Tirohanga Whānui o te Ahumahi Takawaenga Rongoā

Ngā takawaenga rongoā
Ko ngā mea e kiia nei he takawaenga rongoā he rauemi mata matū, he hua matū rānei e hiahiatia ana kia whakamahia i roto i te tukanga hanga rongoā. Ka taea te whakaputa i ēnei hua matū i roto i ngā whare matū noa me te kore e whiwhi raihana hanga rongoā, ā, ka taea te whakamahi i roto i te hanga me te hanga rongoā mena ka tutuki ngā tohu hangarau i ētahi whakaritenga taumata. Ahakoa kei roto hoki te hanga rongoā i raro i te kāwai matū, he tino kaha ake ngā whakaritenga i ērā mō ngā hua matū whānui. Me whakaae ngā kaihanga o ngā rongoā kua oti me ngā API ki te tiwhikete GMP, engari kāore ngā kaihanga o ngā takawaenga, nā te mea ko ngā takawaenga tonu te hanga me te hanga rauemi mata matū, koinei ngā hua tino taketake me te iti rawa i roto i te mekameka hanga rongoā, ā, kāore e taea te kī he rongoā i tēnei wā, nō reira kāore e hiahiatia he tiwhikete GMP, e whakaiti ana hoki i te paepae whakauru mō ngā kaihanga takawaenga.

Ahumahi takawaenga rongoā
Ko ngā kamupene matū e whakaputa ana, e tukatuka ana hoki i ngā takawaenga waro/kore-waro, i ngā API rānei mā ngā kamupene rongoā hei hanga i ngā hua rongoā kua oti mā te hanga matū, koiora rānei e ai ki ngā paerewa kounga tino pakari. I konei ka wehea ngā takawaenga rongoā ki ngā umanga iti e rua, ko te CMO me te CRO.

Kaiwhakahaere Matua
Ko te Whakahaere Hanga Kirimana e pā ana ki tētahi whakahaere hanga kirimana, arā, ka tukuna e te kamupene rongoā te tukanga hanga ki tētahi hoa mahi. Ko te mekameka pakihi o te umanga CMO rongoā ka tīmata i te nuinga o te wā me ngā rauemi mata rongoā motuhake. Me kimi e ngā kamupene o te umanga ngā rauemi mata matū taketake me te tukatuka i aua rauemi hei whakauru rongoā motuhake, kātahi ka tukatukahia hei rauemi tīmatanga API, hei takawaenga cGMP, hei API me ngā hanganga. I tēnei wā, ko ngā kamupene rongoā nui o te ao whānui ka whakatū hononga rautaki roa me te iti o ngā kaiwhakarato matua, ā, ko te oranga tonutanga o ngā kamupene i roto i tēnei umanga ka kitea nuitia mā roto i ā rātou hoa mahi.

CRO
Ko te Whakahaere Rangahau Kirimana (Haumanu) e pā ana ki tētahi whakahaere rangahau kirimana, e tukuna ana e ngā kamupene rongoā te wāhanga rangahau ki tētahi hoa mahi. I tēnei wā, ko te nuinga o te umanga e hangai ana ki te hanga ritenga, te R&D ritenga me te rangahau me te hoko kirimana rongoā. Ahakoa te tikanga, ahakoa he hua auaha te hua takawaenga rongoā, ko te whakataetae matua o te kamupene ka aromatawaihia tonutia e te hangarau R&D hei huānga tuatahi, e whakaatahia ana i roto i ngā kiritaki, i ngā hoa mahi rānei o te kamupene.

Te mekameka uara mākete hua rongoā
Pikitia
(Whakaahua mai i Qilu Securities)

Te mekameka ahumahi o te ahumahi takawaenga rongoā
Pikitia
(Pikitia mai i te Whatunga Mōhiohio Ahumahi o Haina)

