Chidule cha Makampani Opanga Mankhwala Osiyanasiyana

Mankhwala ophatikizana
Zomwe zimatchedwa mankhwala osakaniza mankhwala kwenikweni ndi zinthu zopangira mankhwala kapena mankhwala omwe amafunika kugwiritsidwa ntchito popanga mankhwala. Mankhwalawa amatha kupangidwa m'mafakitale wamba a mankhwala popanda kupeza chilolezo chopanga mankhwala, ndipo angagwiritsidwe ntchito popanga ndi kupanga mankhwala bola ngati zizindikiro zaukadaulo zikukwaniritsa zofunikira zina. Ngakhale kupanga mankhwala kumagweranso m'gulu la mankhwala, zofunikira zake ndizokhwima kuposa za mankhwala wamba. Opanga mankhwala omalizidwa ndi ma API ayenera kuvomereza satifiketi ya GMP, pomwe opanga mankhwala osakaniza sakuyenera kuvomereza satifiketi ya GMP, chifukwa mankhwala osakaniza akadali kupanga ndi kupanga mankhwala osakaniza, omwe ndi zinthu zoyambira komanso zotsika kwambiri mu unyolo wopanga mankhwala, ndipo sangatchulidwe kuti mankhwala pakadali pano, kotero safunikira satifiketi ya GMP, yomwe imachepetsanso malire olowera kwa opanga mankhwala osakaniza.

Makampani opanga mankhwala
Makampani opanga mankhwala omwe amapanga ndi kukonza zinthu zamkati/zopanda organic kapena ma API a makampani opanga mankhwala kuti apange mankhwala omalizidwa pogwiritsa ntchito mankhwala kapena zinthu zamoyo motsatira miyezo yokhwima ya khalidwe. Pano, zinthu zamkati za mankhwala zimagawidwa m'magawo awiri ang'onoang'ono monga CMO ndi CRO.

CMO
Bungwe Lopanga Mapangano limatanthauza bungwe lopanga mankhwala, zomwe zikutanthauza kuti kampani yopanga mankhwala imapereka njira yopangira kwa mnzake. Unyolo wamalonda wa makampani opanga mankhwala a CMO nthawi zambiri umayamba ndi zipangizo zapadera zopangira mankhwala. Makampani omwe ali mumakampaniwa amafunika kupeza zinthu zoyambira zopangira mankhwala ndikuzikonza kukhala zosakaniza zapadera zopangira mankhwala, zomwe kenako zimasinthidwa kukhala zinthu zoyambira za API, ma intermediates a cGMP, ma API ndi ma formulations. Pakadali pano, makampani akuluakulu opanga mankhwala padziko lonse lapansi amakonda kukhazikitsa mgwirizano wanthawi yayitali ndi ogulitsa ochepa, ndipo kupulumuka kwa makampani mumakampaniwa kumaonekera kwambiri kudzera mwa anzawo.

CRO
Bungwe Lofufuza za Mgwirizano (Clinical) limatanthauza bungwe lofufuza za mgwirizano, komwe makampani opanga mankhwala amapereka gawo lofufuzira kwa mnzake. Pakadali pano, makampaniwa amadalira kwambiri kupanga mwamakonda, kafukufuku ndi chitukuko cha mankhwala ndi kafukufuku ndi malonda a mgwirizano wa mankhwala. Mosasamala kanthu za njira, kaya mankhwala apakati ndi chinthu chatsopano kapena ayi, mpikisano waukulu wa kampaniyo umaweruzidwabe ndi ukadaulo wa kafukufuku ndi chitukuko ngati chinthu choyamba, chomwe chimawonekera mwa makasitomala kapena ogwirizana nawo a kampaniyo.

Unyolo wamtengo wapatali pamsika wa zinthu zamankhwala
Chithunzi
(Chithunzi chochokera ku Qilu Securities)

Unyolo wamakampani opanga mankhwala pakati
Chithunzi
(Chithunzi chochokera ku China Industry Information Network)

