I-MIT-Ivy Industry lishishini eliphakathi lamayeza kunye neekhemikhali elidibanisa imveliso, intengiso kunye nophando lwesayensi. Ngezixhobo zemveliso eziphambili kunye netekhnoloji yemveliso, sigcina ubudlelwane obuhle bentsebenziswano namaziko ophando lwesayensi kunye neeyunivesithi ezinkulu neziphakathi. Sibandakanyeka kakhulu ekuveliseni nasekuthengiseni uthotho lwezixhobo zeyeza, ngakumbi kunyango lwe-AIDS, amayeza entliziyo kunye nemithambo yegazi, kunye nokuxhasa izixhobo zeyeza ezichasene nokuvuvukala. Iimveliso ze-sodium azide, i-triphenyl chloromethane, i-L-valine methyl ester hydrochloride zithengiswa ekhaya nakwamanye amazwe.1. Ukwaziswa kwezixhobo zeyeza. Izixhobo zeyeza zibhekisa kwiimveliso zexesha eliphakathi ezifana nezinto eziluhlaza, izixhobo kunye nezinto ezincedisayo ezisetyenziswa ekuveliseni iimveliso zeyeza. Enyanisweni, zezinye zezinto zekhemikhali okanye iimveliso zekhemikhali kwinkqubo yokwenziwa kwamayeza.UmfanekisoAbavelisi bamayeza abucala kunye nezinto ezisebenzayo zamayeza kufuneka bamkele isiqinisekiso se-GMP. Izixhobo zeyeza, nangona zisetyenziswa ekuveliseni amayeza, ngokuyintloko zizinto zokwenziwa kunye nokuveliswa kwezinto zekhemikhali eziluhlaza. Zezona mveliso zisisiseko nezisezantsi kwikhonkco lemveliso yamayeza kwaye azinakuthiwa ngamayeza, ngoko ke isiqinisekiso se-GMP asifuneki. Izinto eziphakathi zamayeza zinokuveliswa kwizityalo zekhemikhali eziqhelekileyo kwaye zingasetyenziswa ekuhlanganiseni iimveliso zamayeza kumanqanaba athile. Oku kunciphisa umda wokungena kushishino lwabavelisi abaphakathi. Umfanekiso2. Ubungakanani beshishini leemveliso zamayeza Ngokulungiswa kwesakhiwo semizi-mveliso, ukudluliselwa kwemveliso yamazwe ngamazwe kunye nokuphuculwa ngakumbi kohlu lwabasebenzi bamazwe ngamazwe kwiinkampani ezinkulu zamayeza zamazwe ngamazwe, iTshayina ibe sisiseko esibalulekileyo semveliso yamayeza kwihlabathi liphela kwicandelo labasebenzi bemveliso yamayeza. NgokweNgxelo yoPhando malunga noPhuhliso lweShishini leeMveliso zamayeza zaseTshayina (2016), ukusuka ngo-2011 ukuya ku-2015, ishishini leemveliso zamayeza zaseTshayina kunye nexabiso lazo lilonke lemveliso landa unyaka nonyaka, kunye nezinga lokukhula lonyaka elimalunga ne-13.5%. Phakathi kwazo, ixabiso lilonke lemveliso yezixhobo zamayeza eTshayina lifikelele kwi-422.56 yeebhiliyoni zeeyuan ngo-2015, ukunyuka kwe-9.88% ngonyaka. Imveliso yeshishini ifikelele kwi-17.2 yezigidi zeetoni, inyuke nge-10.26 yeepesenti ngonyaka. Ixabiso lemveliso yeshishini leemveliso zamayeza eTshayina liza kuba kufutshane ne-1 trillion yuan ngo-2020. Umfanekiso3. Iimpawu zoshishino ze-intermediates zamayezaIshishini lifuna ukulungiswa nokuphuculwa ngokukhawuleza: Inqanaba lobuchwepheshe lilonke laseTshayina lisephantsi kakhulu, kwaye zimbalwa iinkampani ezivelisa inani elikhulu le-intermediates zamayeza eziphambili kunye