Igice cya I, Incamake yinganda

I. Imiti ihuza imiti: inganda zambukiranya inganda nubuvuzi

Abahuza mu bya farumasi ni ibintu biciriritse mubikorwa bya API synthesis, imiti myiza yimiti, idasaba ko nta ruhushya rwo gukora imiti rutanga umusaruro, rushobora kugabanywa hashingiwe ku ngaruka ku bwiza bwa nyuma bwa API mu gihe kitari GMP hagati na GMP hagati (imiti y’imiti yakozwe munsi y'ibisabwa na GMP byasobanuwe na ICHQ7).

Uruganda rwimiti rwimiti bivuga inganda zikora imiti zitunganya kandi zigatunganya abahuza kama / organic organique cyangwa imiti mbisi yimiti yimiti hakoreshejwe uburyo bwa sintetike ya chimique cyangwa biosynetique hakoreshejwe ubuziranenge bukomeye.

(1) Imiti igabanya ubukana bwa farumasi irashobora kugabanywa mu nganda za CRO na CMO.

CMO: Gukora AmasezeranoOrganisation bivuga uruganda rwashinzwe, bivuze ko uruganda rukora imiti rutanga umusaruro uhuza umufatanyabikorwa.Urunani rwubucuruzi rwimiti ya CMO muri rusange rutangirana nibikoresho bidasanzwe bya farumasi.Uruganda rukora inganda rugomba kugura ibikoresho byibanze byimiti no kubishyira mubikoresho byihariye bya farumasi, kandi gusubiramo bizagenda buhoro buhoro ibikoresho byo gutangiza API, abahuza cGMP, API, nimyiteguro.Kugeza ubu, amasosiyete akomeye y’imiti y’amahanga akunda gushyiraho ubufatanye burambye bwigihe kirekire hamwe nabatanga isoko ryibanze, kandi kubaho kwamasosiyete muruganda biragaragara binyuze mubafatanyabikorwa babo.

CRO: Amasezerano (Clinical) Ishirahamwe ryubushakashatsi bivuga ikigo gishinzwe ubushakashatsi bwamasezerano yashinzwe aho ibigo bikorerwamo ibya farumasi bitanga ubushakashatsi kubufatanye.Kugeza ubu, inganda ahanini zishingiye ku bicuruzwa byabigenewe, ubushakashatsi bwihariye n’iterambere ndetse n’ubushakashatsi bw’imiti ya farumasi, kugurisha nk’ubufatanye bw’ibanze, uko byagenda kose, hatitawe ku bicuruzwa biva mu mahanga bivura ibicuruzwa ni udushya, suzuma ubushobozi bw’ibanze mu kigo buracyakomeza ubushakashatsi n'ikoranabuhanga ryiterambere nkibintu byambere, uruhande rugaragara nkabakiriya cyangwa abafatanyabikorwa ba sosiyete yo hasi.

(2) Uhereye mubyiciro byubucuruzi bwubucuruzi, imishinga yo hagati irashobora kugabanywa muburyo rusange nuburyo bwihariye.

Muri rusange, abakora inganda nto n'iziciriritse bakora inganda rusange bafata uburyo rusange, kandi abakiriya babo usanga ahanini bakora ibiyobyabwenge rusange, mugihe inganda nini zo hagati zifite ubushakashatsi bukomeye nubushobozi bwiterambere zifata uburyo bwihariye kubucuruzi bwibiyobyabwenge bishya.Moderi yihariye irashobora kuzamura neza viscosity hamwe nabakiriya.

Muburyo rusange bwibicuruzwa, ibigo byerekana ibyifuzo rusange byabakiriya benshi ukurikije ibyavuye mubushakashatsi bwisoko kandi bigakora ibikorwa byubucuruzi byihariye nkubushakashatsi niterambere, umusaruro, nigurisha nkintangiriro.Nukuvuga ko, mbere yibikorwa byubucuruzi byihariye, nta mubano w’abakiriya washyizweho hagati yikigo nabakiriya rusange.Kuva icyo gihe, murwego rwo gukora ibikorwa byubucuruzi byihariye, ibigo muri rusange bikomeza itumanaho rihoraho nabakiriya ba leta kugirango ibyifuzo rusange byabakiriya ba leta byuzuzwe.Kubwibyo, kugurisha ibicuruzwa rusange nibicuruzwa rusange, hanyuma abakiriya benshi.Icyitegererezo cyubucuruzi gishingiye ku bicuruzwa rusange n’ibanze, kandi ikigo n’abakiriya rusange ni umubano wabakiriya gusa.Mu nganda zimiti, icyitegererezo cyibicuruzwa rusange gikoreshwa cyane cyane mubushakashatsi niterambere, kubyara no kugurisha abahuza imiti, API nimyiteguro ikenewe kumiti rusange.

