Pharmaceutical Intermediates Industry Overview

Li-intermediates tsa meriana
Seo ho thoeng ke li-intermediate tsa meriana ha e le hantle ke lisebelisoa tse tala tsa lik'hemik'hale kapa lihlahisoa tsa lik'hemik'hale tse hlokang ho sebelisoa ha ho etsoa lithethefatsi. Lihlahisoa tsena tsa lik'hemik'hale li ka hlahisoa limela tsa lik'hemik'hale tse tloaelehileng ntle le ho fumana laesense ea tlhahiso ea lithethefatsi, 'me li ka sebelisoa ho kopantseng le ho hlahisa lithethefatsi ha feela matšoao a theknoloji a finyella litlhoko tse itseng tsa boemo. Le hoja motsoako oa meriana le oona o oela tlas'a sehlopha sa lik'hemik'hale, litlhoko li thata ho feta tsa lihlahisoa tsa lik'hemik'hale tse akaretsang. Baetsi ba litlhare tse phethiloeng le li-API ba hloka ho amohela setifikeiti sa GMP, athe baetsi ba li-intermediates ba sa etse joalo, hobane li-intermediates e ntse e le motsoako le tlhahiso ea lihlahisoa tsa lihlahisoa tsa lik'hemik'hale, e leng lihlahisoa tsa motheo le tse ka tlaase ho ketane ea tlhahiso ea lithethefatsi, 'me e ke ke ea e-ba teng. e bitsoang lithethefatsi leha ho le joalo, kahoo ha e hloke setifikeiti sa GMP, e leng se theolang monyako oa ho kena bakeng sa baetsi ba lipakeng.

Indasteri ea lipakeng tsa meriana
Likhamphani tsa lik'hemik'hale tse hlahisang le ho sebetsana le li-organic/inorganic intermediates kapa li-API bakeng sa lik'hamphani tsa meriana bakeng sa ho etsa lihlahisoa tsa meriana tse felileng ka metsoako ea lik'hemik'hale kapa ea baeloji ho latela maemo a thata a boleng. Mona li-intermediate tsa meriana li arotsoe ka liindasteri tse peli tse nyenyane tsa CMO le CRO.

CMO
Contract Manufacturing Organization e bolela mokhatlo o etsang likonteraka, ho bolelang hore k'hamphani ea meriana e fana ka ts'ebetso ea tlhahiso ho molekane. Letoto la khoebo la indasteri ea meriana ea CMO hangata le qala ka lisebelisoa tse khethehileng tsa lihlahisoa tsa meriana. Lik'hamphani tse indastering li tlameha ho fana ka lisebelisoa tsa mantlha tsa lik'hemik'hale ebe li li sebetsa ka metsoako e khethehileng ea meriana, e ntan'o sebetsoa hore e be lisebelisoa tsa ho qala tsa API, li-intermediate tsa cGMP, li-API le liforomo. Hona joale, lik'hamphani tse kholo tsa machaba tsa meriana li atisa ho theha likamano tsa nako e telele tsa leano le palo e nyenyane ea bafani ba mantlha, 'me ho phela ha lik'hamphani lefapheng lena ho bonahala haholo ka balekane ba bona.

KAROLO
Mokhatlo oa Lipatlisiso oa Konteraka (Clinical) o bua ka mokhatlo oa lipatlisiso tsa konteraka, moo lik'hamphani tsa meriana li fanang ka karolo ea lipatlisiso ho molekane. Hajoale, indasteri e ipapisitse le tlhahiso ea tloaelo, R&D ea moetlo le lipatlisiso le thekiso ea konteraka ea meriana. Ho sa tsotelehe mokhoa oo, hore na sehlahisoa sa mahareng sa meriana ke sehlahisoa se ncha kapa che, tlholisano ea mantlha ea k'hamphani e ntse e ahloloa ke theknoloji ea R&D e le eona ntho ea pele, e bonts'itsoeng ho bareki kapa balekane ba tlase ba k'hamphani.

