GUANGHAN, CHINA / ACCESSWIRE / Agasti 20, 2021 / Ngomhla wama-27 ku-Epreli, uZhang Ge, uSihlalo weBhodi kunye noMongameli weSichuan Deebio Pharmaceutical Co., Ltd. (emva koku kuthiwa yi-Deebio), uthathe inxaxheba kwi-China Bio-enzyme yoPhuhliso oluPhezulu oluPhezulu. Isemina.Uthe kule ntlanganiso, “Emva kweminyaka engama-27 yophuhliso, siye saphuhla sisuka kwindibano yocweyo encinci saya kwinkampani esemgangathweni ye-API yamayeza.Namhlanje, i-Deebio yimveliso ye-bio-enzyme ekhokelayo kwihlabathi kunye nenkampani yeengcali ze-R&D. ”
UZhang Ge wayeqinisekile ngento awayeyithethile.Idatha ibonisa ukuba i-Deebio ineziqinisekiso kunye nobuchule bokuvelisa ngaphezu kweentlobo ze-10 ze-Bio-enzyme API, phakathi kwayo i-kallidinogenase ngokusisiseko ihlala kwimarike yehlabathi;izabelo zemarike ze-pancreatin, i-pepsin, i-trypsin-chymotrypsin kunye nezinye iimveliso zidlula i-30%;kwimarike yehlabathi, i-Deebio kuphela kwe-API umthengisi we-elastase, isisombululo esicacileyo se-pepsin kunye ne-pancreatin kunye nomsebenzi ophezulu we-lipase e-China.Ukusukela ngo-2005, i-Deebio ifumene isatifikethi se-CN-GMP kunye ne-EU-GMP, kunye neemveliso zayo ezithunyelwa kumazwe angama-30 kwihlabathi liphela, kubandakanya iYurophu, iMelika, iJapan kunye noMzantsi Korea iminyaka engaphezu kwama-20.Liqabane elide likaSanofi, Celltrion, Nichi-Iko, Livzon kunye nezinye iinkampani ezibalaseleyo zamachiza.
"Ezi mpu melelo zixhamla ikakhulu kubuchule obutsha, ulawulo olusemgangathweni kunye nemveliso eluhlaza."UZhang Ge uthe, "Enkosi kwiinzame zikaDeebio ezingaguqukiyo zomgangatho ophezulu, iimveliso ze-bio-enzyme API zineengenelo ezifana nokusebenza okuphezulu, ukucoceka okuphezulu kunye nozinzo oluphezulu kwaye ke zamkelwa ngokubanzi ngamaqabane."
Ukwenza Okungcono
I-Bio-enzymes iiprotheyini ezinemisebenzi ye-catalytic, eyahluke kwezinye iiprotheni kuba zineziko elisebenzayo.I-API ye-bio-enzymes ifunyenwe ngokuhlukana, ukutsalwa kunye nokuhlanjululwa kwezinto eziphilayo.
“I-Bio-enzyme API lishishini elinotyalo-mali olukhulu, inzuzo ephantsi kunye nomngcipheko omkhulu wobugcisa.Isikali soshishino sincinci.Kwaye zimbalwa iinkampani ezibandakanyekayo kuyo. ”Ngokutsho kukaZhang Ge, umngcipheko ophezulu wezobugcisa ubangelwa umsebenzi we-enzymes okwenza inkqubo yokucoca ibe nzima ngakumbi.Ngokomzekelo, ukuba inkqubo ayilawulwa kakuhle, imveliso ayinakho umsebenzi, kwaye emva koko ilahlekelwe ixabiso layo lonyango.
I-Bio-enzyme API yenye yezinto ezisetyenziswa kwi-bio-pharmaceuticals.Ngobuthi obuphantsi kunye nemiphumo emibi, i-bio-pharmaceuticals ijoliswe kakhulu kunyango lwezifo ezithile kwaye ifakwe ngokulula ngumzimba womntu.Ineempembelelo ezizodwa zonyango kwi-diabetes, izifo zentliziyo, i-tumor kunye nezifo zentsholongwane.
Ifilosofi yam engaguqukiyo yeyokuba logama nje ndisenza into abanye abangayenziyo, ndiyenza ngeyona ndlela ilungileyo.UZhang Ge ukholelwa ukuba isizathu sokuba sele esekelwe kwishishini le-bio-enzyme iminyaka engaphezu kwe-20 luthando lwakhe olusuka entliziyweni ngee-enzymes.Ngo-1990, emva kokuphumelela kwiYunivesithi yaseSichuan (eyayisakuba yiYunivesithi yaseChengdu yeSayensi neTekhnoloji) egxile kakhulu kwi-biochemistry, uZhang Ge wasebenza njengegcisa waza kamva waba ngumlawuli welebhu kwi-Deyang Biochemical Pharmaceutical Factory.Kwiminyaka emihlanu kamva, ngenxa yohlengahlengiso lomzi-mveliso, walithatha eli shishini.
