Isishwankathelo soShishino lweMicimbi yezeMithi

Amayeza aphakathi
Ezi mveliso zibizwa ngokuba zii-pharmaceutical intermediates zizinto ezisetyenziswa kwiikhemikhali okanye iimveliso zeekhemikhali ekufuneka zisetyenziswe kwinkqubo yokwenziwa kwamayeza. Ezi mveliso zeekhemikhali zinokuveliswa kwizityalo zeekhemikhali eziqhelekileyo ngaphandle kokufumana ilayisenisi yokuveliswa kwamayeza, kwaye zingasetyenziswa ekuhlanganisweni nasekuvelisweni kwamayeza logama nje izalathisi zobugcisa zihlangabezana neemfuno ezithile zenqanaba. Nangona ukwenziwa kwamayeza kukwawela phantsi kodidi lweekhemikhali, iimfuno zingqongqo ngakumbi kunezo zeemveliso zeekhemikhali eziqhelekileyo. Abavelisi bamayeza agqityiweyo kunye nee-API kufuneka bamkele isiqinisekiso se-GMP, ngelixa abavelisi bamayeza aphakathi bengasamkeli, kuba amachiza aphakathi aseyi-synthesis kunye nemveliso yezinto ezisetyenziswa kwiikhemikhali kuphela, ezizezona mveliso zisisiseko nezisezantsi kwikhonkco lokuveliswa kwamayeza, kwaye azinakubizwa ngokuba ngamayeza okwangoku, ngoko ke azidingi isiqinisekiso se-GMP, esikwanciphisa umda wokungena kwabavelisi bamayeza aphakathi.

Ishishini leemveliso zamayeza
Iinkampani zeekhemikhali ezivelisa kwaye zicubungula ii-intermediates ze-organic/inorganic okanye ii-API zeenkampani zamayeza ukuze zenze iimveliso zamayeza ezigqityiweyo ngokwenziwa kweekhemikhali okanye kwezinto eziphilayo ngokwemigangatho engqongqo yomgangatho. Apha ii-intermediates zamayeza zahlulwe zaba zii-sub-industry ezimbini i-CMO kunye ne-CRO.

I-CMO
I-Contract Manufacturing Organisation ibhekisa kwi-contract manufacturing organization, nto leyo ethetha ukuba inkampani yamayeza inika iqabane inkqubo yokuvelisa. I-chain yeshishini le-CMO ye-pharmaceutical idla ngokuqala ngezinto ezizodwa ze-pharmaceutical. Iinkampani ezikushishino kufuneka zifumane izinto ezisisiseko ze-chemical raw kwaye zizicubungule zibe zizithako ezikhethekileyo ze-pharmaceutical, ezithi emva koko zicubungulwe zibe zizinto zokuqala ze-API, ii-cGMP intermediates, ii-API kunye nee-formulations. Okwangoku, iinkampani ezinkulu zamayeza zamazwe ngamazwe zidla ngokuseka ubudlelwane bexesha elide kunye nenani elincinci lababoneleli abaphambili, kwaye ukusinda kweenkampani kweli shishini kubonakala kakhulu ngamaqabane azo.

I-CRO
Umbutho woPhando lweSivumelwano (lweKlinikhi) ubhekisa kumbutho wophando lwesivumelwano, apho iinkampani zamayeza zithumela icandelo lophando ngaphandle kwelinye iqabane. Okwangoku, eli shishini lisekelwe kakhulu kwimveliso eyenziwe ngokwezifiso, uphando olucwangcisiweyo kunye nophando lwesivumelwano samayeza kunye nokuthengisa. Nokuba yeyiphi na indlela, nokuba imveliso ephakathi yamayeza yimveliso entsha okanye akunjalo, ukhuphiswano oluphambili lwenkampani lusagwetywa yitekhnoloji ye-R&D njengento yokuqala, ebonakala kubathengi okanye amaqabane asezantsi enkampani.

