Ongororo yeIndasitiri yeMishonga yepakati

Mishonga yepakati
Zvinonzi mishonga yemishonga yepakati (pharmaceutical intermediates) zvinhu zvemakemikari kana zvigadzirwa zvemakemikari zvinoda kushandiswa mukugadzirwa kwemishonga. Izvi zvigadzirwa zvemakemikari zvinogona kugadzirwa mumiti yemakemikari yakajairika pasina kuwana rezenisi yekugadzira mishonga, uye zvinogona kushandiswa mukugadzirwa kwemishonga chero bedzi zviratidzo zvehunyanzvi zvichisangana nezvinodiwa. Kunyangwe kugadzirwa kwemishonga kuchiwirawo pasi pechikamu chemakemikari, zvinodiwa zvakanyanya kupfuura zvezvigadzirwa zvemakemikari zvakajairika. Vagadziri vemishonga yakapedzwa uye maAPI vanofanirwa kugamuchira GMP certification, nepo vagadziri vemishonga yepakati vasingagamuchire, nekuti mishonga yepakati ichiri kugadzirwa kwemakemikari chete, izvo zviri zvigadzirwa zvepasi uye zvepasi muketani yekugadzira mishonga, uye hazvigone kunzi mishonga parizvino, saka havadi GMP certification, iyo inoderedzawo mukana wekupinda wevagadziri vemishonga yepakati.

Indasitiri yemishonga yepakati
Makambani emakemikari anogadzira uye anogadzira zvinhu zvemukati zve organic/inorganic kana ma API emakambani emishonga ekugadzira zvigadzirwa zvemishonga zvakagadzirwa nemakemikari kana zve biological zvichienderana nemazinga emhando yepamusoro. Pano zvinhu zvemukati zvemishonga zvakakamurwa kuita ma sub-industry maviri CMO neCRO.

CMO
Sangano rekugadzira Zvibvumirano (Contract Manufacturing Organization) rinoreva sangano rekugadzira zvibvumirano, zvinoreva kuti kambani yemishonga inopa kambani yemishonga basa rekugadzira kune mumwe mushandi. Bhizinesi rekambani yeCMO yemishonga rinowanzotanga nezvinhu zvemishonga zvemhando yepamusoro. Makambani ari muindasitiri iyi anofanirwa kuwana zvinhu zvemakemikari zvekutanga uye kuzvigadzira kuita zvinhu zvemishonga zvemhando yepamusoro, izvo zvinozogadzirwa kuita zvinhu zvekutanga zveAPI, cGMP intermediates, APIs uye formulations. Parizvino, makambani makuru emishonga epasi rose anowanzo gadzira hukama hwenguva refu nevatengesi vashoma, uye kurarama kwemakambani muindasitiri iyi kunoonekwa zvakanyanya kuburikidza nevabatsiri vavo.

CRO
Sangano reKutsvagisa reContract (Clinical) rinoreva sangano rekutsvaga zvibvumirano, uko makambani emishonga anopa chikamu chekutsvagisa kune mumwe mubatsiri. Parizvino, indasitiri iyi inonyanya kutsamira pakugadzira zvinhu zvakagadzirwa nemaoko, R&D yakagadzirwa nemaoko uye tsvakiridzo yezvibvumirano zvemishonga uye kutengesa. Pasinei nenzira ipi, ingave chigadzirwa chepakati chemishonga chigadzirwa chitsva kana kwete, kukwikwidzana kukuru kwekambani kuchiri kutongwa netekinoroji yeR&D sechinhu chekutanga, icho chinoratidzwa muvatengi vekambani kana vadyidzani.

ketani yemutengo wezvigadzirwa zvemishonga pamusika
Mufananidzo
(Mufananidzo kubva kuQilu Securities)

Cheni yeindasitiri yeindasitiri yemishonga pakati pemishonga
Mufananidzo
(Mufananidzo kubva kuChina Industry Information Network)

