Matsakaici wani nau'i ne mai mahimmanci na samfuran sinadarai masu kyau. Ainihin, su ne nau'i na "kayayyakin da aka gama da su", waɗanda aka yi amfani da su sosai a cikin haɗin magunguna, magungunan kashe qwari, sutura, dyes da kayan yaji.

A cikin magani, ana amfani da tsaka-tsaki don samar da APIs.

Don haka menene masana'antar niche na matsakaicin magunguna?

01

Abubuwan da ake kira tsaka-tsaki na magunguna a zahiri wasu albarkatun sinadarai ne ko samfuran sinadarai da ake amfani da su wajen hada magunguna.
Sinadarin, wanda ba ya buƙatar lasisin kera magunguna, ana iya samar da shi a cikin masana'antar sinadarai ta al'ada kuma, idan ya kai wasu matakan, ana iya amfani da shi wajen haɗa magunguna.

Hoton

A halin yanzu, mafi kyawun nau'ikan masu tsaka-tsakin magunguna sun fi kamar haka:

Matsakaicin Nucleoside.
Irin wannan tsaka-tsaki na magungunan anti-AIDS shine zidovudine, daga Glaxo na Amurka.
Wellcome da Bristol-Myers Squibb sun yi.

Matsakaitan cututtukan zuciya.
Alal misali, sartans na roba sun zama masu amfani da su sosai wajen maganin hauhawar jini saboda ƙarin cikakken sakamako na antihypertensive, ƙananan sakamako masu illa, tasiri mai tsawo (tsayayyen kula da hawan jini na tsawon sa'o'i 24) da kuma ikon yin amfani da shi tare da sauran sartans.
Dangane da kididdiga, a cikin 2015, buƙatun duniya na manyan abubuwan da ke aiki da magungunan sartan (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) ya kai tan 3,300.
Jimlar tallace-tallace sun kai dala biliyan 21.063.

Matsakaicin masu fluorinated.
Magungunan Fluorinated da aka haɗa daga irin waɗannan masu tsaka-tsaki sun haɓaka cikin sauri a cikin 'yan shekarun nan saboda ingantaccen inganci. A cikin 1970, kawai 2% na magungunan fluorine a kasuwa; A shekara ta 2013, kashi 25% na magungunan fluorine sun kasance a kasuwa.
Samfuran wakilai irin su fluoroquinolone anti-infective drugs, antidepressant fluoxetine da antifungal fluconazole suna da adadi mai yawa a cikin amfani da asibiti, daga cikinsu akwai nau'ikan fluoroquinolone na rigakafin kamuwa da cuta na kusan kashi 15% na kasuwar duniya na magungunan rigakafin cutar.
Bugu da kari, trifluoroethanol wani muhimmin tsaka-tsaki ne don hada magungunan anesthetics, yayin da trifluoromethylaniline muhimmin matsakaici ne don hada magungunan zazzabin cizon sauro, magungunan kumburi da analgesic, magungunan prostate da antidepressants, kuma hasashen kasuwa yana da fa'ida sosai. .

Heterocyclic matsakaici.
Tare da pyridine da piperazine a matsayin wakilai, an fi amfani dashi a cikin kira na maganin ciwon daji, yawancin magungunan ciki, magungunan ƙwayoyin cuta da ƙwayoyin cuta, magungunan antihypertensive masu tasiri sosai da sababbin magungunan ciwon daji na nono letrozole.

02

Matsakaicin magunguna sune muhimmiyar hanyar haɗi a cikin sarkar masana'antar harhada magunguna.

Hoton

Upstream shine ainihin albarkatun sinadarai, yawancin su samfuran petrochemical, kamar acetylene, ethylene, propylene, butene da butadiene, toluene da xylene.

Matsakaicin magunguna sun kasu kashi na farko da na gaba.
Daga cikin su, masu samar da tsaka-tsakin farko na iya samar da tsaka-tsaki mai sauƙi kawai kuma suna gaban sarkar masana'antu tare da mafi girman matsa lamba da farashin farashi. Sabili da haka, canjin farashin kayan albarkatun sinadarai na asali yana da babban tasiri a kansu.

A daya hannun kuma, ci-gaba na tsaka-tsaki masu kaya ba wai kawai suna da karfin ciniki mai karfi akan masu samar da kayayyaki na farko ba, amma mafi mahimmanci, saboda suna aiwatar da samar da na'urori masu ci gaba tare da babban abun ciki na fasaha da kuma kula da kusanci da kamfanoni na duniya, ba su da tasiri sosai ta hanyar canjin farashin. na albarkatun kasa.