Ikhonkco lexabiso lemarike yemveliso yamayeza
Umfanekiso
(Umfanekiso ovela kwiQilu Securities)

Uluhlu lweshishini leshishini eliphakathi lamayeza
Umfanekiso
(Umfanekiso ovela kwi-China Industry Information Network)

Ulwahlulo lwe-Pharmacy Intermediates
Ii-intermediates zamayeza zinokwahlulwa zibe ziindidi ezinkulu ngokweendawo ezisetyenziswayo, ezifana nee-intermediates zamayeza okubulala iintsholongwane, ii-intermediates zamayeza okubulala iintsholongwane kunye namayeza okubulala iintlungu, ii-intermediates zamayeza enkqubo yentliziyo kunye nee-intermediates zamayeza okubulala umhlaza. Kukho iintlobo ezininzi zee-intermediates ezithile zamayeza, ezifana ne-imidazole, i-furan, ii-intermediates ze-phenolic, ii-intermediates ezinuka kamnandi, i-pyrrole, i-pyridine, ii-reagents ze-biochemical, i-sulfur-containing, i-nitrogen-containing, ii-halogen compounds, ii-heterocyclic compounds, i-starch, i-mannitol, i-microcrystalline cellulose, i-lactose, i-dextrin, i-ethylene glycol, i-sugar powder, ii-inorganic salts, ii-intermediates ze-ethanol, i-stearate, ii-amino acids, i-ethanolamine, ii-potassium salts, ii-sodium salts kunye nezinye ii-intermediates, njl.
Isishwankathelo sophuhliso lweshishini lezonyango eTshayina
Ngokutsho kwe-IMS Health Incorporated, ukususela ngo-2010 ukuya ku-2013, imakethi yamayeza yehlabathi igcine ukukhula okuzinzileyo, ukusuka kwi-US$793.6 yeebhiliyoni ngo-2010 ukuya kwi-US$899.3 yeebhiliyoni ngo-2013, kunye nemakethi yamayeza ebonisa ukukhula okukhawulezileyo ukusukela ngo-2014, ikakhulu ngenxa yemakethi yaseMelika. Nge-CAGR ye-6.14% ukusukela ngo-2010 ukuya ku-2015, imakethi yamayeza yamazwe ngamazwe kulindeleke ukuba ingene kumjikelo wokukhula okucothayo ukusukela ngo-2015 ukuya ku-2019. Nangona kunjalo, njengoko amayeza efunwa kakhulu, ukukhula okuqinisekileyo kulindeleke ukuba kube namandla kakhulu kwixesha elizayo, kunye nemakethi yehlabathi yamayeza esondela kwi-US$1.22 trillion ngo-2019.
Umfanekiso
(Umfanekiso ovela kwi-IMS Health Incorporated)
Okwangoku, ngokulungiswa ngokutsha kwemizi-mveliso kweenkampani ezinkulu zamayeza zamazwe ngamazwe, ukudluliselwa kwemveliso yamazwe ngamazwe kunye nokuphuculwa ngakumbi kolwahlulo lwabasebenzi lwamazwe ngamazwe, iTshayina ibe sisiseko esibalulekileyo semveliso ephakathi kwicandelo lemisebenzi kwihlabathi liphela kwishishini lamayeza. Ishishini lamayeza aphakathi laseTshayina lenze inkqubo epheleleyo ukusuka kuphando nophuhliso ukuya kwimveliso kunye nokuthengisa. Ukususela kuphuhliso lwamayeza aphakathi kwihlabathi, inqanaba leteknoloji yenkqubo iyonke yaseTshayina lisephantsi kakhulu, inani elikhulu lamayeza aphakathi aphambili kunye namayeza amatsha anelungelo lobunikazi axhasa amashishini emveliso aphakathi mancinci, akwinqanaba lophuhliso lokuphucula nokuphucula isakhiwo semveliso.
Ixabiso lemveliso yeshishini leekhemikhali ezisebenzisana namayeza eTshayina ukususela ngo-2011 ukuya ku-2015
Umfanekiso
(Umfanekiso ovela kwiZiko loPhando lweShishini laseTshayina)
Ngexesha lowama-2011-2015, imveliso yeshishini leekhemikhali zamayeza eTshayina ikhule minyaka le, ngowama-2013, imveliso yekhemikhali zamayeza eTshayina yayiziitoni ezingama-568,300, yathunyelwa kwamanye amazwe iitoni ezingama-65,700, ngowama-2015 imveliso yekhemikhali zamayeza eTshayina yayimalunga neetoni ezingama-676,400.
Izibalo zemveliso phakathi kwamayeza ekhemikhali aseTshayina zowama-2011-2015
Umfanekiso
(Umfanekiso ovela kwi-China Merchant Industry Research Institute)
Ukunikezelwa kwezixhobo zokuxuba amayeza eTshayina kuyabonakala kakhulu kunemfuno, kwaye ukuxhomekeka ekuthunyelweni kwamanye amazwe kuya kusanda kancinci kancinci. Nangona kunjalo, ukuthunyelwa kwamanye amazwe eTshayina kugxile kakhulu kwiimveliso ezininzi ezifana nevithamini C, ipenicillin, i-acetaminophen, i-citric acid kunye neetyuwa kunye nee-esters zayo, njl. Ezi mveliso zibonakaliswa yimveliso enkulu, amashishini amaninzi emveliso, ukhuphiswano olukhulu kwimarike, ixabiso eliphantsi lemveliso kunye nexabiso elongezelelweyo, kwaye imveliso yazo ngobuninzi ibangele imeko yokunikezelwa kwemveliso kudlule imfuno kwimarike yasekhaya yamayeza. Iimveliso ezinomxholo ophezulu wetekhnoloji zisaxhomekeke kakhulu ekuthunyelweni kwamanye amazwe.
Ukukhusela ii-amino acid zamayeza, uninzi lwamashishini emveliso yasekhaya anohlobo olunye lwemveliso kunye nomgangatho ongaguqukiyo, ikakhulu kwiinkampani zangaphandle ze-biopharmaceutical ukuze zenze ngokwezifiso imveliso yeemveliso. Kuphela ngamashishini athile anamandla ophando nophuhliso, izixhobo zemveliso eziphambili kunye namava kwimveliso enkulu anokufumana inzuzo ephezulu kukhuphiswano.
Uhlalutyo lweshishini lezonyango laseTshayina

