Daga wani karamin bita a cikin 1990s wanda zai iya samar da danyen API guda ɗaya kawai zuwa masana'antar bio-enzyme mai jagorancin duniya tare da ƙarfin R&D mai ƙarfi a yau, babban mai samar da pancreatin a duniya kuma farkon mai samar da bio-enzyme API na GMP na China, Deebio ya sayar. samfuransa zuwa ƙasashe da yankuna sama da 30, kuma yana fara faɗaɗa ra'ayi game da balaguron duniya.

Kasancewar kasuwancin Burgeon bayan shekaru 27 na haɓaka

A shekarar 1990, Zhang Ge, shugaban kamfanin Deebio a halin yanzu, ya sauke karatu daga jami'ar Sichuan (tsohon jami'ar kimiyya da fasaha ta Chengdu) a matsayin babban jami'in kimiyyar halittu, ya kuma fara aikinsa a masana'antar harhada magunguna ta Deyang Biochemical a matsayin kwararre kuma darektan dakin gwaje-gwaje.A cikin shekara ta huɗu, wata dama ta sake fasalin kasuwancin ta taso, ya karɓi kamfanin tare da kawo wasu abokan haɗin gwiwa don sake gina wuraren tsufa da hannu.A cikin Disamba 1994, Sichuan Deyang Biochemical Products Co., Ltd. aka kafa bisa hukuma.

Babu wanda ya yi tsammanin cewa Deebio ya kusan faɗuwa ƙasa da shekara ɗaya bayan kafuwar sa.

"A farkon shekarun 1990, fahimtar inganci a cikin masana'antar bio-enzyme na gida gabaɗaya ba ta da ƙarfi, kuma fahimtarmu game da enzymes har yanzu tana kan matakin da aikin enzyme shine komai."Zhang Ge ya tuna.A cikin Maris 1995, sabon kafuwar Deyang Biochemical Products ya sami odarsa ta farko: fitar da danyen kallidinogenase zuwa Japan.Duk da haka, an dawo da kayan da aka fitar zuwa kasashen waje saboda bambancin ƴan milligrams a cikin mai.“Da kamfaninmu ya yi fatara da a wancan lokacin da abokin aikinmu ya nemi diyya domin adadin kudin ya kasance alkaluman ilmin taurari a gare mu. Abin farin cikin shi ne, bayan wasu shawarwari, abokin ciniki ya amince ya bar mu mu mayar da kayan maimakon ya nemi diyya. " in ji Zhang Ge.

Hatsari da dama koyaushe suna tare.Darasin da muka koya daga shari'ar da ke sama shine cewa muna buƙatar saita sandar don inganci.A cikin shekaru 27 da suka biyo baya, Deebio ya sadaukar da kansa ga ƙayyadaddun ƙa'idodin inganci kuma, a sakamakon haka, ya sami damar girma a hankali.

A yau, Deebio yana da duka cancanta da damar don samar da fiye da 10 bio-enzyme APIs, wanda kallidinogenase ya mamaye mafi yawan kasuwannin kyauta na duniya yayin da kasuwar pancreatin, pepsin, chymotrypsin da sauran samfuran kowanne ya kai 30% ko fiye.Deebio kuma shine kawai mai siyar da Sinawa don samar da elastase, bayyananniyar bayani pepsin da babban lipase pancreatin APIs a kasuwannin duniya.

Jagoranci masana'antu a kan baya na tushe mai ƙarfi da ci gaba da ingantawa

Ba abu mai sauƙi ba ne don ci gaban Deebio.

A shekarar 1997, lokacin da Deebio ya sami damar ci gaba da gudanar da ayyukansa na yau da kullun, ya fara samar da hadin gwiwa tsakanin masana'antu da jami'o'i-bincike tare da jami'o'i da cibiyoyin bincike, ciki har da jami'ar Tsinghua, kwalejin kimiyyar kasar Sin, jami'ar Sichuan, jami'ar harhada magunguna ta kasar Sin, da dai sauransu. sakamakon, nan da nan Deebio ya zama jagoran masana'antu a iyawar fasaha.

A cikin Janairu 2003, don ƙara haɓaka inganci, Deebio ya kafa haɗin gwiwa, Deyang Sinozyme Pharmaceutical Co., Ltd. tare da abokin tarayya na Jamus wanda ke da ingantattun fasahohi da damar gudanarwa.A cikin shekaru 18 na hadin gwiwa, abokin aikin na Jamus yana ziyartar Deebio akai-akai, don ba da jagoranci da sa ido, tare da gabatar da sabbin hanyoyin sarrafa tsarin inganci ga Deebio, ta yadda za a iya daga darajar tsarin sarrafa Deebio zuwa matakin koli na kasa da kasa.

