Mutu I, Chidule cha Viwanda

I. Pharmaceutical intermediates industry: crossover industry of chemical industry and medicine

Mankhwala apakatikati ndi zinthu zapakatikati pakupanga kwa API, mankhwala abwino opangira mankhwala, osafunikira chilolezo chopanga mankhwala kuti apange, chomwe chingagawidwe kutengera momwe API yomaliza imakhudzira mtundu wapakatikati wa GMP ndi wapakatikati wa GMP (mankhwala apakatikati opangidwa. pansi pa zofunikira za GMP zofotokozedwa ndi ICHQ7).

Makampani opanga mankhwala amatanthawuza mabizinesi omwe amapanga ndikusintha ma organic/inorganic intermediates kapena mankhwala opangira mabizinesi opanga mankhwala pogwiritsa ntchito njira zopangira mankhwala kapena biosynthetic pansi pamiyezo yabwino kwambiri.

(1) Pharmaceutical intermediate subindustry akhoza kugawidwa mu CRO ndi CMO mafakitale.

CMO: Contract ManufacturingOrganisation imatanthawuza wopanga makontrakitala omwe apatsidwa, zomwe zikutanthauza kuti kampani yopanga mankhwala imatulutsa ulalo wopangira kwa mnzake.Bizinesi yamabizinesi amakampani a CMO nthawi zambiri imayamba ndi zida zapadera zamankhwala.Makampani amakampani amayenera kugula zida zopangira mankhwala ndikuziika m'magulu apadera azamankhwala, ndipo kukonzanso pang'onopang'ono kumapanga zida zoyambira za API, ma cGMP intermediates, API, ndi kukonzekera.Pakalipano, makampani akuluakulu opanga mankhwala amitundu yosiyanasiyana amakonda kukhazikitsa mgwirizano wanthawi yayitali ndi othandizira ochepa, ndipo kupulumuka kwamakampani pamakampaniwo kumawonekera kudzera mwa anzawo.

CRO: Contract (Clinical) Research Organisation imanena za bungwe lofufuza za makontrakitala komwe makampani opanga mankhwala amapereka ulalo wofufuza kwa anzawo.Pakali pano, makampani makamaka kupanga makonda, kafukufuku makonda ndi chitukuko ndi kafukufuku mankhwala mgwirizano, malonda monga mgwirizano waukulu, ziribe kanthu njira, kaya mankhwala intermediates mankhwala ndi nzeru mankhwala, kuweruza pachimake mpikisano wa ogwira ntchito akadali kufufuza. ndi luso lachitukuko monga chinthu choyamba, mbali zimaonekera monga makasitomala kunsi kwa mtsinje wa kampani kapena othandizana nawo.

(2) Kuchokera kumagulu amitundu yamabizinesi, mabizinesi apakatikati amatha kugawidwa m'njira zambiri komanso makonda.

Nthawi zambiri, opanga ang'onoang'ono ndi apakatikati amatenga njira yofananira, ndipo makasitomala awo nthawi zambiri amakhala opanga mankhwala amtundu uliwonse, pomwe opanga akuluakulu apakatikati omwe ali ndi kafukufuku wamphamvu komanso luso lachitukuko amatengera mabizinesi opangira mankhwala osokoneza bongo.Mtundu wosinthidwa umatha kukulitsa kukhuthala kwamakasitomala ndi makasitomala.

Pansi pa mtundu wazinthu zonse, mabizinesi amazindikira zosowa zamakasitomala ambiri malinga ndi zotsatira za kafukufuku wamsika ndikuchita zinthu zina zamabizinesi monga kafukufuku ndi chitukuko, kupanga, ndi kugulitsa ngati poyambira.Izi zikutanthauza kuti, bizinesi isanachitike, palibe ubale wokhazikika wamakasitomala womwe unakhazikitsidwa pakati pa bizinesi ndi makasitomala aboma.Kuyambira pamenepo, pochita zinthu zinazake zamabizinesi, mabizinesi nthawi zambiri amangolumikizana pafupipafupi ndi makasitomala aboma kuti awonetsetse kuti zosowa za makasitomala onse zikukwaniritsidwa.Chifukwa chake, kugulitsa kwazinthu zopangidwa ndi generic ndizinthu zamba, kenako makasitomala ambiri.Mtundu wamabizinesi umatengera zinthu wamba komanso zoyambira, ndipo mabizinesi ndi makasitomala aboma amangokhala ubale wamakasitomala wotayirira.M'makampani opanga mankhwala, mtundu wazinthu zamtundu uliwonse umagwiritsidwa ntchito makamaka pakufufuza ndi chitukuko, kupanga ndi kugulitsa kwapakati pamankhwala, API ndi kukonzekera kofunikira pamankhwala amtundu uliwonse.