Muburyo bwo kwihitiramo, abakiriya bateganijwe batanga amakuru yibanga kumushinga nyuma yo gusinyana amasezerano yibanga na rwiyemezamirimo, kandi bagasobanura ibyifuzo byabigenewe. Uruganda rutangirira kubikenewe byabakiriya babigenewe kugirango bakore ubushakashatsi niterambere, umusaruro, kugurisha nibindi ibikorwa byubucuruzi byihariye.Ni ukuvuga ko, mbere yo gukora ibikorwa byubucuruzi byihariye, ibigo byashizeho umubano runaka wabakiriya nabakiriya babigenewe.Kubera rero, mugikorwa cyo gukora ibikorwa byubucuruzi byihariye, ibigo bigomba gukomeza guhoraho, inzira ebyiri kandi itumanaho ryimbitse hamwe nabakiriya babigenewe kugirango tumenye neza ko ibikenewe byabakiriya babigenewe muburyo bwose. Kubwibyo, kugurisha ibicuruzwa byabigenewe ni abakiriya babigenewe, hanyuma ibicuruzwa byabigenewe.Icyitegererezo cyubucuruzi cyashizweho kubakiriya bishingiye kandi nibyingenzi, kandi hariho umubano wa hafi wabakiriya hagati yikigo nabakiriya babigenewe.Mu nganda zimiti, uburyo bwihariye bukoreshwa cyane cyane mubushakashatsi, iterambere, umusaruro no kugurisha abahuza imiti, API n'imyiteguro ikenewe kumiti igezweho.

II.Amategeko n'amabwiriza ajyanye n'inganda

Abahuza mu bya farumasi ni abo mu nganda z’imiti, ariko zirakomeye kuruta ibicuruzwa rusange by’imiti.Abakora inganda n’abakuze na API bakeneye guhabwa icyemezo cya GMP, ariko ntabwo ari abahuza (usibye abahuza ba GMP basabwa hakurikijwe amahame ya GMP), ibyo bikaba bigabanya inganda. inzitizi kubakora bahuza.

Nka sosiyete yihariye yubushakashatsi n’iterambere ry’imiti ihuza imiti, ibikorwa byayo bibyara umusaruro bibujijwe n’amategeko arengera ibidukikije muri Repubulika y’Ubushinwa, Itegeko rya Repubulika y’Ubushinwa ku bijyanye n’umutekano w’akazi, Itegeko ry’ibicuruzwa by’ibicuruzwa bya Repubulika y’abaturage. Ubushinwa nandi mategeko n'amabwiriza.

Inganda nziza z’imiti nishami ryingenzi ryinganda zubushinwa.Mu myaka yashize, leta yongeye gushyigikira inganda nziza z’imiti mu nyandiko nyinshi za porogaramu. Inganda zikomoka ku binyabuzima zikomoka ku buhanga mu bya farumasi nazo ni imwe mu nganda zigenda zitera imbere n’igihugu.

, Inzitizi z'inganda

1. inzitizi zabakiriya

Uruganda rwa farumasi rwihariwe ninganda nkeya zimiti yimiti myinshi.Ubuvuzi bwa oligarchs bwitonda cyane muguhitamo abatanga serivise zitanga hanze, kandi igihe cyo kugenzura kubatanga isoko gishya ni kirekire muri rusange. wemere igihe kirekire cyo gusuzuma kugirango ubone icyizere cyabakiriya bo hasi, hanyuma ube isoko ryibanze.