Ketane ea boleng ba 'maraka oa lihlahisoa tsa meriana
Setšoantšo
(Setšoantšo se tsoang ho Qilu Securities)

Indasteri ea indasteri ea li-intermediates tsa meriana
Setšoantšo
(Setšoantšo se tsoang China Industry Information Network)

Pharmaceutical intermediates classification
Li-intermediate tsa meriana li ka aroloa ka lihlopha tse kholo ho latela likarolo tsa ts'ebeliso, joalo ka li-intermediate bakeng sa lithibela-mafu, li-intermediate tsa antipyretic le analgesic, li-intermediate bakeng sa lithethefatsi tsa tsamaiso ea pelo le li-intermediate tsa meriana bakeng sa anti-cancer. Ho na le mefuta e mengata ea li-intermediate tse khethehileng tsa meriana, tse kang imidazole, furan, phenolic intermediates, monko o monate, pyrrole, pyridine, li-reagents tsa biochemical, sebabole se nang le naetrojene, metsoako ea halogen, metsoako ea heterocyclic, starch, mannitol, microcrystalline cellulose. , dextrin, ethylene glycol, phofo ea tsoekere, matsoai a inorganic, ethanol intermediates, stearate, amino acid, ethanolamine, letsoai la potasiamo, letsoai la sodium le li-intermediates tse ling, joalo-joalo.
Kakaretso ea nts'etsopele ea indasteri ea lipakeng tsa meriana Chaena
Ho latela IMS Health Incorporated, ho tloha 2010 ho isa 2013, 'maraka oa lefats'e oa meriana o bolokile mokhoa o tsitsitseng oa kholo, ho tloha ho US $793.6 bilione ka 2010 ho isa ho US $899.3 billion ka 2013,' me mmaraka oa meriana o bonts'a kholo e potlakileng ho tloha 2014, haholoholo ka lebaka la 'maraka oa US. . Ka CAGR ea 6.14% ho tloha 2010-2015, 'maraka oa machaba oa meriana o lebelletsoe ho kena potolohong e liehang ea kholo ho tloha 2015-2019. Leha ho le joalo, kaha meriana e batloang ka thata, kholo ea kholo e lebelletsoe ho ba matla haholo nakong e tlang, 'me 'maraka oa lefats'e oa meriana o atamela US $1.22 trillion ka 2019.
Setšoantšo
(Setšoantšo se tsoang ho IMS Health Incorporated)
Hajoale, ka tlhophiso bocha ea indasteri ea lik'hamphani tse kholo tsa machaba tsa meriana, phetisetso ea tlhahiso ea linaha tse fapaneng le ntlafatso e tsoelang pele ea karohano ea machaba ea basebetsi, China e fetohile setsi sa bohlokoa sa tlhahiso ea lipakeng karolong ea lefats'e ea basebetsi indastering ea meriana. Indasteri ea lipakeng tsa meriana ea China e thehile sistimi e batlang e feletse ho tloha ho lipatlisiso le nts'etsopele ho isa tlhahiso le thekiso. Ho tloha nts'etsopele ea li-intermediates tsa meriana lefats'eng, boemo ba theknoloji ea China ka kakaretso bo ntse bo le tlase, palo e kholo ea li-intermediate tse tsoetseng pele tsa meriana le litlhare tse ncha tsa patent tse tšehetsang likhoebo tsa tlhahiso ea li-intermediates li batla li le nyane, li maemong a nts'etsopele ea ntlafatso ea sebopeho sa sehlahisoa le ntlafatso. .
Boleng ba tlhahiso ea indasteri ea li-chemical pharmaceutical intermediates China ho tloha 2011 ho isa 2015
Setšoantšo
(Setšoantšo se tsoang Setsing sa Patlisiso sa Indasteri ea Khoebo ea China)
Nakong ea 2011-2015, tlhahiso ea indasteri ea lik'hemik'hale ea lik'hemik'hale ea Chaena e ile ea eketseha selemo le selemo, ka 2013, tlhahiso ea lik'hemik'hale tsa meriana ea Chaena e ne e le lithane tse 568,300, tse rometsoeng lithane tse 65,700, ka 2015 lihlahisoa tsa lik'hemik'hale tsa lik'hemik'hale tsa 2015 li ne li ka bang 40.
2011-2015 China lik'hemik'hale meriana intermediates indasteri lipalopalo tsa tlhahiso
Setšoantšo
(Setšoantšo se tsoang Setsing sa Patlisiso sa Indasteri ea Khoebo ea China)
Phepelo ea li-intermediate tsa meriana Chaena e hlahelletse ho feta tlhokahalo, 'me ho itšetleha ka thepa e tsoang linaheng tse ling ho ntse ho eketseha butle-butle. Leha ho le joalo, lihlahisoa tsa China li tsepamisitsoe haholo lihlahisoa tse ngata tse kang vithamine C, penicillin, acetaminophen, citric acid le letsoai la eona le li-ester, joalo-joalo. Lihlahisoa tsena li khetholloa ka tlhahiso e kholo ea lihlahisoa, likhoebo tse ngata tsa tlhahiso, tlhōlisano e matla ea 'maraka, theko e tlaase ea sehlahisoa le boleng bo ekelitsoeng, 'me tlhahiso ea bona ea bongata e bakile boemo ba phepelo e fetang tlhokeho ea' maraka oa mahareng oa meriana ea lehae. Lihlahisoa tse nang le litaba tsa theknoloji e phahameng li ntse li itšetlehile haholo ka thepa e tsoang linaheng tse ling.
Bakeng sa ts'ireletso ea li-amino acid tsa meriana, likhoebo tse ngata tsa tlhahiso ea malapeng li na le sehlahisoa se le seng le boleng bo sa tsitsang, haholo-holo bakeng sa lik'hamphani tse tsoang linaheng tse ling tsa biopharmaceutical ho iketsetsa tlhahiso ea lihlahisoa. Ke likhoebo tse ling feela tse nang le matla a ho etsa lipatlisiso le nts'etsopele, lisebelisoa tse tsoetseng pele tsa tlhahiso le boiphihlelo tlhahisong e kholo li ka fumanang phaello e phahameng tlholisanong.
Tlhahlobo ea indasteri ea lipakeng tsa meriana ea China

