Isishwankathelo soShishino lwamaYeza

Amayeza aphakathi
Izinto ezibizwa ngokuba ngama-pharmaceutical intermediates ngokwenene ziyimichiza ekrwada okanye imveliso yeekhemikhali ekufuneka zisetyenziswe kwinkqubo yokudibanisa amachiza. Ezi mveliso zemichiza zinokuveliswa kwizityalo zemichiza eziqhelekileyo ngaphandle kokufumana iphepha-mvume lokuvelisa ichiza, kwaye zingasetyenziswa ekudibaneni nasekuveliseni amachiza okoko nje izikhombisi zobugcisa zihlangabezana neemfuno ezithile zenqanaba. Nangona ukudityaniswa kwamayeza nako kuwela phantsi kodidi lweekhemikhali, iimfuno zingqongqo kunezo zeemveliso zemichiza ngokubanzi. Abavelisi bamachiza agqityiweyo kunye nee-APIs kufuneka bamkele isatifikethi se-GMP, ngelixa abavelisi be-intermediate bengenzi, kuba abaphakathi basesekuphela kokudibanisa kunye nokuveliswa kwezinto ezisetyenziselwa ukuhlanjululwa kweekhemikhali, ezona zisisiseko kunye neemveliso ezisezantsi kwikhonkco lokuvelisa iziyobisi, kwaye azikwazi abizwa ngokuba ngamachiza okwangoku, ngenxa yoko abafuni isatifikethi se-GMP, ekwathoba umda wokungena kubavelisi abaphakathi.

Ishishini eliphakathi kwezamayeza
Iinkampani zeMichiza ezivelisa kwaye ziqhube i-organic/inorganic intermediates okanye ii-APIs zeenkampani zamachiza ukuze zenze iimveliso zamayeza ezigqityiweyo ngemichiza okanye i-biological synthesis ngokwemigangatho engqongqo yobulunga. Apha ama-pharmaceutical intermediates ahlulwe abe ngamashishini amancinci amabini e-CMO kunye ne-CRO.

CMO
IContract Manufacturing Organisation ibhekiselele kumbutho wokwenziwa kwekhontrakthi, okuthetha ukuba inkampani yoxubo-mayeza ikhuphela ngaphandle inkqubo yokwenziwa kweqabane. Ikhonkco leshishini leshishini le-CMO lamayeza liqala ngokubanzi ngemathiriyeli ekrwada yamayeza. Iinkampani kwishishini kufuneka zikhuphe izinto ezisisiseko zemichiza ekrwada kwaye zisetyenzwe zibe zithako ezikhethekileyo zamayeza, ezithi ke zicutshungulwe zibe zizixhobo zokuqalisa ze-API, i-cGMP intermediates, i-APIs kunye nokwakheka. Okwangoku, iinkampani ezinkulu zamayeza ezizwe ngezizwe zikholisa ukuseka ubudlelwane bexesha elide kunye nenani elincinci lababoneleli abaphambili, kwaye ukusinda kweenkampani kolu shishino kubonakala kakhulu ngamahlakani abo.

I-CRO
Ikhontrakthi (yezonyango) Umbutho woPhando ubhekisa kumbutho wophando ngekhontrakthi, apho iinkampani ezixuba amayeza zikhupha icandelo lophando kwiqabane. Okwangoku, ishishini lisekelwe ikakhulu kwimveliso yesiko, i-R&D yesiko kunye nophando lwekhontrakthi yamayeza kunye neentengiso. Nokuba yeyiphi na indlela, nokuba imveliso yamayeza ephakathi yimveliso evelisa izinto ezintsha okanye hayi, ukukhuphisana okungundoqo kwenkampani kusagwetywa ngetekhnoloji ye-R&D njengento yokuqala, ebonakaliswa kubathengi abasezantsi okanye amaqabane enkampani.