nokuxhasa i-intermediates zamayeza amatsha anelungelo lobunikazi, akwinqanaba lophuhliso lokuphucula nokuphucula ulwakhiwo lwemveliso. Kuphela ngamashishini athile anamandla ophando nophuhliso, izixhobo zemveliso eziphambili kunye namava emveliso enkulu anokufumana inzuzo ephezulu kukhuphiswano. Ubungakanani beshishini obuzinzileyo: Abavelisi abakhulu ngokusisiseko bathatha imveliso eyenzelwe wena njengomzekelo wabo ophambili weshishini. Phantsi kwemodeli yemveliso eyenzelwe wena, ubudlelwane bentsebenziswano phakathi kwabathengi abakhulu kunye nabathengisi buzinzile, kwaye okukhona intsebenziswano isondela, kokukhona inqanaba lokuthembana liphezulu, kwaye iindidi zentsebenziswano ezibonelelwa ngabathengi abakhulu ziya kuba phezulu. Kuthatha ixesha elide ukutshintsha ababoneleli. Ngoko ke, njengeshishini eliqinileyo, amashishini aphakathi kwamayeza agxila kakhulu kumashishini angaphandle aziwayo amachiza okwangoku. Nje ukuba inkampani ingene kwinkqubo yomthengisi oyintloko weenkampani ezinkulu zamayeza, zombini isikali semveliso kunye nomda wenzuzo epheleleyo zigcine imeko ezinzileyo. Ukuthunyelwa kwamanye amazwe okuphantsi ikakhulu: iindawo eziphambili zokuthunyelwa kwamanye amazwe zezixhobo zamayeza eTshayina yi-EU, uMntla Melika, uMbindi Mpuma, uMzantsi-mpuma we-Asia, njl. Ukuthunyelwa kwamanye amazwe kwelizwe lethu kugxile kakhulu kwi-vitamin C, i-penicillin, i-acetaminophen, i-citric acid kunye neetyuwa zayo kunye nee-esters, ezifana neempahla, iimpawu zeemveliso kukuveliswa kweemveliso, amashishini emveliso, ukhuphiswano lwemarike lunamandla, ixabiso lemveliso kunye nexabiso elongezelelweyo liphantsi, imveliso enkulu yazo ibangele imeko yokugqithiswa kwemarike yezixhobo zamayeza zasekhaya. Iimveliso zobuchwepheshe obuphezulu zisangeniswa kakhulu. Amashishini amancinci naphakathi: amashishini emveliso ikakhulu ngamashishini abucala, ukusebenza okuguquguqukayo, isikali sotyalo-mali asisikhulu, ngokusisiseko phakathi kwezigidi ezilishumi ukuya kwezingamashumi amabini ezigidi ze-yuan. Uxinzelelo lwengingqi: ukusasazwa kwemimandla kwamashishini emveliso kugxile kakhulu, kujikeleze iifektri ezininzi ezinkulu zamayeza, ikakhulu zisasazwa eTaizhou, eZhejiang naseJintan, eJiangsu njengeziko le ummandla. IZhejiang Huangyan, iTaizhou, iNanjing Jintan, iShijiazhuang, iJinan (kubandakanya iZibo), emantla-mpuma (iSiping, iFushun) kunye nezinye iindawo ezineemeko ezilungileyo zophuhliso lwezixube zeyeza ziphuhliswe ngokukhawuleza kakhulu. Uhlaziyo olukhawulezileyo lwemveliso: imveliso ngokubanzi ithengiswa kwiminyaka emi-3 ukuya kwemi-5 kamva, izinga layo lenzuzo liya kwehla kakhulu, nto leyo enyanzela amashishini ukuba aphuhlise iimveliso ezintsha rhoqo okanye aphucule rhoqo inkqubo yemveliso, ukuze kugcinwe inzuzo ephezulu yemveliso. Ukhuphiswano olunzulu: kuba inzuzo yemveliso yezixube zeyeza iphezulu kuneyeemveliso