1, mekhoa ea tlhahiso ea tloaelo ea indasteri ea meriana
Taba ea pele, ho nka karolo lipatlisisong tsa moreki le nts'etsopele ea sethala se secha sa lithethefatsi, se hlokang setsi sa R&D sa k'hamphani se na le bokhoni bo matla ba ho nchafatsa.
Taba ea bobeli, ho ntlafatso ea sehlahisoa sa moreki, ho kopana le tsela ea ts'ebetso ea tlhahiso e kholo, e hlokang bokhoni ba k'hamphani ba ho holisa sehlahisoa le bokhoni ba ntlafatso ea ts'ebetso e tsoelang pele ea theknoloji e hlophisitsoeng ea sehlahisoa hamorao, e le ho kopana le litlhoko tsa tlhahiso ea tekanyo ea sehlahisoa, ho fokotsa litšenyehelo tsa tlhahiso ka ho tsoelang pele le ho matlafatsa tlhōlisano ea sehlahisoa.
Ntlha ea boraro, ke ho cheka le ho ntlafatsa ts'ebetso ea lihlahisoa sethaleng sa tlhahiso ea bongata ba bareki, e le ho finyella litekanyetso tsa boleng ba lik'hamphani tsa linaheng tse ling.

2. Litšobotsi tsa indasteri ea lipakeng tsa meriana ea China
Tlhahiso ea meriana e hloka palo e kholo ea lik'hemik'hale tse khethehileng, tseo boholo ba tsona li neng li hlahisoa ke indasteri ea meriana ka boeona, empa ka ho teba ha karohano ea sechaba le tsoelo-pele ea theknoloji ea tlhahiso, indasteri ea meriana e ile ea fetisetsa li-intermediate tsa meriana ho lik'hamphani tsa lik'hemik'hale. bakeng sa tlhahiso. Li-intermediate tsa meriana ke lihlahisoa tse ntle tsa lik'hemik'hale, 'me tlhahiso ea li-intermediate tsa meriana e fetohile indasteri e kholo indastering ea machaba ea lik'hemik'hale. Hajoale, indasteri ea meriana ea Chaena e hloka mefuta e ka bang 2,000 ea lihlahisoa tsa lik'hemik'hale le li-intermediates selemo se seng le se seng, ka tlhokahalo ea lithane tse fetang limilione tse 2.5. Ha thomello ea li-intermediate tsa meriana ho fapana le thomello ea meriana e tla ba tlas'a lithibelo tse fapaneng linaheng tse tsoang kantle ho naha, hammoho le tlhahiso ea lefats'e ea li-intermediate tsa meriana linaheng tse tsoelang pele, litlhoko tsa hona joale tsa tlhahiso ea meriana ea Chaena ea lisebelisoa tse tala tsa lik'hemik'hale le li-intermediate li ka lumellana. , karolo e nyenyane feela ea tlhokahalo ea ho kenya. Mme ka lebaka la matlotlo a mangata a China, litheko tsa thepa e tala li tlase, ho na le li-intermediates tse ngata tsa meriana le tsona li fihletse palo e kholo ea li-export.

