Zapakati ndi mtundu wofunika kwambiri wa mankhwala abwino. M'malo mwake, ndi mtundu wa "zomaliza zomaliza", zomwe zimagwiritsidwa ntchito kwambiri popanga mankhwala, mankhwala ophera tizilombo, zokutira, utoto ndi zonunkhira.

Muzamankhwala, apakatikati amagwiritsidwa ntchito kupanga ma API.

Ndiye kodi niche industry ya pharmaceutical intermediates ndi iti?

01

Zomwe zimatchedwa pharmaceutical intermediates kwenikweni ndi mankhwala ena opangira mankhwala kapena mankhwala omwe amagwiritsidwa ntchito popanga mankhwala.
Mankhwalawa, omwe safuna chilolezo chopanga mankhwala, amatha kupangidwa m'mafakitale odziwika bwino ndipo, akafika pamlingo wina, atha kugwiritsidwa ntchito popanga mankhwala.

Chithunzi

Pakadali pano, mitundu yodalirika kwambiri yamankhwala apakatikati mwamankhwala makamaka ndi awa:

Nucleoside intermediates.
Mtundu uwu wapakatikati kaphatikizidwe wa anti-AIDS mankhwala makamaka zidovudine, ku United States Glaxo.
Wellcome ndi Bristol-Myers Squibb amapanga.

Zapakati pamtima.
Mwachitsanzo, ma sartan opangidwa agwiritsidwa ntchito kwambiri pochiza matenda oopsa chifukwa cha mphamvu yawo yowonjezereka ya antihypertensive, zotsatira zochepa, mphamvu yayitali (kuwongolera kokhazikika kwa kuthamanga kwa magazi kwa maola 24) komanso kutha kugwiritsidwa ntchito pamodzi ndi sartans ena.
Malinga ndi ziwerengero, mu 2015, kufunikira kwapadziko lonse kwazinthu zazikulu za sartan (potaziyamu losartan, olmesartan, valsartan, irbesartan, telmisartan, candesartan) zidafika matani 3,300.
Zogulitsa zonse zinali $21.063 biliyoni.

Fluorinated intermediates.
Mankhwala opangidwa ndi fluorinated opangidwa kuchokera kuzinthu zotere akukula mofulumira m'zaka zaposachedwa chifukwa cha mphamvu zawo zabwino kwambiri. Mu 1970, 2% yokha ya mankhwala opangidwa ndi fluorinated anali pamsika; pofika 2013, 25% ya mankhwala fluorinated anali pa msika.
Mankhwala oimira monga fluoroquinolone anti-infective drugs, antidepressant fluoxetine ndi antifungal fluconazole account for high proposal in medical use, which fluoroquinolone anti-infective drugs account for about 15% of the global market share of anti-infective drugs.
Kuphatikiza apo, trifluoroethanol ndi gawo lapakati lofunikira pakuphatikizika kwamankhwala oletsa ululu, pomwe trifluoromethylaniline ndiyofunikira pakati pakupanga mankhwala oletsa malungo, anti-inflammatory and analgesic drugs, anti-prostate drugs and anti-depressants, ndipo chiyembekezo chamsika ndi chokulirapo. .

Heterocyclic intermediates.
Ndi pyridine ndi piperazine monga oimira, amagwiritsidwa ntchito makamaka popanga mankhwala odana ndi zilonda zam'mimba, mankhwala ochuluka a m'mimba, odana ndi kutupa ndi anti-infective, mankhwala othandiza kwambiri a antihypertensive ndi mankhwala atsopano a khansa ya m'mawere letrozole.

02

Mankhwala apakatikati ndi ofunikira kwambiri pamakampani opanga mankhwala.

Chithunzi

Kumtunda ndi zinthu zopangira mankhwala, zomwe zambiri zimakhala zopangira petrochemical, monga acetylene, ethylene, propylene, butene ndi butadiene, toluene ndi xylene.

Mankhwala apakatikati amagawidwa m'magulu apakati komanso apamwamba.
Pakati pawo, ogulitsa oyambira apakatikati atha kungopereka zopanga zosavuta zapakatikati ndipo ali kutsogolo kwa unyolo wamafakitale omwe ali ndi mpikisano waukulu kwambiri komanso kuthamanga kwamitengo. Chifukwa chake, kusinthasintha kwamitengo yazinthu zopangira mankhwala kumakhudza kwambiri.

Kumbali inayi, ogulitsa apamwamba apakatikati sangokhala ndi mphamvu zotsutsana ndi ogulitsa oyambira, koma chofunikira kwambiri, chifukwa amapanga zida zapamwamba zokhala ndi luso lapamwamba komanso kulumikizana kwambiri ndi makampani amitundu yambiri, sakhudzidwa kwambiri ndi kusinthasintha kwamitengo. wa zipangizo.