1, inkqubo yemveliso yesiko kushishino lwamayeza aphakathi
Okokuqala, ukuthatha inxaxheba kuphando nophuhliso lwamayeza amatsha olufunwa ngumthengi, nto leyo ethetha ukuba iziko le-R & D lenkampani linamandla amakhulu okuvelisa izinto ezintsha.
Okwesibini, kuphuhliso lwemveliso oluyimvavanyo lomthengi, ukuhlangabezana nendlela yenkqubo yemveliso enkulu, efuna amandla okwandisa ubunjineli benkampani kwimveliso kunye nokukwazi ukuphucula inkqubo eqhubekayo yetekhnoloji yemveliso eyenzelwe wena kamva, ukuze kuhlangatyezwane neemfuno zemveliso yesikali semveliso, kuncitshiswe rhoqo iindleko zemveliso kwaye kuphuculwe ukukhuphisana kwemveliso.
Okwesithathu, kukwetyisa nokuphucula inkqubo yeemveliso kwinqanaba lokuveliswa kwabathengi ngobuninzi, ukuze kuhlangatyezwane nemigangatho yomgangatho yeenkampani zangaphandle.

2. Iimpawu zeshishini le-medicine laseTshayina
Ukuveliswa kwamayeza kufuna inani elikhulu leekhemikhali ezikhethekileyo, uninzi lwazo olwaluveliswa lishishini lamayeza ngokwalo, kodwa ngokwanda kokwahlulwa kwemisebenzi yoluntu kunye nenkqubela phambili yetekhnoloji yemveliso, ishishini lamayeza litshintshele ezinye iikhemikhali eziphakathi zamayeza kwiinkampani zamachiza ukuze zenziwe. Iikhemikhali eziphakathi zamayeza ziimveliso zeekhemikhali ezilungileyo, kwaye ukuveliswa kweekhemikhali eziphakathi kwamayeza kube lishishini elikhulu kushishino lwamazwe ngamazwe lweekhemikhali. Okwangoku, ishishini lamayeza laseTshayina lifuna malunga neentlobo ezingama-2 000 zezixhobo ezikrwada zeekhemikhali kunye neziphakathi minyaka le, ngemfuno engaphezulu kwe-2.5 yezigidi zeetoni. Njengoko ukuthunyelwa kwamanye amazwe kweekhemikhali eziphakathi kwamayeza ngokungafaniyo nokuthunyelwa kwamanye amazwe kwamayeza kuya kuthotyelwa yimiqathango eyahlukeneyo kumazwe angenisa amayeza, kunye nemveliso yehlabathi yeekhemikhali eziphakathi kwamayeza kumazwe asaphuhlayo, iimfuno zangoku zemveliso yamayeza aseTshayina zezinto ezikrwada zeekhemikhali kunye neziphakathi zinokulingana, inxalenye encinci kuphela yesidingo sokungenisa. Kwaye ngenxa yezixhobo ezininzi zaseTshayina, amaxabiso ezinto ezikrwada aphantsi, kukho iikhemikhali eziphakathi ezininzi ezikwazileyo ukuthengisa kwamanye amazwe.