Kugawa kwa mankhwala pakati
Mankhwala ophatikizana amatha kugawidwa m'magulu akuluakulu malinga ndi magawo ogwiritsira ntchito, monga mankhwala ophatikizana a maantibayotiki, mankhwala ophatikizana a antipyretic ndi analgesic, mankhwala ophatikizana a mtima ndi mitsempha yamagazi ndi mankhwala ophatikizana a khansa. Pali mitundu yambiri ya mankhwala ophatikizana, monga imidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycol, shuga ufa, inorganic salts, ethanol intermediates, stearate, amino acids, ethanolamine, potaziyamu salts, sodium salts ndi zina zotero.
Chidule cha chitukuko cha makampani opanga mankhwala ku China
Malinga ndi IMS Health Incorporated, kuyambira 2010 mpaka 2013, msika wapadziko lonse wa mankhwala udapitiliza kukula, kuyambira US $793.6 biliyoni mu 2010 mpaka US $899.3 biliyoni mu 2013, pomwe msika wa mankhwala ukuwonetsa kukula mwachangu kuyambira 2014, makamaka chifukwa cha msika waku US. Ndi CAGR ya 6.14% kuyambira 2010-2015, msika wapadziko lonse wa mankhwala ukuyembekezeka kulowa munthawi yocheperako kuyambira 2015-2019. Komabe, popeza mankhwala akufunidwa kwambiri, kukula konse kukuyembekezeka kukhala kwamphamvu kwambiri mtsogolo, pomwe msika wapadziko lonse wa mankhwala ukuyandikira US $1.22 thililiyoni pofika 2019.
Chithunzi
(Chithunzi chochokera ku IMS Health Incorporated)
Pakadali pano, chifukwa cha kukonzanso mafakitale amakampani akuluakulu opanga mankhwala ochokera m'mayiko osiyanasiyana, kusamutsa kupanga kwa makampani ochokera m'mayiko osiyanasiyana komanso kukonzanso kwa magawo a ntchito padziko lonse lapansi, China yakhala maziko ofunikira kwambiri opanga pakati pa ntchito padziko lonse lapansi. Makampani opanga mankhwala ochokera ku China apanga dongosolo lathunthu kuyambira kafukufuku ndi chitukuko mpaka kupanga ndi kugulitsa. Kuchokera pakukula kwa makampani opanga mankhwala padziko lonse lapansi, ukadaulo wonse wa njira ku China ukadali wotsika, chiwerengero chachikulu cha makampani opanga mankhwala apamwamba komanso mankhwala atsopano omwe amathandizira makampani opanga mankhwala ndi ochepa, ali mu gawo la chitukuko cha kukonza kapangidwe ka mankhwala ndi kukweza.
Mtengo wotuluka wa makampani opanga mankhwala osakaniza mankhwala ku China kuyambira 2011 mpaka 2015
Chithunzi
(Chithunzi chochokera ku China Business Industry Research Institute)
Mu 2011-2015, kuchuluka kwa makampani opanga mankhwala ku China kunakula chaka ndi chaka, mu 2013, kuchuluka kwa mankhwala ku China kunali matani 568,300, ndipo kunatumizidwa kunja matani 65,700, pofika mu 2015 kuchuluka kwa mankhwala ku China kunali pafupifupi matani 676,400.
Ziwerengero za kupanga mankhwala apakati a mankhwala ku China kuyambira 2011 mpaka 2015
Chithunzi
(Chithunzi chochokera ku China Merchant Industry Research Institute)
Kupezeka kwa mankhwala ophatikizana ku China kukuonekera kwambiri kuposa kufunikira kwa mankhwala, ndipo kudalira kutumiza kunja kukuwonjezeka pang'onopang'ono. Komabe, kutumiza kunja kwa China kumayang'ana kwambiri zinthu zambiri monga vitamini C, penicillin, acetaminophen, citric acid ndi mchere ndi ma esters ake, ndi zina zotero. Zinthuzi zimadziwika ndi kutulutsa kwakukulu kwa zinthu, mabizinesi opanga zinthu zambiri, mpikisano waukulu pamsika, mtengo wotsika wazinthu komanso mtengo wowonjezera, ndipo kupanga kwawo kwakukulu kwapangitsa kuti zinthu ziperekedwe mopitirira kufunikira kwa zinthu zomwe zimagulitsidwa m'dziko muno. Zinthu zomwe zili ndi ukadaulo wapamwamba zimadalira kwambiri kutumizidwa kunja.
Pofuna kuteteza mankhwala a amino acid, makampani ambiri opanga mankhwala m'nyumba ali ndi mtundu umodzi wa mankhwala komanso khalidwe losakhazikika, makamaka makampani akunja opanga mankhwala a biopharmaceutical kuti asinthe kupanga kwa mankhwala. Makampani ena okha omwe ali ndi mphamvu zofufuzira komanso chitukuko champhamvu, malo opangira zinthu zapamwamba komanso odziwa bwino ntchito yopanga zinthu zazikulu ndi omwe angapeze phindu lalikulu pampikisano.
Kusanthula kwa makampani opanga mankhwala ku China

