Intermediates yog ib yam tseem ceeb heev ntawm cov khoom siv tshuaj zoo. Hauv cov ntsiab lus, lawv yog ib hom "cov khoom lag luam ib nrab", uas tau siv dav hauv kev sib xyaw tshuaj, tshuaj tua kab, txheej, dyes thiab txuj lom.

Hauv tshuaj, cov tshuaj nruab nrab yog siv los tsim APIs.

Yog li dab tsi yog kev lag luam niche ntawm kws tshuaj intermediates?

01

Cov tshuaj hu ua intermediates yog cov khoom siv tshuaj lom neeg los yog cov khoom siv tshuaj siv hauv cov txheej txheem ntawm cov tshuaj synthesis.
Cov tshuaj, uas tsis tas yuav muaj daim ntawv tso cai tsim tshuaj, tuaj yeem tsim nyob rau hauv cov nroj tsuag tshuaj thiab, thaum nws nce mus txog qee qib, tuaj yeem siv rau hauv cov tshuaj synthesis.

Daim duab

Tam sim no, cov kev cog lus zoo tshaj plaws ntawm cov tshuaj intermediates feem ntau yog raws li hauv qab no:

Nucleoside intermediates.
Hom kev sib xyaw nruab nrab ntawm cov tshuaj tiv thaiv AIDS no feem ntau yog zidovudine, los ntawm Tebchaws Meskas Glaxo.
Wellcome thiab Bristol-Myers Squibb ua nws.

Cov kab mob plawv.
Piv txwv li, hluavtaws sartans tau siv dav hauv kev kho mob ntshav siab vim lawv ua tiav cov nyhuv antihypertensive, tsawg dua cov kev mob tshwm sim, kev ua haujlwm ntev (kev tswj cov ntshav siab rau 24 teev) thiab muaj peev xwm siv tau nrog lwm cov sartans.
Raws li kev txheeb cais, xyoo 2015, kev thov thoob ntiaj teb rau cov tshuaj sartan loj (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) tau mus txog 3,300 tons.
Tag nrho kev muag khoom yog $ 21.063 billion.

Fluorinated intermediates.
Cov tshuaj fluorinated synthesized los ntawm cov intermediates no tau tsim sai heev nyob rau hauv xyoo tas los no vim lawv ua tau zoo heev. Xyoo 1970, tsuas yog 2% ntawm cov tshuaj fluorinated nyob hauv khw; Los ntawm 2013, 25% ntawm cov tshuaj fluorinated nyob rau hauv lub khw.
Cov khoom lag luam sawv cev xws li fluoroquinolone tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob fluoxetine thiab tshuaj tiv thaiv kab mob fluconazole rau qhov kev faib ua feem ntau hauv kev siv tshuaj kho mob, ntawm cov tshuaj fluoroquinolone tshuaj tiv thaiv kab mob suav txog li 15% ntawm lub ntiaj teb kev lag luam feem ntawm cov tshuaj tiv thaiv kab mob.
Tsis tas li ntawd, trifluoroethanol yog ib qho tseem ceeb nruab nrab rau cov synthesis ntawm cov tshuaj loog, thaum trifluoromethylaniline yog ib qho tseem ceeb nruab nrab ntawm cov synthesis ntawm antimalarial tshuaj, anti-inflammatory thiab analgesic tshuaj, anti-prostate tshuaj thiab anti-depressants, thiab kev ua lag luam zeem muag yog dav heev. .

Heterocyclic intermediates.
Nrog pyridine thiab piperazine ua cov neeg sawv cev, nws yog tsuas yog siv nyob rau hauv lub synthesis ntawm anti-ulcer tshuaj, bulk gastric tshuaj, anti-inflammatory thiab tshuaj tiv thaiv kab mob, zoo heev antihypertensive tshuaj thiab tshiab anti-mob cancer tshuaj letrozole.