A lokacin kasuwanci a kasuwar EU, Sanofi, Novartis da wasu kamfanoni da yawa sun gudanar da bincike akai-akai a Deebio.Waɗannan tsauraran binciken sun taimaka sosai don ƙara haɓaka hanyoyin Deebio da fasaha.Don ba da misali, a cikin 2018, Deebio ya haɗu tare da ƙwararrun fasaha daga Berlin-Chemie don haɗa kai don warware wani muhimmin batu na fasaha a cikin samarwa, wanda, da zarar an warware shi, ya inganta ingancin samfura sosai.

Godiya ga shekaru na gwaninta da sadaukar da kai ga ayyukan kimiyya, Deebio ya jagoranci masana'antar dangane da ingancin samfuri da ikon gudanarwa, kuma ya haɓaka fasahar kariyar ayyukan enzyme na musamman.Ta hanyar kunnawa mara lalacewa, ana iya tada zymogen tare da daidaito, kuma ana iya amfani da fasahar sarrafa maɓalli na kariyar aikin enzyme mai cikakken tsari don cimma babban aiki, babban tsabta da kwanciyar hankali na samfurori na bio-enzyme.

Ana fitarwa zuwa EU da wasu ƙasashe da yankuna sama da 30

Kamar yadda aka sani, EU GMP yana cikin mafi tsauraran matakan magunguna a duniya.Fiye da shekaru 20 da suka gabata, masana'antun bio-enzyme API na cikin gida sun cika da ƙalubale yayin ƙoƙarin bin ƙa'idar.

"Philosofina ya kasance, muddin na yi abin da wasu ba su yi ba, zan yi mafi kyau kuma in buga kasa a guje."Yayin da ake fuskantar matsaloli, Zhang Ge ya tsara manufofinsa, sa'an nan ya tashi tsaye don nemo hanyar cimma su.

A cikin 2005, duk da kalubale da yawa, Deebio ya zama masana'anta na farko na kasar Sin don samun takardar shaidar GMP na EU don APIs na bio-enzyme.Kamfanin daga baya ya wuce takardar shedar GMP ta kasar Sin, kuma, kwanan nan, yana da ikon sarrafa tsarin ingancin FDA, Japan PMDA, da Koriya ta Kudu MFDS.

Da yake cin gajiyar fiye da shekaru 20 na sadaukar da kai ga ingantattun buƙatun inganci, kuma ba tare da ƙoƙartawa ba a cikin ƙoƙarin sa na ƙirƙira da kuma samun jarin da ya dace, Deebio ya kafa haɗin gwiwa na dogon lokaci tare da manyan kamfanonin harhada magunguna na duniya ciki har da Novartis, Sanofi, Berlin-Chemie da Nichi -Iko Pharmaceutical.An fitar da samfuran kamfanin zuwa Turai, Amurka, Japan da Koriya ta Kudu sama da shekaru 20, tare da hanyoyin tallace-tallace zuwa kasashe da yankuna sama da 30.

Duk da haka, Deebio bai daina ci gaba ba.

Kamfanin ya kammala rajistar MFDS a Koriya ta Kudu, kuma ya mika fayilolin rajista na PMDA na Japan, yayin da takardar shaidar FDA ta Amurka ke kan hanyar kammalawa cikin shekaru biyu.Sabon taron GMP da aka gina bisa ga ka'idojin FDA yanzu yana shiga matakin samar da gwaji.Deebiotech (Chengdu) Co., Ltd., dake Wenjiang, Chengdu, an shirya fara aiki a hukumance a watan Oktoba.

Duba gaba, Zhang Ge yana cike da kwarin gwiwa."Deebio zai zama dandamali mai ban sha'awa mai ban sha'awa tare da cikakkun cancantar GMP, cikakkun fasaha na fasaha, kulawa mai mahimmanci, da daidaiton ingancin samfurin. Har ila yau, a shirye muke mu yi aiki tare da gaskiya tare da abokai masu ra'ayi don yin aiki tare, tare da burin. na rayuwa daidai da tsammanin zamanin da kuma rungumar damar cin nasara a kasuwannin hada-hadar magunguna ta duniya cikin sauri a yau."