1, njira zopangira mankhwala apakati amakampani opanga mankhwala
Choyamba, kutenga nawo mbali mu kafukufuku ndi chitukuko cha mankhwala atsopano kwa makasitomala, zomwe zimafuna kuti malo ofufuza ndi chitukuko cha kampani akhale ndi luso lamphamvu lopanga zinthu zatsopano.
Kachiwiri, kukulitsa zinthu kwa kasitomala koyambirira, kukwaniritsa njira yopangira zinthu zazikulu, zomwe zimafuna luso la kampani lokulitsa zinthu komanso luso lopitiliza kukonza ukadaulo wazinthu zomwe zasinthidwa mtsogolo, kuti zikwaniritse zosowa za kupanga zinthu, kuchepetsa mtengo wopangira zinthu mosalekeza ndikuwonjezera mpikisano wazinthuzo.
Chachitatu, ndi kuwongolera ndikuwongolera njira yogulitsira zinthu pamlingo wokulirapo wa makasitomala, kuti akwaniritse miyezo yabwino yamakampani akunja.

2. Makhalidwe a makampani opanga mankhwala ku China
Kupanga mankhwala kumafuna mankhwala ambiri apadera, omwe ambiri mwa iwo adapangidwa ndi makampani opanga mankhwala okha, koma chifukwa cha kufalikira kwa kugawikana kwa anthu pantchito komanso kupita patsogolo kwa ukadaulo wopanga, makampani opanga mankhwala adasamutsa mankhwala ena ophatikizana kupita kumakampani opanga mankhwala kuti apange. Mankhwala ophatikizana ndi mankhwala ndi mankhwala abwino, ndipo kupanga mankhwala ophatikizana kwakhala makampani akuluakulu mumakampani opanga mankhwala apadziko lonse lapansi. Pakadali pano, makampani opanga mankhwala aku China amafunikira mitundu pafupifupi 2,000 ya mankhwala ndi zinthu zina zophatikizana chaka chilichonse, zomwe zimafuna matani opitilira 2.5 miliyoni. Popeza kutumiza mankhwala osiyanasiyana mosiyana ndi kutumiza mankhwala kunja kudzakumana ndi zoletsa zosiyanasiyana m'maiko otumiza kunja, komanso kupanga mankhwala padziko lonse lapansi kupita kumayiko osatukuka, zosowa za mankhwala aku China zomwe zimapangidwira mankhwala ndi zinthu zina zophatikizana zimatha kufanana, gawo laling'ono chabe la kufunika kotumiza kunja. Ndipo chifukwa cha kuchuluka kwa zinthu ku China, mitengo ya zinthu ndi yotsika, pali mankhwala ambiri ophatikizana omwe adakwaniritsa kutumiza kunja kwakukulu.

Pakadali pano, China ikufunika zinthu zopangira mankhwala ndi zinthu zina zapakati zamitundu yoposa 2500, ndipo kufunika kwa pachaka kwafika matani 11.35 miliyoni. Pambuyo pa zaka zoposa 30 za chitukuko, zosowa za China zopangira mankhwala ndi zinthu zina zapakati zakhala zikugwirizana. Kupanga zinthu zapakati ku China makamaka kumachitika mu mankhwala opha tizilombo toyambitsa matenda ndi oletsa kutupa.

Mu makampani onse, makampani opanga mankhwala ku China ali ndi makhalidwe asanu ndi limodzi: Choyamba, makampani ambiri ndi achinsinsi, ntchito yosinthasintha, kuchuluka kwa ndalama si kwakukulu, makamaka pakati pa mamiliyoni mpaka yuan imodzi kapena zikwi ziwiri miliyoni; Chachiwiri, kufalikira kwa mabizinesi m'malo osiyanasiyana kuli kwakukulu, makamaka ku Taizhou, Zhejiang Province ndi Jintan, Jiangsu Province ngati likulu; Chachitatu, chifukwa cha chidwi chowonjezeka cha dzikolo pa kuteteza chilengedwe, kukakamizidwa kwa mabizinesi kumanga malo ochiritsira chitetezo cha chilengedwe kukukwera Chachinayi, liwiro lokonzanso zinthu ndi lachangu, ndipo phindu lidzatsika kwambiri patatha zaka 3 mpaka 5 pamsika, zomwe zimakakamiza mabizinesi kupanga zinthu zatsopano kapena kukonza njira mosalekeza kuti apeze phindu lalikulu; Chachisanu, popeza phindu la kupanga mankhwala ophatikizana ndi apamwamba kuposa a mankhwala wamba, ndipo njira yopangira ndi yofanana, mabizinesi ang'onoang'ono ambiri a mankhwala amalowa nawo pakupanga mankhwala ophatikizana, zomwe zimapangitsa kuti mpikisano ukhale wolimba kwambiri mumakampani. Chachisanu ndi chimodzi, poyerekeza ndi API, phindu la kupanga mankhwala ophatikizana ndi lochepa, ndipo njira yopangira API ndi mankhwala ophatikizana ndi yofanana, kotero mabizinesi ena samangopanga mankhwala ophatikizana, komanso amagwiritsa ntchito zabwino zawo kuti ayambe kupanga API. Akatswiri adanenanso kuti kupanga mankhwala ophatikizana ndi njira yopangira API ndi njira yosapeŵeka. Komabe, chifukwa chogwiritsa ntchito API kamodzi, makampani opanga mankhwala ali ndi mphamvu yayikulu, mabizinesi am'nyumba nthawi zambiri amapanga zinthu koma osagwiritsa ntchito izi. Chifukwa chake, opanga ayenera kukhazikitsa ubale wokhazikika wa nthawi yayitali ndi makampani opanga mankhwala, kuti atsimikizire kuti malonda azinthu ndi osavuta.

