Zvinhu zvepakati-kati imhando yakakosha yezvigadzirwa zvemakemikari akanaka. Muchidimbu, imhando ye "zvigadzirwa zvakapedzwa zvishoma", izvo zvinoshandiswa zvakanyanya mukugadzira mishonga, mishonga yezvipembenene, machira ekuputira, madhayi nezvinonhuwira.

Mukurapa, zvinhu zvepakati zvinoshandiswa kugadzira maAPI.

Saka chii chiri indasitiri yemishonga iri pakati pemishonga?

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Zvinonzi mishonga yemishonga ndeimwe yezvinhu zvemakemikari kana zvigadzirwa zvemakemikari zvinoshandiswa mukugadzirwa kwemishonga.
Kemikari iyi, iyo isingade rezenisi yekugadzira mishonga, inogona kugadzirwa mufekitori yemakemikari yakajairika uye, kana yasvika padanho rakati, inogona kushandiswa mukugadzira mishonga.

Mufananidzo wacho

Parizvino, mhando dzinonyanya kuvimbiswa dzemishonga dzinotevera ndedzinotevera:

Zvinhu zvepakati zveNucleoside.
Rudzi urwu rwemishonga yekudzivirira AIDS inonyanya kugadzirwa ne zidovudine, inobva kuUnited States Glaxo.
Wellcome naBristol-Myers Squibb vanobudirira.

Zvinobatsira pamwoyo.
Semuenzaniso, mishonga yesartans yakagadzirwa yave kushandiswa zvakanyanya mukurapa BP nekuda kwesimba rayo rakakwana rekuderedza BP, migumisiro mishoma, kushanda kwenguva refu (kudzora BP kwemaawa makumi maviri nemana) uye kugona kushandiswa pamwe chete nedzimwe mishonga yesartans.
Zvichienderana nehuwandu, muna 2015, kudiwa kwepasi rose kwezvinhu zvikuru zvinoshanda mumishonga yesartan (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) kwakasvika matani 3,300.
Mari yese yaitengeswa yaive mabhiriyoni makumi maviri nerimwe nemakumi matanhatu nematatu emadhora ($21.063 bhiriyoni).

Zvidimbu zvine fluorine.
Mishonga ine fluorine yakagadzirwa kubva mumishonga yakadaro yakakurumidza kukura mumakore achangopfuura nekuda kwekushanda kwayo kwakanaka. Muna 1970, 2% chete yemishonga ine fluorine ndiyo yaive pamusika; pakasvika 2013, 25% yemishonga ine fluorine yaive pamusika.
Zvigadzirwa zvakaita semishonga inorwisa utachiona yefluoroquinolone, antidepressant fluoxetine uye antifungal fluconazole zvinonyanya kushandiswa mukurapa, pakati pazvo mishonga inorwisa utachiona yefluoroquinolone inoita 15% yemusika wepasi rose wemishonga inorwisa utachiona.
Pamusoro pezvo, trifluoroethanol chinhu chakakosha pakugadzirwa kwemishonga inonyaradza marwadzo, nepo trifluoromethylaniline iri chinhu chakakosha pakugadzirwa kwemishonga inorwisa malaria, mishonga inorwisa kuzvimba uye inonyaradza marwadzo, mishonga inorwisa prostate uye mishonga inorwisa kushushikana, uye tarisiro yemusika yakakura kwazvo.

Heterocyclic intermediates.
Nekushandisa pyridine nepiperazine, inonyanya kushandiswa mukugadzirwa kwemishonga yekurwisa maronda, mishonga yakawanda yemudumbu, mishonga yekudzivirira kuzvimba nekutapukira, mishonga inoshanda zvikuru yekuderedza BP uye mishonga mitsva yekurwisa kenza yemazamu letrozole.

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Mishonga yepakati ibasa rakakosha muindasitiri yemishonga.

Mufananidzo wacho

Pamusoro pemvura ndipo pane zvinhu zvemakemikari zvakakosha, zvakawanda zvacho zviri zvigadzirwa zve petrochemical, zvakaita se acetylene, ethylene, propylene, butene ne butadiene, toluene ne xylene.

Mishonga inopindirana nemakemikari yakakamurwa kuita mishonga inopindirana nemidziyo yepamusoro.
Pakati pavo, vatengesi vepakati vekutanga vanogona kupa zvigadzirwa zvepakati zviri nyore chete uye vari pamberi pemaindasitiri vane kumanikidzwa kukuru kwemakwikwi uye kumanikidzwa kwemitengo. Nokudaro, kuchinja-chinja kwemitengo yezvinhu zvemakemikari zvine simba guru pavari.

