Kuva mu mahugurwa mato mu myaka ya za 90 yashoboraga kubyara API imwe gusa kugeza ku ruganda rukora bio-enzyme ku isi ku isi rufite ubushobozi bukomeye bwa R&D muri iki gihe, rutanga pancreatin nini ku isi ndetse n’Ubushinwa bwa mbere bwa GMP bwemejwe na bio-enzyme API, Deebio yagurishije. ibicuruzwa byayo mubihugu n'uturere birenga 30, kandi bigatangira kubona ibintu byinshi byurugendo rwisi.

Kwiyongera mubucuruzi nyuma yimyaka 27 yo gukura

Mu 1990, Zhang Ge, usanzwe ari perezida akaba na perezida wa Deebio, yarangije muri kaminuza ya Sichuan (yahoze ari kaminuza y’ubumenyi n’ikoranabuhanga ya Chengdu) nk'umuhanga mu binyabuzima, atangira umwuga we mu ruganda rukora imiti rwa Deyang Biochemical Farumasi n’umuyobozi wa laboratoire.Mu mwaka wa kane, amahirwe yo kuvugurura imishinga yarabyutse, afata isosiyete azana abafatanyabikorwa bamwe kugirango bubake ibikoresho bishaje n'intoki.Ukuboza 1994, Sichuan Deyang Biochemical Products Co., Ltd yashinzwe ku mugaragaro.

Ntamuntu numwe wari witeze ko Deebio yahombye hafi yumwaka umwe gusa yashinzwe.

"Mu ntangiriro ya za 90, ubumenyi bw’ubuziranenge mu nganda zo mu bwoko bwa bio-enzyme mu gihugu ntabwo bwari bukomeye, kandi imyumvire yacu ku misemburo yari ikiri ku rwego aho ibikorwa bya enzyme ari byose."Zhang Ge yibukije.Muri Werurwe 1995, Deyang Biochemical Products iherutse gushingwa yakiriye itegeko ryayo rya mbere: kohereza ibicuruzwa mu mahanga mu Buyapani kallidinogenase.Nyamara, ibicuruzwa byoherejwe hanze byagaruwe kubera itandukaniro rya miligarama nkeya mubinure."Isosiyete yacu yari guhomba iyo umukiriya asaba indishyi muri kiriya gihe kubera ko umubare w'amafaranga ari imibare y’inyenyeri kuri twe. Ku bw'amahirwe, nyuma y'ibiganiro bimwe na bimwe, umukiriya yemeye kutwemerera kongera ibicuruzwa aho kudusaba indishyi, "byasobanuwe na Zhang Ge.

Ingaruka n'amahirwe burigihe kubana.Isomo twakuye murubanza rwavuzwe haruguru nuko dukeneye gushyiraho umurongo muremure cyane kubwiza.Mu myaka 27 yakurikiyeho, Deebio yiyemeje kubahiriza ubuziranenge bukomeye kandi, kubera iyo mpamvu, yari yarashoboye gukura neza.

Uyu munsi, Deebio afite impamyabumenyi n'ubushobozi bwo gukora APIs zirenga 10 za bio-enzyme, muri zo, kallidinogenase ifata igice kinini cy'isoko ryisanzuye ku isi mu gihe umugabane w'isoko rya pancreatine, pepsin, chymotrypsin n'ibindi bicuruzwa wageze kuri 30% cyangwa byinshi.Deebio nimwe mubushinwa bwonyine butanga elastase, igisubizo gisobanutse pepsin hamwe na lipase pancreatin APIs nyinshi kumasoko yisi.

Kuyobora inganda inyuma yumusingi ukomeye kandi uhora utezimbere

Ntabwo byabaye urugendo rworoshye rwo guteza imbere Deebio.

Mu 1997, ubwo Deebio yashoboye gukomeza imikorere isanzwe, yatangiye guteza imbere ubufatanye bwa hafi n’inganda-kaminuza n’ubushakashatsi hamwe na za kaminuza n’ibigo by’ubushakashatsi, birimo kaminuza ya Tsinghua, Ishuri Rikuru ry’Ubushinwa, Kaminuza ya Sichuan, Kaminuza y’imiti y’Ubushinwa, n’ibindi nka a ibisubizo, Deebio yahise aba umuyobozi winganda mubushobozi bwa tekiniki.

Muri Mutarama 2003, mu rwego rwo kurushaho kunoza ireme, Deebio yashinze umushinga uhuriweho, Deyang Sinozyme Pharmaceutical Co., Ltd afatanije n’umudage w’umudage wari ufite ikoranabuhanga n’ubushobozi bwiza bwo kuyobora.Mu myaka 18 y'ubufatanye, umufatanyabikorwa w’Ubudage yagiye asura Deebio buri gihe kugira ngo atange ubuyobozi n’ubugenzuzi, ashyiraho uburyo bunoze bwo gucunga neza sisitemu ya Deebio, kugira ngo ubushobozi bwa Deebio bufite ubushobozi bwo gucunga neza ubuziranenge ku rwego mpuzamahanga.