Hajoale, China e hloka lik'hemik'hale tse tšehetsang lisebelisoa tse tala le li-intermediate tsa mefuta e fetang 2500, tlhoko ea selemo le selemo e fihlile ho lithane tse limilione tse 11.35. Kamora lilemo tse fetang 30 tsa nts'etsopele, litlhoko tsa tlhahiso ea meriana ea China ea lisebelisoa tse tala tsa lik'hemik'hale le li-intermediate li khonne ho lumellana. Tlhahiso ea li-intermediates Chaena e haholo-holo ka lithethefatsi tse thibelang likokoana-hloko le antipyretic.

Ho pholletsa le indasteri, indasteri ea meriana ea Chaena e na le litšobotsi tse tšeletseng: Pele, boholo ba likhoebo ke likhoebo tsa poraefete, ts'ebetso e tenyetsehang, tekanyo ea matsete ha e kholo, ha e le hantle pakeng tsa limilione ho ea ho li-yuan tse limilione tse likete tse peli kapa tse peli; Ea bobeli, kabo ea libaka tsa likhoebo e batla e tsepamisitsoe, haholo-holo Taizhou, Profinseng ea Zhejiang le Jintan, Profinseng ea Jiangsu e le setsi; Ntlha ea boraro, ka tlhokomelo e ntseng e eketseha ea naha ho ts'ireletso ea tikoloho, khatello ea likhoebo ho haha ​​​​libaka tsa phekolo ea tšireletso ea tikoloho e ntse e eketseha Ntlha ea bone, lebelo la ho nchafatsa sehlahisoa le potlakile, 'me phaello ea phaello e tla theoha haholo ka mor'a lilemo tse 3 ho isa ho tse 5' marakeng, ho qobella likhoebo. ho hlahisa lihlahisoa tse ncha kapa ho ntlafatsa ts'ebetso e tsoelang pele e le ho fumana phaello e phahameng; Ea bohlano, kaha phaello ea tlhahiso ea li-intermediates tsa meriana e phahame ho feta ea lihlahisoa tsa lik'hemik'hale tse akaretsang, 'me ts'ebetso ea tlhahiso e ntse e tšoana, likhoebo tse nyenyane tsa lik'hemik'hale li kena boemong ba ho hlahisa li-intermediates tsa meriana, e leng se etsang hore ho be le tlhōlisano e matla ka ho eketsehileng indastering ea Botšelela. , ha e bapisoa le API, phaello ea phaello ea ho hlahisa li-intermediate e tlaase, 'me mokhoa oa tlhahiso ea API le li-intermediates tsa meriana li tšoana, kahoo likhoebo tse ling ha li hlahise li-intermediates feela, empa hape li sebelisa melemo ea tsona ho qala ho hlahisa API. Litsebi li bontšitse hore tlhahiso ea li-intermediates tsa meriana ho ea ho tataiso ea nts'etsopele ea API ke mokhoa o ke keng oa qojoa. Leha ho le joalo, ka lebaka la tšebeliso e le 'ngoe ea API, ka lik'hamphani tsa meriana li na le tšusumetso e kholo, likhoebo tsa malapeng li atisa ho hlahisa lihlahisoa empa ha ho basebelisi ba ketsahalo ena. Ka hona, bahlahisi ba lokela ho theha kamano ea nako e telele ea phepelo e tsitsitseng le lik'hamphani tsa meriana, e le ho netefatsa thekiso e ntle ea lihlahisoa.