02

Pharmaceutical intermediates yog qhov txuas tseem ceeb hauv kev lag luam kws tshuaj.

Daim duab

Upstream yog cov khoom siv tshuaj lom neeg yooj yim, feem ntau yog cov khoom siv petrochemical, xws li acetylene, ethylene, propylene, butene thiab butadiene, toluene thiab xylene.

Pharmaceutical intermediates yog subdivided rau hauv thawj intermediates thiab advanced intermediates.
Ntawm lawv, thawj cov neeg muab khoom nruab nrab tuaj yeem tsuas yog muab cov khoom nruab nrab yooj yim thiab yog nyob rau pem hauv ntej ntawm cov khoom lag luam nrog cov kev sib tw loj tshaj plaws thiab cov nqi siab. Yog li ntawd, tus nqi hloov pauv ntawm cov khoom siv tshuaj lom neeg muaj txiaj ntsig zoo rau lawv.

Ntawm qhov tod tes, cov neeg muag khoom nruab nrab qib siab tsis yog tsuas yog muaj kev sib tham muaj zog tshaj cov neeg muab khoom lag luam, tab sis qhov tseem ceeb tshaj, vim tias lawv ua cov khoom lag luam qib siab nrog cov ntsiab lus siab thiab tswj kom muaj kev sib cuag nrog ntau lub teb chaws, lawv tsis tshua cuam tshuam los ntawm tus nqi hloov pauv. ntawm raw khoom.

Qhov nruab nrab nce mus rau kev lag luam tshuaj zoo tshuaj.
Cov neeg tsim khoom ntawm cov tshuaj intermediates ua ke cov intermediates los yog crude APIs, thiab muag cov khoom nyob rau hauv daim ntawv ntawm cov khoom siv tshuaj rau cov tuam txhab tshuaj, uas refine lawv thiab ces muag lawv li tshuaj.

Pharmaceutical intermediates suav nrog cov khoom lag luam thiab cov khoom lag luam customized. Raws li qhov sib txawv outsourcing cov kev pabcuam theem, cov qauv kev lag luam customized ntawm cov neeg nruab nrab tuaj yeem muab faib ua CRO (kev cog lus tshawb fawb thiab kev loj hlob outsourcing) thiab CMO (cog ntau lawm outsourcing).

Yav dhau los, CMO kev lag luam outsourcing hom feem ntau yog siv nyob rau hauv kws tshuaj intermediates.
Raws li tus qauv CMO, cov tuam txhab kws tshuaj outsource ntau lawm rau cov neeg koom tes.
Yog li ntawd, kev lag luam saw feem ntau pib nrog cov khoom siv tshuaj tshwj xeeb.
Cov tuam txhab lag luam yuav tsum tau yuav cov khoom siv tshuaj lom neeg yooj yim thiab muab faib ua cov khoom siv tshuaj tshwj xeeb, thiab tom qab ntawd rov ua dua rau API pib cov ntaub ntawv, cGMP intermediates, APIs thiab kev npaj.

Tab sis, raws li cov tuam txhab tshuaj rau kev tswj hwm tus nqi thiab kev ua haujlwm tau zoo, cov kev pabcuam tsim tawm yooj yim tsis tuaj yeem ua tau raws li qhov kev thov ntawm kev lag luam, CDMO hom (kev tshawb fawb thiab kev loj hlob outsourcing) tshwm sim nyob rau lub sijhawm keeb kwm, CDMO xav tau kev tsim kho kev lag luam los koom nrog. tus neeg muas zaub nyob rau hauv cov txheej txheem ntawm kev tshawb fawb thiab kev loj hlob, muab cov txheej txheem kev txhim kho los yog optimization, paub loj-scale ntau lawm zoo, txo nqi ntau lawm,
Nws muaj txiaj ntsig ntau dua li cov qauv CMO.