zeekhemikhali, kwaye inkqubo yemveliso yezi zimbini iyafana ngokusisiseko, amashishini amancinci amaninzi amachiza ajoyina imveliso yezixube zeyeza, nto leyo ekhokelela kukhuphiswano olunzima kakhulu kushishino.4. Iintlobo ze-Pharmaceutical Intermediates Kukho iintlobo ezininzi ze-Pharmaceutical Intermediates, kuquka i-cephalosporin Intermediates, i-amino acid protectant series, i-Vitamin Intermediates, i-Quinolone Intermediates, kunye nezinye iintlobo ze-Intermediates, ezifana ne-Medical Disinfectant Intermediates, i-Antiepileptic Drug Intermediates, i-Flooropyridine Intermediates, i-Steroid Pharmaceutical Intermediates, njl. Ngokweenkalo zesicelo sazo, zinokwahlulwa zibe yi-antibiotic drug intermediates, i-Antipyretic kunye ne-Analgesic Drug Intermediates, i-Cardiovascular System Drug Intermediates, i-Anti-Cancer Drug Intermediates njalo njalo. Okwangoku, kukho malunga namakhulu eemveliso ze-Pharmaceutical Intermediates, kwaye zihlala zivelisa izinto ezintsha, zenza amashishini amaninzi amahle kwi-Pharmaceutical Intermediates. Kukho iintlobo ezininzi ze-Pharmaceutical Intermediates ezithile. Ezifana ne-Imidazole, i-Furan, i-Phenolic Intermediates, i-Aromatic Intermediates, i-Pyrrole, i-Pyridine, i-Biochemical Reagents, i-Sulfur, i-nitrogen, i-Halogen Compounds, i-Heterocyclic Compounds, i-Microcrystalline Cellulose, i-Starch, i-Mannitol, i-Lactose, i-Dextrin, i-Ethylene glycol, iswekile ecoliweyo, i-Inorganic Salts, i-ethanol Intermediates, i-Stearic Acid, i-amino acid kunye ne-ethanol ityuwa ye-amine, i-sylvite, ityuwa yesodium kunye nezinye izinto eziphakathi kunye nokunye. Umfanekiso5. I-Patent CliffUkusukela ngo-2000, imakethi yehlabathi ye-generics iqhubekile nokukhula ngokukhawuleza kunemakethi iyonke yamayeza, ikhula ngaphezu kokuphindwe kabini kuneemveliso ezinelungelo lobunikazi. Imakethi yehlabathi yamayeza aqhelekileyo kulindeleke ukuba ifikelele kwi-$180 yeebhiliyoni ngo-2013, kwaye i-CAGR yemakethi yehlabathi yamayeza aqhelekileyo ukusukela ngo-2005 ukuya ku-2013 kulindeleke ukuba ifikelele kwi-14.7%. Imakethi yehlabathi ye-generics kulindeleke ukuba ikhule nge-10% ukuya kwi-14% kwiminyaka emihlanu ezayo, ngokukhawuleza kakhulu kunokukhula okulindelweyo kwe-4% ukuya kwi-6% kwishishini lonke lamayeza. Kunokuqikelelwa ukuba uphuhliso lwemakethi yamayeza aqhelekileyo luya kukhuthaza uphuhliso lweshishini eliphakathi lamayeza.Ukususela ngo-2010 ukuya ku-2020, imakethi yehlabathi yamayeza iya kungenisa amaza aphezulu okuphelelwa yiPatent, phakathi kwawo, ukusukela ngo-2013 ukuya ku-2020, iintlobo zokuphelelwa yiPatent zehlabathi ziya kuba ngaphezulu kwama-200 ngonyaka, eyaziwa ngokuba yi-"Patent Cliff" ehlabathini.Ngo-2014, kuya kubakho incopho yamayeza anelungelo lobunikazi. Ukuphelelwa lixesha, apho kuya kubakho incopho ngo-2014, kunye namayeza angama-326 e-patent aphela. Unyaka ka-2010 no-2017 