Ko te umanga matū pai te mara ōhanga o te whakaputa matū pai i roto i te umanga matū, he rerekē tēnei i ngā hua matū whānui, i ngā matū papatipu rānei. Ko te umanga matū pai tētahi o ngā tohu nui o te taumata hangarau whānui o tētahi whenua. Ko ōna āhuatanga taketake ko te whakaputa matū pai kounga teitei, maha-momo, motuhake, maha-mahi rānei mō te ōhanga o te ao me te oranga o te tangata me te hangarau hou me te teitei. He nui te kiato hangarau o te umanga matū pai, ā, he nui te uara tāpiri. Mai i te tekau tau atu i 1970, kua nekehia e ētahi whenua kua whanake te arotahi rautaki o te whanaketanga o te umanga matū ki te umanga matū pai, ā, kua noho te whakateretere i te whanaketanga o te umanga matū pai hei ia o te ao. Kei roto i ngā matū pai ngā patu pepeke, ngā rongoā, ngā tae (ngā tae), me ētahi atu. Kei roto i ngā matū motuhake ngā tāpiringa kai, ngā tāpiringa kai, ngā piripiri, ngā matū horoi, ngā matū maimoatanga wai, ngā matū hiako, ngā matū mara hinu, ngā matū hiko, ngā matū hanga pepa me ētahi atu mara neke atu i te 50.
Ko ngā takawaenga rongoā e pā ana ki ngā matū takawaenga i hangaia i roto i te tukanga hanga rongoā matū, ā, nō roto i ngā hua matū pai. Ka taea te wehewehe i ngā takawaenga rongoā ki ngā takawaenga paturopi, ngā takawaenga whakaheke wera me te mamae, ngā takawaenga ngakau, me ngā takawaenga anticancer e ai ki ā rātou mara tono. Ko te ahumahi whakarunga o ngā takawaenga rongoā ko te ahumahi rauemi mata matū taketake, ko te ahumahi whakararo ko te ahumahi API matū me te whakarite. Hei taonga nui, ka tino rerekē te utu o ngā rauemi mata matū taketake, e pā tika ana ki te utu whakaputa o ngā umanga. Ka wehea ngā takawaenga rongoā ki ngā takawaenga tuatahi me ngā takawaenga matatau, ko te takawaenga tuatahi nā te uaua o te hangarau whakaputa kāore i te teitei, he iti ngā utu, ā, ko te uara tāpiri i roto i te āhuatanga tuku nui, ko ngā takawaenga matatau ko ngā hua tauhohenga takawaenga tuatahi, ki te whakataurite ki te takawaenga tuatahi, he hanganga uaua, kotahi noa iho, he torutoru rānei ngā taahiraa ki te whakarite i ngā hua whakararo uara-tāpiri teitei, ko tōna taumata tawhē nui he teitei ake i te tawhē nui o te ahumahi takawaenga. I te mea ka taea e ngā kaiwhakarato takawaenga tuatahi te whakarato i te whakaputa takawaenga ngawari, kei te pito o mua o te mekameka ahumahi rātou me te pēhanga whakataetae nui rawa atu me te pēhanga utu, me te piki haere o te utu o He nui te pānga o ngā rauemi mata matū taketake ki a rātou. I tētahi atu taha, ehara i te mea he kaha te mana whiriwhiri a ngā kaiwhakarato takawaenga matua ki ngā kaiwhakarato iti iho, engari he mea nui ake, ko rātou te kawenga mō te hanga takawaenga matatau me te ihirangi hangarau teitei, ā, he hononga tata atu ki ngā kamupene o te ao whānui, nō reira he iti ake te pānga o ngā piki me ngā heke o te utu o ngā rauemi mata ki a rātou. Ka taea te whakarōpū i ngā takawaenga kore-GMP me ngā takawaenga GMP i runga i te nui o te awe ki te kounga API whakamutunga. Ko te takawaenga kore-GMP e pā ana ki te takawaenga rongoā i mua i te rauemi tīmatanga API; ko te takawaenga GMP e pā ana ki te takawaenga rongoā i hangaia i raro i ngā whakaritenga o te GMP, arā, he matū i hangaia i muri i te rauemi tīmatanga API, i roto i ngā mahi hanga API, ā, ka pāngia e ngā huringa ngota ngota, e te whakapai ake rānei i mua i te noho hei API.
Ka whakaoho tonu te pikinga pari patent tuarua i te hiahia mō ngā takawaenga o runga.
