Zinthu zapakati ndi mtundu wofunika kwambiri wa mankhwala abwino. Mwachidule, ndi mtundu wa "zinthu zomwe zatha ntchito pang'ono", zomwe zimagwiritsidwa ntchito kwambiri popanga mankhwala, mankhwala ophera tizilombo, zokutira, utoto ndi zonunkhira.

Mu zamankhwala, zinthu zolumikizirana zimagwiritsidwa ntchito popanga ma API.

Ndiye kodi makampani odziwika bwino a mankhwala ophatikizana ndi chiyani?

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Zomwe zimatchedwa kuti mankhwala ophatikizana kwenikweni ndi zinthu zopangira mankhwala kapena mankhwala omwe amagwiritsidwa ntchito popanga mankhwala.
Mankhwalawa, omwe safuna chilolezo chopanga mankhwala, amatha kupangidwa mu chomera chamankhwala wamba ndipo, akafika pamlingo winawake, angagwiritsidwe ntchito popanga mankhwala.

Chithunzicho

Pakadali pano, mitundu yodziwika bwino kwambiri ya mankhwala ochiritsira ndi awa:

Ma nyukiliya apakati.
Mtundu uwu wa mankhwala oletsa matenda a Edzi makamaka ndi zidovudine, wochokera ku United States Glaxo.
Wellcome ndi Bristol-Myers Squibb akwanitsa.

Othandizira pa matenda a mtima.
Mwachitsanzo, ma sartans opangidwa akhala akugwiritsidwa ntchito kwambiri pochiza kuthamanga kwa magazi chifukwa cha mphamvu yawo yonse yoletsa kuthamanga kwa magazi, zotsatirapo zochepa, kugwira ntchito kwa nthawi yayitali (kulamulira kuthamanga kwa magazi mokhazikika kwa maola 24) komanso kuthekera kogwiritsidwa ntchito limodzi ndi ma sartans ena.
Malinga ndi ziwerengero, mu 2015, kufunikira kwa mankhwala akuluakulu a sartan padziko lonse lapansi (losartan potassium, olmesartan, valsartan, irbesartan, telmisartan, candesartan) kunafika matani 3,300.
Malonda onse anali $21.063 biliyoni.

Zosakaniza zapakati zokhala ndi fluorine.
Mankhwala okhala ndi fluorine opangidwa kuchokera ku mankhwala oterewa apangidwa mofulumira m'zaka zaposachedwapa chifukwa cha mphamvu zawo zabwino kwambiri. Mu 1970, 2% yokha ya mankhwala okhala ndi fluorine anali pamsika; pofika mu 2013, 25% ya mankhwala okhala ndi fluorine anali pamsika.
Zinthu zoyimira monga mankhwala oletsa matenda a fluoroquinolone, mankhwala oletsa kupsinjika maganizo a fluoxetine ndi fluconazole yoyambitsa matenda a antifungal ndizofunika kwambiri pakugwiritsidwa ntchito kuchipatala, pakati pawo mankhwala oletsa matenda a fluoroquinolone ndi pafupifupi 15% ya msika wapadziko lonse wa mankhwala oletsa matenda.
Kuphatikiza apo, trifluoroethanol ndi chinthu chofunikira kwambiri popanga mankhwala oletsa ululu, pomwe trifluoromethylaniline ndi chinthu chofunikira kwambiri popanga mankhwala oletsa malungo, mankhwala oletsa kutupa ndi ochepetsa ululu, mankhwala oletsa kutupa kwa prostate ndi mankhwala oletsa kupsinjika maganizo, ndipo msika uli ndi mwayi waukulu.

Ma heterocyclic intermediates.
Ndi pyridine ndi piperazine monga zoyimira, imagwiritsidwa ntchito makamaka popanga mankhwala oletsa zilonda zam'mimba, mankhwala oletsa kutupa ndi oletsa matenda, mankhwala othandiza kwambiri oletsa kuthamanga kwa magazi komanso mankhwala atsopano oletsa khansa ya m'mawere a letrozole.

02

Mankhwala ophatikizana ndi ofunikira kwambiri mu unyolo wamakampani opanga mankhwala.

Chithunzicho

Kumtunda kuli zinthu zoyambira zopangira mankhwala, zomwe zambiri mwa izo ndi zinthu zopangidwa ndi petrochemical, monga acetylene, ethylene, propylene, butene ndi butadiene, toluene ndi xylene.

Mankhwala ophatikizana amagawidwa m'magulu awiri: oyambira pakati ndi apamwamba pakati.
Pakati pawo, ogulitsa zinthu zoyambira zapakatikati amatha kupereka zinthu zosavuta zapakatikati ndipo ali patsogolo pa unyolo wa mafakitale omwe ali ndi mpikisano waukulu komanso kupsinjika kwamitengo. Chifukwa chake, kusinthasintha kwamitengo ya zinthu zoyambira zamakemikolo kumakhudza kwambiri.