2. inzitizi ya tekiniki

Niba gutanga serivisi zinoze zongerewe agaciro nishingiro ryibikorwa bya farumasi bitanga serivisi za farumasi. Uruganda rwimiti rukora imiti rugomba guca mu cyuho cya tekiniki cyangwa kuzibira inzira yambere kandi rugatanga inzira nziza yimiti, kugirango bigabanye neza ibiyobyabwenge ikiguzi cy'umusaruro.Nta gihe kinini, ubushakashatsi buhenze cyane nishoramari ryiterambere hamwe nububiko bwikoranabuhanga, biragoye ko imishinga yo hanze yinganda yinjira mubyukuri.

3. inzitizi zimpano

Guhanga udushya no gukoresha inganda zikoreshwa mu buhanga mu bya farumasi bisaba umubare munini w’ubushakashatsi n’iterambere ryiza, impano yo gucunga umusaruro n’abakozi bashinzwe imishinga. Ibigo bya buri muntu bigomba gushyiraho urugero rwimyitwarire yujuje ubuziranenge bwa cGMP, kandi biragoye gushyiraho irushanwa R & ipiganwa. D hamwe nitsinda ryindobanure mumatsinda mugihe gito.

4. inzitizi zujuje ubuziranenge

Inganda zo hagati zifite ishingiro cyane ku masoko yo hanze.Hamwe n’ibisabwa gukurikiranwa n’ubuziranenge bwa FDA, EMA n’izindi nzego zishinzwe kugenzura ibiyobyabwenge, ibicuruzwa bitatsinze igenzura ntibishobora kwinjira ku isoko ry’ibicuruzwa bitumizwa mu mahanga.

5. inzitizi zigenga ibidukikije

Inganda ziciriritse ni iz'inganda zikora imiti, kandi zigomba kubyazwa umusaruro hakurikijwe ibipimo ngenderwaho by’igihugu bigenzura ibidukikije ku nganda zikora imiti. Inganda ziciriritse zifite ikoranabuhanga ry’inyuma zizishyura amafaranga menshi yo kurwanya umwanda n’igitutu cy’amabwiriza, ndetse n’inganda gakondo z’imiti zitanga umusaruro mwinshi cyane umwanda, gukoresha ingufu nyinshi nibicuruzwa byongerewe agaciro bizahura no kurandurwa byihuse.

IV.Impamvu zishobora guteza inganda

1.Ingaruka ziterwa no kwibanda kubakiriya

Kurugero, nkuko bigaragara kuri prospectus yimigabane ya Boteng, abakiriya bayo benshi ni Johnson & Johnson Pharmaceutical, bangana na 60% byinjiza, iki kintu gishobora no kuboneka kubatanga hagati nka Yaben Chemical.

2. Ingaruka z’ibidukikije

1. Ubushakashatsi niterambere, umusaruro, nogurisha abahuza imiti, inganda nizo nganda nziza zikora imiti.Dukurikije ingingo zijyanye n’inyandiko ya Huanfa [2003] No101, inganda z’imiti zagenwe nk’umwanda ukabije

3. ingaruka zivunjisha, ingaruka zo kugabanyirizwa imisoro

Uruganda rwimiti rwimiti rushingiye cyane kubucuruzi bwohereza ibicuruzwa hanze, bityo rero guhindura igipimo cy’ivunjisha no kugabanyirizwa imisoro yoherezwa mu mahanga bizagira ingaruka runaka ku nganda zose.

4. Ingaruka zo guhindagurika kw'ibikoresho fatizo

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Inganda zo hagati zifite ibikoresho binini kandi bitatanye bikenerwa ninganda zo hagati.Inganda zayo zo hejuru n’inganda shingiro z’imiti, zizagerwaho n’imihindagurikire y’ibiciro fatizo harimo n’ibiciro bya peteroli.(witondere kugereranya gutambuka kugiciro cyibikoresho byingenzi byibanze byikigo.）

5. ibyago byibanga tekinike

Ihiganwa ryibanze ryinganda zikorana buhanga mubikorwa byikoranabuhanga bigaragarira mubikorwa bya chimique, guhitamo catalizator no kugenzura inzira, mugihe tekinoroji yingenzi ifite imiterere yihariye, kandi ikoranabuhanga ryibanze nikimwe mubintu byingenzi mubikorwa byikigo. .

