Kubva kumusangano diki muma1990s waingokwanisa kuburitsa API imwe chete isina kuchena kune inotungamira pasi rose bio-enzyme inogadzira ine yakasimba R&D kugona nhasi, hombe pasirese pancreatin mutengesi uye wekutanga weEU GMP-yakasimbiswa bio-enzyme API mugadziri, Deebio akatengesa. zvigadzirwa zvayo kunyika dzinopfuura makumi matatu nematunhu, uye inotanga maonero akafara erwendo rwepasirese.

Kuwedzera bhizinesi kuvapo mushure memakore makumi maviri nemanomwe ekukura

Muna 1990, Zhang Ge, parizvino sachigaro uye purezidhendi weDeebio, akapedza kudzidza kuSichuan University (yaimbova Chengdu University of Science and Technology) semukuru webiochemical ndokutanga basa rake paDeyang Biochemical Pharmaceutical Factory senyanzvi uye mutungamiriri werabhoritari.Mugore rechina, mukana wekuti kugadziridzwa kwebhizinesi kwamuka, akatora kambani uye akaunza vamwe vaanoshanda navo kuti vavakezve nzvimbo dzekuchembera nemaoko.Muna Zvita 1994, Sichuan Deyang Biochemical Products Co., Ltd. yakagadzwa zviri pamutemo.

Hapana aitarisira kuti Deebio akapotsa abhuroka isingasviki gore rimwe chete mushure mekuvambwa kwayo.

"Mukutanga kwema1990, kuziva kwemhando muindasitiri yebio-enzyme indasitiri kwaisava kwakasimba, uye kunzwisisa kwedu maenzayimu kwaive kuchiri pachinhanho chekuti basa re enzyme riri zvese."Zhang Ge akayeuka.Muna Kurume 1995, iyo ichangobva kuvambwa yeDeyang Biochemical Products yakagamuchira kurongeka kwayo kwekutanga: kutengeswa kunze kwenyika crude kallidinogenase kuJapan.Nekudaro, izvo zvakatengeswa kunze kwenyika zvakadzoserwa nekuda kwekusiyana kwemamirigiramu mashoma mumafuta emukati."Kambani yedu ingadai yakabhuroka dai mutengi akatipa muripo panguva iyoyo sezvo mari yacho yainge iri nyeredzi kwatiri. Sezvineiwo, mushure mekutaurirana, mutengi wacho akabvuma kutibvumira kuti tigadzirise chigadzirwa pane kutikumbira muripo. " akatsanangura Zhang Ge.

Njodzi nemikana zvinogara zviripo.Chidzidzo chatakawana kubva munyaya iri pamusoro ndechekuti taifanira kuseta bhawa repamusoro zvakanyanya nekuda kwemhando.Mukati memakore akatevera e27, Deebio akazvipira kune akasimba emhando zviyero uye, semhedzisiro, akange akwanisa kukura zvishoma nezvishoma.

Nhasi, Deebio ine zvese zvinodiwa uye kugona kugadzira anopfuura gumi bio-enzyme APIs, iyo, kallidinogenase yayo inotora ruzhinji rwepasirese musika ukuwo chikamu chemusika chepancreatin, pepsin, chymotrypsin nezvimwe zvigadzirwa chasvika makumi matatu muzana muzana. kana kupfuura.Deebio zvakare ndiye ega Chinese mutengesi we elastase, yakajeka mhinduro pepsin uye yakakwira lipase pancreatin APIs mumusika wepasi rose.

Kutungamira indasitiri kumusana kwenheyo yakasimba uye inogara yakavandudzwa

Izvo zvave zvisiri nyore kukwira kwekuvandudzwa kweDeebio.

Muna 1997, Deebio payakakwanisa kuchengetedza kushanda kwayo kwakajairika, yakatanga kukudziridza kudyidzana kweindasitiri-yunivhesiti-tsvakurudzo pamwe nemayunivhesiti uye masangano ekutsvagisa, kusanganisira Tsinghua University, Chinese Academy of Sciences, Sichuan University, China Pharmaceutical University, etc. mhedzisiro, Deebio munguva pfupi akazova mutungamiriri weindasitiri mukugona kwehunyanzvi.

Muna Ndira 2003, kuti awedzere kuvandudza mhando, Deebio akatanga mubatanidzwa, Deyang Sinozyme Pharmaceutical Co., Ltd. pamwe chete nemumwe wekuGerman uyo aive nehunyanzvi hwekuita uye kugona manejimendi.Munguva yemakore gumi nemasere ekushandira pamwe, mubatsiri weGerman aigara achishanyira Deebio kuti ape nhungamiro nekutarisa, achiunza nzira dzemhando yepamusoro dzekutonga kuDeebio, kuitira kuti akwidzire Deebio's quality system management kugona kusvika padanho repamusoro repasirese.