Lub downstream feem ntau yog API ntau lawm kev lag luam, thiab API yog nyob rau hauv upstream thiab downstream kev lag luam saw kev sib raug zoo nrog kev npaj.
Yog li ntawd, qhov kev xav tau ntawm kev npaj tshuaj hauv qab dej yuav cuam tshuam ncaj qha rau qhov kev thov ntawm API, thiab tom qab ntawd cuam tshuam qhov kev thov ntawm qhov nruab nrab.

Los ntawm qhov kev xav ntawm tag nrho cov kev lag luam saw, cov kws tshuaj intermediates tseem nyob rau theem kev loj hlob tam sim no, thiab qhov nruab nrab cov nyiaj tau los nruab nrab feem ntau yog 15-20%, thaum qhov nyiaj tau los nruab nrab ntawm API yog 20-25%, thiab qhov nruab nrab. Cov nyiaj tau los tag nrho ntawm cov kev npaj tshuaj hauv qab no yog siab li 40-50%. Obviously, tag nrho cov nyiaj tau los ntawm qhov qis qis yog qhov siab dua li ntawm cov dej ntws.
Yog li, kev lag luam tshuaj nruab nrab tuaj yeem txuas ntxiv cov khoom lag luam, nce cov txiaj ntsig ntawm cov khoom lag luam thiab txhim kho kev ruaj ntseg ntawm kev muag khoom los ntawm kev tsim API yav tom ntej.

03

Kev txhim kho siab ntawm kev lag luam tshuaj intermediates hauv Suav teb tau pib xyoo 2000.

Nyob rau lub sijhawm ntawd, cov tuam txhab tshuaj hauv cov teb chaws tsim kho tau them nyiaj ntau dua rau kev tshawb fawb thiab kev tsim khoom thiab kev tsim kho kev lag luam raws li lawv cov kev sib tw tseem ceeb, thiab ua kom nrawm rau kev hloov pauv ntawm cov khoom nruab nrab thiab cov tshuaj sib xyaw ua ke rau cov teb chaws tsim cov nqi qis.
Yog li ntawd, kev lag luam tshuaj intermediates hauv Suav teb tau ua tiav txoj kev loj hlob zoo los ntawm kev siv lub sijhawm no.
Tom qab ntau tshaj kaum xyoo ntawm kev txhim kho ruaj khov, nrog kev txhawb nqa ntawm lub teb chaws tag nrho cov kev cai thiab cov cai, Tuam Tshoj tau dhau los ua lub hauv paus tseem ceeb ntawm kev tsim khoom hauv ntiaj teb kev faib ua haujlwm hauv kev lag luam tshuaj.

Los ntawm 2012 txog 2018, cov zis ntawm Tuam Tshoj tus kws tshuaj intermediates kev lag luam tau nce los ntawm kwv yees li 8.1 lab tons nrog kev lag luam loj txog li 168.8 billion yuan mus txog 10.12 lab tons nrog kev lag luam loj ntawm 2010.7 billion yuan.

Daim duab

Tuam Tshoj tus kws tshuaj intermediates kev lag luam tau ua tiav kev lag luam muaj zog sib tw, thiab txawm tias qee lub tuam txhab tsim khoom nruab nrab tau tsim cov intermediates nrog cov qauv molecular complex thiab cov kev cai siab. Ib tug loj tus naj npawb ntawm influential khoom tau pib dominate lub thoob ntiaj teb kev ua lag luam.

Txawm li cas los xij, feem ntau, kev lag luam nruab nrab hauv Suav teb tseem nyob rau lub sijhawm txhim kho ntawm cov khoom tsim kho kom zoo thiab kho dua tshiab, thiab qib thev naus laus zis tseem tsawg.
Thawj kws tshuaj intermediates tseem yog cov khoom tseem ceeb hauv kev lag luam kws tshuaj intermediates, thiab muaj ob peb lub tuam txhab tsim cov khoom lag luam qib siab heev thiab txhawb cov khoom nruab nrab ntawm cov tshuaj tshiab patented.