Tsakanin ya kai ga masana'antar sinadarai masu kyau na harhada magunguna.
Masu kera magunguna na tsaka-tsaki suna haɗa tsaka-tsaki ko ɗanyen APIs, kuma suna sayar da samfuran a cikin nau'ikan samfuran sinadarai ga kamfanonin harhada magunguna, waɗanda ke tace su sannan kuma suna sayar da su azaman magunguna.

Matsakaicin magunguna sun haɗa da samfuran gama-gari da samfuran da aka keɓance. Dangane da matakan sabis na fitar da kayayyaki daban-daban, samfuran kasuwancin da aka keɓance na tsaka-tsaki za a iya raba su gabaɗaya zuwa CRO (binciken kwangila da fitar da haɓakawa) da CMO (fitarwa na samar da kwangila).

A da, yanayin fitar da kasuwancin CMO an fi amfani dashi a tsaka-tsakin magunguna.
A ƙarƙashin tsarin CMO, kamfanonin harhada magunguna suna ba da kayan samarwa ga abokan haɗin gwiwa.
Don haka, sarkar kasuwanci gabaɗaya tana farawa da kayan albarkatun magunguna na musamman.
Kamfanonin masana'antu suna buƙatar siyan kayan albarkatun sinadarai na asali da rarrabawa da sarrafa su zuwa kayan albarkatun magunguna na musamman, sannan a sake sarrafa su cikin kayan farawa API, tsaka-tsakin cGMP, APIs da shirye-shirye.

Amma, kamar yadda kamfanonin magunguna don sarrafa farashi da buƙatun inganci, ayyukan samar da kayayyaki masu sauƙi sun kasa biyan buƙatun kasuwancin, yanayin CDMO (binciken samarwa da fitar da haɓakawa) ya taso a lokacin tarihi, CDMO yana buƙatar ƙera masana'antar samarwa don shiga ciki. abokin ciniki a cikin aiwatar da bincike da haɓakawa, don samar da ingantaccen tsari ko haɓakawa, gane ingancin samarwa mai girma, rage farashin samarwa,
Yana da riba mafi girma fiye da samfurin CMO.

Ƙarƙashin ƙasa shine galibi masana'antar samar da API, kuma API ɗin yana cikin alaƙar sarkar masana'antu ta sama da ƙasa tare da shirye-shiryen.
Sabili da haka, buƙatar amfani da shirye-shiryen magani na ƙasa zai shafi buƙatar API kai tsaye, sannan kuma ya shafi buƙatar matsakaici.

Daga mahangar dukkanin sarkar masana'antu, masu matsakaicin magunguna har yanzu suna cikin ci gaban ci gaban a halin yanzu, kuma matsakaicin babban riba gabaɗaya shine 15-20%, yayin da matsakaicin babban riba na API shine 20-25%, kuma matsakaici Babban riba na shirye-shiryen magunguna na ƙasa ya kai 40-50%. Babu shakka, yawan ribar da ake samu na ɓangaren da ke ƙasa yana da girma fiye da na ɓangaren sama.
Sabili da haka, kamfanoni masu tsaka-tsakin magunguna na iya ƙara haɓaka sarkar samfur, haɓaka ribar samfur da haɓaka kwanciyar hankali na tallace-tallace ta hanyar samar da API a nan gaba.

03

An fara babban ci gaban masana'antar hada magunguna a kasar Sin a shekarar 2000.

A wancan lokacin, kamfanonin harhada magunguna a kasashen da suka ci gaba sun mai da hankali sosai kan bincike da bunkasuwar kayayyaki da bunkasuwar kasuwa a matsayin ginshikin gasa, tare da hanzarta mika masu tsaka-tsaki da hada magunguna zuwa kasashe masu tasowa masu rahusa.
Don haka, masana'antar matsakaicin magunguna a kasar Sin ta samu babban ci gaba ta hanyar amfani da wannan dama.
Bayan fiye da shekaru goma na ci gaba da ci gaba, tare da goyon bayan ka'idoji da manufofi na kasa baki daya, kasar Sin ta zama muhimmiyar cibiyar samar da kayayyaki ta tsaka-tsaki a bangaren ma'aikata na duniya a masana'antar harhada magunguna.

