Cov tshuaj intermediates yog ib hom tshuaj lom neeg tseem ceeb heev. Qhov tseem ceeb, lawv yog ib hom "cov khoom tiav ib nrab", uas siv dav hauv kev tsim tshuaj, tshuaj tua kab, tshuaj pleev xim, xim pleev xim thiab cov txuj lom.

Hauv kev kho mob, cov tshuaj intermediates yog siv los tsim cov APIs.

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

01

Cov tshuaj intermediates uas hu ua tshuaj yog qee cov khoom siv tshuaj lom neeg lossis cov khoom siv tshuaj siv rau hauv cov txheej txheem ntawm kev tsim tshuaj.
Cov tshuaj lom neeg, uas tsis tas yuav muaj daim ntawv tso cai tsim tshuaj, tuaj yeem tsim tawm hauv cov chaw tsim tshuaj ib txwm muaj thiab, thaum nws mus txog qee qib, tuaj yeem siv rau hauv kev tsim cov tshuaj.

Daim duab

Tam sim no, cov tshuaj intermediates uas muaj kev cia siab tshaj plaws yog cov hauv qab no:

Cov tshuaj nucleoside intermediates.
Hom kev tsim cov tshuaj tiv thaiv AIDS no feem ntau yog zidovudine, los ntawm Tebchaws Meskas Glaxo.
Zoo siab thiab Bristol-Myers Squibb ua tiav.

Cov tshuaj intermediates rau cov hlab ntsha hauv lub plawv.
Piv txwv li, cov tshuaj sartans tsim tau siv dav hauv kev kho mob ntshav siab vim lawv cov txiaj ntsig tiv thaiv ntshav siab dua, tsawg dua cov kev mob tshwm sim, kev ua haujlwm ntev (kev tswj ntshav siab ruaj khov rau 24 teev) thiab lub peev xwm siv ua ke nrog lwm cov tshuaj sartans.
Raws li cov ntaub ntawv txheeb cais, xyoo 2015, qhov kev thov thoob ntiaj teb rau cov tshuaj sartan tseem ceeb (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) tau txog 3,300 tons.
Tag nrho cov muag khoom yog $ 21.063 billion.

Cov tshuaj fluorinated intermediates.
Cov tshuaj fluorinated uas ua los ntawm cov tshuaj intermediates no tau tsim kho sai heev nyob rau xyoo tas los no vim lawv cov txiaj ntsig zoo heev. Xyoo 1970, tsuas muaj 2% ntawm cov tshuaj fluorinated nyob rau hauv kev ua lag luam; los ntawm xyoo 2013, 25% ntawm cov tshuaj fluorinated nyob rau hauv kev ua lag luam.
Cov khoom sawv cev xws li fluoroquinolone tshuaj tiv thaiv kev kis kab mob, antidepressant fluoxetine thiab antifungal fluconazole suav nrog feem ntau hauv kev siv kho mob, ntawm cov tshuaj fluoroquinolone tiv thaiv kev kis kab mob suav txog li 15% ntawm kev lag luam thoob ntiaj teb ntawm cov tshuaj tiv thaiv kev kis kab mob.
Ntxiv rau, trifluoroethanol yog ib qho tseem ceeb rau kev tsim cov tshuaj loog, thaum trifluoromethylaniline yog ib qho tseem ceeb rau kev tsim cov tshuaj tiv thaiv kab mob malaria, tshuaj tiv thaiv kev o thiab tshuaj analgesic, tshuaj tiv thaiv prostate thiab tshuaj tiv thaiv kev nyuaj siab, thiab kev cia siab ntawm kev ua lag luam yog dav heev.

Cov tshuaj nruab nrab heterocyclic.
Nrog pyridine thiab piperazine ua tus sawv cev, nws yog siv rau hauv kev tsim cov tshuaj tiv thaiv kab mob qog, cov tshuaj gastric ntau, cov tshuaj tiv thaiv kev o thiab cov tshuaj tiv thaiv kev kis kab mob, cov tshuaj tiv thaiv kev ntshav siab zoo heev thiab cov tshuaj tiv thaiv mob qog noj ntshav tshiab letrozole.

02

Cov tshuaj intermediates yog ib qho tseem ceeb hauv kev lag luam tshuaj.

Daim duab

Cov dej ntws yog cov khoom siv tshuaj lom neeg tseem ceeb, feem ntau yog cov khoom lag luam petrochemical, xws li acetylene, ethylene, propylene, butene thiab butadiene, toluene thiab xylene.