Munguva yebhizinesi mumusika weEU, Sanofi, Novartis uye mamwe makambani akati wandei aigara achiitisa ongororo muDeebio.Aya maodhisheni akaomesesa akabatsira pamwero mukuru kuenderera mberi nekuvandudza maitiro aDeebio uye matekinoroji.Kupa muenzaniso, muna 2018, Deebio akabatana nenyanzvi dzehunyanzvi kubva kuBerlin-Chemie kugadzirisa pamwe chete nyaya yakakosha yehunyanzvi mukugadzira, iyo, kana yagadziriswa, yakavandudza zvakanyanya kunaka kwechigadzirwa.

Kutenda kumakore eruzivo uye kuzvipira kumaitiro esainzi, Deebio akatungamira indasitiri maererano nemhando yechigadzirwa uye kugona kwekutungamira, uye yakagadzira yakasarudzika yakazara-yekuita enzyme kuchengetedza tekinoroji.Kuburikidza nekushandiswa kusingaparadzi, zymogen inogona kumutswa nekunyatso, uye iyo yakakosha yekudzora tekinoroji ye-yakazara-process enzyme yekudzivirira basa inogona kushandiswa kuwana basa repamusoro, kuchena kwepamusoro uye kugadzikana kwakanyanya kwezvinhu zvebio-enzyme.

Exports kuEU uye kupfuura dzimwe nyika makumi matatu nematunhu

Sezvinozivikanwa, EU GMP iri pakati peakanyanya kuomarara zvinodhaka pasi rose.Anopfuura makore makumi maviri apfuura, vagadziri vepamba bio-enzyme API vakasangana nematambudziko pavakayedza kutevedzera chiyero.

"Uzivi hwangu hwagara huripo, chero bedzi ndichiita zvisingaitwe nevamwe, ndichaita zvakanakisisa uye ndorova pasi."Mukutarisana nematambudziko, Zhang Ge anoisa zvibodzwa uye anobva atanga kutsvaga nzira yekusangana nazvo.

Muna 2005, kunyangwe zvipingamupinyi zvakati wandei, Deebio akave wekutanga mugadziri wechiChinese kuwana EU GMP chitupa chebio-enzyme APIs.Iyo femu yakazopasa chitupa cheChinese GMP, uye, nguva pfupi yadarika, ine hunyanzvi hwekutonga system yeUS FDA, Japan PMDA, uye South Korea MFDS.

Achibatsirwa kubva kumakore anopfuura makumi maviri ekuzvipira kune zvakaomarara zvinodiwa zvemhando yepamusoro, uye nekusashingirira mukutsvaga kwayo hunyanzvi uye mukuwana mari inodiwa, Deebio akatanga kudyidzana kwenguva refu nehofori dzepasi rose dzemishonga dzinosanganisira Novartis, Sanofi, Berlin-Chemie naNichi. -Iko Pharmaceutical.Zvigadzirwa zvekambani iyi zvakatengeswa kuEurope, US, Japan neSouth Korea kweanopfuura makore makumi maviri, paine nzira dzekutengesa munyika dzinopfuura makumi matatu nematunhu.

Zvakangodaro, Deebio haambomira kufambira mberi.

Iyo kambani yapedza kunyoreswa kwayo kweMFDS muSouth Korea, uye yakaendesa mafaera ayo ekunyoresa eJapan PMDA, ukuwo USA FDA certification iri munzira yekupedzwa mukati memakore maviri.Iyo itsva GMP workshop yakavakwa zvinoenderana neFDA miyero yave kupinda muyedzo yekugadzira nhanho.Deebiotech (Chengdu) Co., Ltd., iri muWenjiang, Chengdu, yakarongerwa kutanga kushanda zviri pamutemo muna Gumiguru.

Tichitarisa kumberi, Zhang Ge azere nechivimbo."Deebio ichave chikuva chinokatyamadza chine hunyanzvi hwakazara hweGMP, matekinoroji akazara, manejimendi akasimba, uye mhando yechigadzirwa inowirirana. Isu takagadzirirawo kushanda nepedyo uye pachena neshamwari dzine pfungwa dzakafanana kuti tiite zvakawanda pamwe chete, nechinangwa. yekurarama zvinoenderana nezvinotarisirwa nenguva uye kugamuchira mukana wekuhwina mumusika wepasi rose wemishonga wepasi rose uri kukura nhasi. "