6. ivugurura ryikoranabuhanga mugihe gishobora kugerwaho

7. tekinike yo gukuramo ubwonko

Igice cya II, Imiterere yisoko

I. Ubushobozi bwinganda

Nk’uko bigaragara ku ihuriro ry’ubushakashatsi ku isoko ry’Ubushinwa “Raporo y’ubushakashatsi bw’ingamba zo gushora imari mu mwaka wa 2015-2020” yerekana ko abashakashatsi bo mu Bushinwa bahuza inganda Isesengura ry’inganda Isesengura ry’isoko ry’Ubushinwa ryerekanye ko Ubushinwa bukeneye amoko arenga 2000 y’ibikoresho fatizo n’abahuza bashyigikira imiti inganda buri mwaka, hamwe na toni zirenga miliyoni 2.5.Nyuma yimyaka irenga 30 yiterambere, ibikoresho fatizo byimiti nabahuza bikenerwa mugukora imiti yubushinwa birashobora guhura cyane, kandi ibice bike gusa bigomba gutumizwa hanze. Byongeye kandi, kubera ku butunzi bukungahaye mu Bushinwa hamwe n’ibiciro fatizo by’ibanze, abahuza benshi bageze ku bicuruzwa byinshi byoherezwa mu mahanga.

Raporo ya “Fine Chemical Pharmaceutical Interintermediates Industry Analysis Report” yashyizwe ahagaragara na Qilu Securities mu 2013, kubera iyimurwa ry’ibicuruzwa biva mu mahanga biva muri Aziya, abahuza imiti y’imiti mu Bushinwa bafite ibyiza bigaragara, bikaba biteganijwe ko biziyongera ku kigereranyo cy’umwaka kingana na 18 % (umuvuduko w’ubwiyongere bw’isi ku isi ugera kuri 12%) kugabana imirimo no gutanga umusaruro hanze bigenda bihinduka ikinyamakuru The Times, muri 2017 agaciro k'isoko ry'umusaruro ku isi ku isi rizagera kuri miliyari 63 z'amadolari, CAGR12% .Ibiciro by'inganda mu Bushinwa biri munsi ya 30-50% ugereranije n'Uburayi na Amerika, Isoko ryamasoko rikomeza iterambere ryinshi, ibikorwa remezo biruta Ubuhinde nubushobozi bwinshi bwabakozi, ariko bike FDA yemejwe na API hamwe nimyiteguro, Kubwibyo rero, hemejwe ko Ubushinwa buzakomeza gufata iyambere mubikorwa by’imiti ihuza imiti. Ubushinwa ibicuruzwa biva mu mahanga biva hanze 6% by'umusaruro wohereza hanze ku isi, ariko uziyongera kugera kuri miliyari 5 z'amadolari kuri 18% mu myaka itanu iri imbere.

Ibiranga inganda

1.Inganda nyinshi zitanga umusaruro ni ibigo byigenga, imikorere yoroheje, igipimo gito cyishoramari, ahanini hagati ya miliyoni nyinshi kugeza kuri miliyoni 1 cyangwa 2;

2.Ikwirakwizwa ry’akarere mu nganda zibyara umusaruro usanga ryibanze cyane cyane mu turere hamwe na Zhejiang Taizhou na Jiangsu Jintan nkikigo;

3.Mu gihe ibibazo by’ibidukikije bigenda byiyongera ku bibazo by’ibidukikije, igitutu cy’inganda zitanga umusaruro zo kubaka ibigo byita ku bidukikije cyiyongera;(witondere ibihano, kubahiriza)

4.Ivugurura ryibicuruzwa ryihuta cyane.Imyaka itanu nyuma yibicuruzwa muri rusange ku isoko, inyungu yinyungu iragabanuka cyane, bihatira ibigo guhora biteza imbere ibicuruzwa bishya cyangwa guhora bitezimbere umusaruro, kugirango bikomeze inyungu nyinshi;

5.Kuberako inyungu yumusaruro wabunzi ba farumasi iruta ibicuruzwa bivura imiti, gahunda yo kubyaza umusaruro byombi irasa cyane, bityo rero imishinga mito mito mito myinshi yinjiye murwego rwabahuza imiti, bigatuma habaho irushanwa ridahungabana muruganda. ;

6. Ugereranije na API, inyungu yinyungu yumuhuza wumusaruro ni muke, kandi inzira yumusaruro wa API nabahuza imiti irasa.Kubwibyo, ibigo bimwe ntabwo bitanga abahuza gusa, ahubwo binakoresha inyungu zabo bwite kugirango bitange API.