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

Ikhonkco leshishini leshishini eliphakathi kwishishini
Umfanekiso
(Umfanekiso ovela kwiNethiwekhi yoLwazi loShishino lwaseTshayina)

Ulwahlulo lwezamayeza aphakathi
Amayeza aphakathi amayeza anokohlulwa abe ngamacandelo amakhulu ngokweenkalo zesicelo, ezifana neziphakathi zamayeza okubulala iintsholongwane, amayeza e-antipyretic kunye ne-analgesic, aphakathi kumachiza enkqubo ye-cardiovascular system kunye ne-pharmaceutical intermediate for anti-cancer. Kukho iintlobo ezininzi zemidazole, i-furan, i-phenolic intermediates, i-aromatics intermediates, i-pyrrole, i-pyridine, i-biochemical reagents, i-sulfur-containing, i-nitrogen-containing, i-halogen compounds, i-heterocyclic compounds, i-starch, i-mannitol, i-microcrystalline cellulose. , i-dextrin, i-ethylene glycol, i-sugar powder, i-salts ye-inorganic, i-ethanol intermediates, i-stearate, i-amino acids, i-ethanolamine, iityuwa ze-potassium, iityuwa zesodium kunye nezinye i-intermediates, njl.
Amagqabantshintshi ngophuhliso lweshishini lamayeza aphakathi eTshayina
Ngokutsho kwe-IMS Health Incorporated, ukusuka ku-2010 ukuya ku-2013, imarike yamayeza yehlabathi igcine ukukhula okuzinzileyo, ukusuka kwi-US $ 793.6 yebhiliyoni ngo-2010 ukuya kwi-US $ 899.3 yebhiliyoni ngo-2013, kunye nemarike yamayeza ebonisa ukukhula ngokukhawuleza ukusuka ngo-2014, ngenxa yemarike yaseMelika. . Nge-CAGR ye-6.14% ukusuka kwi-2010-2015, imarike yamayeza yamazwe ngamazwe kulindeleke ukuba ingene kumjikelo wokukhula ocothayo ukusuka kwi-2015-2019. Nangona kunjalo, njengoko amayeza efunwa ngokungqongqo, ukukhula kwentsalela kulindeleke ukuba komelele kakhulu kwixesha elizayo, kunye nemarike yehlabathi yamayeza isondela kwi-US$1.22 yetriliyoni ngo-2019.
Umfanekiso
(Umfanekiso osuka kwi-IMS Health Incorporated)
Ngokwangoku, ngohlengahlengiso lwemveliso yeenkampani ezinkulu zamazwe ngamazwe ezixuba amayeza, ukuhanjiswa kwemveliso yezizwe ngezizwe kunye nokuphuculwa ngakumbi kwecandelo labasebenzi bamazwe ngamazwe, i-China iye yaba sisiseko esibalulekileyo semveliso ephakathi kwicandelo lehlabathi labasebenzi kushishino lwamayeza. Ishishini laseTshayina eliphakathi kwezamayeza lenze inkqubo epheleleyo ukusuka kuphando kunye nophuhliso ukuya kwimveliso kunye neentengiso. Ukususela kuphuhliso intermediates amayeza ehlabathini, inkqubo yobugcisa China iyonke inqanaba iteknoloji isephantsi ngokwentelekiso, inani elikhulu intermediates amayeza kunye patent amayeza amatsha axhasa intermediates imveliso amashishini zincinane ngokwentelekiso, ikwinqanaba lophuhliso lwesakhiwo imveliso ukulungelelaniswa kunye nokuphuculwa. .
Ixabiso lemveliso kwishishini lemichiza yamayeza e-China ukusuka ngo-2011 ukuya ku-2015
Umfanekiso
(Umfanekiso ovela kwiziko loPhando loShishino lwaseTshayina)
Ngexesha lika-2011-2015, imveliso yemveliso yekhemikhali yamayeza aseTshayina yakhula unyaka nonyaka, ngo-2013, imveliso yaseTshayina yekhemikhali yamayeza yayingama-568,300 eetoni, yathunyelwa ngaphandle iitoni ezingama-65,700, ngo-2015 imveliso ye-China yekhemikhali yekhemikhali to766 yayimalunga ne-400.
2011-2015 China ikhemikhali amayeza intermediates imveliso manani kwimveliso
Umfanekiso
(Umfanekiso ovela kwiziko loPhando loShishino lwaseTshayina)
Ukunikezelwa kwamayeza aphakathi kwe-pharmaceutical e-China kubonakala ngakumbi kunemfuno, kwaye ukuxhomekeka kokuthumela ngaphandle kuyanda ngokuthe ngcembe. Nangona kunjalo, iimveliso ezithunyelwa ngaphandle zaseTshayina zigxininiswe kwiimveliso ezininzi ezifana nevithamin C, ipenicillin, i-acetaminophen, i-citric acid kunye neetyuwa zayo kunye ne-esters, njl. ixabiso elongezelelweyo, kunye nemveliso yabo ngobuninzi ibangele imeko yonikezelo oludlula imfuno kwimarike intermediates amayeza asekhaya. Iimveliso ezinomxholo ophezulu weteknoloji zisaxhomekeke kakhulu ekungenisweni.
Ukukhusela i-amino acid intermediate pharmaceutical, uninzi lwamashishini emveliso yasekhaya anemveliso enye eyahlukeneyo kunye nomgangatho ongazinzanga, ingakumbi kwiinkampani zangaphandle ze-biopharmaceutical ukuba zilungele ukuveliswa kweemveliso. Kuphela ngamashishini athile anophando olomeleleyo kunye namandla ophuhliso, amaziko emveliso aphucukileyo kunye namava kwimveliso emikhulu anokufumana inzuzo ephezulu kukhuphiswano.
Uhlalutyo lweshishini laseTshayina eliphakathi kwamayeza