yiminyaka emibini encopho, kunye namayeza angama-205 kunye nama-242 e-patent aphela ngokulandelelana. Amayeza aphelelwe lixesha ikakhulu ngamayeza okulwa nosulelo, i-endocrine, inkqubo yemithambo-luvo kunye namayeza entliziyo, anobukhulu obukhulu bemarike. Ukuphelelwa lixesha okukhulu kwamayeza angaphandle e-patent kuya kuzisa izinto ezintsha ezikhuthazayo kushishino lwamayeza aphakathi e-China. Kuba emva kokuphelelwa lixesha kwamayeza e-patent, ukuveliswa kwamayeza aqhelekileyo anxulumeneyo kuya kuqhuma, okuya kuqhuba ukukhula ngokukhawuleza kwemfuno yamayeza aphakathi anxulumene nawo. Umfanekiso 6. Uxinzelelo lwendalo I-China sele ingumthumeli omkhulu we-API intermediates, kunye nomngcolisi omkhulu. Abavelisi be-pharmaceutical intermediates bangamalungu eshishini leekhemikhali ezintle, kuya kubakho umngcipheko wongcoliseko ohambelanayo. Ngokwezibalo ezivela kwiSebe lezoKhuselo lweNdalo, ixabiso elipheleleyo lemveliso yeshishini lamayeza lasekhaya lingaphantsi kwe-3 ekhulwini ye-GDP yelizwe, kodwa inani lilonke lokukhutshwa kongcoliseko lifikelela kwi-6 ekhulwini. Phakathi kwazo zonke iintlobo zamayeza, i-API emelwe kakhulu ziivithamini kunye ne-penicillin ingamalungu eshishini longcoliseko oluphezulu kunye nokusetyenziswa kwamandla aphezulu, okungcolisa umoya namanzi ngokukodwa. Ngokuhambelana nokuthunyelwa okuhlangeneyo kweSebe lezoKhuselo lweNdalo, nge-15 kaFebruwari 2017, iqela lokuhlola elikhethekileyo lomgangatho womoya kwikota yokuqala ka-2017 labhengeza ukuba ukuqhutywa koxinzelelo eShijiazhuang bekungasekho, kwaye urhulumente wesithili wayesasekelwe kakhulu kubasebenzi be-Environmental Protection Bureau ekuphunyezweni kwesicwangciso semozulu esingxamisekileyo songcoliseko olukhulu, ngelixa amanye amasebe engabandakanyekanga kwinqanaba eliphezulu. Ungcoliseko lwamashishini amancinci naphakathi avelisa i-pharmaceutical intermediates eShijiazhuang lubi kakhulu. Amashishini e-pharmaceutical ngeteknoloji yasemva iya kuthwala iindleko eziphezulu zokulawula ungcoliseko kunye noxinzelelo lolawulo, kwaye amashishini emveli eyeza amayeza avelisa ikakhulu ungcoliseko oluphezulu, ukusetyenziswa kwamandla aphezulu kunye neemveliso ezinexabiso eliphantsi (ezifana ne-penicillin, iivithamini, njl.njl.) aya kujongana nokupheliswa ngokukhawuleza. Ukunamathela kwimveliso entsha kunye nokuphuhlisa iteknoloji yamayeza eluhlaza kuye kwaba yindlela yophuhliso lwexesha elizayo kushishino lwamayeza aphakathi. Umfanekiso
7. Iinkokheli zoshishino
imboni ye-mit-ivy
Inkampani yeZhejiang NHU Ltd.Plo Co., Ltd
I-Lianhe Chemical Technology Co., Ltd. I-Anhui Bayi Chemical Co. Ltd. I-Zhejiang Huahai Pharmaceutical Co. Ltd. I-Zhejiang Hisoar Pharmaceutical Co., Ltd. I-Jiangsu Jiujiu Technology Co., Ltd. I-Federal pharmaceutical (chengdu) co., LTD. I-Zhejiang Yongtai Technology Co., Ltd. I-Suzhou Tianma Specialty Chemicals Co., Ltd.