3, zopinga zolowera m'makampani
①Zopinga za makasitomala
Makampani opanga mankhwala amayendetsedwa ndi makampani angapo opanga mankhwala ochokera m'mayiko osiyanasiyana. Magulu akuluakulu opanga mankhwala amasamala kwambiri posankha opereka chithandizo chakunja ndipo nthawi zambiri amakhala ndi nthawi yayitali yowunikira ogulitsa atsopano. Makampani a CMO opanga mankhwala ayenera kukwaniritsa njira zolumikizirana za makasitomala osiyanasiyana, ndipo ayenera kupitiliza kuwunika nthawi yayitali asanayambe kupeza chidaliro cha makasitomala ena, kenako nkukhala ogulitsa awo akuluakulu.
②Zopinga zaukadaulo
Kutha kupereka ntchito zapamwamba zaukadaulo ndiye maziko a kampani yopereka chithandizo chamankhwala kwa anthu ena. Makampani a CMO a mankhwala ayenera kuthana ndi zopinga zaukadaulo kapena zopinga m'njira zawo zoyambirira ndikupereka njira zowongolera njira zopangira mankhwala kuti achepetse ndalama zopangira mankhwala. Popanda ndalama zambiri komanso zokwera mtengo pakufufuza ndi chitukuko komanso ukadaulo, zimakhala zovuta kuti makampani akunja kwa makampani alowe mumakampaniwa.
③Zopinga za talente
N'zovuta kuti makampani a CMO apange gulu lopikisana la R&D ndi kupanga pakapita nthawi yochepa kuti akhazikitse njira yogwirira ntchito yogwirizana ndi cGMP.
④Zopinga zowongolera khalidwe
Bungwe la FDA ndi mabungwe ena olamulira mankhwala akhala akukhwimitsa kwambiri malamulo awo owongolera khalidwe, ndipo zinthu zomwe sizikupambana mayeso sizingalowe m'misika ya mayiko otumiza mankhwala kunja.
⑤ Zopinga zolamulira zachilengedwe
Makampani opanga mankhwala omwe ali ndi njira zakale zoyendetsera ntchito adzakhala ndi ndalama zambiri zowongolera kuipitsa mpweya komanso mavuto olamulira, ndipo makampani opanga mankhwala achikhalidwe omwe amapanga kuipitsa mpweya kwambiri, kugwiritsa ntchito mphamvu zambiri komanso zinthu zochepa zowonjezera (monga penicillin, mavitamini, ndi zina zotero) adzakumana ndi mavuto ofulumira. Kutsatira njira zatsopano zopangira zinthu zatsopano ndikupanga ukadaulo wobiriwira wa mankhwala kwakhala njira yopititsira patsogolo chitukuko cha makampani opanga mankhwala a CMO.