I-1, i-pharmaceutical intermediates inkqubo yokuvelisa isiko
Okokuqala, ukuthatha inxaxheba kuphando lwabathengi kunye nophuhliso lwenqanaba elitsha lamachiza, elifuna iziko lenkampani le-R & D linamandla okuvelisa izinto ezintsha.
Okwesibini, ukukhulisa imveliso yokulinga yomthengi, ukuhlangabezana nendlela yenkqubo yemveliso emikhulu, efuna isakhono sokukhulisa ubunjineli kwimveliso kunye nokukwazi ukuphuculwa kwenkqubo eqhubekayo yeteknoloji yemveliso elungiselelweyo kwixesha elizayo, ukuze ukuhlangabezana neemfuno zomlinganiselo wemveliso, ukwehlisa ngokuqhubekayo iindleko zemveliso nokwandisa ukukhuphisana kwemveliso.
Okwesithathu, kukugaya kunye nokuphucula inkqubo yeemveliso kwinqanaba lokuvelisa ubuninzi babathengi, ukwenzela ukuhlangabezana nemigangatho yomgangatho weenkampani zangaphandle.

2. Iimpawu zeshishini laseTshayina eliphakathi kwezamayeza
Imveliso yamayeza ifuna inani elikhulu leekhemikhali ezikhethekileyo, uninzi lwazo lwaveliswa lishishini lamayeza ngokwalo, kodwa ngokunzulu kweyantlukwano yentlalo yabasebenzi kunye nenkqubela phambili yetekhnoloji yemveliso, ishishini loxubo mayeza lidlulisele amanye amayeza aphakathi kumashishini ekhemikhali. ukwenzela imveliso. Amayeza aphakathi ziimveliso zemichiza ezintle, kwaye ukuveliswa kwamayeza aphakathi kwamayeza kuye kwaba lishishini elikhulu kwishishini lemichiza lamazwe ngamazwe. Okwangoku, ishishini lamayeza laseTshayina lifuna malunga nama-2,000 eentlobo zemathiriyeli ekrwada kunye neziphakathi minyaka le, kunye nemfuno engaphezulu kwe-2.5 yezigidi zeetoni. Njengoko ukuthunyelwa kwamanye amazwe amayeza aphakathi amayeza ngokungafaniyo nokuthunyelwa kwamanye amazwe kwamachiza kuya kuba phantsi kwezithintelo ezahlukeneyo kumazwe angenisayo, kunye nokuveliswa kwehlabathi kwamayeza aphakathi kumazwe asakhasayo, iimfuno zangoku zemveliso yamayeza aseTshayina kwimathiriyeli ekrwada yeekhemikhali kunye nabaphakathi banokuhambelana ngokusisiseko. , kuphela inxalenye encinci yesidingo sokungenisa. Kwaye ngenxa yobutyebi obuninzi baseTshayina, amaxabiso ezinto ezikrwada aphantsi, kukho amayeza amaninzi aphakathi afumene inani elikhulu lokuthengisa ngaphandle.