III.Icyerekezo cyiterambere kizaza cyinganda zahuza

1. kwibanda ku nganda haba ku isi no mu Bushinwa ni bike, kandi Ubushinwa CMO na CRO buracyafite umwanya munini wo gutera imbere

Inganda zita ku nganda ziri hasi haba ku isi ndetse no mu Bushinwa. Abahuza imiti ntibagarukira gusa ku kurinda ipatanti, kandi ntibakeneye icyemezo cya GMP, bityo inzitizi yinjira yinjira ni mike, kandi hari ibicuruzwa byinshi.Kubwibyo, haba ku isi ndetse no mu Bushinwa, inganda ziba nke, kandi kohereza abahuza imiti ntibisanzwe.

Isi yose: Imiti 10 yambere ya farumasi ya CMO ya 2010 ihagarariye munsi ya 30%, batatu ba mbere ni Lonza Ubusuwisi (Ubusuwisi), Catalent (USA) na BoehringerIngelheim (Ubudage) .Lonza ,, isosiyete nini ya CMO nini ku isi, yinjije miliyari 11,7 mu mwaka wa 2011, bingana na 6% gusa ya CMO kwisi.

2. ibicuruzwa bitandukanye kandi bigera no murwego rwohejuru rwurunigi rwinganda

Byuzuye uhereye kumusaruro mwinshi wumuhuza wo hasi kugeza ku bicuruzwa byiza byo mu rwego rwo hejuru bigezweho, no kwaguka no mubindi bikorwa byubuvuzi.Ibi bifite ibisabwa cyane mubuyobozi nimbaraga za tekinike yikigo, ariko kandi bigomba no kumenyekanisha abakiriya, nubufatanye igihe nacyo gifite ingaruka zikomeye kubwimbitse bwubufatanye.

3. ifata serivisi ziva hanze

Uruganda rwa serivise zitanga serivisi zikomeje kwaguka, gukora serivisi ziva hanze (CMO + CRO): kuva muri CMO kugera hejuru, no gukora CRO (outsourcing R & D serivisi), ifite ibisabwa cyane mubuhanga nubushakashatsi bwikigo ndetse imbaraga ziterambere.

4. yibanze kuri farumasi, kwibasira API nimyiteguro yo hepfo yumuhuza

5. ikorana cyane nabakiriya benshi kugirango basangire imbuto zo gukura rusange no kuzamura agaciro kingenzi

Ubwinshi bw’inganda zikoreshwa mu bya farumasi ziri hejuru cyane ugereranije n’inganda zikora imiti, kandi icyifuzo kizaza gituruka ahanini ku bakiriya benshi: duhereye ku kwibanda ku nganda, uruganda rukora imiti ku isi ni rwinshi (kwibanda ku mishinga icumi ya mbere y’imiti ku isi ni 41.9 ) Ibihangange byinshi mu bya farumasi nisoko nyamukuru yibisabwa muri iki gihe no mu gihe kizaza. Gufunga abakiriya bakomeye bigamije ibikenewe mu gihe kizaza.

Igice cya III Inganda zijyanye ninganda

I. Urutonde rwamasosiyete munganda zo hagati

1, Ikoranabuhanga rya Medialisation

Uruganda ruyobora ibicuruzwa byabigenewe: Ikoranabuhanga rya Lianhua ni uruganda ruyoboye imiti yica udukoko n’imiti ikoreshwa mu Bushinwa, kandi umubare w’ibicuruzwa byabigenewe uragenda wiyongera uko umwaka utashye.

Ibyiza bya tekiniki: uburyo bwa okiside ya ammonia butangiza tekinoroji ya nitrile, binyuze mugukoresha catalizator nshya nibikoresho bigezweho byo gukora, ikoranabuhanga rigera kurwego mpuzamahanga ruyoboye, igiciro gito kandi inzira yo gukora ntabwo ahanini ari uburozi.

2, Yakobo

Umusaruro wa Customstom wica udukoko twica udukoko hamwe nu miti wateye imbere.Abahuza imiti yica udukoko ni abahuza cyane cyane BPP yumuti wica udukoko twa chloroworm benzoamide na CHP, aho CHP ibanziriza BPP. Abahuza mubuvuzi ahanini barwanya epileptike nabahuza anti-tumouror, hamwe nibiranga ibiranga ubwoko buto.

