, wasayansi wamkulu, anali ndi udindo wotsatira ndikuwunika ku CFDA Drug Review Center (CDE).Adayambitsanso dongosolo la State Drug Administration of China, lomwe ndi njira zitatu zamalamulo zamalamulo, malamulo, ndi malangizo aukadaulo a State Drug Administration.Adafotokozanso za njira zolembetsera ndi kuvomera ku China Biological Products Licensing Application (BLA) ndi New Drug Application (NDA).Anatsimikizira kuti kusintha kwa kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka anthu.Pamapeto pake, adawonetsa malingaliro ake pakusintha kwamtsogolo kwa kayendetsedwe kazamankhwala ku China.Dr. Wang watitsogolera ife kuti tionenso ndondomeko yeniyeni ya zosintha za Drug Administration Law of the People's Republic of China ndi Regulations on Drug Registration and Administration, ndi zomwe zimakhudza kwambiri pamakampani a R & D a mankhwala m'zaka zaposachedwa.
Counttar Rigel yodzipanga yokha yolembedwa ndi ALIT Life Sciences ndiyabwino pazochitika zamaluso komanso zagolide ngati izi.Countstar Altair idapangidwa mwapadera kuti izigwira ntchito.Kasamalidwe kake ka data ndi magwiridwe antchito amagwirizana kwathunthu ndi FDA 21 CFR Part11.Imathanso kupereka ntchito zotsimikizira za 3Q zamitundu yosiyanasiyana yotsimikizira.Zimathetsa nkhawa za makasitomala amakampani okhudza kuwongolera khalidwe.
Pamalo amsonkhanowo, akatswiri ambiri ochokera kumakampaniwo adabwera kudzalankhulana ndikukambirana, ndipo aliyense watsimikizira kuti Rigel amachita bwino komanso amatsatira mogwirizana.Countstar ipitilizabe kulimbikitsa malingaliro asayansi okhwima komanso osamala, kuwongolera nthawi zonse, ndikuthandizira makampani opanga ma antibody kukhala ndi chitukuko chabwinoko.
Countstar Altair imapereka ntchito zoyeserera, ndipo ilandila aliyense kuti alembetse!
