Kusukela kuworkshop encane ngeminyaka yawo-1990 eyayikwazi ukukhiqiza i-API eyodwa kuphela engahluziwe iye kumkhiqizi ohamba phambili emhlabeni we-bio-enzyme onamandla amakhulu e-R&D namuhla, umphakeli omkhulu we-pancreatin emhlabeni kanye nomkhiqizi wokuqala waseChina we-EU GMP-certified bio-enzyme API, u-Deebio udayisile. imikhiqizo yayo iye emazweni nasezifundeni ezingaphezu kuka-30, futhi iqala umbono obanzi wohambo lwamazwe ngamazwe.

Ukuba khona kwebhizinisi elikhulayo ngemuva kweminyaka engama-27 yokukhula

Ngo-1990, u-Zhang Ge, okwamanje ongusihlalo nomongameli we-Deebio, waphothula eSichuan University (eyayiyi-Chengdu University of Science and Technology) njenge-biochemical major and waqala umsebenzi wakhe e-Deyang Biochemical Pharmaceutical Factory njengochwepheshe kanye nomqondisi welabhorethri.Ngonyaka wesine, kwavela ithuba lokuthi ukuhlelwa kabusha kwebhizinisi kwavuswa, wathatha inkampani futhi waletha abanye ozakwethu ukuze bakhe kabusha izikhungo ezigugile ngesandla.NgoDisemba 1994, iSichuan Deyang Biochemical Products Co., Ltd. yasungulwa ngokusemthethweni.

Akekho owayelindele ukuthi i-Deebio icishe ingabi namali ngaphansi konyaka owodwa ngemuva kwesisekelo sayo.

"Ekuqaleni kwawo-1990, ukuqwashisa ngekhwalithi embonini yasekhaya ye-bio-enzyme ngokuvamile kwakungenamandla, futhi ukuqonda kwethu ama-enzyme kwakusesesiteji lapho umsebenzi we-enzyme uyikho konke."U-Zhang Ge uyakhumbula.Ngo-March 1995, i-Deyang Biochemical Products esanda kusungulwa yathola i-oda layo lokuqala: ukuthunyelwa kwe-kallidinogenase engahluziwe e-Japan.Nokho, izimpahla ezithunyelwe kwamanye amazwe zabuyiswa ngenxa yomehluko wamamiligremu ambalwa kokuqukethwe kwamafutha."Inkampani yethu ngabe ibhuntshile ukube ikhasimende belifuna isinxephezelo ngaleso sikhathi njengoba le mali ibilingana nathi. Ngenhlanhla, ngemuva kokuxoxisana, ikhasimende lavuma ukuthi siwuthenge kabusha esikhundleni sokusicela isinxephezelo. " kuchaza uZhang Ge.

Izingozi namathuba kuhlala kukhona.Isifundo esisitholile kuleli cala elingenhla wukuthi sidinga ukubeka izinga eliphezulu kakhulu.Phakathi neminyaka engama-27 eyalandela, u-Deebio wazibophezela kumazinga aqinile ekhwalithi futhi, ngenxa yalokho, ukwazile ukukhula kancane kancane.

Namuhla, i-Deebio inazo zombili izimfanelo namandla okukhiqiza ama-API we-bio-enzyme angaphezu kwe-10, okuthi, i-kallidinogenase yayo ithathe ingxenye enkulu yemakethe yamahhala yomhlaba wonke kuyilapho isabelo semakethe se-pancreatin, i-pepsin, i-chymotrypsin neminye imikhiqizo isifinyelele ku-30%. noma ngaphezulu.U-Deebio futhi ukuphela komphakeli waseShayina we-elastase, i-pepsin yesixazululo esicacile kanye nama-API aphezulu we-lipase pancreatin emakethe yomhlaba.

Ukuhola imboni ngemuva kwesisekelo esiqinile nesithuthukiswa njalo

Akubanga yindlela elula yokuthuthukisa i-Deebio.

Ngo-1997, lapho u-Deebio ekwazi ukulondoloza ukusebenza kwawo okuvamile, waqala ukuthuthukisa ukubambisana okuseduze kocwaningo lwemboni-inyuvesi-inyuvesi namanyuvesi nezikhungo zocwaningo, okuhlanganisa i-Tsinghua University, i-Chinese Academy of Sciences, i-Sichuan University, i-China Pharmaceutical University, njll. umphumela, u-Deebio ngokushesha waba umholi wemboni emandleni obuchwepheshe.

NgoJanuwari 2003, ukuze kuthuthukiswe ikhwalithi, u-Deebio wasungula ibhizinisi elihlanganyelwe, i-Deyang Sinozyme Pharmaceutical Co., Ltd. ngokuhlanganyela nozakwethu waseJalimane owayenobuchwepheshe obungcono namandla okuphatha.Phakathi neminyaka engu-18 yokubambisana, uzakwethu waseJalimane ubevame ukuvakashela i-Deebio ukuze anikeze isiqondiso nokuqondisa, ethula izindlela zokuphatha isistimu yekhwalithi ethuthukisiwe ku-Deebio, ukuze akhuphule amandla okuphatha uhlelo lwekhwalithi ka-Deebio ezingeni eliphezulu kakhulu lamazwe ngamazwe.