Kupatsanurwa kwemishonga pakati pemishonga
Mishonga inogona kukamurwa kuita zvikamu zvikuru zvichienderana nenzvimbo dzekushandisa, dzakadai semishonga inorwisa mabhakitiriya, mishonga inorwisa hutachiona uye inonyaradza marwadzo, mishonga inorwisa mwoyo uye mishonga inorwisa kenza. Kune mhando dzakawanda dzemishonga inorwisa kenza, dzakadai seimidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycol, sugar powder, inorganic salts, ethanol intermediates, stearate, amino acids, ethanolamine, potassium salts, sodium salts nezvimwe zvinorwisa kenza, nezvimwewo.
Pfupiso yekuvandudzwa kweindasitiri yemishonga muChina
Sekureva kweIMS Health Incorporated, kubva muna 2010 kusvika 2013, musika wepasi rose wemishonga wakaramba uchikura zvakadzikama, kubva paUS$793.6 bhiriyoni muna 2010 kusvika paUS$899.3 bhiriyoni muna 2013, musika wemishonga uchikura nekukurumidza kubva muna 2014, kunyanya nekuda kwemusika weUS. NeCAGR ye6.14% kubva muna 2010-2015, musika wepasi rose wemishonga unotarisirwa kupinda muchikamu chekukura zvishoma nezvishoma kubva muna 2015-2019. Zvisinei, sezvo mishonga iri kudiwa zvakanyanya, kukura kwakazara kunotarisirwa kuve kwakasimba mune ramangwana, nemusika wepasi rose wemishonga uri kusvika paUS$1.22 trillion panosvika 2019.
Mufananidzo
(Mufananidzo kubva kuIMS Health Incorporated)
Parizvino, nekugadziriswazve kwemaindasitiri kwemakambani makuru emishonga epasi rose, kutamiswa kwekugadzirwa kwenyika dzakawanda uye kugadziridzwa kwechikamu chevashandi chepasi rose, China yave nzvimbo yakakosha yekugadzira pakati nepakati muchikamu chevashandi chepasi rose muindasitiri yemishonga. Indasitiri yemishonga yepakati peChina yakagadzira hurongwa hwakakwana kubva pakutsvagisa nekuvandudza kusvika pakugadzira nekutengesa. Kubva pakuvandudzwa kwemishonga yepasi rose, nhanho yehunyanzvi hwemaitiro eChina ichiri yakaderera, nhamba huru yemishonga yepamusoro uye mishonga mitsva yepatenti inotsigira mishonga yepakati madiki, iri muchikamu chekuvandudza nekugadzirisa chimiro chechigadzirwa.
Kukosha kwekugadzirwa kweindasitiri yemishonga yemakemikari muChina kubva muna 2011 kusvika 2015
Mufananidzo
(Mufananidzo kubva kuChina Business Industry Research Institute)
Munguva ya2011-2015, kugadzirwa kwemishonga yemakemikari muChina kwakawedzera gore negore, muna 2013, kugadzirwa kwemishonga yemakemikari muChina kwaive matani 568,300, kutengeswa kunze kwenyika matani 65,700, pakasvika gore ra2015 kugadzirwa kwemishonga yemakemikari muChina kwaive matani angangoita 676,400.
Nhamba dzekugadzirwa kwemishonga yemakemikari yeChina kubva muna 2011 kusvika 2015
Mufananidzo
(Mufananidzo kubva kuChina Merchant Industry Research Institute)
Kuwanikwa kwemishonga yepakati muChina kwave kuzivikanwa kupfuura kudiwa, uye kuvimba nekutengesa kunze kwenyika kuri kuwedzera zvishoma nezvishoma. Zvisinei, zvinhu zvinotengeswa kunze kwenyika muChina zvinonyanya kusanganisirwa muzvigadzirwa zvakawanda zvakaita sevhitamini C, penicillin, acetaminophen, citric acid nemunyu wayo nemaesters, nezvimwewo. Zvigadzirwa izvi zvinoonekwa nekubuda kwezvigadzirwa zvakawanda, mabhizinesi akawanda ekugadzira, makwikwi emusika akasimba, mutengo wakaderera wezvigadzirwa uye kukosha kwakawedzerwa, uye kugadzirwa kwazvo kwakakonzera mamiriro ekuwanikwa kwezvinhu kupfuura kudiwa mumusika wemishonga yepakati. Zvigadzirwa zvine tekinoroji yepamusoro zvichiri kunyanya kuvimba nekutenga zvinhu zvinotengeswa kunze kwenyika.
Kuti zvidzivirire mishonga yemishonga ye amino acid, makambani mazhinji ekugadzira mishonga yemuno ane mhando imwe chete yezvigadzirwa uye mhando isina kugadzikana, kunyanya makambani ekunze emishonga ye biopharmaceutical anogadzirisa kugadzirwa kwezvigadzirwa. Mamwe makambani chete ane simba rakasimba rekutsvagisa nekusimudzira, nzvimbo dzekugadzira dzepamusoro uye ruzivo mukugadzira zvinhu zvakakura ndiwo anogona kuwana purofiti yakawanda mumakwikwi.
Kuongororwa kweindasitiri yemishonga yepakati peChina