Te whakarōpūtanga o ngā takawaenga rongoā
Ka taea te wehewehe i ngā takawaenga rongoā ki ngā kāwai nui e ai ki ngā mara tono, pērā i ngā takawaenga mō ngā paturopi, ngā takawaenga mō ngā rongoā whakaheke wera me te whakamamae mamae, ngā takawaenga mō ngā rongoā pūnaha ngakau me ngā takawaenga rongoā mō te mate pukupuku. He maha ngā momo takawaenga rongoā motuhake, pērā i te imidazole, te furan, ngā takawaenga phenolic, ngā takawaenga kakara, te pyrrole, te pyridine, ngā tauhohenga matū koiora, ngā pūhui kei roto te whanariki, kei roto te hauota, ngā pūhui halogen, ngā pūhui heterocyclic, te māngaro, te mannitol, te cellulose microcrystalline, te lactose, te dextrin, te ethylene glycol, te paura huka, ngā tote inorganic, ngā takawaenga etanoru, te stearate, ngā waikawa amino, te ethanolamine, ngā tote pāhare pāporo, ngā tote konutai me ētahi atu takawaenga, me ētahi atu.
He tirohanga whānui mō te whanaketanga o te umanga takawaenga rongoā i Haina
E ai ki a IMS Health Incorporated, mai i te tau 2010 ki te 2013, i mau tonu te tipu o te mākete rongoā o te ao, mai i te US$793.6 piriona i te tau 2010 ki te US$899.3 piriona i te tau 2013, me te tere ake o te tipu o te mākete rongoā mai i te tau 2014, nā te mākete o Amerika te nuinga. Me te CAGR o te 6.14% mai i te tau 2010-2015, e matapaetia ana ka uru te mākete rongoā o te ao ki tētahi huringa tipu puhoi mai i te tau 2015-2019. Heoi, i te mea he nui te tono mō ngā rongoā, e matapaetia ana ka tino kaha te tipu kupenga a meake nei, me te mākete o te ao mō ngā rongoā e tata ana ki te US$1.22 trillion i te tau 2019.
Whakaahua
(Whakaahua mai i IMS Health Incorporated)
I tēnei wā, nā te hanganga anō o ngā kamupene rongoā nunui o te ao, te whakawhiti i te whakaputanga o te ao, me te whakapai ake i te wehenga mahi o te ao, kua noho a Haina hei turanga whakaputa takawaenga nui i roto i te wehenga mahi o te ao i roto i te umanga rongoā. Kua hangaia e te umanga takawaenga rongoā o Haina he pūnaha tino oti mai i te rangahau me te whanaketanga ki te whakaputa me te hoko. Mai i te whanaketanga o ngā takawaenga rongoā o te ao, kei te iti tonu te taumata hangarau tukatuka whānui o Haina, he nui ngā takawaenga rongoā matatau me ngā rongoā hou patent e tautoko ana i ngā umanga whakaputa takawaenga he iti noa iho, kei roto i te wāhanga whanaketanga o te arotau me te whakapai ake i te hanganga hua.
Te uara putanga o te umanga takawaenga rongoā matū i Haina mai i te tau 2011 ki te 2015
Pikitia
(Pikitia mai i te Haina Pakihi Ahumahi Rangahau Institute)
I waenganui i te tau 2011 ki te 2015, i piki ake te putanga o ngā takawaenga matū rongoā o Haina i ia tau, i te tau 2013, ko te putanga o ngā takawaenga matū rongoā o Haina he 568,300 tana, ā, ko te putanga o ngā takawaenga matū rongoā o Haina he 65,700 tana i kaweakehia, ā, i te tau 2015 ko te putanga o ngā takawaenga matū rongoā o Haina he tata ki te 676,400 tana.
Ngā tatauranga whakaputa ahumahi takawaenga matū rongoā Haina 2011-2015
Pikitia
(Pikitia mai i te China Merchant Industry Research Institute)
He nui ake te tuku o ngā takawaenga rongoā i Haina i te tono, ā, kei te piki haere te whakawhirinaki ki ngā kaweake. Heoi, ko ngā kaweake o Haina e aro nui ana ki ngā hua papatipu pērā i te huaora C, te penicillin, te acetaminophen, te waikawa citric me ōna tote me ngā esters, me ētahi atu. Ko ēnei hua e tohuhia ana e te nui o te putanga hua, te nui ake o ngā umanga whakaputa, te whakataetae mākete kaha, te iti o te utu hua me te uara tāpiri, ā, nā te nui o te tuku i roto i te mākete takawaenga rongoā o te motu i hua ake ai te āhua o te tuku i tua atu i te tono. Ko ngā hua he nui te hangarau kei te whakawhirinaki tonu ki te kawemai.
Hei tiaki i ngā takawaenga rongoā waikawa amino, he kotahi te momo hua o te nuinga o ngā umanga whakaputa ā-rohe, ā, he koretake te kounga, ko te nuinga he mea whakarite ki ngā kamupene rongoā koiora o tāwāhi hei hanga hua. Ko ētahi umanga anake he kaha rangahau me te whanaketanga, he matatau ki ngā whare whakaputa me te wheako ki te whakaputa nui ka taea te whiwhi hua nui i roto i te whakataetae.
Te tātaritanga o te umanga takawaenga rongoā o Haina

