He momo matū tino pai ngā takawaenga. Ko te tikanga, he momo "hua haurua-oti", e whakamahia whānuitia ana i roto i te hanga rongoā, patupatu pepeke, paninga, tae me ngā mea kakara.

I roto i te rongoā, ka whakamahia ngā takawaenga hei hanga API.

Nā, he aha te ahumahi motuhake o ngā takawaenga rongoā?

01

Ko ngā mea e kiia nei he takawaenga rongoā he rauemi mata matū, he hua matū rānei e whakamahia ana i roto i te tukanga hanga rongoā.
Ka taea te whakaputa i te matū, kāore nei e hiahiatia he raihana hanga rongoā, i roto i tētahi wheketere matū tikanga, ā, ina tae ki ētahi taumata, ka taea te whakamahi i roto i te hanga rongoā.

Te pikitia

I tēnei wā, ko ngā momo rongoā tino whai hua ko ēnei e whai ake nei:

Ngā takawaenga nucleoside.
Ko tēnei momo takawaenga o ngā rongoā ārai-AIDS ko te zidovudine te nuinga, mai i te United States Glaxo.
I tae atu a Wellcome rāua ko Bristol-Myers Squibb.

Ngā takawaenga mō te ngākau.
Hei tauira, kua whānuitia te whakamahinga o ngā sartan hangai hei rongoā i te toto toto tiketike nā te mea he tino pai ake te pānga ki te toto toto tiketike, he iti ake ngā pānga taha, he roa te whai huatanga (he pumau te whakahaere i te toto toto mō ngā haora 24) me te kaha ki te whakamahi tahi me ētahi atu sartan.
E ai ki ngā tatauranga, i te tau 2015, i eke te tono ā-ao mō ngā matū hohe nui o te rongoā sartan (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) ki te 3,300 tana.
Ko te tapeke o ngā hoko he $21.063 piriona.

Ngā takawaenga kua whakapūhaumāotahia.
Kua tere te whanaketanga o ngā rongoā whai pūhaumāota i hangaia mai i aua takawaenga i ngā tau tata nei nā te mea he tino whai hua. I te tau 1970, e 2% noa iho o ngā rongoā whai pūhaumāota i runga i te mākete; i te tau 2013, e 25% o ngā rongoā whai pūhaumāota i runga i te mākete.
Ko ngā hua matua pērā i ngā rongoā ārai-mate fluoroquinolone, te fluoxetine rongoā pouri me te fluconazole harore he nui te whakamahinga haumanu, ā, e 15% o te wāhanga mākete o te ao mō ngā rongoā ārai-mate ko ngā rongoā fluoroquinolone.
Hei tāpiritanga, he takawaenga nui te trifluoroethanol mō te hanga rongoā whakangāwari, ko te trifluoromethylaniline he takawaenga nui mō te hanga rongoā ārai-malaria, rongoā ārai-mumura me te whakamamae mamae, rongoā ārai-repeure me ngā rongoā ārai-pōuri, ā, he whānui rawa te tirohanga mākete.

Ngā takawaenga heterocyclic.
Me te pyridine me te piperazine hei māngai, e whakamahia ana i roto i te hanganga o ngā rongoā anti-whewhe, ngā rongoā puku nui, ngā rongoā anti-inflammatory me te anti-infective, ngā rongoā antihypertensive tino whai hua me ngā rongoā anti-cancer hou letrozole.

02

He hononga nui ngā takawaenga rongoā i roto i te mekameka ahumahi rongoā.

Te pikitia

Kei te awa whakarunga ko ngā rauemi matū taketake, ko te nuinga he hua hinu, pērā i te acetylene, te ethylene, te propylene, te butene me te butadiene, te toluene me te xylene.

Kua wehea ngā takawaenga rongoā ki ngā takawaenga tuatahi me ngā takawaenga matatau.
I roto i a rātou, ko ngā kaiwhakarato takawaenga matua ka taea anake te whakarato i ngā mahi takawaenga māmā, ā, kei mua tonu rātou i te mekameka ahumahi me te taumahatanga whakataetae me te taumahatanga utu nui rawa atu. Nō reira, he nui te pānga o te piki me te heke o te utu 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 matatau ki ngā kaiwhakarato matua, engari he mea nui ake, nā te mea ko rātou te kaihanga o ngā takawaenga matatau me ngā ihirangi hangarau teitei, ā, he tata tonu te hononga ki ngā kamupene o te ao, kāore rātou i te tino pāngia e te piki me te heke o te utu o ngā rauemi mata.