3, litšitiso tsa ho kena indastering
①Litšitiso tsa bareki
Indasteri ea meriana e laoloa ke lik'hamphani tse 'maloa tsa machaba tse etsang meriana. Li-oligarchs tsa meriana li hlokolosi haholo khethong ea bona ea bafani ba litšebeletso tsa kantle ho naha 'me ka kakaretso ba na le nako e telele ea tlhahlobo bakeng sa bafani ba bacha. Likhamphani tsa Meriana tsa CMO li hloka ho kopana le mekhoa ea puisano ea bareki ba fapaneng, 'me li hloka ho feta nako e telele ea tlhahlobo e tsoelang pele pele li ka fumana tšepo ea bareki ba tlase, ebe joale ba fetoha barekisi ba bona ba mantlha.
②Litšitiso tsa theknoloji
Bokhoni ba ho fana ka lits'ebeletso tsa boleng bo phahameng ba thekenoloji ke motheo oa k'hamphani ea ts'ebeletso ea phepelo ea meriana. Likhamphani tsa Meriana tsa CMO li hloka ho phunyeletsa litšitiso tsa tekheniki kapa litšitiso litseleng tsa tsona tsa mantlha le ho fana ka litsela tsa ho ntlafatsa ts'ebetso ea meriana ho fokotsa ka nepo litšenyehelo tsa tlhahiso ea lithethefatsi. Ntle le matsete a nako e telele, a theko e phahameng ho lipatlisiso le nts'etsopele le mehloli ea theknoloji, ho thata hore lik'hamphani tse kantle ho indasteri li kene indastering e le kannete.
③Litšitiso tsa litalenta
Ho thata ho lik'hamphani tsa CMO ho theha R&D ea tlholisano le sehlopha sa tlhahiso ka nako e khuts'oane ho theha mofuta oa khoebo o lumellanang le cGMP.
④Litšitiso tsa taolo ea boleng
FDA le mekhatlo e meng e laolang lithethefatsi e se e le thata ho feta litlhoko tsa bona tsa taolo ea boleng, 'me lihlahisoa tse sa feteng tlhahlobo li ke ke tsa kena' marakeng oa linaha tse tsoang kantle ho naha.
⑤ Litšitiso tsa taolo ea tikoloho
Lik'hamphani tsa meriana tse nang le lits'ebetso tse siiloeng ke nako li tla jara litšenyehelo tse phahameng tsa taolo ea tšilafalo le khatello ea taolo, 'me lik'hamphani tsa setso tsa meriana tse hlahisang haholo tšilafalo e phahameng, tšebeliso e phahameng ea matla le lihlahisoa tsa boleng bo tlaase (mohlala penicillin, livithamine, joalo-joalo) li tla tobana le ho felisoa ka potlako. Ho latela ts'ebetso ea boqapi le ho nts'etsapele theknoloji e tala ea meriana e fetohile tataiso ea nts'etsopele ea indasteri ea meriana ea CMO.