Kune rumwe rutivi, vatengesi vepakati vane hunyanzvi havangovi nesimba guru rekutaurirana pamusoro pevatengesi vekutanga chete, asi chinonyanya kukosha ndechekuti, nekuti vanoita basa rekugadzira vatengesi vepakati vane hunyanzvi hwepamusoro uye vanoramba vachibatana nemakambani epasi rose, havanyanyi kukanganiswa nekuchinja kwemitengo yezvinhu zvakagadzirwa.

Nzvimbo dzepakati dzinoshanda muindasitiri yemishonga.
Vagadziri vemishonga inobatanidza mishonga vanogadzira mishonga inobatanidza mishonga kana kuti maAPI asina kuchena, uye vanotengesa zvigadzirwa zvacho muchimiro chezvigadzirwa zvemakemikari kumakambani emishonga, ayo anozvinatsa obva azvitengesa semishonga.

Mishonga yepakati inosanganisira zvigadzirwa zvemhando yepamusoro uye zvigadzirwa zvakagadzirwa. Zvichienderana nematanho akasiyana ebasa rekunze, mamodheru ebhizinesi akagadzirwa evapakati anogona kukamurwa kuita CRO (kutsvagisa kwezvibvumirano nekuvandudza) uye CMO (kuburitsa zvibvumirano).

Kare, nzira yeCMO business outsourcing yainyanya kushandiswa mumishonga yepakati.
Pasi pemuenzaniso weCMO, makambani emishonga anopa mabasa ekugadzira kune vamwe vanobatanidzwa.
Saka, kutengeserana kunowanzo tanga nezvinhu zvemishonga zvine hunyanzvi.
Makambani eindasitiri anofanirwa kutenga zvinhu zvemakemikari zvepakutanga uye kuzvironga nekuzvigadzira muzvikamu zvemishonga chaiyo, uye ozozvigadzirisa kuita zvinhu zvekutanga zveAPI, cGMP intermediates, APIs uye magadzirirwo.

Asi, sezvo makambani emishonga achitsvaga nzira dzekugadzirisa mitengo uye kushanda zvakanaka, mabasa ekugadzira kunze akakundikana kusangana nezvinodiwa nemabhizinesi, CDMO mode (tsvakiridzo yekugadzira nekusimudzira kunze) inomuka panguva yenhoroondo, CDMO inoda kugadziriswa kwemakambani ekugadzira kuti atore chikamu mukutsvaga nekusimudzira, kupa kuvandudzwa kwemaitiro kana kugadzirisa, kuwana mhando huru yekugadzira, kuderedza mutengo wekugadzira,
Ine purofiti yakakwira kupfuura CMO model.

Nzvimbo iri pasi pemvura inonyanya kuve indasitiri yekugadzira maAPI, uye API iri muhukama hwepamusoro nepasi peindasitiri nekugadzirira.
Saka, kudiwa kwemushonga wekugadzirisa mushonga unoteverwa kuchakanganisa zvakananga kudiwa kweAPI, uye zvozokanganisa kudiwa kwemushonga wepakati.

Kubva pamaonero emakambani ese eindasitiri, mishonga yepakati ichiri muchikamu chekukura parizvino, uye avhareji yepurofiti yakazara inowanzova 15-20%, nepo avhareji yepurofiti yakazara yeAPI iri 20-25%, uye avhareji yepurofiti yakazara yemishonga iri pasi pe40-50%. Zviri pachena kuti purofiti yakazara yechikamu chiri pasi pemvura yakakwira zvakanyanya kupfuura yechikamu chiri kumusoro.
Saka, makambani epakati pemishonga anogona kuwedzera huwandu hwezvigadzirwa, kuwedzera purofiti yechigadzirwa uye kuvandudza kugadzikana kwekutengesa nekugadzira API mune ramangwana.

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Kukura kukuru kweindasitiri yemishonga muChina kwakatanga muna 2000.

Panguva iyoyo, makambani emishonga munyika dzakabudirira akanyanya kutarisisa kutsvagisa nekugadzira zvigadzirwa uye kukura kwemusika senzira huru yekukwikwidzana, uye akakurumidzisa kutamiswa kwemishonga yepakati uye yekugadzira mishonga inoshanda kunyika dziri kusimukira nemitengo yakaderera.
Saka, indasitiri yemishonga muChina yakawana budiriro yakanaka nekushandisa mukana uyu.
Mushure memakore anopfuura gumi ebudiriro yakatsiga, nerutsigiro rwemitemo yenyika pamwe nehurongwa, China yave nzvimbo yakakosha yekugadzira pakati nepakati muchikamu chepasi rose chevashandi muindasitiri yemishonga.

Kubva muna 2012 kusvika 2018, kugadzirwa kweindasitiri yemishonga yepakati peChina kwakawedzera kubva pamatani angangoita mamiriyoni 8.1 nehukuru hwemusika hwemayuan angangoita mabhiriyoni 168.8 kusvika pamatani angangoita mamiriyoni 10.12 nehukuru hwemusika hwemayuan angangoita mabhiriyoni 2010.7.