1, maitiro ekugadzira mishonga yepakati pemishonga
Chekutanga, kutora chikamu mukutsvaga nekugadzira mishonga mitsva yemutengi, izvo zvinoda kuti nzvimbo yeR & D yekambani ive nehunyanzvi hwakasimba hwekugadzira zvinhu zvitsva.
Chechipiri, kuwedzera chigadzirwa chemutengi, kusangana nenzira yekugadzirwa kukuru, izvo zvinoda kugona kwekambani kuwedzera chigadzirwa uye kugona kwekuvandudza tekinoroji yechigadzirwa yakagadziridzwa panguva inotevera, kuitira kuti zvizadzise zvinodiwa pakugadzirwa kwechigadzirwa, kuderedza mutengo wekugadzira nguva dzose uye kuwedzera kukwikwidza kwechigadzirwa.
Chechitatu, ndechekufungisisa nekuvandudza maitiro ezvigadzirwa panguva yekugadzirwa kwevatengi vakawanda, kuitira kuti zvienderane nezvinodiwa nemakambani ekunze.

2. Hunhu hweindasitiri yemishonga yepakati peChina
Kugadzirwa kwemishonga kunoda huwandu hwakawanda hwemakemikari akakosha, mazhinji acho aigadzirwa neindasitiri yemishonga pachayo, asi nekuwanda kwekupatsanurwa kwevashandi munharaunda uye kufambira mberi kwetekinoroji yekugadzira, indasitiri yemishonga yakaendesa mamwe maindasitiri emishonga kumakambani emakemikari kuti agadzire. Makambani emishonga anogadzira mishonga zvigadzirwa zvemakemikari zvakanaka, uye kugadzirwa kwemakambani emishonga kwave indasitiri huru muindasitiri yemakemikari yepasi rose. Parizvino, indasitiri yemishonga yeChina inoda mhando dzezvinhu zvemakemikari nezvinosanganisa zvemakemikari dzinosvika 2,000 gore rega rega, zvichidikanwa matani anopfuura mamiriyoni 2.5. Sezvo kutengeswa kwemishonga kunze kwenyika kusiyana nekutengeswa kwemishonga kunze kwenyika kuchave pasi pezvirambidzo zvakasiyana munyika dzinopinza, pamwe nekugadzirwa kwemishonga pasi rose kunyika dzichiri kusimukira, zvinodiwa pari zvino zvekugadzira mishonga yeChina yezvinhu zvemakemikari nezvinosanganisa zvinogona kuenzana, chikamu chidiki chete chekudiwa kwekupinza. Uye nekuda kwezviwanikwa zvakawanda zveChina, mitengo yezvinhu zvekugadzira yakaderera, kune akawanda maindasitiri emishonga akabudirirawo kutengesa zvinhu zvakawanda kunze kwenyika.

Parizvino, China inoda zvinhu zvemakemikari zvinotsigira mishonga uye zvinhu zvepakati zvinodarika 2500, uye kudiwa kwegore negore kwakasvika matani mamiriyoni 11.35. Mushure memakore anopfuura makumi matatu ekuvandudzwa, zvinodiwa neChina pakugadzira mishonga yezvinhu zvemakemikari uye zvinhu zvepakati zvakakwanisa kuenzana. Kugadzirwa kwezvinhu zvepakati muChina kunonyanya kuwanikwa mumishonga inorwisa mabhakitiriya uye inorwisa hutachiona.

Muindasitiri yese, indasitiri yemishonga yeChina ine zvinhu zvitanhatu: Chekutanga, makambani mazhinji ndeemakambani akazvimirira, mashandiro anochinjika, chiyero chekudyara hachina kukura, chiri pakati pemamiriyoni kusvika kumamiriyoni zviuru zviviri zveyuan; Chechipiri, kupararira kwemakambani munzvimbo dzakasiyana-siyana kwakabatana zvakanyanya, kunyanya muTaizhou, Zhejiang Province neJintan, Jiangsu Province senzvimbo iri pakati; Chechitatu, nekuwedzera kwekutarisa kwekuchengetedza nharaunda munyika, kumanikidzwa kwemakambani kuvaka nzvimbo dzekuchengetedza nharaunda kuri kuwedzera Chechina, kukurumidza kwekuvandudzwa kwechigadzirwa kuri kukurumidza, uye purofiti ichadzikira zvakanyanya mushure memakore matatu kusvika mashanu mumusika, zvichimanikidza makambani kugadzira zvigadzirwa zvitsva kana kuvandudza maitiro acho nguva dzose kuitira kuti awane purofiti yakakwira; Cheshanu, sezvo purofiti yekugadzirwa kwemishonga inopindirana nemakemikari yakakwira kupfuura yezvigadzirwa zvemakemikari zvakajairika, uye maitiro ekugadzira akafanana, makambani madiki emakemikari akawanda anobatanidzwa mukugadzira mishonga inopindirana nemakemikari, zvichikonzera kukwikwidzana kwakanyanya muindasitiri. Chetanhatu, zvichienzaniswa neAPI, purofiti yekugadzirwa kwemishonga inopindirana yakaderera, uye maitiro ekugadzira eAPI nemishonga inopindirana akafanana, saka mamwe mabhizinesi haangogadziri mishonga inopindirana chete, asi anoshandisawo zvakanakira zvavo kutanga kugadzira API. Nyanzvi dzakataura kuti kugadzirwa kwemishonga inopindirana nekutungamira kwekuvandudzwa kweAPI inzira isingadzivisike. Nekudaro, nekuda kwekushandiswa kamwe chete kweAPI, nemakambani emishonga ane simba guru, mabhizinesi emuno anowanzo gadzira zvigadzirwa asi pasina vashandisi vechiitiko ichi. Naizvozvo, vagadziri vanofanirwa kugadzira hukama hwakagadzikana kwenguva refu hwekugovera nemakambani emishonga, kuitira kuve nechokwadi chekutengesa zvigadzirwa zvakanaka.