Abakiriya nyamukuru b’isosiyete bose ni ibihangange mu bihugu byinshi, muri byo abahuza imiti yica udukoko ni DuPont, naho abahuza imiti ni Teva na Roche. Uburyo bwa Customer buteza imbere imikoranire yabakiriya no gufunga ibyifuzo byimbere. Fata ubufatanye na DuPont nkurugero, Nkumushinga utanga ingamba. ya DuPont, ubufatanye bwubatse urufatiro rukomeye rwo kwizerana n'inzitizi zo kwinjira mu myaka myinshi, kandi ubujyakuzimu bw’ubufatanye bwakomeje kwiyongera.

3, Ikoranabuhanga rya Wanchang

Ikoranabuhanga rya Wanchang ni nyampinga utagaragara mu rwego rwa farumasi yica udukoko.Ibicuruzwa byingenzi byingenzi ni trimethyl proformate na trimethyl proformate.Mu mwaka wa 2009, umugabane w’isoko ku isi wari 21.05% na 29.25%, ku buryo ariwo utanga umusaruro mwinshi ku isi.

Ikoranabuhanga ridasanzwe, inyungu nini yuzuye yinyungu rusange, ifite ibiranga ubuziranenge n'umusaruro mwinshi, ishoramari rito, imikorere myiza yubukungu. Kugeza ubu, inganda za protoformate ku isi zarangije kuvugurura oligopoly, abanywanyi ntibagura umusaruro.Isosiyete ifite inyungu zikomeye zo guhatanira , gukoresha udushya twa patenti yuburyo bwa "imyanda ya hydrocyanic acide" inzira, irushanwa rirakomeye.

4, Imigabane ya Boteng

Itsinda ryibanze rya tekiniki, hamwe ninyungu zigaragara mubushakashatsi niterambere, rirashobora gutanga serivisi zihuriweho na R & D hamwe na serivisi zibyara umusaruro, kandi bigahinduka imiti yo mu rwego rwa mbere yimiti yimiti ihuza ibicuruzwa nubushakashatsi niterambere ryiterambere.Bigamije ahanini gutanga imiti ihuza imiti yihariye , iterambere no gutanga umusaruro kumasosiyete mpuzamahanga yimiti yimiti n’ibiyobyabwenge bivura biofarmaceutical, byagereranijwe nibipimo bya kabiri kandi byiza

1.Ikipe ifite imbaraga zihoraho zubushakashatsi nubushobozi bwiterambere (birimo ubushakashatsi niterambere, ntabwo abantu bose bashobora kwinjira muruganda. Tugomba kwitondera imyaka yikipe n'imiterere yamasomo n'uburambe bwahise);

2. yerekanye ibicuruzwa, bihuye nabakiriya rusange cyangwa udushya twibiyobyabwenge (imiterere yipatanti yivumbuwe, ibyo abakiriya ba entreprise bafite, ibikomoka kumiti irangiye bihuye, ibyerekana, nubushobozi bwisoko ryerekana);

3. intego zifite ubushobozi bwo kwiteza imbere kubicuruzwa byabigenewe, cyangwa no kuri CRO cyangwa CMO, aho kubyara ibicuruzwa bisanzwe bisanzwe;(barashobora kandi kwiteza imbere bagana uruganda rukora imiti, ariko bakeneye inkunga yimari nikirango)

4.Kuzuza intego ni byiza, kandi nta gihano kiva mu kurengera ibidukikije, gasutamo n'abashinzwe imisoro.

Reba:

(1) <>, Itangazamakuru ryubuzima bwabaturage, integuro ya 8, Werurwe 2013;

(2) Umugabane wa Boteng: IPO itanga kumugaragaro kandi urutonde kuri Growth Enterprise Board prospectus;

(3) UBS Gene: —— <>, Gicurasi 2015;

(4) Imiti ya Guorui: “Uruganda rwa farumasi utazi”;

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(7) Impapuro za Qilu: <> ”.Icumi na rimwe muri 15 yambere yimiti yimiti yashizeho umubano wabakiriya.