Mu bucuruzi ku isoko ry’ubumwe bw’ibihugu by’Uburayi, Sanofi, Novartis n’andi masosiyete menshi yakoraga igenzura muri Deebio.Iri genzura rikomeye ryafashije muri byinshi kurushaho kunoza imikorere n’ikoranabuhanga bya Deebio.Tanga urugero, muri 2018, Deebio yafatanije ninzobere mu bya tekinike baturutse i Berlin-Chemie kugira ngo bafatanyirize hamwe gukemura ikibazo gikomeye cya tekiniki mu musaruro, kimaze gukemuka, kizamura cyane ubwiza bw’ibicuruzwa.

Bitewe nuburambe bwimyaka nubwitange mubikorwa bya siyanse, Deebio yayoboye inganda mubijyanye nubwiza bwibicuruzwa nubushobozi bwo gucunga, kandi yateje imbere tekinoroji idasanzwe yo kurinda ibikorwa bya enzyme.Binyuze mubikorwa bidasenya, zymogen irashobora gukangurwa neza, kandi tekinoroji yingenzi yo kugenzura ibikorwa bya enzyme yuzuye yo kurinda ibikorwa irashobora gukoreshwa kugirango igere kubikorwa byinshi, isuku ryinshi hamwe n’umutekano muke wibicuruzwa bio-enzyme.

Ibyoherezwa mu bihugu by’Uburayi no mu bindi bihugu birenga 30

Nkuko bizwi, EU GMP iri mubipimo bikaze byibiyobyabwenge ku isi.Imyaka irenga 20 irashize, uruganda rwa bio-enzyme API murugo rwugarijwe nibibazo mugihe bagerageza kubahiriza ibipimo.

"Filozofiya yanjye yamyeho, igihe cyose nzakora ibyo abandi badakora, nzabikora neza kandi nkubite hasi niruka."Mu guhangana n'ingorane, Zhang Ge yishyiriraho intego hanyuma yiyemeza gushaka uburyo bwo kuzigeraho.

Mu 2005, nubwo hari ibibazo byinshi, Deebio abaye uruganda rwa mbere rwabashinwa babonye icyemezo cya EU GMP kuri bio-enzyme APIs.Isosiyete yaje gutsinda icyemezo cya GMP mu Bushinwa, kandi, vuba aha, ifite ubushobozi bwo gucunga neza sisitemu yo muri Amerika FDA, Ubuyapani PMDA, na Koreya yepfo MFDS.

Yungukiye mu myaka irenga 20 yiyemeje gukurikiza ibisabwa byujuje ubuziranenge, kandi nta mbaraga yakoresheje mu gushaka udushya no kubona ishoramari rikenewe, Deebio yashyizeho ubufatanye burambye n’ibihangange mu bya farumasi ku isi birimo Novartis, Sanofi, Berlin-Chemie na Nichi. -Iko Pharmaceutical.Ibicuruzwa by'uru ruganda byoherejwe mu Burayi, Amerika, Ubuyapani na Koreya y'Epfo mu myaka irenga 20, hamwe n'inzira zo kugurisha mu bihugu n'uturere birenga 30.

Nubwo bimeze bityo, Deebio ntahwema gutera intambwe.

Isosiyete yarangije kwiyandikisha muri MFDS muri Koreya y'Epfo, kandi yatanze dosiye zo kwiyandikisha mu Buyapani PMDA, mu gihe icyemezo cya USA FDA kiri mu nzira yo kuzura mu myaka ibiri.Amahugurwa mashya ya GMP yubatswe akurikije ibipimo bya FDA ubu yinjiye mubyiciro byo kugerageza.Biteganijwe ko Deebiotech (Chengdu) Co, Ltd, i Wenjiang, Chengdu, biteganijwe gutangira imirimo mu Kwakira.

Urebye imbere, Zhang Ge yuzuye ikizere."Deebio igiye kuba urubuga rushimishije rufite impamyabumenyi ya GMP yuzuye, ikoranabuhanga ryuzuye, imicungire ikaze, ndetse n’ubuziranenge bw’ibicuruzwa. Turashaka kandi gukorana bya hafi kandi mu mucyo n’inshuti duhuje ibitekerezo kugira ngo dukore byinshi hamwe, dufite intego. yo kubaho mu buryo buteganijwe n'ibihe no gukoresha amahirwe yo gutsindira isoko ry’imiti ku isi ryiyongera cyane muri iki gihe. "