“Ngelo xesha, umzi-mveliso wamachiza ezinto eziphilayo wawusele uza kuguqulwa ube yinkampani exuba amayeza.Ndaya kumzi-mveliso ukuze ndihlole yaye ndabona ukuba abantu abaselula abambalwa babehlaziya indawo yokusebenzela encinane endala.Ubuso babo babugqunywe ngamanzi nodaka.Phakathi kwabo kwakukho uZhang Ge.UZhong Guangde, owayesakuba nguSekela Mlawuli kwiZiko loLawulo lwezoNyango lwePhondo laseSichuan, ukhumbula edanduluka esithi, “UZhang Ge usengulaa mfana uselula esenza izinto ezibonakalayo emehlweni am.”
NgoDisemba 1994, uZhang Ge waseka iSichuan Deyang Biochemical Products Co., Ltd. Nje ukuba isungulwe, yaphantse yatshona.
“Ebutsheni beminyaka yee-1990, ulwazi lomgangatho weshishini laseTshayina le-Bio-enzyme lwalungomelelanga, kwaye ukuqonda kwethu ii-enzymes kwakusalinganiselwe kulwazi lokuba umsebenzi olungileyo we-enzyme wanele.”Ngokutsho kukaZhang Ge, ngoMatshi ka-1995, i-Deyang Biochemical Products Co., Ltd. yafumana umyalelo wayo wokuqala we-kallidinogenase ekrwada yokuthunyelwa kwimarike yaseJapan.Nangona kunjalo, iimveliso zanqatshwa ngenxa yokwahlukana kweemilligrams ezimbalwa kumxholo wamafutha.“Ukuba elinye iqela licela imbuyekezo, inkampani yayiza kubhanga, kwaye imali yembuyekezo yayilingana neenkwenkwezi ngelo xesha.Ngethamsanqa, ngolungelelwaniso, elinye iqela alizange lisicele ukuba sihlawule kodwa masiphinde sinikeze iimveliso, ”utshilo uZhang Ge.
La mava afundise uZhang Ge, owayesaqala ishishini, isifundo esibalulekileyo kwaye wamenza waqonda ukuba umgangatho wemveliso ngumsebenzi wenkampani.Kule minyaka ingama-27 ilandelayo yophuhliso, inkampani ibisoloko ibambelele kwimigangatho engqongqo yobulunga.Ngokusekelwe kwiminyaka yophando olusisiseko, i-Deebio iye yahlala iphucula iteknoloji yayo, ngaloo ndlela idala inkqubo epheleleyo yokukhusela umsebenzi we-enzyme, ukuvuselela okungonakalisiyo kunye neteknoloji yokucoca ngokuchanekileyo ukuqinisekisa umsebenzi ophezulu, ukucoceka okuphezulu kunye nokuzinza okuphezulu kweemveliso ze-Bio-enzyme API.
Ukonga nzame zokuTyala imali kuTshintsho
“Ishishini le-bio-enzyme API libonakaliswa ngamanani amancinci kunye nokwahluka.Ngaphandle kokutsha kweteknoloji, imveliso enye okanye ezimbini azinakuxhasa inkampani ukuba iphuhlise.I-Deebio inemveliso enye kuphela ukususela ekusekweni kwayo.Kodwa namhlanje kukho ngaphezu kweshumi elinesibini le-bio-enzyme APIs, engenakwahlulwa kutyalo-mali lwethu oluqhubekayo kwitekhnoloji. ”Utshilo uZhang Ge.
I-Trypsin-Chymotrypsin yi-enzyme ye-proteolytic eyahlulwe kwaye ihlanjululwe kwi-pancreas ye-porcine.Yenye yeemveliso eziphambili zikaDeebio.I-R&D yale mveliso izuze kwintsebenziswano yophando lweshishini-yunivesithi.Ngo-1963, u-Qi Zhengwu, umphandi kwi-Shanghai Institute of Physiology and Biochemistry ye-Chinese Academy of Sciences, wasebenzisa i-recrystallization ukukhupha ikristale edibeneyo ye-chymotrypsin kunye ne-trypsin kwi-pancreas ye-porcine, ebizwa ngokuba yi-trypsin-chymotrypsin.Le enzyme ayizange yenziwe kwimizi-mveliso ngaphezu kweminyaka engama-30.UZhang Ge wabona ithuba kuyo.“Ngo-1997, siye sasebenzisana neqela lophando lesifundiswa u-Qi Zhengwu ukuze siqonde ukwenziwa kwe-trypsin-chymotrypsin kwaye safumana inzuzo entle kwezoqoqosho nezentlalo.Ngexesha elifanelekileyo, ngaphezu kweetoni ezingama-20 ngonyaka zale mveliso zathunyelwa eIndiya.”Ngokutsho kukaZhang Ge, isifundiswa uQi Zhengwu wathi, “Okumangalisayo kukuba, iimveliso zam zenziwa ngamashishini aselokishini nakwiilali.