Daga shekarar 2012 zuwa 2018, yawan kayayyakin da ake samu a tsaka-tsakin harhada magunguna na kasar Sin ya karu daga kimanin tan miliyan 8.1 da girman kasuwar ya kai kimanin yuan biliyan 168.8 zuwa kusan tan miliyan 10.12 da girman kasuwar ya kai yuan biliyan 2010.7.

Hoton

Kamfanonin matsakaicin magunguna na kasar Sin sun samu gagarumar gogayya a kasuwa, har ma wasu masana'antun samar da kayayyaki na kasar Sin sun sami damar samar da matsakaicin matsakaicin tsarin kwayoyin halitta da manyan bukatun fasaha. Yawancin kayayyaki masu tasiri sun fara mamaye kasuwannin duniya.

Duk da haka, a gaba ɗaya, matsakaicin masana'antu a kasar Sin har yanzu yana cikin lokacin haɓaka tsarin samfura da haɓakawa, kuma matakin fasaha har yanzu yana da ƙasa kaɗan.
Matsakaicin magunguna na farko har yanzu sune manyan samfuran a cikin masana'antar magunguna, kuma akwai ƴan masana'antu da ke samar da adadi mai yawa na ci-gaba na magunguna da tallafawa samfuran matsakaici na sabbin magunguna.

A halin yanzu, manyan kamfanonin A-share da aka jera a cikin matsakaicin masana'antu sune Yaben Chemical, Lianhua Technology, Boten, da Wanrun, waɗanda ke shirin saka hannun jarin Yuan miliyan 630 don gina hanyoyin samar da magunguna da ayyukan API tare da jimlar tan 3,155. / shekara.
Suna ci gaba da haɓaka nau'ikan samfuran ta hanyar bincike da haɓakawa, don samun sabbin hanyoyin.

Yaben Chemical Co.,Ltd.
Daga cikin su, ABAH, wani matsakaicin maganin cututtukan cututtukan fata, an sanya shi a hukumance a cikin Oktoba 2014, mai karfin tan 1,000.
Enzyme fermentation fasahar an samu nasarar gabatar da shi a cikin tsaka-tsakin zuciya da jijiyoyin jini don haɓaka gasa samfuran.
A cikin 2017, kamfanin ya sami ACL, wani kamfani na magunguna mai aiki a Malta, yana haɓaka shimfidarsa a kasuwannin likitancin duniya da kuma haɓaka canji da haɓaka tushen gida.

BTG (300363): mayar da hankali kan sababbin hanyoyin magunguna / kasuwancin CMO na musamman na API, manyan samfuran su ne magungunan magunguna don rigakafin cutar hepatitis C, anti-AIDS, hypolipidemia da analgesia, kuma shine babban mai ba da sabis na tsaka-tsakin Sofebuvir na Gileyad anti-hepatitis. C magani.
A cikin 2016, jimlar kudaden shiga na maganin ciwon sukari + anti-hepatitis C tsaka-tsakin magungunan ya kai miliyan 660, wanda ya kai kashi 50% na jimlar kudaden shiga.
Koyaya, tun 2017, saboda sannu a hankali warkar da masu cutar hanta da kuma raguwar yawan majiyyata, tallace-tallacen Gileyad na magungunan hanta na C ya fara raguwa. Haka kuma, tare da kare haƙƙin mallaka, an ƙaddamar da ƙarin magungunan rigakafin cutar hepatitis C, kuma gasar ta ci gaba da ƙaruwa, wanda ya haifar da raguwar umarni da kudaden shiga.
A halin yanzu, kamfanin ya canza daga kasuwancin CMO zuwa kasuwancin CDMO don gina babban dandalin sabis na duniya don kamfanonin harhada magunguna.

Fasahar Alliance (002250):
Kayayyakin tsaka-tsaki na harhada magunguna sun fi shiga cikin magungunan antitumor, autoimmune, magungunan fungal, magungunan zuciya da jijiyoyin jini, magungunan ciwon sukari, maganin damuwa, magungunan hauhawar jini, magungunan mura, irin su na asali duk suna cikin wuraren warkewa na kasuwa mafi shahara da fa'ida a duniya. , saurin bunƙasa a cikin 'yan shekarun nan, haɓakar haɓakar haɓakar kuɗin shiga kusan kashi 50%.
Daga cikin su, an sanya "fitin na shekara-shekara na tan 300 na Chunidine, ton 300 na Fluzolic Acid da ton 200 na Cyclopyrimidine Acid Project" a cikin nasara tun daga 2014.