Kumbali inayi, ogulitsa zinthu zapamwamba kwambiri samangokhala ndi mphamvu zogulira zinthu zazikulu, komanso chofunika kwambiri, chifukwa amapanga makampani apamwamba kwambiri omwe ali ndi zinthu zambiri zaukadaulo ndipo amalumikizana kwambiri ndi makampani apadziko lonse lapansi, sakhudzidwa kwambiri ndi kusinthasintha kwa mitengo ya zinthu zopangira.

Malo ofikira apakati ndi a makampani opanga mankhwala abwino.
Opanga mankhwala ophatikizana amapanga zinthu zophatikizana kapena ma API osakonzedwa bwino, ndikugulitsa zinthuzo mu mawonekedwe a mankhwala ku makampani opanga mankhwala, omwe amawayeretsa kenako nkuwagulitsa ngati mankhwala.

Mankhwala ophatikizana ndi mankhwala amaphatikizapo zinthu zodziwika bwino komanso zinthu zomwe zasinthidwa. Malinga ndi magawo osiyanasiyana a ntchito zoperekera chithandizo kwa anthu ena, mitundu ya bizinesi yosinthidwa ya anthu ophatikizana nthawi zambiri imatha kugawidwa m'magulu awiri: CRO (kafukufuku wa mgwirizano ndi chitukuko) ndi CMO (kuperekera chithandizo kwa anthu ena).

Kale, njira yopezera ntchito kwa CMO inkakhala yogwiritsidwa ntchito kwambiri m'makampani opanga mankhwala.
Motsatira chitsanzo cha CMO, makampani opanga mankhwala amapereka ntchito kwa ogwirizana nawo.
Chifukwa chake, unyolo wa bizinesi nthawi zambiri umayamba ndi zipangizo zapadera zopangira mankhwala.
Makampani opanga zinthu ayenera kugula zinthu zoyambira za mankhwala ndikuzigawa m'magulu ndikuzikonza kukhala zinthu zapadera zopangira mankhwala, kenako kuzisintha kukhala zinthu zoyambira za API, zinthu zapakati pa cGMP, ma API ndi zokonzekera.

Koma, monga makampani opanga mankhwala pofuna kuwongolera ndalama ndi magwiridwe antchito, ntchito zosavuta zopangira kunja sizikukwaniritsa zosowa za mabizinesi, njira ya CDMO (kafukufuku wopanga ndi chitukuko) imachitika panthawi yakale, CDMO imafuna makampani opanga mwamakonda kuti achite nawo kafukufuku ndi chitukuko, kuti apereke kusintha kwa njira kapena kukonza, kukwaniritsa mtundu waukulu wa kupanga, kuchepetsa mtengo wopanga,
Ili ndi phindu lalikulu kuposa chitsanzo cha CMO.

Gawo lotsikirapo ndi makamaka makampani opanga ma API, ndipo API ili muubwenzi wa mafakitale apamwamba ndi otsika ndi kukonzekera.
Chifukwa chake, kufunika kwa mankhwala omwe amaperekedwa pambuyo pake kudzakhudza mwachindunji kufunika kwa API, kenako kudzakhudza kufunika kwa mankhwala apakatikati.

Kuchokera pamalingaliro a unyolo wonse wa mafakitale, makampani opanga mankhwala adakali pagawo lokulirapo pakadali pano, ndipo phindu lapakati nthawi zambiri limakhala 15-20%, pomwe phindu lapakati la API ndi 20-25%, ndipo phindu lapakati la mankhwala opangidwa pansi ndi lalikulu ngati 40-50%. Mwachiwonekere, phindu lonse la gawo lotsika ndi lalikulu kwambiri kuposa la gawo lokwera.
Chifukwa chake, makampani opanga mankhwala amatha kupititsa patsogolo unyolo wazinthu, kuwonjezera phindu lazinthu ndikukweza kukhazikika kwa malonda popanga API mtsogolo.

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Kukula kwakukulu kwa makampani opanga mankhwala ku China kunayamba mu 2000.

Pa nthawiyo, makampani opanga mankhwala m'mayiko otukuka ankayang'ana kwambiri kafukufuku wa zinthu ndi chitukuko komanso chitukuko cha msika monga mpikisano wawo waukulu, ndipo anafulumizitsa kusamutsa mankhwala apakatikati ndi kupanga mankhwala ogwiritsidwa ntchito kumayiko osatukuka ndi ndalama zochepa.
Chifukwa chake, makampani opanga mankhwala ku China apeza chitukuko chabwino kwambiri pogwiritsa ntchito mwayi uwu.
Pambuyo pa zaka zoposa khumi za chitukuko chokhazikika, mothandizidwa ndi malamulo ndi mfundo zadziko lonse, China yakhala maziko ofunikira kwambiri opanga pakati pa ntchito padziko lonse lapansi mumakampani opanga mankhwala.