Tam sim no, cov tuam txhab sib tw A-kev sib tw ntau dua hauv kev lag luam nruab nrab yog Yaben Chemical, Lianhua Technology, Boten, thiab Wanrun, uas npaj yuav nqis peev 630 lab yuan hauv kev tsim kho cov tshuaj intermediates thiab API cov haujlwm nrog tag nrho cov peev txheej ntawm 3,155 tons. / xyoo.
Lawv txuas ntxiv txhim kho ntau yam khoom los ntawm kev tshawb fawb thiab kev tsim kho, txhawm rau nrhiav txoj hauv kev tshiab.

Yaben Chemical Co., Ltd. (300261): Peb cov khoom tseem ceeb muaj xws li tshuaj tua kab mob intermediates, tshuaj antiepileptic intermediates thiab antiviral intermediates.
Ntawm lawv, ABAH, tshuaj tiv thaiv kab mob nruab nrab, tau muab tso rau hauv kev tsim khoom thaum Lub Kaum Hli 2014, nrog lub peev xwm ntawm 1,000 tons.
Enzyme fermentation thev naus laus zis tau ua tiav nkag mus rau hauv cov hlab plawv nruab nrab los txhim kho cov kev sib tw ntawm cov khoom.
Hauv xyoo 2017, lub tuam txhab tau txais ACL, lub tuam txhab tshuaj tshuaj nquag hauv Malta, ua kom nws cov txheej txheem hauv kev lag luam kho mob thoob ntiaj teb thiab tsav kev hloov pauv thiab txhim kho lub hauv paus.

BTG (300363): tsom rau cov tshuaj intermediates tshiab / API customized CMO lag luam, cov khoom tseem ceeb yog cov tshuaj intermediates rau kev tiv thaiv kab mob siab C, tiv thaiv AIDS, hypolipidemia thiab analgesia, thiab nws yog tus tseem ceeb ntawm Sofebuvir intermediates rau Gilead's anti-hepatitis. C tshuaj.
Hauv 2016, tag nrho cov nyiaj tau los ntawm kev tiv thaiv kab mob ntshav qab zib + tshuaj tiv thaiv kab mob siab C tau nce mus txog 660 lab, suav txog 50% ntawm tag nrho cov nyiaj tau los.
Txawm li cas los xij, txij li xyoo 2017, vim qhov kev kho mob ntawm cov neeg mob siab C thiab cov neeg mob tsawg zuj zus, Gilead qhov muag tshuaj kho kab mob siab C pib poob qis. Tsis tas li ntawd, nrog rau qhov tas sij hawm ntawm patents, ntau thiab ntau cov tshuaj tiv thaiv kab mob siab C tau pib, thiab kev sib tw txuas ntxiv mus ntxiv, ua rau poob qis ntawm kev txiav txim nruab nrab thiab nyiaj tau los.
Tam sim no, lub tuam txhab tau hloov los ntawm CMO kev lag luam mus rau CDMO kev lag luam los tsim kom muaj kev pabcuam thoob ntiaj teb rau kev lag luam tshuaj.

Alliance Technology (002250):
Pharmaceutical intermediates cov khoom lag luam feem ntau koom nrog cov tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob, tshuaj ntshav qab zib, tshuaj tiv thaiv kev ntxhov siab, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob khaub thuas, xws li cov hauv paus yog tag nrho hauv cov chaw kho mob ntawm lub ntiaj teb nrov tshaj plaws thiab thoob plaws lub khw. , qhov kev loj hlob sai nyob rau hauv xyoo tas los no, cov nyiaj tau los sib txuas ntawm kev loj hlob ntawm kwv yees li 50%.
Ntawm lawv, "txhua xyoo tso zis ntawm 300 tons ntawm Chunidine, 300 tons ntawm Fluzolic Acid thiab 200 tons ntawm Cyclopyrimidine Acid Project" tau muab tso rau hauv kev tsim ua tiav txij li xyoo 2014.