4. Likhoebo tsa ka hare tsa meriana tse thathamisitsoeng malapeng
Ho tloha boemong ba ketane ea indasteri, lik'hamphani tse 6 tse thathamisitsoeng tsa lik'hemik'hale tse ntle tse hlahisang li-intermediate tsa meriana kaofela li pheletsong e tlase ea ketane ea indasteri. Ebang ke ho mofani oa litšebeletso tsa profeshenale kapa ho API le katoloso ea tlhahiso, matla a tekheniki ke ona a susumetsang kamehla.
Mabapi le matla a thekenoloji, lik'hamphani tse nang le theknoloji boemong bo ka sehloohong ba machaba, matla a matla a polokelo le matsete a phahameng ho R&D li ratoa.
Sehlopha sa I: Lianhua Technology le Arbonne Chemical. Lianhua Technology e na le litheknoloji tse robeli tsa mantlha tse kang ammonia oxidation le fluorination e le motheo oa eona oa theknoloji, oo hydrogen oxidation e leng boemong bo ka sehloohong ba machaba. Abenomics ke moetapele oa machaba oa lithethefatsi tsa chiral, haholo-holo ho theknoloji ea eona ea ho arola lik'hemik'hale le ho etsa morabe, 'me e na le matsete a phahameng ka ho fetisisa a R&D, a ikarabellang bakeng sa 6.4% ea lekeno.
Sehlopha sa II: Wanchang Technology le Yongtai Technology. Mokhoa oa Wanchang Technology oa litšila oa hydrocyanic acid ke mokhoa o theko e tlaase le o tsoetseng pele ka ho fetisisa bakeng sa tlhahiso ea li-ester tsa prototrizoic acid. Ka lehlakoreng le leng, Yongtai Technology e tsebahala ka lik'hemik'hale tsa eona tse ntle tsa fluorine.
Sehlopha sa III: Tianma Fine Chemical le Bikang (eo pele e neng e tsejoa e le Jiuzhang).
Papiso ea matla a tekheniki a lik'hamphani tse thathamisitsoeng
Setšoantšo
Papiso ea bareki le mefuta ea papatso ea lik'hamphani tse lipakeng tsa meriana tse thathamisitsoeng
Setšoantšo
Papiso ea tlhokahalo e tlase le nako ea bophelo ba patent ea lihlahisoa tsa lik'hamphani tse thathamisitsoeng
Litšoantšo
Tlhahlobo ea tlholisano ea lihlahisoa tsa lik'hamphani tse thathamisitsoeng
Litšoantšo
Tsela ea ho ntlafatsa li-intermediate tse ntle tsa lik'hemik'hale
Litšoantšo
(Litšoantšo le lisebelisoa tse tsoang ho Qilu Securities)
Litebello tsa nts'etsopele ea indasteri ea lipakeng tsa meriana ea China
Joaloka indasteri ea bohlokoa lefapheng la indasteri e ntle ea lik'hemik'hale, tlhahiso ea meriana e fetohile sepheo sa nts'etsopele le tlhōlisano lilemong tse fetileng tsa 10, ka tsoelo-pele ea saense le theknoloji, meriana e mengata e 'nile ea ntlafatsoa ka mokhoa o tsoelang pele molemong oa moloko oa batho. ea meriana ena e itšetlehile ka tlhahiso ea li-intermediate tse ncha, tsa boleng bo phahameng ba meriana, kahoo meriana e mecha e sirelelitsoe ke litokelo tsa molao, ha ba-intermediate le bona ba se na mathata, kahoo li-intermediate tse ncha tsa meriana lapeng le linaheng tse ling Sebaka sa nts'etsopele ea 'maraka le tebello ea kopo. li ts'episa haholo.
Litšoantšo

Hona joale, tataiso ea lipatlisiso tsa li-intermediates tsa lithethefatsi e bonahala haholo-holo ka ho qaptjoa ha metsoako ea heterocyclic, metsoako e nang le fluorine, metsoako ea chiral, metsoako ea likokoana-hloko, joalo-joalo Ho ntse ho e-na le lekhalo le itseng pakeng tsa tsoelo-pele ea meriana ea meriana le litlhoko tsa indasteri ea meriana. naheng ea China. Lihlahisoa tse ling tse nang le litlhoko tse phahameng tsa tekheniki li ke ke tsa hlophisoa bakeng sa tlhahiso ea China 'me ha e le hantle li itšetlehile ka ho kenya thepa, tse kang anhydrous piperazine, propionic acid, joalo-joalo Le hoja lihlahisoa tse ling li ka finyella litlhoko tsa indasteri ea meriana ea malapeng ho latela bongata, empa e phahameng. litšenyehelo le boleng ha li finyelle maemo, tse amang tlholisano ea lihlahisoa tsa meriana mme li hloka ho ntlafatsa ts'ebetso ea tlhahiso, joalo ka TMB, p-aminophenol, D-PHPG, joalo-joalo.
Ho lebelletsoe hore lilemong tse 'maloa tse tlang, lipatlisiso tse ncha tsa lefats'e tsa lithethefatsi li tla shebana le lihlopha tse 10 tse latelang tsa lithethefatsi: lithethefatsi tse ntlafatsang ts'ebetso ea boko, lithethefatsi tse khahlanong le lefu la ramatiki, litlhare tse thibelang AIDS, anti-hepatitis le lithethefatsi tse ling tsa kokoana-hloko, lipid. -ho theola lithethefatsi, anti-thrombotic lithethefatsi, anti-tumor lithethefatsi, platelet-activating factor antagonists, glycoside cardiac stimulants, antidepressants, anti-psychotic le anti-anxiety drugs, joalo-joalo. nts'etsopele ea li-intermediates tsa meriana le mokhoa oa bohlokoa oa ho atolosa sebaka se secha sa 'maraka.