Kuyambira mu 2012 mpaka 2018, kuchuluka kwa mankhwala ochokera ku China kunakwera kuchoka pa matani pafupifupi 8.1 miliyoni okhala ndi kukula kwa msika wa yuan pafupifupi 168.8 biliyoni kufika pa matani pafupifupi 10.12 miliyoni okhala ndi kukula kwa msika wa yuan wa 2010.7 biliyoni.

Chithunzicho

Makampani opanga mankhwala ku China apeza mpikisano wamphamvu pamsika, ndipo ngakhale makampani ena opanga mankhwala apakatikati akwanitsa kupanga mankhwala apakatikati okhala ndi kapangidwe kovuta ka mamolekyulu komanso zofunikira kwambiri paukadaulo. Zinthu zambiri zotchuka zayamba kulamulira msika wapadziko lonse lapansi.

Komabe, kawirikawiri, makampani apakati ku China akadali mu nthawi yokonza ndi kukweza kapangidwe ka zinthu, ndipo mulingo waukadaulo ukadali wotsika.
Mankhwala oyambira apakati a mankhwala akadali mankhwala akuluakulu mumakampani opanga mankhwala, ndipo pali makampani ochepa omwe amapanga mankhwala ambiri apamwamba komanso othandizira mankhwala atsopano omwe ali ndi patent.

Pakadali pano, makampani omwe ali ndi mpikisano waukulu pa A-share m'makampani apakati ndi Yaben Chemical, Lianhua Technology, Boten, ndi Wanrun, omwe akukonzekera kuyika ndalama zokwana 630 miliyoni yuan pomanga mapulojekiti apakati a mankhwala ndi API okhala ndi mphamvu zokwana matani 3,155 pachaka.
Akupitiriza kupanga zinthu zosiyanasiyana kudzera mu kafukufuku ndi chitukuko, kuti apeze njira zatsopano.

Yaben Chemical Co., Ltd. (300261): Zogulitsa zathu zazikulu zikuphatikizapo mankhwala oletsa kutupa, mankhwala oletsa khunyu komanso mankhwala oletsa mavairasi.
Pakati pawo, ABAH, mankhwala oletsa khunyu, idayamba kupangidwa mwalamulo mu Okutobala 2014, yokhala ndi mphamvu zokwana matani 1,000.
Ukadaulo wa enzyme fermentation unayambitsidwa bwino mu zinthu zapakati pa mtima kuti zinthuzo zipikisane bwino.
Mu 2017, kampaniyo idagula ACL, kampani yogwira ntchito yogulitsa mankhwala ku Malta, zomwe zidapangitsa kuti ipangidwe mwachangu pamsika wazachipatala wapadziko lonse lapansi ndikuyendetsa kusintha ndi kukweza maziko am'dziko.

BTG (300363): imayang'ana kwambiri pamakampani opanga mankhwala atsopano / API customized CMO, zinthu zazikulu ndi mankhwala oletsa matenda a chiwindi C, anti-AIDS, hypolipidemia ndi analgesia, ndipo ndiye wogulitsa wamkulu wa Sofebuvir wa mankhwala oletsa matenda a chiwindi C a Gilead.
Mu 2016, ndalama zonse zomwe zimapezeka kuchokera ku mankhwala ochepetsa shuga ndi matenda a chiwindi C zinafika pa 660 miliyoni, zomwe zimapangitsa 50% ya ndalama zonse zomwe zinapezeka.
Komabe, kuyambira mu 2017, chifukwa cha kuchira pang'onopang'ono kwa odwala a hepatitis C komanso kuchepa kwa chiwerengero cha odwala, kugulitsa mankhwala a hepatitis C ku Gilead kunayamba kuchepa. Kuphatikiza apo, pamene ma patent atha, mankhwala ambiri oletsa matenda a hepatitis C adayambitsidwa, ndipo mpikisano unapitilirabe kukula, zomwe zinapangitsa kuti maoda apakati ndi ndalama zichepe.
Pakadali pano, kampaniyo yasintha kuchoka ku bizinesi ya CMO kupita ku bizinesi ya CDMO kuti ipange nsanja yotsogola padziko lonse lapansi yopereka chithandizo kwa makampani opanga mankhwala.

Ukadaulo wa Alliance (002250):
Mankhwala ophatikizana a mankhwala amagwiritsidwa ntchito makamaka mu mankhwala oletsa chotupa, autoimmune, mankhwala opha ma fungal, mankhwala a mtima, mankhwala a shuga, mankhwala oletsa kupanikizika, mankhwala oletsa kuthamanga kwa magazi, mankhwala oletsa chimfine, monga mankhwala oyambira onse ali m'madera ochiritsira a msika wotchuka kwambiri padziko lonse lapansi, kukula kwachangu m'zaka zaposachedwa, kuchuluka kwa ndalama zomwe zimaphatikizidwa ndi pafupifupi 50%.
Pakati pawo, "kutulutsa kwapachaka kwa matani 300 a Chunidine, matani 300 a Fluzolic Acid ndi matani 200 a Cyclopyrimidine Acid Project" kwakhala kukuchitika motsatizana kuyambira mu 2014.