1, te tukanga whakaputa ritenga ahumahi takawaenga rongoā
Tuatahi, kia whai wāhi atu ki te rangahau me te whakawhanaketanga o ngā rongoā hou a te kiritaki, e hiahia ana kia kaha te kaha auaha o te pokapū R&D a te kamupene.
Tuarua, ki te whakanui hua whakamātautau a te kiritaki, kia tutuki ai te huarahi tukanga o te whakaputanga tauine nui, e hiahia ana ki te kaha whakanui hangarau a te kamupene o te hua me te kaha ki te whakapai tonu i te tukanga hangarau hua ritenga i te wā e whai ake nei, kia tutuki ai ngā hiahia o te whakaputanga tauine hua, kia whakaiti tonu ai i te utu whakaputa me te whakarei ake i te whakataetae o te hua.
Tuatoru, he mea hei keri me te whakapai ake i te tukanga whakaputa hua a ngā kiritaki, kia tutuki ai ngā paerewa kounga o ngā kamupene o tāwāhi.

2. Ngā āhuatanga o te umanga takawaenga rongoā o Haina
He nui ngā matū motuhake e hiahiatia ana mō te hanga rongoā, ko te nuinga i hangaia i te tuatahi e te umanga rongoā tonu, engari nā te hohonu haere o te wehenga mahi pāpori me te ahunga whakamua o te hangarau hanga, i whakawhitihia e te umanga rongoā ētahi takawaenga rongoā ki ngā umanga matū hei hanga. He hua matū pai ngā takawaenga rongoā, ā, kua noho te hanga takawaenga rongoā hei umanga nui i roto i te umanga matū o te ao. I tēnei wā, e hiahia ana te umanga rongoā o Haina ki te 2,000 momo rauemi mata matū me ngā takawaenga i ia tau, me te tono neke atu i te 2.5 miriona tana. I te mea ko te kaweake o ngā takawaenga rongoā, he rerekē ki te kaweake o ngā rongoā, ka pāngia e ngā here maha i roto i ngā whenua kawemai, me te hanga takawaenga rongoā o te ao ki ngā whenua whakawhanake, ko ngā hiahia hanga rongoā Hainamana o nāianei mō ngā rauemi mata matū me ngā takawaenga ka taea te taurite, he wāhanga iti noa iho o te hiahia ki te kawemai. Ā, nā te nui o ngā rauemi a Haina, he iti ngā utu rauemi mata, he maha ngā takawaenga rongoā i tutuki ai te maha o ngā kaweake.

I tēnei wā, e hiahiatia ana e Haina ngā rauemi mata tautoko matū me ngā takawaenga neke atu i te 2500 momo, ā, ko te hiahia ā-tau kua eke ki te 11.35 miriona tana. I muri i te neke atu i te 30 tau o te whanaketanga, kua taea e Haina te whakatutuki i ngā hiahia hanga rongoā o Haina mō ngā rauemi mata me ngā takawaenga matū. Ko te nuinga o te hanga takawaenga i Haina ko ngā rongoā patu huakita me ngā rongoā whakaheke wera.

I roto i te umanga, e ono ngā āhuatanga o te umanga takawaenga rongoā o Haina: Tuatahi, ko te nuinga o ngā umanga he umanga tūmataiti, he ngāwari te whakahaere, kāore i te nui te tauine haumi, i waenga i te miriona ki te kotahi, i te rua mano miriona yuan rānei; Tuarua, ko te tohatoha whenua o ngā umanga he tino kukū, ko te nuinga kei Taizhou, Zhejiang Province me Jintan, Jiangsu Province hei pokapū; Tuatoru, me te aro nui o te whenua ki te tiaki taiao, kei te piki haere te pēhanga ki ngā umanga ki te hanga whare maimoatanga tiaki taiao. Tuawhā, he tere te tere whakahou hua, ā, ka tino heke te tawhē hua i muri i te 3 ki te 5 tau i te mākete, ka akiaki i ngā umanga ki te whakawhanake i ngā hua hou, ki te whakapai tonu rānei i te tukanga kia nui ake ai ngā hua; Tuarima, nā te mea he nui ake te hua o te whakaputanga o ngā takawaenga rongoā i ērā o ngā hua matū whānui, ā, he rite tonu te tukanga whakaputa, he maha ake ngā umanga matū iti e uru atu ana ki ngā rarangi o te whakaputa takawaenga rongoā, ka hua ake he whakataetae kaha i roto i te umanga. Tuaono, ki te whakaritea ki te API, he iti te tawhē hua o te whakaputa takawaenga, ā, he rite tonu te tukanga whakaputa o te API me ngā takawaenga rongoā, nō reira kāore ētahi umanga e whakaputa takawaenga anake, engari e whakamahi ana hoki i ō rātou ake painga ki te tīmata whakaputa API. I tohu ngā tohunga ko te whakaputanga o ngā takawaenga rongoā ki te ahunga whanaketanga API he ia e kore e taea te karo. Heoi, nā te whakamahinga kotahi o te API, he nui te pānga o ngā kamupene rongoā, he maha ngā wā ka whakawhanakehia e ngā umanga ā-rohe ngā hua engari kāore he kaiwhakamahi o te āhuatanga. Nō reira, me whakatū e ngā kaihanga he whanaungatanga tuku pumau mo te wā roa me ngā kamupene rongoā, kia pai ai te hokohoko hua.