3, zvipingamupinyi zvekupinda muindasitiri
①Zvipingamupinyi zvevatengi
Indasitiri yemishonga inotongwa nemakambani mashoma emishonga epasi rose. Makambani emishonga anongwarira zvikuru pakusarudza kwavo vanopa mabasa ekunze uye kazhinji vane nguva yakareba yekuongorora vatengesi vatsva. Makambani eCMO emishonga anofanirwa kusangana nemaitiro ekutaurirana evatengi vakasiyana, uye anofanira kuenderera mberi nekuongororwa vasati vawana kuvimba nevatengi vari pasi, uye vozova vatengesi vavo vakuru.
②Zvipingamupinyi zvehunyanzvi
Kugona kupa mabasa ehunyanzvi hwepamusoro ndiyo musimboti wekambani inopa rubatsiro rwemishonga kune dzimwe nzvimbo. Makambani eCMO emishonga anofanirwa kupinda mumatambudziko ehunyanzvi kana kuvharika kwenzira dzavo dzekutanga uye kupa nzira dzekugadzirisa maitiro emishonga kuti aderedze zvinobudirira mari yekugadzira mishonga. Pasina mari yakareba uye inodhura mukutsvaga nekuvandudza uye kuchengetedza tekinoroji, zvinonetsa kuti makambani ari kunze kweindasitiri apinde muindasitiri zvechokwadi.
③Zvipingamupinyi zvetarenda
Zvakaoma kuti makambani eCMO avake timu yemakwikwi yeR&D nekugadzira zvinhu munguva pfupi kuti vagadzire modhi yebhizinesi inoenderana necGMP.
④Zvipingamupinyi zvemitemo yemhando yepamusoro
FDA nedzimwe nzvimbo dzinoona nezvemishonga dzava kuramba dzichiomesa mitemo yavo panyaya dzehunhu, uye zvigadzirwa zvisingapfuure ongororo hazvigone kupinda mumisika yenyika dzinotenga mishonga.
⑤ Zvipingamupinyi zvemitemo yezvakatipoteredza
Makambani emishonga ane maitiro ekare achabhadhara mari yakawanda yekudzora kusvibiswa uye kumanikidzwa kwemutemo, uye makambani emishonga echinyakare anonyanya kugadzira kusvibiswa kwakanyanya, kushandisa simba rakawanda uye zvigadzirwa zvine kukosha kushoma (semuenzaniso penicillin, mavhitamini, nezvimwewo) achakurumidza kubviswa. Kutevedzera hunyanzvi hwekugadzira uye kugadzira tekinoroji yemishonga yakasvibirira kwave kuri kutungamira kweramangwana reindasitiri yeCMO yemishonga.