Emva kokungcamla ubumnandi bobuchule obutsha, iDeebio iye yandisa ngakumbi utyalo-mali lwayo kwitekhnoloji, kwaye yaphuhlisa intsebenziswano esondeleyo kushishino-yunivesithi-uphando kunye neYunivesithi yaseTsinghua, iChinese Academy yeSayensi, iYunivesithi yaseSichuan, iYunivesithi yaseChina yezamayeza kunye namanye amaziko emfundo ephakamileyo kunye namaziko ophando. , ukwakhiwa ngokubambisana kweelabhoratri, ngokuqhubekayo ukuphucula uphando lwezenzululwazi kunye namandla okuvelisa izinto ezintsha kunye nokwakha imveliso kunye neqela le-R&D elinamandla okuguqula ubuchwephesha obufumene ngokulandelelana ubugcisa obunamalungelo awodwa omenzi ali-15.
Ukuze kuphuculwe ngakumbi umgangatho wemveliso, ngo-2003, uDeebio usebenzisane neqabane laseJamani elinobuchwepheshe obuphambili kunye namandla okulawula ukuseka intsebenziswano ebizwa ngokuba yiDeyang Sinozyme Pharmaceutical Co., Ltd. “Ngaloo nyaka, satyala imali engaphezu kwezigidi ezingama-20 zeeyuan. ukwakha iplanti entsha, enezixhobo zemveliso ezakhiwayo ngezixhobo eziphezulu zehlabathi.Ngexesha elifanayo, umzi-mveliso unokwakhiwa e-China nge-5 yezigidi zeeyuan.Iindleko zokwakha iSinozyme zilingana naleyo yeefektri ezi-4. "NgokukaZhang Ge, iqabane laseJamani lityelele inkampani ukunika isikhokelo iintsuku ezilishumi nyanga zonke.Ngokungeniswa kweendlela zolawulo lwenkqubo yomgangatho ophezulu, amandla olawulo lwenkqubo yeSinozyme aphakanyiselwe kwelona nqanaba liphezulu lamazwe ngamazwe.
Kwi-2005, i-Sinozyme yaba yinkampani yokuqala ye-pancreatin yaseTshayina ukufumana isatifikethi se-EU-GMP;ngo-2011, iSichuan Deebio Pharmaceutical Co., Ltd. yasekwa;kwi-2012, u-Deebio wafumana isatifikethi se-CN-GMP;ngoJanuwari 2021, Deebio (Chengdu) Bio-technology Co., Ltd. yasekwa kwi-R&D, ukuveliswa kunye nokusetyenziswa kweziyobisi ezigqityiweyo eziphezulu kunye namalungiselelo e-enzyme ye-biotechnology.
“Ndicinga ukuba iinkampani kufuneka zizimisele ukutyala imali kwimveliso yetekhnoloji entsha.UDeebio wakha umzi-mveliso omtsha rhoqo kwi-7 ukuya kwiminyaka eyi-8.Kule minyaka, uninzi lwenzuzo lutyalwe kulwakhiwo lweshishini, ukuguqulwa kwezixhobo zemveliso kunye nokwazisa italente.Abaninizabelo kunye nabaphathi bafumana izabelo ezimbalwa. ”UZhang Ge, owayesakuba yinjineli, ukuqonda ngokupheleleyo ukubaluleka kotyalo-mali lwetekhnoloji.Wagcina isantya sezinto ezintsha, kwaye wadwelisa uluhlu lwezinto eziza kwenziwa: I-workshop entsha ye-GMP ye-Deebio eyakhiwe ngokuhambelana nemigangatho ye-FDA yaqalwa kunyaka odlulileyo kwaye kulindeleke ukuba igqitywe ekupheleni kukaMeyi kwaye ifake imveliso yovavanyo;I-Deebio (Chengdu) i-Bio-technology Co., Ltd., e-Wenjiang, e-Chengdu, iqalise ngokusemthethweni ukwakhiwa ngo-Ephreli 26 kwaye kulindeleke ukuba isetyenziswe ngokusemthethweni ngo-Oktobha.
“Imveliso yohlaza yeyona nto Ndizingca ngayo”
Ungcoliseko lwe-API luhlala luyinkxalabo kuluntu, kwaye ukukhuselwa kwendalo kuye kwaba yindawo ephezulu yoxinzelelo emisela ukusinda kwamashishini.Ukubambelela kwimveliso eluhlaza yiyona nto uZhang Ge azidla ngayo.