Cov tshuaj intermediates raug muab faib ua cov tshuaj intermediates thawj zaug thiab cov tshuaj intermediates siab heev.
Ntawm lawv, cov neeg muab khoom nruab nrab tseem ceeb tsuas yog tuaj yeem muab cov khoom nruab nrab yooj yim thiab nyob rau pem hauv ntej ntawm cov saw hlau kev lag luam nrog kev sib tw loj tshaj plaws thiab kev nyuaj siab ntawm tus nqi. Yog li ntawd, kev hloov pauv ntawm tus nqi ntawm cov khoom siv tshuaj lom neeg yooj yim muaj kev cuam tshuam loj rau lawv.

Ntawm qhov tod tes, cov neeg muag khoom nruab nrab siab heev tsis yog tsuas muaj lub hwj chim sib tham zoo dua li cov neeg muag khoom tseem ceeb, tab sis qhov tseem ceeb dua, vim tias lawv ua cov khoom nruab nrab siab heev nrog cov ntsiab lus kev siv tshuab siab thiab tswj kev sib cuag ze nrog cov tuam txhab thoob ntiaj teb, lawv tsis tshua cuam tshuam los ntawm kev hloov pauv ntawm tus nqi ntawm cov khoom siv raw.

Qhov nruab nrab ncav cuag yog cov tshuaj lom neeg zoo hauv kev lag luam tshuaj.
Cov chaw tsim khoom ntawm cov tshuaj intermediates synthesizes intermediates lossis crude APIs, thiab muag cov khoom lag luam hauv daim ntawv ntawm cov khoom siv tshuaj rau cov tuam txhab tshuaj, uas ua kom zoo dua thiab tom qab ntawd muag lawv ua tshuaj.

Cov tshuaj intermediates suav nrog cov khoom lag luam dav dav thiab cov khoom lag luam customized. Raws li cov theem kev pabcuam outsourcing sib txawv, cov qauv lag luam customized ntawm cov khoom lag luam intermediates feem ntau tuaj yeem muab faib ua CRO (kev tshawb fawb thiab kev txhim kho outsourcing) thiab CMO (kev tsim khoom cog lus outsourcing).

Yav dhau los, CMO kev lag luam outsourcing hom feem ntau yog siv rau hauv cov tshuaj intermediates.
Raws li tus qauv CMO, cov tuam txhab tshuaj muab cov khoom lag luam rau cov neeg koom tes.
Yog li ntawd, cov saw hlau ua lag luam 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 faib ua pawg thiab ua cov khoom siv tshuaj tshwj xeeb, thiab tom qab ntawd rov ua dua rau hauv cov khoom siv pib API, cGMP intermediates, APIs thiab kev npaj.

Tab sis, raws li cov tuam txhab tshuaj rau kev tswj tus nqi thiab kev ua haujlwm tau zoo, cov kev pabcuam yooj yim tsim khoom tsis tau ua tiav qhov kev thov ntawm cov tuam txhab, CDMO hom (kev tshawb fawb tsim khoom thiab kev tsim khoom outsourcing) tshwm sim thaum lub sijhawm keeb kwm, CDMO xav tau kev hloov kho cov tuam txhab tsim khoom kom koom nrog cov neeg siv khoom hauv cov txheej txheem ntawm kev tshawb fawb thiab kev txhim kho, los muab kev txhim kho lossis kev ua kom zoo dua, paub txog qhov zoo ntawm kev tsim khoom loj, txo cov nqi tsim khoom,
Nws muaj cov nyiaj tau los ntau dua li tus qauv CMO.

Cov downstream feem ntau yog API kev lag luam tsim khoom, thiab API yog nyob rau hauv upstream thiab downstream kev lag luam saw hlau kev sib raug zoo nrog kev npaj.
Yog li ntawd, qhov kev thov siv ntawm cov tshuaj downstream yuav cuam tshuam ncaj qha rau qhov kev thov ntawm API, thiab tom qab ntawd cuam tshuam rau qhov kev thov ntawm cov khoom nruab nrab.

Los ntawm qhov kev xav ntawm tag nrho cov saw hlau kev lag luam, cov tshuaj intermediates tseem nyob rau theem kev loj hlob tam sim no, thiab qhov nruab nrab ntawm cov nyiaj tau los feem ntau yog 15-20%, thaum qhov nruab nrab ntawm cov nyiaj tau los ntawm API yog 20-25%, thiab qhov nruab nrab ntawm cov nyiaj tau los ntawm kev npaj tshuaj downstream yog siab txog 40-50%. Nws yog qhov tseeb tias qhov nyiaj tau los ntawm qhov downstream yog siab dua li ntawm qhov upstream.
Yog li ntawd, cov tuam txhab 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 khov ntawm kev muag khoom los ntawm kev tsim API yav tom ntej.