Okwangoku, iChina idinga iikhemikhali ezixhasa izinto eziluhlaza kunye neziphakathi kweentlobo ezingaphezu kwama-2500, imfuno yonyaka yafikelela kwi-11.35 yezigidi zeetoni. Emva kweminyaka engaphezulu kwe-30 yophuhliso, iimfuno zemveliso yamayeza e-China yemathiriyeli ekrwada yeekhemikhali kunye nabaphakathi baye bakwazi ukuhambelana. Imveliso ye-intermediates e-China ikakhulu kwi-antibacterial and antipyretic drug.

Kulo lonke ishishini, ishishini intermediates China amayeza ineempawu ezintandathu: Okokuqala, uninzi lwamashishini ngamashishini abucala, ukusebenza bhetyebhetye, isikali utyalo-mali ayikho enkulu, ngokusisiseko phakathi kwezigidi ukuya kwenye okanye amabini amawaka ezigidi yuan; Okwesibini, ukusasazwa ngokwejografi kwamashishini kugxininiswe kakhulu, ngakumbi eTaizhou, kwiPhondo laseZhejiang naseJintan, kwiPhondo laseJiangsu njengeziko; Okwesithathu, kunye nokwanda kwengqalelo yelizwe ekukhuselweni kwendalo, uxinzelelo kumashishini ukwakha amaziko onyango lokusingqongileyo luyanda Okwesine, isantya sokuvuselela imveliso sikhawuleza, kwaye umda wenzuzo uya kuhla kakhulu emva kweminyaka emi-3 ukuya kwemi-5 kwimarike, ukunyanzelisa amashishini. ukuphuhlisa iimveliso ezintsha okanye ukuphucula inkqubo ngokuqhubekayo ukuze ufumane inzuzo ephezulu; Okwesihlanu, ekubeni inzuzo yemveliso yamayeza aphakathi amayeza iphezulu kunaleyo yeemveliso zemichiza ngokubanzi, kwaye inkqubo yokuvelisa iyafana, amashishini emichiza amancinci angena kuluhlu lokuvelisa abaphakathi bamayeza, okukhokelela kukhuphiswano oluqatha kushishino lwesithandathu. , xa kuthelekiswa ne-API, umda wenzuzo yokuvelisa i-intermediates iphantsi, kwaye inkqubo yokuvelisa i-API kunye ne-pharmaceutical intermediates iyafana, ngoko ke amanye amashishini angavelisi kuphela abaphakathi, kodwa asebenzise inzuzo yabo ukuqala ukuvelisa i-API. Iingcali zibonise ukuba ukuveliswa kwamayeza aphakathi kwi-pharmaceutical ukuya kwicala lophuhliso lwe-API yinto engenakuphepheka. Nangona kunjalo, ngenxa yokusetyenziswa okukodwa kwe-API, ngeenkampani zamachiza zinempembelelo enkulu, amashishini asekhaya ahlala ephuhlisa iimveliso kodwa akukho basebenzisi bento. Ke ngoko, abavelisi kufuneka baseke ubudlelwane bexesha elide obuzinzile bokubonelela kunye neenkampani zamachiza, ukuze kuqinisekiswe ukuthengiswa kwemveliso egudileyo.