Mufananidzo wacho

Indasitiri yemishonga yekuChina yakawana makwikwi akasimba pamusika, uye kunyange mamwe makambani ekugadzira mishonga ekuChina akakwanisa kugadzira mishonga yekuChina ine maumbirwo akaomarara emamorekuru uye zvinodiwa zvehunyanzvi. Zvigadzirwa zvakawanda zvine simba zvakatanga kutonga pamusika wepasi rose.

Zvisinei, kazhinji, indasitiri yepakati muChina ichiri munguva yekuvandudzwa kwekugadzirwa kwezvigadzirwa, uye nhanho yetekinoroji ichiri yakaderera.
Mishonga yepamusoro yepakati nepakati ichiri zvigadzirwa zvikuru muindasitiri yemishonga yepakati nepakati, uye kune makambani mashoma anogadzira mishonga yepamusoro yakawanda uye anotsigira zvigadzirwa zvepakati zvemishonga mitsva ine patent.

Parizvino, makambani ane makwikwi akawanda muindasitiri yepakati ndeaya Yaben Chemical, Lianhua Technology, Boten, naWanrun, ayo anoronga kuisa mari inosvika mamiriyoni mazana matanhatu nemakumi matatu emamiriyoni eyuan mukuvaka mishonga yepakati uye mapurojekiti eAPI ane huwandu hwematani zviuru zvitatu nemazana mashanu nemashanu pagore.
Vanoramba vachigadzira zvigadzirwa zvakasiyana-siyana kuburikidza nekutsvaga nekugadzira, kuitira kuti vawane nzira itsva.

Yaben Chemical Co., Ltd. (300261): Zvigadzirwa zvedu zvikuru zvinosanganisira mishonga yekudzivirira bundu, mishonga yekudzivirira epileptic uye mishonga yekudzivirira mavhairasi.
Pakati pavo, ABAH, mushonga wekudzivirira pfari, wakatanga kugadzirwa zviri pamutemo muna Gumiguru 2014, uchikwanisa kurema matani chiuru.
Tekinoroji yekuvirisa ma enzymes yakaunzwa zvinobudirira muzvikamu zvepakati pemwoyo kuti zvigadzirwa zvikwanise kukwikwidzana.
Muna 2017, kambani iyi yakatenga ACL, kambani inoshanda mukurapa mishonga muMalta, ichikurumidzisa kugadzirwa kwayo mumusika wezvekurapa wepasi rose uye ichitungamira shanduko nekuvandudzwa kwenzvimbo yemuno.

BTG (300363): yakatarisana nemakambani matsva emishonga / API yakagadzirirwa CMO, zvigadzirwa zvikuru mishonga yekurapa hepatitis C, anti-AIDS, hypolipidemia uye analgesia, uye ndiyo inonyanya kupa Sofebuvir mishonga yekurapa hepatitis C yeGilead.
Muna 2016, mari yose inowanikwa nemishonga yekurapa chirwere cheshuga + yehepatitis C yakasvika mamiriyoni mazana matanhatu nemakumi matanhatu, zvichiita 50% yemari yose.
Zvisinei, kubvira muna 2017, nekuda kwekurapwa zvishoma nezvishoma kwevarwere vane hepatitis C uye kudzikira kwehuwandu hwevarwere, kutengeswa kwemishonga yehepatitis C neGilead kwakatanga kudzikira. Uyezve, nekupera kwemvumo, mishonga yakawanda yekurwisa hepatitis C yakatanga, uye makwikwi akaramba achiwedzera, zvichikonzera kudzikira kwemitengo yepakati nemari inowanikwa.
Parizvino, kambani iyi yachinja kubva kubhizinesi reCMO kuenda kubhizinesi reCDMO kuti ivake nzvimbo inotungamira pasi rose yebasa remabhizinesi emishonga.

Tekinoroji yeAlliance (002250):
Mishonga yepakati pemishonga inonyanya kubatanidzwa mumishonga inoderedza bundu, mishonga yekudzivirira muviri, mishonga inorwisa fungus, mishonga yemwoyo, mishonga yeshuga, mishonga inorwisa antidepressants, mishonga inorwisa BP, mishonga inorwisa furuwenza, yakadai seyekutanga, zvese zviri munzvimbo dzekurapa dzemusika wepasi rose, kukura nekukurumidza mumakore achangopfuura, mwero wekukura kwemari inosvika 50%.
Pakati pazvo, "gore negore matani mazana matatu eChunidine, matani mazana matatu eFluzolic Acid uye matani mazana maviri eCyclopyrimidine Acid Project" akaburitswa zvakatevedzana kubvira muna 2014.