03

Kev loj hlob ntawm kev lag luam tshuaj intermediates hauv Suav teb tau pib xyoo 2000.

Lub sijhawm ntawd, cov tuam txhab tshuaj hauv cov tebchaws tsim kho tau them sai dua rau kev tshawb fawb thiab kev txhim kho khoom thiab kev txhim kho kev ua lag luam ua lawv qhov kev sib tw tseem ceeb, thiab ua kom nrawm dua kev hloov pauv ntawm cov tshuaj nruab nrab thiab kev tsim tshuaj nquag mus rau cov tebchaws tsim kho nrog cov nqi qis dua.
Yog li ntawd, kev lag luam tshuaj intermediates hauv Suav teb tau ua tiav kev loj hlob zoo heev 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 txoj cai thiab cov cai tswjfwm, Tuam Tshoj tau dhau los ua lub hauv paus tseem ceeb hauv kev faib ua haujlwm thoob ntiaj teb hauv kev lag luam tshuaj.

Txij xyoo 2012 txog 2018, cov khoom tsim tawm ntawm Tuam Tshoj txoj kev lag luam tshuaj nruab nrab tau nce ntxiv los ntawm kwv yees li 8.1 lab tons nrog rau kev lag luam loj ntawm kwv yees li 168.8 billion yuan mus rau kwv yees li 10.12 lab tons nrog rau kev lag luam loj ntawm 2010.7 billion yuan.

Daim duab

Tuam Tshoj txoj kev lag luam tshuaj intermediates tau ua tiav kev sib tw ua lag luam muaj zog, thiab txawm tias qee lub tuam txhab tsim khoom nruab nrab kuj tau tsim cov khoom nruab nrab nrog cov qauv molecular nyuaj thiab cov kev xav tau siab. Muaj ntau cov khoom muaj hwj chim tau pib tswj hwm kev lag luam thoob ntiaj teb.

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

Tam sim no, cov tuam txhab A-share uas muaj npe nrov 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 cov tshuaj nruab nrab thiab cov haujlwm API nrog tag nrho cov peev xwm ntawm 3,155 tons / xyoo.
Lawv txuas ntxiv tsim ntau yam khoom los ntawm kev tshawb fawb thiab kev txhim kho, txhawm rau nrhiav txoj hauv kev tshiab.

Yaben Chemical Co., Ltd. (300261): Peb cov khoom tseem ceeb suav nrog cov tshuaj tiv thaiv qog nqaij hlav, cov tshuaj tiv thaiv qaug dab peg thiab cov tshuaj tua kab mob.
Ntawm lawv, ABAH, ib qho tshuaj tiv thaiv kab mob qaug dab peg, tau raug tsim tawm thaum Lub Kaum Hli 2014, nrog lub peev xwm ntawm 1,000 tons.
Cov thev naus laus zis enzyme fermentation tau ua tiav hauv cov khoom siv plawv nruab nrab kom txhim kho kev sib tw ntawm cov khoom.
Xyoo 2017, lub tuam txhab tau yuav ACL, ib lub tuam txhab tshuaj muaj zog hauv Malta, ua kom nws txoj kev teeb tsa hauv kev lag luam kho mob thoob ntiaj teb sai dua thiab tsav tsheb kev hloov pauv thiab kev txhim kho ntawm lub hauv paus hauv tebchaws.

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

Kev Koom Tes Tshuab (002250):
Cov khoom siv tshuaj intermediates feem ntau yog koom nrog cov tshuaj tiv thaiv qog, autoimmune, antifungal tshuaj, cardiovascular tshuaj, ntshav qab zib tshuaj, antidepressants, antihypertensive tshuaj, tshuaj tiv thaiv kab mob khaub thuas, xws li cov khoom yooj yim yog txhua yam nyob rau hauv thaj chaw kho mob ntawm lub ntiaj teb nrov tshaj plaws thiab dav dav ntawm kev ua lag luam, kev loj hlob sai hauv xyoo tas los no, cov nyiaj tau los ntawm kev loj hlob ntawm kwv yees li 50%.
Ntawm lawv, "cov khoom tsim tawm txhua xyoo ntawm 300 tons ntawm Chunidine, 300 tons ntawm Fluzolic Acid thiab 200 tons ntawm Cyclopyrimidine Acid Project" tau muab tso rau hauv kev tsim khoom sib law liag txij li xyoo 2014.