3, imiqobo yokungena kwishishini
①Izithintelo zabathengi
Ishishini loxubo mayeza lilawulwa ziinkampani ezimbalwa zamazwe ngamazwe ezixuba amayeza. Ii-oligarchs zamachiza zilumke kakhulu ekukhetheni kwabo ababoneleli ngenkonzo yangaphandle kwaye ngokubanzi banexesha elide lokuhlola ababoneleli abatsha. Iinkampani ze-CMO zamachiza kufuneka zihlangabezane neepatheni zonxibelelwano zabathengi abahlukeneyo, kwaye kufuneka ziqhube ixesha elide lovavanyo oluqhubekayo ngaphambi kokuba zizuze ukuthembela kubathengi abasezantsi, kwaye babe ngababoneleli babo abaphambili.
②Imiqobo yobuchwephesha
Ikhono lokubonelela ngeenkonzo zethekhnoloji eziphezulu zexabiso elongezelelweyo lilitye lembombo lenkampani yenkonzo yokukhupha amayeza. Iinkampani ezixuba amayeza e-CMO kufuneka zigqobhoze imiqobo yobugcisa okanye imiqobo kwiindlela zazo zokuqala kwaye zibonelele ngeendlela zokuphucula inkqubo yamayeza ukuze kucuthwe ngempumelelo iindleko zokuvelisa amachiza. Ngaphandle kwexesha elide, utyalo-mali oluphezulu kuphando kunye nophuhliso kunye noovimba bobuchwephesha, kunzima kwiinkampani ezingaphandle kweshishini ukuba zingene ngokwenene kwishishini.
③Imiqobo yetalente
Kunzima kwiinkampani zeCMO ukwakha iR&D ekhuphisanayo kunye neqela lemveliso ngexesha elifutshane ukuseka imodeli yeshishini ehambelana ne-cGMP.
④Izithintelo zolawulo lomgangatho
I-FDA kunye nezinye ii-arhente ezilawula amachiza ziye zaqina ngakumbi kwiimfuno zabo zokulawula umgangatho, kwaye iimveliso ezingaphumeleli uphicotho-zincwadi azikwazi ukungena kwiimarike zamazwe angenisayo.
⑤ Imiqobo yolawulo lwendalo esingqongileyo
Iinkampani zoxubo-mayeza 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 zexabiso eliphantsi (umz. penicillin, iivithamini, njl.) ziya kujongana nokupheliswa ngokukhawuleza. Ukubambelela kwinkqubo yokuvelisa izinto ezintsha kunye nokuphuhlisa itekhnoloji yezoxubo zamayeza eziluhlaza kuye kwaba luphuhliso lwexesha elizayo kwishishini leCMO lamayeza.