Ka rerekē te ahumahi takawaenga rongoā i raro i te mana o te tono whānui o te ahumahi rongoā o raro, ā, ko tōna auau he rite tonu ki te ahumahi rongoā. Ka taea te wehewehe i ēnei awe ki ngā āhuatanga o waho me ngā āhuatanga o roto: ko ngā āhuatanga o waho e pā ana ki te huringa whakaae o ngā rongoā hou kei te mākete; ko ngā āhuatanga o roto e pā ana ki te huringa tiaki patent o ngā rongoā auaha. Ko te tere o te whakaae rongoā hou e ngā tari whakahaere rongoā pēnei i te FDA he awe anō hoki ki te ahumahi. Ina pai te roanga o te wā whakaae rongoā hou me te maha o ngā rongoā hou kua whakaaetia ki ngā kamupene rongoā, ka puta te tono mō ngā ratonga tuku rongoā ki waho. I runga i te maha o ngā rongoā matū hou me ngā rongoā koiora hou kua whakaaetia e te FDA i te tekau tau kua hipa, ka haere tonu te maha o ngā whakaaetanga rongoā hou ki te whakaputa tono mō ngā takawaenga o runga, ā, ka tautoko i te ahumahi kia mau tonu te pikinga teitei. Kia pau te tiaki patent o ngā rongoā auaha, ka tino pai ake ngā rongoā whānui, ā, ka koa tonu ngā kaihanga takawaenga ki te tipu tere o te tono i roto i te wā poto. E ai ki ngā tatauranga a Evaluate, mai i te tau 2017 ki te 2022, ka eke ki te 194 piriona yuan te mākete rongoā e pāngia ana e te wā paunga o te mana pateni, koinei te tuarua o ngā pikinga o te mana pateni mai i te tau 2012.
I ngā tau tata nei, me te whānui haere me te uaua o te hanganga rongoā, kua heke te angitu o te rangahau me te whanaketanga rongoā hou, ā, kua piki tere te utu rangahau me te whanaketanga rongoā hou a McKinsey i roto i te Nat. Rev. DrugDiscov. "I te tau 2006-2011, ko te angitu o te rangahau me te whanaketanga rongoā hou he 7.5% noa iho, mai i te tau 2012 ki te 2014, nā te pai o te whiriwhiringa o ngā macromolecules koiora me te iti o te paitini o te tawhiti ngaro (ko ngā rongoā kei te wāhanga whanaketanga mutunga, arā, mai i te wāhanga haumanu III ki te rārangi kua whakaaetia he 74% te angitu), he paku piki ake te angitu whānui o te rangahau me te whanaketanga rongoā, engari he uaua tonu te tautoko i te 16.40% te angitu i ngā tau 90. Kua piki ake te utu mō te rārangi angitu o tētahi rongoā hou mai i te $1.188 piriona i te tau 2010 ki te $2.18 piriona i te tau 2018, tata ki te rua. I taua wā, kei te heke tonu te hokinga mai o ngā rongoā hou. I te tau 2018, ko ngā kamupene rongoā nunui TOP12 o te ao i whiwhi i te hokinga mai o te 1.9% i runga i te haumi ki te rangahau me te whanaketanga."
Nā te pikinga ake o ngā utu rangahau me te hekenga o te hokinga mai o te haumitanga rangahau me te whanaketanga kua nui te pēhanga ki ngā kamupene rongoā, nō reira ka whiriwhiri rātou ki te tuku i te tukanga whakaputa ki ngā umanga CMO a muri ake nei hei whakaiti i ngā utu. E ai ki a ChemicalWeekly, ko te tukanga whakaputa e 30% o te utu katoa o ngā rongoā taketake. Ka taea e te tauira CMO/CDMO te āwhina i ngā kamupene rongoā ki te whakaiti i te utu katoa o te whakaurunga rawa pumau, te whai huatanga o te whakaputa, ngā rauemi tangata, te tiwhikete, te arotake me ētahi atu āhuatanga mā te 12-15%. Hei tāpiri, mā te WHAKAMAHI i te aratau CMO/CDMO ka āwhina i ngā kamupene rongoā ki te whakapai ake i te hua tauhohenga, te whakapoto i te huringa penapena me te whakanui ake i te tauwehenga haumaru, ka taea te whakaora i te wā whakaritenga whakaputa, te whakapoto i te huringa rangahau me te whanaketanga o ngā rongoā auaha, te whakateretere i te tere o te hokohoko rongoā, me te āhei i ngā kamupene rongoā ki te whiwhi i ngā hua patent.