Ko ngā pito waenga kei roto i te umanga matū pai rongoā.
Ka hangaia e ngā kaihanga o ngā takawaenga rongoā ngā takawaenga, ngā API mata rānei, ka hoko i ngā hua hei hua matū ki ngā kamupene rongoā, ka whakamahine i aua hua, kātahi ka hoko atu hei rongoā.

Kei roto i ngā takawaenga rongoā ngā hua whānui me ngā hua ritenga. E ai ki ngā wāhanga ratonga tuku mahi ki waho, ka taea te wehewehe i ngā tauira pakihi ritenga o ngā takawaenga ki te CRO (te tuku mahi rangahau me te whakawhanake kirimana) me te CMO (te tuku mahi whakaputa kirimana).

I ngā wā o mua, ko te aratau tuku pakihi CMO i whakamahia nuitia i roto i ngā takawaenga rongoā.
I raro i te tauira CMO, ka tukuna e ngā kamupene rongoā te mahi whakaputa ki ngā hoa mahi.
Nō reira, ka tīmata te mekameka pakihi me ngā rauemi mata rongoā motuhake.
Me hoko e ngā kamupene ahumahi ngā rauemi mata matū taketake, ka whakarōpū, ka tukatuka hoki i aua rauemi hei rauemi mata rongoā motuhake, kātahi ka tukatuka anō hei rauemi tīmatanga API, hei takawaenga cGMP, hei API me ngā whakaritenga.

Engari, i te mea kāore i taea e ngā kamupene rongoā te whakatutuki i ngā hiahia o te whakahaere utu me te whai hua, ngā ratonga whakaputa ngāwari ki waho te whakatutuki i te hiahia o te hinonga, ka puta te aratau CDMO (rangahau whakaputa me te whakawhanaketanga ki waho) i tēnei wā, me whakarite e te CDMO ngā hinonga whakaputa kia uru atu ai te kiritaki ki te tukanga rangahau me te whanaketanga, kia pai ake ai te tukanga, kia tutuki ai te kounga whakaputa nui, kia whakaitihia ai te utu whakaputa.
He nui ake ngā huamoni i te tauira CMO.

Ko te nuinga o te ahumahi whakaputa API ko te API, ā, kei roto te API i te whanaungatanga mekameka ahumahi whakarunga me te whakarunga me te whakarite.
Nō reira, ka pā tika te hiahia mō te whakamahinga o te rongoā o muri mai ki te hiahia o te API, kātahi ka pā ki te hiahia o te takawaenga.

Mai i te tirohanga a te mekameka ahumahi katoa, kei te tipu tonu ngā takawaenga rongoā i tēnei wā, ā, ko te reiti hua toharite ko te 15-20%, ko te reiti hua toharite o te API ko te 20-25%, ā, ko te reiti hua toharite o ngā whakaritenga rongoā o raro ko te 40-50%. He mārama, he nui ake te reiti hua o te wāhanga o raro i tērā o te wāhanga o runga.
Nō reira, ka taea e ngā umanga takawaenga rongoā te whakawhānui ake i te mekameka hua, te whakapiki i te hua o te hua, me te whakapai ake i te pumau o ngā hoko mā te whakaputa API a meake nei.

03

I tīmata te whanaketanga nui o te umanga takawaenga rongoā i Haina i te tau 2000.

I taua wā, i 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, i tere ake te whakawhiti i ngā takawaenga me te hanganga rongoā hohe ki ngā whenua whakawhanake me ngā utu iti.
Nō reira, kua tino pai te whanaketanga o te umanga takawaenga rongoā i Haina mā te whakamahi i tēnei whai wāhitanga.
I muri i te neke atu i te tekau tau o te whanaketanga pumau, me te tautoko o ngā ture me ngā kaupapa here whānui o te motu, kua noho a Haina hei turanga whakaputa takawaenga nui i roto i te wehenga mahi o te ao i roto i te umanga rongoā.

Mai i te tau 2012 ki te tau 2018, i piki ake te putanga o te umanga takawaenga rongoā o Haina mai i te 8.1 miriona tana me te rahi o te mākete o te 168.8 piriona yuan ki te 10.12 miriona tana me te rahi o te mākete o te 2010.7 piriona yuan.