3, ngā arai whakaurunga ahumahi
①Ngā arai a te kiritaki
E puritia ana te umanga rongoā e ētahi kamupene rongoā o te ao whānui. He tino tupato ngā rangatira rongoā i roto i tā rātou whiriwhiri i ngā kaiwhakarato ratonga ki waho, ā, he roa te wā tirotiro mō ngā kaiwhakarato hou. Me tutuki i ngā kamupene CMO rongoā ngā tauira whakawhitiwhiti kōrero a ngā kiritaki rerekē, me te whai i tētahi wā roa o te aromatawai tonu i mua i te whiwhi i te whakawhirinaki o ngā kiritaki o muri mai, kātahi ka noho hei kaiwhakarato matua mō rātou.
②Ngā arai hangarau
Ko te kaha ki te whakarato ratonga hangarau-tāpiri teitei te tūāpapa o tētahi kamupene ratonga tuku rongoā ki waho. Me pakaru e ngā kamupene CMO rongoā ngā arai hangarau, ngā aukati rānei i roto i ā rātou huarahi taketake, me te whakarato huarahi arotau tukanga rongoā hei whakaiti i ngā utu whakaputa rongoā. Ki te kore he haumi roa, he nui te utu ki te rangahau me te whanaketanga me ngā rahui hangarau, he uaua ki ngā kamupene i waho o te umanga te uru atu ki te umanga.
③Ngā arai taranata
He uaua ki ngā kamupene CMO te hanga i tētahi tīma R&D me te whakaputa whakataetae i roto i te wā poto hei whakatū i tētahi tauira pakihi e tutuki ana i ngā whakaritenga cGMP.
④Ngā arai ture kounga
Kua kaha haere te FDA me ētahi atu tari whakahaere rongoā ki te whakauaua i ā rātou whakaritenga whakahaere kounga, ā, ko ngā hua kāore e paahitia te arotake, kāore e taea te uru ki ngā mākete o ngā whenua kawemai.
⑤ Ngā arai ture taiao
Ko ngā kamupene rongoā he tawhito ā rātou tukanga ka pikau i ngā utu whakahaere parahanga nui me te pēhanga ture, ā, ko ngā kamupene rongoā tuku iho e whakaputa ana i te parahanga nui, te whakapaunga pūngao nui me ngā hua iti-tāpiri uara (hei tauira, te penicillin, ngā huaora, me ētahi atu) ka tere te whakakorenga. Ko te piri ki te auahatanga tukanga me te whakawhanake i te hangarau rongoā matomato kua noho hei huarahi whanaketanga ā-muri mō te umanga CMO rongoā.