Munjira yosinthira makonda, makasitomala okhazikika amapereka zinsinsi kubizinesi atasaina pangano lachinsinsi ndi bizinesiyo, ndikuwunikira zofunikira za makonda.Bizinesi imayamba kuchokera pazosowa zamakasitomala okhazikika kuti achite kafukufuku ndi chitukuko, kupanga, kugulitsa ndi zina. Izi zikutanthauza kuti, asanayambe kuchita bizinesi inayake, mabizinesi akhazikitsa ubale wotsimikizika wamakasitomala ndi makasitomala okhazikika. kulankhulana mozama ndi makasitomala osinthidwa kuti awonetsetse kuti zosowa za makasitomala osinthika m'zinthu zonse.Chifukwa chake, malonda a malonda opangidwa ndi makonda ndi makasitomala okhazikika, ndiyeno makonda opangidwa.Njira yamabizinesi imasinthidwa makonda malinga ndi makasitomala komanso pachimake, ndipo pali ubale wapamtima wamakasitomala pakati pa bizinesi ndi makasitomala osinthidwa.Mumakampani opanga mankhwala, njira yosinthira makonda imagwira ntchito makamaka pakufufuza, chitukuko, kupanga ndi kugulitsa kwapakati pamankhwala, API. ndi kukonzekera kofunikira kwa mankhwala atsopano.

II.Malamulo ndi malamulo okhudzana ndi mafakitale

Opanga mankhwala apakati ndi amakampani opanga mankhwala, koma amakhala okhwimitsa kwambiri kuposa mankhwala wamba. Opanga akuluakulu ndi ma API amayenera kulandira chiphaso cha GMP, koma osati opanga apakatikati (kupatulapo ma GMP apakatikati omwe amafunikira pansi pamiyezo ya GMP), zomwe zimachepetsa mwayi wamakampani. malire kwa opanga apakati.

Monga bizinesi yokhazikika yopangira kafukufuku & chitukuko chapakati pazamankhwala, ntchito zake zopanga zimayendetsedwa ndi Environmental Protection Law of the People's Republic of China, Law of the People's Republic of China on Work Safety, Product Quality Law of the People's Republic of China. China ndi malamulo ndi malamulo ena.

Makampani opanga mankhwala abwino ndi gawo lofunikira pamakampani opanga mankhwala aku China.M'zaka zaposachedwa, boma lidabwerezanso kuthandizira kwake kwamakampani opanga mankhwala abwino m'mabuku ambiri adongosolo.Makampani otsika a biomedical of pharmaceutical intermediates nawonso ndi amodzi mwamafakitale omwe akutukuka kumene molimbika ndi dziko.

Ⅲ, zopinga zamakampani

1. zolepheretsa makasitomala

Makampani opanga mankhwala amalamulidwa ndi mabungwe angapo amitundu mitundu.Oligarchs azachipatala ndi osamala kwambiri posankha opereka chithandizo, ndipo nthawi yoyang'anira ogulitsa atsopano nthawi zambiri imakhala yayitali.Mabizinesi apakatikati a Pharmaceutical ayenera kukumana ndi njira zolankhulirana za makasitomala osiyanasiyana, ndipo akuyenera kutero vomerezani nthawi yayitali yowunika mosalekeza kuti mupeze chidaliro chamakasitomala akutsika, kenako ndikukhala omwe amawasamalira.

2. chotchinga luso

Kaya akupereka chithandizo chamakono chamtengo wapatali chamtengo wapatali ndicho maziko a makampani ogulitsa mankhwala opangira mankhwala. kupanga mtengo.Popanda nthawi yayitali, kafukufuku wokwera mtengo komanso ndalama zachitukuko ndi nkhokwe zaukadaulo, ndizovuta kuti mabizinesi akunja kwamakampaniwo alowemodi.