4. Makambani akanyorwa mumakambani emishonga emuno
Kubva panzvimbo yekambani yeindasitiri, makambani matanhatu akanyorwa emakemikari akanaka anogadzira mishonga yemishonga ari pasi pekambani yeindasitiri. Ingava kambani inopa mabasa ekunze kana kuti API nekuwedzera kugadzirwa, simba rehunyanzvi ndiro simba guru rinoramba riripo.
Panyaya yekusimba kwetekinoroji, makambani ane tekinoroji iri pamberi pasi rose, simba rakasimba rekuchengetedza uye mari yakawanda muR&D ndiwo anofarirwa.
Boka I: Lianhua Technology neArbonne Chemical. Lianhua Technology ine matekinoroji masere makuru akadai seammonia oxidation nefluorination senzvimbo yayo yetekinoroji, iyo hydrogen oxidation iri pamberi pasi rose. Abenomics inotungamira pasi rose mumishonga yechiral, kunyanya mumatekinoroji ayo ekuparadzanisa makemikari neracemization, uye ine mari yakawanda yekudyara muR&D, ichiwana 6.4% yemari inowanikwa.
Boka Rechipiri: Wanchang Technology neYongtai Technology. Nzira yeWanchang Technology yekushandisa gasi rakaora inonzi hydrocyanic acid ndiyo nzira inodhura zvishoma uye yepamusoro-soro yekugadzira maester eprototrizoic acid. Kune rumwe rutivi, Yongtai Technology inozivikanwa nemakemikari ayo efluorine fine.
Boka rechitatu: Tianma Fine Chemical neBikang (yaimbozivikanwa seJiuzhang).
Kuenzanisa simba rehunyanzvi remakambani akanyorwa
Mufananidzo
Kuenzanisa kwevatengi uye mamodheru ekushambadzira emakambani akanyorwa emishonga pakati pemakambani
Mufananidzo
Kuenzanisa kwezvinodiwa zviri pasi uye hupenyu hwepatent hwezvigadzirwa zvemakambani akanyorwa
Mifananidzo
Kuongororwa kwemakwikwi ezvigadzirwa zvemakambani akanyorwa
Mifananidzo
Nzira yekuvandudza michina yakanaka yemakemikari
Mifananidzo
(Mifananidzo nezvinhu zvakatorwa kubva kuQilu Securities)
Mikana yekuvandudza indasitiri yemishonga yepakati peChina
Seindasitiri yakakosha mumunda weindasitiri yemakemikari akanaka, kugadzirwa kwemishonga kwave kuri chinhu chinonyanya kukwezva makwikwi mumakore gumi apfuura, nekufambira mberi kwesainzi netekinoroji, mishonga yakawanda yave ichigadzirwa nguva dzose kuti ibatsire vanhu, kugadzirwa kwemishonga iyi kunoenderana nekugadzirwa kwemishonga mitsva, yepamusoro-soro, saka mishonga mitsva inodzivirirwa nemapatenti, nepo mishonga mitsva isina matambudziko, saka mishonga mitsva yemishonga iri mukati menyika nekunze kwenyika Nzvimbo yekuvandudza musika uye mukana wekushandisa zvinovimbisa zvikuru.
Mifananidzo

Parizvino, nzira yekutsvagisa yemishonga inopindirana nayo inonyanya kuratidzwa mukugadzirwa kwemakemikari ane heterocyclic, makemikari ane fluorine, makemikari echiral, makemikari ebhayoloji, nezvimwewo. Pachine musiyano pakati pekuvandudzwa kwemishonga inopindirana nezvinodiwa neindasitiri yemishonga muChina. Zvimwe zvigadzirwa zvine zvinodiwa zvehunyanzvi hwepamusoro hazvigone kurongeka kuti zvigadzirwe muChina uye zvinonyanya kuvimba nekutenga kunze kwenyika, senge anhydrous piperazine, propionic acid, nezvimwewo. Kunyangwe zvimwe zvigadzirwa zvichigona kusangana nezvinodiwa neindasitiri yemishonga yemuno maererano nehuwandu, asi mutengo wakakwira uye mhando hazvisi kusvika padanho rakajairika, izvo zvinokanganisa kukwikwidzana kwezvigadzirwa zvemishonga uye zvinoda kuvandudza maitiro ekugadzira, senge TMB, p-aminophenol, D-PHPG, nezvimwewo.
Zvinotarisirwa kuti mumakore mashoma anotevera, tsvakiridzo itsva yemishonga pasi rose ichatarisa pamhando gumi dzemishonga dzinotevera: mishonga yekuvandudza mashandiro europi, mishonga yekurapa arthritis, mishonga yeAIDS, mishonga yekudzivirira hepatitis nemimwe mishonga yehutachiona, mishonga yekuderedza mafuta mumuviri, mishonga yekudzivirira thrombosis, mishonga yekudzivirira bundu, mishonga yekudzivirira platelet-activating factor antagonists, glycoside cardiac stimulants, mishonga yekudzivirira kuora mwoyo, mishonga yekudzivirira psychotic uye yekudzivirira kuzvidya mwoyo, nezvimwewo. Kuti mishonga iyi igadzire mishonga yayo yepakati ndiyo nzira yekuvandudza mishonga yepakati mune ramangwana uye nzira yakakosha yekuwedzera nzvimbo itsva yemusika.