Okwangoku, iTshayina ifuna izinto ezisetyenziswa ngamakhemikhali kunye nezinto ezisetyenziswa ngamachiza ezingaphezulu kwama-2500, imfuno yonyaka ifikelele kwi-11.35 yezigidi zeetoni. Emva kweminyaka engaphezu kwama-30 yophuhliso, iimfuno zemveliso yamayeza zaseTshayina zezinto ezisetyenziswa ngamachiza kunye nezinto ezisetyenziswa ngamayeza ziye zakwazi ukulingana. Imveliso yezinto ezisetyenziswa ngamayeza eTshayina ikakhulu ikwimithi yokulwa neentsholongwane kunye neyokulwa ne-pyretic.

Kuyo yonke le shishini, ishishini leemveliso zamayeza eTshayina lineempawu ezintandathu: Okokuqala, uninzi lwamashishini ngamashishini abucala, ukusebenza okuguquguqukayo, isikali sotyalo-mali asisikhulu, ngokuyintloko siphakathi kwezigidi ukuya kwi-yuan enye okanye ezimbini zezigidi; Okwesibini, ukusasazwa kweendawo zamashishini kugxile kakhulu, ikakhulu eTaizhou, kwiPhondo laseZhejiang naseJintan, kwiPhondo laseJiangsu njengesikhungo; Okwesithathu, njengoko ilizwe ligxininisa ngakumbi kukhuseleko lokusingqongileyo, uxinzelelo kumashishini okwakha izibonelelo zonyango lokhuseleko lokusingqongileyo luyanda Okwesine, isantya sokuvuselelwa kwemveliso sikhawuleza, kwaye umda wenzuzo uya kwehla kakhulu emva kweminyaka emi-3 ukuya kwemi-5 kwimarike, nto leyo enyanzela amashishini ukuba aphuhlise iimveliso ezintsha okanye aphucule inkqubo ngokuqhubekayo ukuze afumane inzuzo ephezulu; Okwesihlanu, ekubeni inzuzo yemveliso ye-pharmaceutical intermediates iphezulu kuneyeemveliso zeekhemikhali eziqhelekileyo, kwaye inkqubo yemveliso iyafana, amashishini amancinci amaninzi amachiza ajoyina uluhlu lokuvelisa i-pharmaceutical intermediates, nto leyo ekhokelela kukhuphiswano olunzima ngakumbi kushishino. Okwesithandathu, xa kuthelekiswa ne-API, umda wenzuzo yokuvelisa i-pharmaceutical intermediates uphantsi, kwaye inkqubo yemveliso ye-API kunye ne-pharmaceutical intermediates iyafana, ngoko amanye amashishini awavelisi nje kuphela i-pharmaceutical intermediates, kodwa asebenzisa neenzuzo zawo ukuqala ukuvelisa i-API. Iingcali zibonise ukuba ukuveliswa kwe-pharmaceutical intermediates kwicala lophuhliso lwe-API ngumkhwa ongenakuphepheka. Nangona kunjalo, ngenxa yokusetyenziswa kwe-API kanye, ziinkampani zamayeza ezinempembelelo enkulu, amashishini asekhaya ahlala ephuhlisa iimveliso kodwa akukho basebenzisi bale nto. Ke ngoko, abavelisi kufuneka baseke ubudlelwane obuzinzileyo bexesha elide neenkampani zamayeza, ukuze kuqinisekiswe ukuthengiswa kwemveliso okugudileyo.