4. Makampani olembetsedwa ndi makampani opanga mankhwala m'dziko muno
Kuchokera pa udindo wa unyolo wa makampani, makampani 6 omwe atchulidwa a mankhwala abwino omwe amapanga mankhwala ophatikizana onse ali pansi pa unyolo wa makampani. Kaya ndi akatswiri opereka chithandizo chakunja kapena API ndi kukulitsa kapangidwe kake, mphamvu yaukadaulo ndiyo mphamvu yokhazikika yoyendetsera.
Ponena za mphamvu zaukadaulo, makampani omwe ali ndi ukadaulo wapamwamba padziko lonse lapansi, mphamvu zosungira ndalama zambiri komanso ndalama zambiri mu kafukufuku ndi chitukuko amayamikiridwa.
Gulu Loyamba: Lianhua Technology ndi Arbonne Chemical. Lianhua Technology ili ndi ukadaulo wofunikira zisanu ndi zitatu monga ammonia oxidation ndi fluorination ngati maziko ake aukadaulo, omwe hydrogen oxidation ili patsogolo padziko lonse lapansi. Abenomics ndi mtsogoleri wapadziko lonse lapansi mu mankhwala a chiral, makamaka muukadaulo wake wogawa mankhwala ndi racemization, ndipo ili ndi ndalama zambiri zofufuzira ndi chitukuko, zomwe zimapangitsa kuti pakhale 6.4% ya ndalama zomwe amapeza.
Gulu Lachiwiri: Wanchang Technology ndi Yongtai Technology. Njira ya Wanchang Technology yogwiritsira ntchito mpweya wotayira wa hydrocyanic acid ndiyo njira yotsika mtengo komanso yapamwamba kwambiri yopangira ma ester a prototrizoic acid. Koma Yongtai Technology imadziwika ndi mankhwala ake abwino a fluorine.
Gulu Lachitatu: Tianma Fine Chemical ndi Bikang (yomwe kale inkadziwika kuti Jiuzhang).
Kuyerekeza mphamvu zaukadaulo za makampani omwe alembedwa
Chithunzi
Kuyerekeza makasitomala ndi mitundu yotsatsa ya makampani olembetsa mankhwala
Chithunzi
Kuyerekeza kwa kufunikira kwa zinthu zomwe zili pansi pa nthaka komanso nthawi ya moyo wa patent wa zinthu zomwe makampani olembetsedwa amagulitsa
Zithunzi
Kusanthula kwa mpikisano wa malonda a makampani omwe atchulidwa
Zithunzi
Njira yopititsira patsogolo mankhwala abwino apakati
Zithunzi
(Zithunzi ndi zinthu zochokera ku Qilu Securities)
Chiyembekezo cha chitukuko cha makampani opanga mankhwala ku China
Monga makampani ofunikira kwambiri pamakampani opanga mankhwala abwino, kupanga mankhwala kwakhala chinthu chofunikira kwambiri pakukula ndi mpikisano m'zaka 10 zapitazi, ndi kupita patsogolo kwa sayansi ndi ukadaulo, mankhwala ambiri apangidwa mosalekeza kuti apindule anthu, kupanga mankhwala awa kumadalira kupanga mankhwala atsopano, apamwamba kwambiri, kotero mankhwala atsopano amatetezedwa ndi ma patent, pomwe mankhwala ena omwe ali nawo alibe mavuto, kotero mankhwala atsopano omwe ali mkati mwawo ndi kunja Malo okulira msika ndi mwayi wogwiritsa ntchito ndi abwino kwambiri.
Zithunzi

Pakadali pano, njira yofufuzira ya mankhwala ophatikizana ikuwonekera makamaka mu kapangidwe ka mankhwala ophatikizana, mankhwala okhala ndi fluorine, mankhwala a chiral, mankhwala achilengedwe, ndi zina zotero. Palinso kusiyana pakati pa chitukuko cha mankhwala ophatikizana ndi zofunikira za makampani opanga mankhwala ku China. Zinthu zina zomwe zili ndi zofunikira paukadaulo sizingakonzedwe kuti zipangidwe ku China ndipo zimadalira kwambiri kutumizidwa kunja, monga anhydrous piperazine, propionic acid, ndi zina zotero. Ngakhale kuti zinthu zina zimatha kukwaniritsa zofunikira za makampani opanga mankhwala am'nyumba pankhani ya kuchuluka, koma mtengo ndi khalidwe lokwera sizili bwino, zomwe zimakhudza mpikisano wa mankhwala ndipo zimafunika kukonza njira zopangira, monga TMB, p-aminophenol, D-PHPG, ndi zina zotero.
Zikuyembekezeka kuti m'zaka zingapo zikubwerazi, kafukufuku watsopano wa mankhwala padziko lonse lapansi adzayang'ana kwambiri mitundu 10 ya mankhwala: mankhwala owonjezera ntchito ya ubongo, mankhwala oletsa nyamakazi, mankhwala oletsa matenda a AIDS, mankhwala oletsa chiwindi ndi mavairasi ena, mankhwala ochepetsa mafuta m'thupi, mankhwala oletsa thrombosis, mankhwala oletsa chotupa, mankhwala oletsa ma platelet, mankhwala olimbikitsa mtima a glycoside, mankhwala oletsa kupsinjika maganizo, mankhwala oletsa nkhawa komanso amisala, ndi zina zotero. Kuti mankhwalawa apange mankhwala oletsa kusokonezeka maganizo ndi njira yofunikira yowonjezerera msika watsopano.