3. zolepheretsa talente

Ukadaulo waukadaulo ndi ntchito zamafakitale zaukadaulo wamafakitale zimafunikira kafukufuku wambiri ndi chitukuko, luso loyang'anira kupanga ndi ogwira ntchito.Mabizinesi a Interbody ayenera kukhazikitsa mtundu wamakhalidwe womwe umakwaniritsa miyezo ya cGMP, ndipo ndizovuta kukhazikitsa R & D ndi gulu lopanga osankhika munthawi yochepa.

4. zopinga zoyendetsera bwino

Makampani apakatikati amadalira kwambiri misika yakunja.Ndi zofunika kuyang'aniridwa mosamalitsa bwino za FDA, EMA ndi mabungwe ena owongolera mankhwala, zinthu zomwe sizinachite kafukufukuyu sizingalowe mumsika wamayiko otengera kunja.

5. zopinga zoyendetsera chilengedwe

Makampani apakatikati ndi amakampani opanga mankhwala, ndipo amayenera kupangidwa molingana ndi malamulo oyang'anira chitetezo chamayiko amakampani opanga mankhwala.Opanga apakati omwe ali ndiukadaulo wakumbuyo adzanyamula ndalama zambiri zowononga kuipitsidwa ndi kukakamizidwa kowongolera, komanso mabizinesi achikhalidwe azamankhwala omwe amatulutsa kwambiri. kuwononga chilengedwe, kugwiritsa ntchito mphamvu kwambiri komanso zinthu zotsika mtengo zomwe zidzawonjezeke kutheratu.

IV.Zowopsa zamakampani

1.Kuopsa kwa kuchuluka kwa makasitomala

Mwachitsanzo, monga momwe zikuwonekera kuchokera kuzinthu zamagulu a Boteng, kasitomala wake wamkulu ndi Johnson & Johnson Pharmaceutical, omwe amawerengera ndalama zoposa 60% za ndalama, chodabwitsa ichi chikhoza kupezekanso kuchokera kwa ogulitsa apakatikati monga Yaben Chemical.

2. Kuopsa kwa chilengedwe

1. Kafukufuku ndi chitukuko, kupanga, ndi kugulitsa kwapakati pa mankhwala, makampaniwa ali m'makampani abwino opangira mankhwala.Malinga ndi zofunikira za chikalata cha Huanfa [2003] No.101, makampani opanga mankhwala amasankhidwa kuti awonongeke kwambiri.

3. Chiwopsezo cha kusinthanitsa, chiwopsezo cha kubwezeredwa kwa msonkho wogulitsa kunja

Makampani opanga mankhwala amadalira kwambiri malonda ogulitsa kunja, kotero kusintha kwa kusintha kwa ndalama ndi kubwezeredwa kwa msonkho wa kunja kudzakhala ndi zotsatira zina pamakampani onse.

4. Kuopsa kwa kusinthasintha kwamitengo yamtengo wapatali

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Makampani apakatikati ali ndi zida zazikulu komanso zomwazika zofunidwa ndi makampani apakatikati.Makampani ake akumtunda ndiye makampani opanga mankhwala, omwe angakhudzidwe ndi kusinthasintha kwamitengo yamafuta kuphatikiza mitengo yamafuta.(tcherani khutu kufananitsa kopingasa kwamitengo yazinthu zofunikira za kampani yomwe mukufuna.)

5. luso chinsinsi chiopsezo

Mpikisano pachimake cha zabwino mankhwala intermediates mabizinesi mu luso zimaonekera mu zochita mankhwala, pachimake chothandizira kusankha ndi kulamulira ndondomeko, pamene matekinoloje ena kiyi ndi chikhalidwe mkulu monopolistic, ndipo pachimake luso ndi chimodzi mwa zinthu zofunika kwambiri pakupanga ndi ntchito ya kampani. .