3, imiqobo yokungena kushishino
①Iingxaki zabathengi
Ishishini lamayeza lilawulwa ziinkampani ezimbalwa zamayeza zamazwe ngamazwe. Iingcali zamayeza zilumkile kakhulu ekukhetheni ababoneleli beenkonzo zokuthumela ngaphandle kwaye ngokubanzi zinexesha elide lokuhlolwa kwababoneleli abatsha. Iinkampani ze-CMO zamayeza kufuneka zihlangabezane neendlela zonxibelelwano zabathengi abahlukeneyo, kwaye kufuneka zenze uvavanyo oluqhubekayo ixesha elide ngaphambi kokuba zifumane ukuthenjwa ngabathengi abasezantsi, kwaye emva koko zibe ngababoneleli bazo abaphambili.
②Imiqobo yobugcisa
Ukukwazi ukubonelela ngeenkonzo zobuchwepheshe obuphezulu yeyona nto ibalulekileyo kwinkampani yeenkonzo zokuthumela amayeza ngaphandle. Iinkampani ze-CMO zamayeza kufuneka zigqithe kwiingxaki zobugcisa okanye imiqobo kwiindlela zazo zokuqala kwaye zibonelele ngeendlela zokuphucula inkqubo yamayeza ukuze kuncitshiswe ngempumelelo iindleko zokuvelisa amayeza. Ngaphandle kotyalo-mali lwexesha elide, olubiza kakhulu kuphando nophuhliso kunye nokugcinwa kwetekhnoloji, kunzima kwiinkampani ezingaphandle kweshishini ukungena ngokwenene kwishishini.
③Iingxaki zetalente
Kunzima kwiinkampani ze-CMO ukwakha iqela le-R&D nelemveliso elikhuphisanayo ngexesha elifutshane ukuze kusekwe imodeli yeshishini ehambelana ne-cGMP.
④Imiqobo yokulawula umgangatho
I-FDA kunye nezinye ii-arhente ezilawula amayeza ziye zaba ngqongqo ngakumbi kwiimfuno zazo zolawulo lomgangatho, kwaye iimveliso ezingaphumeleliyo kuhlolo azinakungena kwiimarike zamazwe angenisa amayeza.
⑤ Imiqobo yokulawula okusingqongileyo
Iinkampani zamayeza ezineenkqubo eziphelelwe lixesha ziya kuthwala iindleko eziphezulu zokulawula ungcoliseko kunye noxinzelelo lolawulo, kwaye iinkampani zamayeza zemveli ezivelisa ikakhulu ungcoliseko oluphezulu, ukusetyenziswa kwamandla aphezulu kunye neemveliso ezinexabiso eliphantsi (umz. i-penicillin, iivithamini, njl.njl.) ziya kujongana nokupheliswa ngokukhawuleza. Ukunamathela kwimveliso entsha kunye nokuphuhlisa iteknoloji yamayeza eluhlaza kuye kwaba yindlela yophuhliso lwexesha elizayo kwishishini lamayeza i-CMO.