Malo apakati ndi a pharmaceutical fine chemical industry.
Opanga mankhwala apakatikati amapangira ma API apakati kapena opanda pake, ndikugulitsa zinthuzo ngati mankhwala kumakampani opanga mankhwala, omwe amawayeretsa ndikumagulitsa ngati mankhwala.

Zapakati pazamankhwala zimaphatikizanso zinthu zina zonse komanso zosinthidwa makonda. Malinga ndi magawo osiyanasiyana a ntchito zotumizira kunja, mitundu yamabizinesi okhazikika apakati amatha kugawidwa kukhala CRO (kafukufuku wa makontrakitala ndi chitukuko chakunja) ndi CMO (kutulutsa kontrakitala).

M'mbuyomu, CMO bizinesi outsourcing mode ankagwiritsidwa ntchito intermediates mankhwala.
Pansi pa chitsanzo cha CMO, makampani opanga mankhwala amatulutsa kupanga kwa anzawo.
Chifukwa chake, unyolo wamabizinesi nthawi zambiri umayamba ndi zida zapadera zamankhwala.
Makampani am'mafakitale amayenera kugula zida zoyambira zamankhwala ndikuzigawa ndikuzipanga kukhala zida zapadera zamankhwala, kenako ndikuzipanganso kukhala zida zoyambira za API, zapakati za cGMP, ma API ndi kukonzekera.

Koma, monga makampani opanga mankhwala owongolera mtengo ndi zofunikira zogwirira ntchito, ntchito zosavuta zopangira ntchito zalephera kukwaniritsa zofunikira zamabizinesi, njira ya CDMO (kafukufuku wopanga ndi kutulutsa chitukuko) imachitika panthawi yanthawi yayitali, CDMO ikufunika mabizinesi opanga makonda kuti atenge nawo mbali. kasitomala ali mkati mwa kafukufuku ndi chitukuko, kupereka kusintha kapena kukhathamiritsa kwa ndondomeko, kuzindikira khalidwe lalikulu la kupanga, kuchepetsa mtengo wopanga,
Ili ndi malire apamwamba kuposa mtundu wa CMO.

Mtsinjewo uli makamaka makampani opanga API, ndipo API ili mumgwirizano wamakampani okwera ndi otsika ndi kukonzekera.
Chifukwa chake, kufunikira kwa kugwiritsidwa ntchito kwa kukonzekera kwamankhwala otsika kumakhudza mwachindunji kufunikira kwa API, kenako kukhudza kufunikira kwapakatikati.

Kutengera momwe mafakitale onse amagwirira ntchito, othandizira azamankhwala akadali pakukula pakali pano, ndipo phindu lalikulu lazachuma nthawi zambiri ndi 15-20%, pomwe phindu la API ndi 20-25%, ndipo pafupifupi Kuchuluka kwa phindu lamankhwala otsika mtengo kumafikira 40-50%. Mwachiwonekere, chiwongola dzanja chonse cha gawo lotsika ndi lalikulu kwambiri kuposa gawo la kumtunda.
Chifukwa chake, mabizinesi apakatikati azachipatala amatha kukulitsa mndandanda wazogulitsa, kukulitsa phindu lazinthu ndikuwongolera kukhazikika kwa malonda popanga API mtsogolo.

03

Kukula kwakukulu kwamakampani opanga mankhwala ku China kudayamba mu 2000.

Panthawi imeneyo, makampani opanga mankhwala m'mayiko otukuka ankapereka chidwi kwambiri pa kafukufuku wa mankhwala ndi chitukuko ndi chitukuko cha msika monga kupikisana kwawo kwakukulu, ndikupititsa patsogolo kusamutsidwa kwa intermediates ndi kaphatikizidwe ka mankhwala ku mayiko omwe akutukuka kumene ndi ndalama zochepa.
Chifukwa chake, makampani opanga mankhwala ku China apeza chitukuko chabwino kwambiri potengera mwayiwu.
Pambuyo pa zaka zopitirira khumi zachitukuko chokhazikika, mothandizidwa ndi malamulo ndi ndondomeko za dziko lonse, dziko la China lakhala lofunika kwambiri pakupanga gawo lapadziko lonse la ogwira ntchito m'makampani opanga mankhwala.