6. zosintha zamakono pa nthawi yake zoopsa

7. luso kukhetsa ubongo chiopsezo

Mutu II, Mikhalidwe Yamsika

I. Mphamvu zamakampani

Malinga ndi China Market Survey Network "2015-2020 Future Market Development Potential and Investment Strategy Research Report" ikuwonetsa kuti China Medical intermediates Industry Analysis China Market Survey Network ofufuza adawonetsa kuti China ikufunika mitundu yopitilira 2,000 yazinthu zopangira ndi zapakati zothandizira mankhwala. makampani chaka chilichonse, ndi ankafuna oposa 2.5 miliyoni tons.After zaka 30 chitukuko, mankhwala zopangira ndi intermediates zofunika kupanga mankhwala China kwenikweni zimagwirizana, ndi mbali zochepa chabe ayenera imported.Moreover, chifukwa ku chuma cholemera cha China ndi mitengo yotsika yazinthu zopangira, ambiri apakati apeza zambiri zogulitsa kunja.

Malinga ndi "Fine Chemical Pharmaceutical Intermediates Industry Analysis Report" yomwe idatulutsidwa ndi Qilu Securities mu 2013, chifukwa chakusamuka kwa mankhwala opangira mankhwala kupita ku Asia, opanga mankhwala aku China ali ndi zabwino zoonekeratu, ndipo akuyembekezeka kukula pamtengo wapachaka wa 18. %. kugawikana kwa ntchito ndi kutulutsa kunja kumakhala chizolowezi cha The Times, mu 2017 mtengo wa msika wapadziko lonse lapansi ufika $ 63 biliyoni, CAGR12%. Kufuna msika kumapitiriza kukula, zomangamanga ndi bwino kuposa India ndi wochuluka talente yosungirako, koma zochepa FDA mbiri API ndi kukonzekera, Choncho, akuweruzidwa kuti China adzapitiriza kutsogolera pharmaceutical intermediates production.China mankhwala outsourcing kupanga mtengo msika kokha 6% yazogulitsa padziko lonse lapansi, koma idzakula mpaka $5 biliyoni pa 18% pazaka zisanu zikubwerazi.

Ⅱ.makhalidwe amakampani

1.Mabizinesi ambiri opanga ndi mabizinesi apayekha, magwiridwe antchito osinthika, masikelo ang'onoang'ono a ndalama, makamaka pakati pa mamiliyoni angapo mpaka 1 kapena 2 miliyoni yuan;

2.Kugawa kwachigawo kwamakampani opanga zinthu kumakhala kokhazikika, makamaka kugawidwa m'madera omwe ali ndi Zhejiang Taizhou ndi Jiangsu Jintan monga likulu;

3.Ndi chidwi chowonjezereka cha zovuta zachilengedwe ku zovuta zachilengedwe, kukakamizidwa kwa mabizinesi opanga kupanga kuti amange malo osamalira zachilengedwe kumawonjezeka;(tcherani khutu ku chilango, kutsata)

Zosintha za 4.Zosintha zimathamanga kwambiri.Pakadutsa zaka zisanu kuchokera pamene chinthucho chimakhala pamsika, phindu lake limatsika kwambiri, zomwe zimakakamiza mabizinesi kuti azipanga zinthu zatsopano nthawi zonse kapena kuwongolera nthawi zonse kupanga, kuti asunge phindu lalikulu;

5.Chifukwa chakuti phindu la mankhwala opangira mankhwala ndi apamwamba kuposa mankhwala, njira zopangira ziwirizi zimakhala zofanana, kotero kuti mabizinesi ang'onoang'ono ang'onoang'ono alowa nawo m'magulu opanga mankhwala opangira mankhwala, zomwe zimapangitsa kuti pakhale mpikisano wosagwirizana ndi makampani. ;

6.Poyerekeza ndi API, malire a phindu la zopangira zopangira ndi otsika, ndipo njira yopangira API ndi mankhwala apakati ndi ofanana.Chifukwa chake, mabizinesi ena samangotulutsa zapakati, komanso amagwiritsa ntchito zabwino zawo kupanga API.

III.Chitukuko chamtsogolo chamakampani apakati

1. Kuchulukirachulukira kwamakampani padziko lonse lapansi komanso ku China ndikotsika, ndipo Chinese CMO ndi CRO akadali ndi mwayi wokulirapo.