Te pikitia

Kua eke te umanga takawaenga rongoā o Haina ki tētahi whakataetae mākete kaha, ā, kua taea e ētahi umanga whakaputa takawaenga te whakaputa takawaenga he hanganga ngota uaua me ngā whakaritenga hangarau teitei. He maha ngā hua whai mana kua tīmata ki te whakahaere i te mākete o te ao.

Heoi, i te nuinga o te wā, kei roto tonu te umanga takawaenga i Haina i te wā whanaketanga o te arotautanga me te whakapai ake i te hanganga hua, ā, he iti tonu te taumata hangarau.
Ko ngā takawaenga rongoā tuatahi tonu ngā hua matua i roto i te umanga takawaenga rongoā, ā, he iti noa ngā umanga e whakaputa ana i te maha o ngā takawaenga rongoā matatau me te tautoko i ngā hua takawaenga o ngā rongoā hou kua patenttia.

I tēnei wā, ko ngā kamupene hea-A kua rārangihia he tino whakataetae i roto i te umanga takawaenga ko Yaben Chemical, Lianhua Technology, Boten, me Wanrun, e whakamahere ana ki te haumi i te 630 miriona yuan ki te hanganga o ngā takawaenga rongoā me ngā kaupapa API me te kaha katoa o te 3,155 tana/tau.
Kei te whakawhanake tonu rātou i te whānuitanga o ngā hua mā te rangahau me te whanaketanga, kia kitea ai he huarahi hou.

Yaben Chemical Co., Ltd. (300261): Kei roto i ā mātou hua matua ngā rongoā ārai pukupuku, ngā rongoā ārai haurangi me ngā rongoā ārai huaketo.
I roto i ēnei, i whakatūria mana a ABAH, he rongoā takawaenga mō te mate haurangi, ki te hanga i te Oketopa 2014, me te kaha o te 1,000 tana.
I whakaurua angitu te hangarau whakapūkara whākōkī ki roto i ngā takawaenga ngākau hei whakarei ake i te whakataetae o ngā hua.
I te tau 2017, i hokona e te kamupene a ACL, he kamupene rongoā matū hohe i Malta, hei whakatere i tana whakatakotoranga i te mākete hauora o te ao, hei akiaki hoki i te panonitanga me te whakapai ake i te turanga ā-rohe.

BTG (300363): e arotahi ana ki ngā takawaenga rongoā auaha / pakihi CMO ritenga API, ko ngā hua matua he takawaenga rongoā mō te ārai i te mate ate C, te ārai i te AIDS, te whakaheke i te lipid me te whakamamae i te mamae, ā, koia te kaiwhakarato matua o ngā takawaenga Sofebuvir mō te rongoā ārai mate ate C a Gilead.
I te tau 2016, ko te tapeke moni whiwhi o ngā rongoā takawaenga mō te mate huka me te mate ate hepatitis C i eke ki te 660 miriona, ko te 50% tēnei o te tapeke moni whiwhi.
Heoi, mai i te tau 2017, nā te ata whakaora o ngā tūroro hepatitis C me te hekenga o te taupori tūroro, ka tīmata te heke o ngā hoko rongoā hepatitis C a Gilead. I tua atu, i te paunga o ngā mana patent, ka nui haere ngā rongoā anti-hepatitis C i whakarewaina, ā, ka kaha haere tonu te whakataetae, ā, ka heke te maha o ngā ota waenga me ngā moni whiwhi.
I tēnei wā, kua huri te kamupene mai i te pakihi CMO ki te pakihi CDMO hei hanga i tētahi tūāpapa ratonga matua o te ao mō ngā umanga rongoā.

Hangarau Hononga (002250):
Ko ngā hua takawaenga rongoā e whai wāhi nui ana ki ngā rongoā ārai-puku, ngā rongoā ārai-pūnaha, ngā rongoā antifungal, ngā rongoā cardiovascular, ngā rongoā mate huka, ngā rongoā antidepressants, ngā rongoā antihypertensive, ngā rongoā anti-rewharewha, pērā i ngā rongoā taketake, kei roto katoa i ngā wāhi rongoā o te ao whānui me te rongonui o te mākete, ā, ko te tere o te tipu i ngā tau tata nei, ko te tere tipu o te moni whiwhi e pā ana ki te 50%.
I roto i ēnei, ko te "putanga ā-tau o te 300 tāne o te Chunidine, 300 tāne o te Waikawa Fluzolic me te 200 tāne o te Kaupapa Waikawa Cyclopyrimidine" kua whakatinanahia i ia tau mai i te tau 2014.