Ngesikhathi sebhizinisi emakethe ye-EU, i-Sanofi, i-Novartis nezinye izinkampani ezimbalwa zazihlala zenza ucwaningo e-Deebio.Lokhu kuhlola okuqinile kwasiza kakhulu ekuthuthukiseni izinqubo nobuchwepheshe buka-Deebio.Ukwenza isibonelo, ngo-2018, u-Deebio wabambisana nochwepheshe bezobuchwepheshe abavela eBerlin-Chemie ukuze baxazulule ngokuhlanganyela inkinga ebalulekile yezobuchwepheshe ekukhiqizeni, okwathi, lapho isixazululiwe, yathuthukisa kakhulu ikhwalithi yomkhiqizo.

Ngenxa yokuhlangenwe nakho kweminyaka eminingi nokuzinikela emisebenzini yesayensi, u-Deebio uye wahola imboni ngokwezinga lomkhiqizo namandla okuphatha, futhi uye wasungula ubuchwepheshe bokuvikela umsebenzi we-enzyme wenqubo egcwele.Ngokusebenzisa okungabhubhisi, i-zymogen ingavuswa ngokunemba, futhi ubuchwepheshe bokulawula obuyinhloko bokuvikelwa komsebenzi we-enzyme yenqubo egcwele bungasetshenziswa ukufeza umsebenzi ophezulu, ukuhlanzeka okuphezulu nokuzinza okuphezulu kwemikhiqizo ye-bio-enzyme.

Ithekelisa ku-EU nakwamanye amazwe angaphezu kwama-30 nezifunda

Njengoba kwaziwa, i-EU GMP iphakathi kwamazinga ezidakamizwa aqinile emhlabeni jikelele.Eminyakeni engaphezu kwengu-20 edlule, abakhiqizi basekhaya be-bio-enzyme API babebhekene nezinselele lapho bezama ukuhambisana nendinganiso.

"Ifilosofi yami ibilokhu ikhona, inqobo nje uma ngenza lokho abanye abakwenzi, ngizokwenza kangcono futhi ngishaye phansi."Lapho ebhekene nobunzima, u-Zhang Ge ubeka imigomo abese ehlela ukuthola indlela yokuhlangabezana nayo.

Ngo-2005, naphezu kwezinselelo ezimbalwa, u-Deebio waba umkhiqizi wokuqala waseShayina ukuthola isitifiketi se-EU GMP sama-API we-bio-enzyme.Le nkampani yabe isiphase isitifiketi se-Chinese GMP, futhi, muva nje, inamandla okuphatha uhlelo lwekhwalithi ye-US FDA, Japan PMDA, kanye ne-South Korea MFDS.

Uzuza eminyakeni engaphezu kwengu-20 yokuzibophezela ezidingweni eziqinile zekhwalithi, futhi engenzi mzamo ekufuneni kwakhe izinto ezintsha nasekutholeni utshalomali oludingekayo, u-Deebio usesungule ubudlelwano besikhathi eside nezikhondlakhondla zemithi yomhlaba wonke okuhlanganisa i-Novartis, iSanofi, iBerlin-Chemie kanye noNichi. -Iko Pharmaceutical.Imikhiqizo yale nkampani ithunyelwe eYurophu, e-US, Japan naseSouth Korea iminyaka engaphezu kwengu-20, namashaneli okuthengisa emazweni angaphezu kuka-30 nasezifundeni.

Noma kunjalo, u-Deebio akayeki ukuqhubekela phambili.

Inkampani isiqedile ukubhaliswa kwayo kwe-MFDS eSouth Korea, futhi ithumele amafayela ayo okubhalisa e-Japan PMDA, kuyilapho ukuqinisekiswa kwe-FDA yase-USA kusendleleni ezoqedwa phakathi neminyaka emibili.Iworkshop entsha ye-GMP eyakhiwe ngokwezindinganiso ze-FDA manje isingena esigabeni sokukhiqiza isilingo.I-Deebiotech (Chengdu) Co., Ltd., etholakala e-Wenjiang, e-Chengdu, ihlelelwe ukuthi iqale ukusebenza ngokusemthethweni ngo-Okthoba.

Uma ubheka phambili, u-Zhang Ge ugcwele ukuzethemba."I-Deebio izoba inkundla ehlaba umxhwele kakhulu eneziqu eziphelele ze-GMP, ubuchwepheshe obugcwele, ukuphatha okuqinile, kanye nekhwalithi yomkhiqizo engaguquki. Sizimisele futhi ukusebenza eduze nangokusobala nabangane abanomqondo ofanayo ukuze senze okwengeziwe ndawonye, ​​sinomgomo wokuphila ngokuvumelana nalokho okulindelekile kule nkathi kanye nokwamukela ithuba lokuwina-win emakethe yemithi yomhlaba wonke ekhula ngokushesha yanamuhla."