Kusakhazikika kwamakampani ndikotsika padziko lonse lapansi komanso ku China.Pakatikati pa Pharmaceutical sizochepa ndi chitetezo cha patent, ndipo safunikira chiphaso cha GMP, kotero kuti malire olowera ndi otsika, ndipo pali zinthu zambiri.Chifukwa chake, padziko lonse lapansi komanso China, ndende yamakampani ndiyotsika, ndipo kutulutsa kwapakati kwamankhwala ndizosiyana.

Padziko Lonse: Makampani 10 apamwamba kwambiri a 2010 a CMO adayimilira zosakwana 30%, atatu apamwamba ndi Lonza Switzerland(Switzerland), Catalent(USA) ndi BoehringerIngelheim(Germany). kuwerengera 6% yokha ya CMO yapadziko lonse lapansi.

2. Zogulitsa zimasiyanasiyana ndikupitilira mpaka kumapeto kwa unyolo wamakampani

Kwathunthu kuchokera kupanga kwambiri otsika-mapeto intermediates ku zabwino mkulu-mapeto mankhwala wapakatikati, ndi kukulitsa ku fields ena zachipatala utumiki fields.This ali ndi zofunika mkulu kasamalidwe ndi luso luso la kampani, komanso ayenera kudziunjikira mbiri kasitomala, ndi mgwirizano. nthawi imakhudzanso kuya kwa mgwirizano.

3. amatengera akatswiri outsourcing ntchito

Makampani ogulitsa ntchito zakunja akupitilira kukula, kupanga ntchito za R & D (CMO + CRO): kuchokera ku CMO kupita kumtunda, ndikuchita ntchito za CRO (outsourcing R & D), zomwe zili ndi zofunikira kwambiri paukadaulo wamakampani ndi kafukufuku ndi mphamvu yachitukuko.

4. imayang'ana pa mankhwala, kuukira API ndikukonzekera kumunsi kwapakati

5. imagwira ntchito mozama ndi makasitomala akuluakulu kuti agawane zipatso za kukula kofanana ndikuwonjezera phindu lalikulu

Kuchulukira kwamakampani opanga mankhwala otsika kwambiri ndikokwera kwambiri kuposa makampani opanga mankhwala, ndipo kufunikira kwamtsogolo makamaka kumachokera kwa makasitomala akuluakulu: kuchokera kumalingaliro azovuta, msika wapadziko lonse lapansi wamankhwala ndiwokwera (kuchuluka kwa mabizinesi khumi apamwamba kwambiri padziko lonse lapansi ndi 41.9 %), zomwe zimapangitsa kufunika kwakukulu kwa mkhalapakati wa CMO kumachokera ku zimphona zamitundu yambiri.Mlingo wa ndende wamakampani apakatikati ndi 20% yokha, mphamvu yolumikizirana ndi yofooka, komanso tsogolo lachitukuko lamtsogolo lidzakhalanso ndi chitukuko chamakampani opanga mankhwala. Zimphona zamitundumitundu zopangira mankhwala ndizo gwero lalikulu la zofuna zapano ndi zamtsogolo.

Mutu III Mabizinesi Okhudzana ndi Makampani

I. Makampani olembedwa m'makampani apakati

1, Medialization Technology

Kutsogola bizinesi yopangidwa mwamakonda: Lianhua Technology ndi bizinesi yotsogola mukupanga mankhwala ophera tizilombo ndi mankhwala ku China, ndipo gawo lazopanga makonda likukulirakulira chaka ndi chaka.

Ubwino waukadaulo: njira ya ammonia oxidation imayambitsa ukadaulo m'munsi mwa nitrile, pogwiritsa ntchito zida zatsopano komanso zida zapamwamba zopangira, ukadaulo umafika pamlingo wapadziko lonse lapansi, wotsika mtengo komanso njira yogwirira ntchito ndiyopanda poizoni.

2, Jacob Chemical

Customstom kupanga mankhwala ophera tizilombo ndi mankhwala otsogola intermediates.Pesticide intermediates makamaka intermediates BPP wa tizilombo chloroworm benzoamide ndi CHP, amene CHP ndi kalambulabwalo wa BPP.Medical intermediates makamaka anti-epileptic intermediates ndi odana ndi chotupa makhalidwe intermediates, mitundu yaying'ono.