“Ngexesha lophuhliso lokuqala lwenkampani, khange sihoye kakhulu imiba yokusingqongileyo.Kodwa ke, njengoko ilizwe libeka phambili iimfuno zokukhuselwa kwendalo, saqala ukuqonda ukubaluleka kwayo. ”Ngokutsho kukaZhang Ge, kwiminyaka elishumi edlulileyo, u-Deebio uye wanikela ingqalelo kakhulu kuyo, ezama ukufezekisa uphuhliso oluzinzileyo.
Yaba sisiganeko esabangela ukuba kubekho utshintsho.“Kwintlanganiso kwiminyaka emininzi eyadlulayo, abaphathi benkampani yethu babeceba imveliso efuna imichiza.Enye yee-reagents zekhemikhali ayinakuthotywa kwaye, ukuba amanzi amdaka aye akhutshelwa emlanjeni, oko kunokubangela ukukhubazeka komntwana.Andizange ndithandabuze ukuthi hayi kule mveliso. ”Ethetha ngesi siganeko, uZhang Ge wayeneemvakalelo kakhulu, “Idolophu yakowethu isecaleni koMlambo iTuojiang, ongaphezulu kweekhilomitha ezingama-200 ukusuka eGuanghan, eSichuan.Yaye umlambo osecaleni komzi-mveliso wethu ungena kuMlambo iTuojiang.Ukukhutshwa ngokuthe ngqo kwamanzi amdaka lulwaphulo-mthetho kwizizukulwana ezizayo.Ngoko andiyi kuyenza into enjalo.
Ukususela ngoko, u-Deebio uye wachaza ukuba nje inkqubo yokuvelisa ibandakanya izinto ezinobuthi kunye neekhemikhali ezinobungozi okanye izinto ezincedisayo ezingenakucutshungulwa ekuphuhlisweni kwemveliso emitsha, uphuhliso aluyi kuvunyelwa, kwaye luye lwagxininisa ekutyaleni imali ekukhuselweni kwendalo. ngaphezu kweminyaka elishumi.
Namhlanje, i-Deebio yakhe iziko lokucocwa kwamanzi amdaka ngokwendlela yegadi enomthamo wokucocwa yonke imihla oyi-1,000m³, namanzi amdaka akhutshwa emva kokufikelela kumgangatho.“Esi sikhundla sanele ukuba sisebenzise iminyaka elishumi.Kwaye igadi iye yakhiwe ngokukodwa phezu kweziko lokucoca amanzi amdaka.Amanzi acociweyo angasetyenziselwa ukukhulisa iintlanzi kunye neentyatyambo zamanzi, ”utshilo uZhang Ge ngokuzingca.
Ukongeza, irhasi eyinkunkuma inokunyangwa ngokutshiza kunye nezinye iindlela, kwaye igesi yebhayoloji ingasetyenziselwa ukufudumeza ibhoyila kwangaphambili emva kokukhupha umoya kunye nokuphelelwa ngamanzi emzimbeni, oko konga i-800m³ yerhasi yendalo yonke imihla.Kwizinto eziqinileyo eziveliswayo, kukho iworkshop ekhethekileyo eqinileyo.Inkunkuma yeprotheyini iguqulwa ibe sisichumisi sebhayoloji kwimizuzu emi-4 ngosomisi kwaye ithunyelwe kwisityalo sebhayoloji yesichumiso.
UZhang Ge uthe ngokweemvakalelo, “Ngoku yonke indawo yesityalo ayivelisi naliphi na ivumba elikhethekileyo, kwaye amanzi amdaka kunye nezinto ezingcolisayo zilawulwa ngocwangco.Ndiyazingca ngoku ngaphezu kokuveliswa kweemveliso, yimpumelelo endiyixabisa kakhulu.”
Ngokuphathelele uphuhliso lwexesha elizayo, uZhang Ge uzele ukuzithemba, “Uphuhliso lweshishini lufuna inkqubela phambili eqhubekayo.Uphuhliso oluphezulu lweshishini le-bio-enzyme ye-API aluthethi kuphela ukuveliswa kweemveliso ezikumgangatho ophezulu, kodwa nokuba nobuchwepheshe obuphezulu, ukusebenza kakuhle, iimfuno zolawulo oluphezulu, kunye neendlela zokuvelisa ezihambelana nokusingqongileyo.UDeebio uyakuthatha ubunkokeli bophuhliso olukumgangatho ophezulu weshishini njengoxanduva lwayo, kwaye akhonze ngentliziyo epheleleyo lonke uluntu ngenxa yempilo yabo kwindlela yophuhliso lobuchule. ”
Ixesha lokuposa: Aug-20-2021