Kuchokera 2012 mpaka 2018, linanena bungwe la China mankhwala intermediates makampani chinawonjezeka kuchokera pafupifupi matani 8.1 miliyoni ndi kukula msika pafupifupi 168.8 biliyoni yuan kufika pafupifupi 10.12 miliyoni matani ndi kukula msika 2010.7 biliyoni yuan.

Chithunzi

China pharmaceutical intermediates makampani akwaniritsa amphamvu msika mpikisano, ndipo ngakhale mabizinesi ena wapakatikati kupanga atha kutulutsa intermediates ndi dongosolo zovuta maselo ndi mkulu zofunika luso. Zinthu zambiri zodziwika bwino zayamba kulamulira msika wapadziko lonse lapansi.

Komabe, ambiri, makampani apakatikati ku China akadali mu nthawi yachitukuko cha kukhathamiritsa kwa kapangidwe kazinthu ndi kukweza, ndipo mulingo waukadaulo ukadali wotsika.
Othandizira mankhwala oyambira akadali zinthu zazikulu mumakampani opanga mankhwala, ndipo pali mabizinesi ochepa omwe akupanga mitundu yambiri yamankhwala apamwamba komanso kuthandizira mankhwala apakatikati amankhwala atsopano ovomerezeka.

Pakadali pano, makampani omwe akupikisana nawo kwambiri a A-share mumakampani apakatikati ndi Yaben Chemical, Lianhua Technology, Boten, ndi Wanrun, omwe akufuna kuyika ndalama zokwana 630 miliyoni pomanga ma projekiti apakatikati ndi ma API okhala ndi matani 3,155. /chaka.
Akupitiriza kupanga zinthu zosiyanasiyana kudzera mu kafukufuku ndi chitukuko, kuti apeze njira zatsopano.

Yaben Chemical Co., Ltd. (300261): Zogulitsa zathu zazikulu zimaphatikizapo antitumor mankhwala intermediates, antiepileptic mankhwala intermediates ndi antiviral intermediates.
Pakati pawo, ABAH, mankhwala oletsa khunyu, adakhazikitsidwa mwalamulo mu Okutobala 2014, ndi mphamvu ya matani 1,000.
Ukadaulo wowotchera ma enzyme udayambitsidwa bwino pakatikati pamtima kuti apititse patsogolo kupikisana kwazinthuzo.
Mu 2017, kampaniyo idapeza ACL, kampani yopanga mankhwala ku Malta, kufulumizitsa masanjidwe ake pamsika wapadziko lonse wa zamankhwala ndikuyendetsa kusintha ndi kukweza kwapakhomo.

BTG (300363) : yoyang'ana kwambiri pazamankhwala apakatikati / API yosinthidwa ndi bizinesi ya CMO, zinthu zazikuluzikulu ndizophatikizira zamankhwala odana ndi chiwindi C, anti-AIDS, hypolipidemia ndi analgesia, ndipo ndi omwe amapereka Sofebuvir intermediates kwa Anti-hepatitis ku Gileadi. C mankhwala.
Mu 2016, ndalama zonse za anti-diabetes + anti-hepatitis C intermediates zidafika 660 miliyoni, zomwe zimawerengera 50% ya ndalama zonse.
Komabe, kuyambira 2017, chifukwa cha kuchira kwapang’onopang’ono kwa odwala a hepatitis C komanso kuchepa kwa chiwerengero cha odwala, malonda a Gileadi a mankhwala a hepatitis C anayamba kuchepa. Komanso, ndi kutha kwa zovomerezeka, mankhwala owonjezera a hepatitis C adayambitsidwa, ndipo mpikisano udapitilirabe, zomwe zidapangitsa kuchepa kwa malamulo apakatikati ndi ndalama.
Pakadali pano, kampaniyo yasintha kuchoka ku bizinesi ya CMO kupita ku bizinesi ya CDMO kuti ipange nsanja yotsogola padziko lonse lapansi yamabizinesi azamankhwala.

Alliance Technology (002250) :
Mankhwala apakatikati apakati amakhudzidwa makamaka ndi mankhwala oletsa kutupa, autoimmune, antifungal mankhwala, mankhwala amtima, matenda a shuga, antidepressants, antihypertensive mankhwala, mankhwala odana ndi chimfine, monga zoyambira zonse zili m'malo achirengedwe amsika otchuka kwambiri padziko lonse lapansi. , kukula kofulumira m'zaka zaposachedwa, kuchuluka kwa ndalama zomwe zimakula pafupifupi 50%.
Pakati pawo, "kutulutsa kwapachaka kwa matani 300 a Chunidine, matani 300 a Fluzolic Acid ndi matani 200 a Cyclopyrimidine Acid Project" apangidwa motsatizana kuyambira 2014.