He painga ngā umanga CMO Hainamana pērā i te iti o te utu o ngā rauemi mata me te mahi, te tukanga me te hangarau ngāwari, me ētahi atu, ā, ko te whakawhiti i te umanga CMO o te ao ki Haina ka whakatairanga i te whakawhānui ake i te wahanga mākete CMO o Haina. E matapaetia ana ka neke atu te mākete CMO/CDMO o te ao i te $102.5 piriona tāra i te tau 2021, me te tere tipu whakakotahi o te 12.73% i te tau 2017-2021, e ai ki te matapae a South.
I te mākete matū pai o te ao i te tau 2014, ko te rongoā me ōna takawaenga, ko ngā patu pepeke me ōna takawaenga ngā umanga iti e rua o te umanga matū pai, e 69% me te 10% ia. He kaha te umanga matū hinu a Haina me te maha o ngā kaihanga rauemi mata matū, kua hanga i ngā rōpū ahumahi, e hanga ana i ngā momo rauemi mata me ngā rauemi āwhina e hiahiatia ana mō te hanga matū pai kounga teitei e wātea ana i Haina, e whakapai ake ana i te whai huatanga me te whakaiti i te utu whānui. I taua wā anō, he pūnaha ahumahi tino oti a Haina, e whakaiti ana i te utu o ngā taputapu matū, te hanga me te tāutanga i Haina i tērā o ngā whenua whakawhanake, tae atu ki te nuinga o ngā whenua whakawhanake, nā reira ka whakaitihia ngā utu haumi me te whakaputa. Hei tāpiri, he nui ngā miihini matū me ngā kaimahi ahumahi kaha me te iti te utu o Haina. Kua whanake te umanga takawaenga i Haina mai i te rangahau pūtaiao me te whanaketanga ki te whakaputa me te hoko i tētahi huinga katoa o te pūnaha tino oti, ka taea e te hanga rongoā o ngā rauemi mata matū me ngā takawaenga mō te taketake te hanga i tētahi huinga katoa, he torutoru noa iho e hiahia ana ki te kawemai, ka taea te whakaputa takawaenga rongoā, ngā takawaenga patu pepeke me ētahi atu kāwai matua 36, neke atu i te Neke atu i te 40,000 ngā momo takawaenga, he maha ngā hua takawaenga kua tutukihia, he nui ake i te 5 miriona tana te nui o ngā kaweake takawaenga i ia tau, kua riro ko ia te kaihanga me te kaweake takawaenga nui rawa atu o te ao.
Kua tino whanake te umanga takawaenga rongoā o Haina mai i te tau 2000. I taua wā, kua nui ake te aro o ngā kamupene rongoā i ngā whenua whakawhanake ki te rangahau me te whanaketanga hua me te whanaketanga mākete hei whakataetae matua, ā, kua tere ake te whakawhiti o ngā takawaenga me te hanganga rongoā hohe ki ngā whenua whakawhanake me ngā utu iti. Nō reira, kua whakamahia e te umanga takawaenga rongoā o Haina tēnei whai wāhitanga kia whiwhi whanaketanga pai rawa atu. I muri i te neke atu i te tekau tau o te whanaketanga pumau, kua noho a Haina hei turanga whakaputa takawaenga nui i roto i te wehenga mahi o te ao i roto i te umanga rongoā me te tautoko o te ture whānui ā-motu me ngā kaupapa here maha. Mai i te tau 2012 ki te 2018, kua piki ake te putanga o te umanga takawaenga rongoā o Haina mai i te 8.1 miriona tana me te rahi o te mākete tata ki te 168.8 piriona yuan ki te 10.12 miriona tana me te rahi o te mākete o te 2017 piriona yuan. Kua eke te umanga takawaenga rongoā o Haina ki te whakataetae kaha i roto i te mākete, ā, kua taea e ētahi kaihanga takawaenga te whakaputa takawaenga me te hanganga ngota uaua me ngā whakaritenga hangarau teitei. Kua tīmata te nuinga o ngā hua whai mana ki te whakahaere i te mākete o te ao. Heoi, i te nuinga o te wā, kei roto tonu te umanga takawaenga o Haina i te wā whanaketanga o te arotau me te whakapai ake i te hanganga hua, ā, he iti tonu te taumata hangarau. Ko te nuinga o ngā hua i roto i te umanga takawaenga rongoā he takawaenga rongoā tuatahi tonu, engari he onge te maha o ngā takawaenga rongoā matatau me ngā takawaenga tautoko o ngā rongoā hou kua patenttia.
Wā tuku: Oketopa-27-2020