Makasitomala akuluakulu a kampaniyi ndi zimphona zamitundu yonse, zomwe pakati pa mankhwala ophera tizilombo ndi DuPont, ndipo ophatikizira mankhwala ndi Teva ndi Roche. Custom mode imapangitsa kuti makasitomala azikhala ndi chidwi komanso kutseka zofunikira zakutsika. Tengani mgwirizano ndi DuPont monga chitsanzo ya DuPont, mgwirizano wamanga maziko olimba a chikhulupiriro ndi zolepheretsa kulowa kwa zaka zambiri, ndipo kuya kwa mgwirizano kwakhala kukukulirakulirabe.

3, Wanchang Technology

Wanchang Technology ndiye ngwazi yosawoneka m'munda wamankhwala opha tizilombo.Zogulitsa zake zazikulu ndi trimethyl proformate ndi trimethyl proformate.Mu 2009, gawo la msika wapadziko lonse lapansi linali 21.05% ndi 29.25% motsatana, zomwe zimapangitsa kuti ikhale yopanga kwambiri padziko lonse lapansi.

Ukadaulo wapadera, phindu lalikulu lambiri, uli ndi mawonekedwe apamwamba komanso zokolola, ndalama zochepa, magwiridwe antchito apamwamba achuma.Pakali pano, makampani opanga ma protoformate padziko lonse lapansi amaliza kukonzanso oligopoly, opikisana nawo samakulitsa kupanga. Kampaniyo ili ndi zabwino zambiri zopikisana , kugwiritsa ntchito luso lachidziwitso cha njira ya "zinyalala za gasi hydrocyanic acid", mpikisano ndi wamphamvu.

4, Boteng Shares

pachimake luso gulu, ndi ubwino zoonekeratu kafukufuku ndi chitukuko, angapereke Integrated makonda R & D ndi ntchito kupanga, ndi kukhala zoweta kalasi yoyamba mankhwala intermediates makonda kupanga ndi kafukufuku ndi chitukuko enterprise.It makamaka kupereka makonda mankhwala intermediates kafukufuku , ntchito zachitukuko ndi kupanga kwa makampani opanga mankhwala amitundumitundu ndi mankhwala opangidwa ndi biopharmaceutical, omwe afananizidwa ndi muyezo wa chandamale chachiwiri komanso chabwino.

1. Gululi liri ndi luso lopitiliza kufufuza ndi chitukuko (kuphatikizapo kafukufuku ndi chitukuko, si aliyense amene angalowe m'makampaniwa. Tiyenera kumvetsera zaka za gulu ndi mapangidwe a maphunziro ndi zochitika zakale);

2. yakhala ndi zinthu, zofananira ndi makasitomala amankhwala amtundu uliwonse kapena otsogola (zochitika zapatent, zomwe makasitomala amabizinesi ali nazo, mankhwala omwe amalizidwa omwe amalizidwa, zomwe zikuwonetsa, ndi kuchuluka kwa msika wazomwe akuwonetsa);

3. Zolinga zimatha kupititsa patsogolo zinthu zosinthidwa makonda, kapena ku CRO kapena CMO, m'malo mongopanga zinthu zofananira;(atha kupitanso kumakampani opanga mankhwala otsika, koma amafunikira thandizo la ndalama ndi mtundu)

4.Kukwaniritsa zolinga ndi kwabwino, ndipo palibe chilango chochokera ku chitetezo cha chilengedwe, miyambo ndi akuluakulu amisonkho.

Zolozera:

(1) <>, People's Health Press, kope la 8, Marichi 2013;

(2) Magawo a Boteng: IPO zopereka zapagulu komanso zolembedwa pa Growth Enterprise Board prospectus;

(3) UBS Gene: —— <>, May 2015;

(4) Guorui Pharmaceutical: "The Pharmaceutical Interbody Industry yomwe Simudziwa";

(5) Yaben Chemical: IPO ndikulemba mndandanda pa Growth Enterprise Board;

(6) Pharmaceutical Supply Chain Alliance:<< Kufufuza Mwakuya ndi Kusanthula kwa Chiyembekezo cha Market Market of Pharmaceutical Interbody Industry>>, April 2016;

(7) Chitetezo cha Qilu: <> ".Eleven mwa makampani apamwamba a 15 opanga mankhwala adakhazikitsa ubale wamakasitomala.