4. Amashishini adweliswe kwiinkampani zamayeza aphakathi zasekhaya
Ukusuka kwindawo yecandelo leshishini, iinkampani ezi-6 ezidwelisiweyo zeekhemikhali ezintle ezivelisa amayeza aphakathi zonke zisezantsi kwikhonkco leshishini. Nokuba ngababoneleli ngeenkonzo abangochwephesha okanye ulwandiso lwe-API kunye nokwakheka, amandla obuchwephesha ngawona aqhuba rhoqo.
Ngokuphathelele amandla etekhnoloji, iinkampani ezinetekhnoloji ekhokelayo kwihlabathi liphela, amandla amakhulu okugcina imali kunye notyalo-mali oluphezulu kwi-R&D ziyathandwa.
Iqela I: I-Lianhua Technology kunye ne-Arbonne Chemical. I-Lianhua Technology ineetekhnoloji ezisibhozo eziphambili ezifana ne-ammonia oxidation kunye ne-fluorination njengesiseko sayo setekhnoloji, apho i-hydrogen oxidation ikwinqanaba eliphambili lamazwe ngamazwe. I-Abenomics yinkokeli yamazwe ngamazwe kwiziyobisi ze-chiral, ingakumbi kubuchwepheshe bayo bokuqhekeka kweekhemikhali kunye nokwahlulahlula, kwaye inotyalo-mali oluphezulu lwe-R&D, olune-6.4% yengeniso.
Iqela lesiBini: iWanchang Technology kunye neYongtai Technology. Indlela yeWanchang Technology ye-hydrocyanic acid yegesi elahliweyo yeyona nkqubo iphantsi kakhulu neyona iphambili yokuvelisa ii-esters ze-prototrizoic acid. Kwelinye icala, iYongtai Technology yaziwa ngeekhemikhali zayo ezintle ze-fluorine.
Iqela lesiThathu: iTianma Fine Chemical kunye neBikang (eyayisaziwa ngokuba yiJiuzhang).
Uthelekiso lwamandla obuchwephesha eenkampani ezidwelisiweyo
Umfanekiso
Uthelekiso lwabathengi kunye neemodeli zokuthengisa zeenkampani ezidityanisiweyo zamayeza
Umfanekiso
Uthelekiso lwemfuno esezantsi kunye nomjikelo wobomi belungelo elilodwa lomenzi weemveliso zeenkampani ezidwelisiweyo
Imifanekiso
Uhlalutyo lokukhuphisana kwemveliso yeenkampani ezidwelisiweyo
Imifanekiso
Indlela yokuphucula izixhobo ezisetyenziswa kwiikhemikhali ezincinci
Imifanekiso
(Imifanekiso kunye nezinto ezikwiQilu Securities)
Amathemba ophuhliso lweshishini lezonyango laseTshayina
Njengoshishino olubalulekileyo kwicandelo leekhemikhali ezintle, imveliso yamayeza iye yaba yinto ephambili kuphuhliso nakukhuphiswano kwiminyaka eli-10 edlulileyo, ngenkqubela phambili yesayensi netekhnoloji, amayeza amaninzi aye aphuhliswa ngokuqhubekayo ukuze kuzuze uluntu, ukwenziwa kwala mayeza kuxhomekeke ekuvelisweni kwamayeza amatsha, asemgangathweni ophezulu, ngoko ke amayeza amatsha akhuselwe ziipatenti, ngelixa amayeza aphakathi nawo engenazo iingxaki, ngoko ke amayeza amatsha aphakathi ekhaya nakwamanye amazwe Indawo yophuhliso lwemarike kunye nethuba lokusetyenziswa lithembisa kakhulu.
Imifanekiso

Okwangoku, indlela yophando lwezihlanganisi zamayeza ibonakala kakhulu ekuqulunqweni kweekhompawundi ze-heterocyclic, iikhompawundi ezine-fluorine, iikhompawundi ze-chiral, iikhompawundi zebhayoloji, njl. Kusekho umsantsa othile phakathi kophuhliso lwezihlanganisi zamayeza kunye neemfuno zoshishino lwamayeza eTshayina. Ezinye iimveliso ezineemfuno zobugcisa eziphezulu azinakucwangciswa ukuba zenziwe eTshayina kwaye ngokusisiseko zixhomekeke ekungenisweni kwamanye amazwe, njenge-anhydrous piperazine, i-propionic acid, njl. Nangona ezinye iimveliso zinokuhlangabezana neemfuno zoshishino lwamayeza lwasekhaya ngokwenani, kodwa iindleko eziphezulu kunye nomgangatho azifikeleli kumgangatho ofanelekileyo, nto leyo echaphazela ukukhuphisana kweemveliso zamayeza kwaye kufuneka kuphuculwe inkqubo yemveliso, efana ne-TMB, i-p-aminophenol, i-D-PHPG, njl.
Kulindeleke ukuba kwiminyaka embalwa ezayo, uphando olutsha lweziyobisi kwihlabathi luza kugxila kwiindidi ezilishumi zamayeza alandelayo: amayeza okuphucula ukusebenza kobuchopho, amayeza okulwa nesifo samathambo, amayeza okulwa ne-AIDS, amayeza okulwa ne-hepatitis kunye namanye amayeza e-viral, amayeza okwehlisa amafutha, amayeza okulwa ne-thrombotic, amayeza okulwa ne-tumor, amayeza avuselela iiplatelet, izikhuthazi zentliziyo ze-glycoside, amayeza okudakumba, amayeza okulwa nesifo sengqondo kunye nokulwa nokuxhalaba, njl. Ukuze la mayeza aphuhlise amayeza awo aphakathi, yindlela yophuhliso lwexesha elizayo lweziyobisi zamayeza kunye nendlela ebalulekileyo yokwandisa indawo entsha yemarike.