4. Ngā umanga kua whakarārangihia mō ngā takawaenga rongoā ā-rohe
Mai i te tūranga o te mekameka ahumahi, ko ngā kamupene matū pai e ono kua whakarārangihia e whakaputa ana i ngā takawaenga rongoā kei te pito raro katoa o te mekameka ahumahi. Ahakoa he kaiwhakarato ratonga tuku mahi ngaio, he API me te whakawhānui hanganga rānei, ko te kaha hangarau te kaha matua e akiaki tonu ana.
Mō te kaha hangarau, ko ngā kamupene whai hangarau kei te taumata o te ao, he kaha te kaha rahui me te haumi nui ki te R&D ka tino manakohia.
Rōpū I: Hangarau Lianhua me te Matū Arbonne. E waru ngā hangarau matua o te Hangarau Lianhua pērā i te whakahāngaitanga haukini me te whakawhanaungatanga fluorine hei pūtake hangarau, ā, ko te whakahāngaitanga hauwai kei te taumata matua o te ao. Ko Abenomics tētahi o ngā kaiārahi o te ao i roto i ngā rongoā chiral, inā koa i roto i āna hangarau wehewehe matū me te whakahāngaitanga racemization, ā, ko ia te kaipupuri moni R&D teitei rawa atu, e 6.4% o ngā moni whiwhi.
Rōpū II: Hangarau Wanchang me te Hangarau Yongtai. Ko te tikanga waikawa hydrocyanic hau para a te Hangarau Wanchang te tukanga iti rawa te utu me te tukanga matatau rawa atu mō te hanga i ngā esters waikawa prototrizoic. I tētahi atu taha, e mōhiotia ana a Yongtai Technology mō āna matū pai fluorine.
Rōpū III: Te Matū Pai o Tianma me Bikang (i mōhiotia i mua ko Jiuzhang).
Te whakataurite i te kaha hangarau o ngā kamupene kua rārangihia
Pikitia
Te whakataurite i ngā kiritaki me ngā tauira hokohoko o ngā kamupene takawaenga rongoā kua whakarārangihia
Pikitia
Te whakataurite i te tono o muri mai me te huringa ora o ngā hua o ngā kamupene kua rārangihia
Ngā pikitia
Te tātari i te whakataetae hua o ngā kamupene kua rārangihia
Ngā pikitia
Te huarahi ki te whakapai ake i ngā takawaenga matū pai
Ngā pikitia
(Ngā pikitia me ngā rauemi mai i Qilu Securities)
Ngā tūmanakohanga whanaketanga o te umanga takawaenga rongoā o Haina
Hei ahumahi nui i roto i te ao o te ahumahi matū pai, kua noho te hanga rongoā hei kaupapa matua mō te whanaketanga me te whakataetae i ngā tau 10 kua pahure ake nei, me te ahunga whakamua o te pūtaiao me te hangarau, he maha ngā rongoā kua whakawhanakehia tonutia hei painga mō te tangata, ko te hanganga o ēnei rongoā e whakawhirinaki ana ki te hanga o ngā takawaenga rongoā hou, kounga teitei, nō reira ka tiakina ngā rongoā hou e ngā patent, engari kāore he raruraru o ngā takawaenga kei a rātou, nō reira he tino whai hua te wāhi whanaketanga mākete me te tirohanga tono mō ngā takawaenga rongoā hou i te kāinga me tāwāhi.
Ngā pikitia

I tēnei wā, ko te aronga rangahau o ngā takawaenga rongoā e whakaatahia ana i roto i te hanganga o ngā pūhui heterocyclic, ngā pūhui kei roto he fluorine, ngā pūhui chiral, ngā pūhui koiora, me ētahi atu. Kei te noho tonu he āputa i waenga i te whanaketanga o ngā takawaenga rongoā me ngā whakaritenga o te umanga rongoā i Haina. Ko ētahi hua he nui ngā whakaritenga hangarau kāore e taea te whakarite mō te whakaputa i Haina, ā, ko te nuinga e whakawhirinaki ana ki te kawemai, pērā i te piperazine anhydrous, te waikawa propionic, me ētahi atu. Ahakoa ka taea e ētahi hua te whakatutuki i ngā whakaritenga o te umanga rongoā ā-rohe i runga i te rahinga, engari ko te utu me te kounga teitei kāore i te eke ki te paerewa, e pā ana ki te whakataetae o ngā hua rongoā me te hiahia kia whakapai ake i te tukanga whakaputa, pērā i te TMB, p-aminophenol, D-PHPG, me ētahi atu.
E matapaetia ana i roto i ngā tau torutoru e whai ake nei, ka arotahi te rangahau rongoā hou o te ao ki ēnei momo rongoā tekau e whai ake nei: ngā rongoā whakapai ake i te mahi roro, ngā rongoā anti-rheumatoid arthritis, ngā rongoā anti-AIDS, ngā rongoā anti-hepatitis me ētahi atu rongoā huaketo, ngā rongoā whakaheke lipid, ngā rongoā anti-thrombotic, ngā rongoā anti-pukupuku, ngā kaiwhakahē i te platelet-activating factor, ngā whakaohooho ngakau glycoside, ngā rongoā antidepressants, ngā rongoā anti-psychotic me te anti-anxiety, me ētahi atu. Ko te whanaketanga o ngā takawaenga rongoā o ēnei rongoā te huarahi ki te whakawhanake i ngā takawaenga rongoā ā muri ake nei, ā, he huarahi nui tēnei ki te whakawhānui i te wāhi mākete hou.