4. Amashishini aphakathi kwezamayeza asekhaya adwelisiweyo
Ukusuka kwindawo yekhonkco loshishino, iinkampani ezi-6 ezidweliswe kwiikhemikhali ezilungileyo ezivelisa abaphakathi bamayeza zonke zikwisiphelo esisezantsi sekhonkco loshishino. Nokuba kumboneleli wenkonzo yokukhupha umsebenzi oqeqeshiweyo okanye kwi-API kunye nolwandiso lolwandiso, amandla obugcisa awona mandla okuqhuba angundoqo.
Ngokwamandla obuchwepheshe, iinkampani ezinobuchwepheshe kwinqanaba lehlabathi elikhokelayo, ukomelela okuqinileyo kunye notyalo-mali oluphezulu kwi-R&D ziyathandwa.
Iqela I: Lianhua Technology kunye Arbonne Chemical. I-Lianhua Technology inobuchwephesha obusibhozo obuphambili obufana ne-ammonia oxidation kunye ne-fluorination njengesiseko sayo setekhnoloji, apho i-hydrogen oxidation ikwinqanaba eliphambili lamazwe ngamazwe. I-Abenomics yinkokeli yamazwe ngamazwe kumachiza e-chiral, ngokukodwa kwi-chemicals splitting kunye ne-racemization technologies, kwaye inotyalo-mali oluphezulu lwe-R & D, olubalelwa kwi-6.4% yengeniso.
Iqela le-II: I-Wanchang Technology kunye ne-Yongtai Technology. Indlela yenkunkuma ye-Wanchang Technology ye-hydrocyanic acid yeyona ndleko iphantsi kunye neyona nkqubo iphambili yokwenziwa kwe-esters ye-prototrizoic acid. I-Yongtai Technology, kwelinye icala, iyaziwa ngeekhemikhali zayo ezintle ze-fluorine.
Iqela le-III: I-Tianma Fine Chemical kunye ne-Bikang (eyaziwa ngokuba yiJiuzhang).
Ukuthelekiswa kwamandla obugcisa beenkampani ezidwelisiweyo
Umfanekiso
Ukuthelekiswa kwabathengi kunye neemodeli zentengiso yeenkampani ezidwelisiweyo zamayeza aphakathi
Umfanekiso
Ukuthelekiswa kwemfuno esezantsi kunye nomjikelo wobomi bepatent yeemveliso zeenkampani ezidwelisiweyo
Imifanekiso
Uhlalutyo lokukhuphisana kwemveliso yeenkampani ezidwelisiweyo
Imifanekiso
Indlela eya kuphuculo lwemichiza ephakathi
Imifanekiso
(Imifanekiso kunye nezixhobo ezivela kwiQilu Securities)
Amathuba ophuhliso lweshishini laseTshayina eliphakathi kwamayeza
Njengomzi-mveliso obalulekileyo kwishishini lemichiza elungileyo, imveliso yamayeza iye yaba yingqwalasela yophuhliso kunye nokhuphiswano kwiminyaka eyi-10 edlulileyo, kunye nenkqubela phambili yesayensi kunye nethekhnoloji, amayeza amaninzi aphuhliswe ngokuqhubekayo ukuze kuxhamle uluntu, ukudibanisa. kula mayeza kuxhomekeke kwimveliso emitsha, ekumgangatho ophezulu wamayeza aphakathi, ngoko ke amachiza amatsha akhuselwe ngamalungelo awodwa omenzi wechiza, ngelixa abaphakathi kuwo bengenangxaki, ngoko ke abaphakathi bamayeza amatsha ekhaya nakwamanye amazwe Indawo yophuhliso lwentengiso kunye nethemba lokusetyenziswa zithembisa kakhulu.
Imifanekiso

Okwangoku, ulwalathiso lophando lwama-intermediates amachiza lubonakaliswa ngokukodwa kwi-synthesis ye-heterocyclic compounds, i-fluorine-containing compounds, i-chiral compounds, i-biological compounds, njl. eTshayina. Ezinye iimveliso ezineemfuno zenqanaba eliphezulu lobugcisa azikwazi ukulungelelaniswa kwimveliso eChina kwaye ngokusisiseko zixhomekeke ekungenisweni, njengepiperazine anhydrous, ipropionic acid, njl. iindleko kunye nomgangatho azikho kumgangatho, ezichaphazela ukukhuphisana kweemveliso zamachiza kunye nesidingo sokuphucula inkqubo yokuvelisa, njenge-TMB, i-p-aminophenol, i-D-PHPG, njl.
Kulindeleke ukuba kule minyaka imbalwa izayo, uphando lwamachiza olutsha lwehlabathi luya kugxininisa kwezi ntlobo ze-10 zamachiza alandelayo: iziyobisi zokuphucula ukusebenza kwengqondo, iziyobisi ezichasene ne-rheumatoid arthritis, i-anti-AIDS, i-anti-hepatitis kunye nezinye iziyobisi zentsholongwane, i-lipid. -ukwehlisa iziyobisi, anti-thrombotic iziyobisi, anti-ithumba iziyobisi, platelet-activating factor antagonists, glycoside stimulants cardiac, antidepressants, anti-psychotic kunye neziyobisi ezichasayo, njl. uphuhliso lwabaphakathi bamachiza kunye nendlela ebalulekileyo yokwandisa indawo entsha yemarike.