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1、1全球醫(yī)藥產(chǎn)業(yè)全球醫(yī)藥產(chǎn)業(yè)研究研究與發(fā)展的與發(fā)展的最新趨勢最新趨勢胡江濱美中藥協(xié) (sapa)北京, 20042報告內(nèi)容 全球制藥界新藥開發(fā)最新概況 新藥開發(fā)值得注意的走向 project in-licensing項(xiàng)目引進(jìn) life cycle management (lcm)產(chǎn)品周期的管理 outsourcingwhat why and (how) ?3223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p 2003pglobal pharmaceutical
2、 sales (us$ billion)4204450100200300400500600yearp = projectionsource: sales data for 1992-2001 supplied by ims health全球藥品銷售全球藥品銷售 1992-2003p40608010012014016018020019921993199419951996199719981999200020012002pyearindexed values (1992 = 100)全球研發(fā)費(fèi)用全球新藥上市研發(fā)時間 (3 year moving average)全球銷售全球銷售,研發(fā)費(fèi)用及研發(fā)時間和
3、新藥上市全球銷售,研發(fā)費(fèi)用及研發(fā)時間和新藥上市1992-2002p5research late developmentearly developmentregulatory assessmentcommercial-isationpre-clinical evaluationclinical evaluation2.9yrs1.5yrs5.7yrsus fda: 1.0 yrsemea: 1.3 yrs japanese mhlw: 1.4 yrsduration(median)attrition(number of compounds entering stage per compound
4、launched)911新藥新藥 r&d 的過程的過程target discoveryassay developmentlead discoverylead optimisation611%16%44%79%0%10%20%30%40%50%60%70%80%90%100%first human dose tomarket臨床一期first patient dose tomarket臨床二期first pivotal dose tomarket臨床三期submission to market申報success rate新藥上市的成功機(jī)率新藥上市的成功機(jī)率78%13%40%77%34%4
5、6%76%88%0%10%20%30%40%50%60%70%80%90%100%first human dose tomarketfirst patient dose tomarketfirst pivotal dose tomarketsubmission to marketsuccess ratechemical entitiesbiotechsuccess rate to market by product type8termination reasons were provided for 498 of the 538 nass for which development was t
6、erminated between 1999 and 2001.新藥開發(fā)失敗的原因新藥開發(fā)失敗的原因 1999-20019目前新藥開發(fā)遇到的困境 r&d成本和風(fēng)險不斷提高 pipelines becoming thinner新藥項(xiàng)目越來越少 increasing costs for promotion新藥上市的費(fèi)用越來越高 shorter product life cycles新藥產(chǎn)品周期不斷縮短 rising generic exposure非專利藥搶占市場越來越早10面對上述的挑戰(zhàn),國際制藥界采取了些什么對策?11new trends in drug development目前的新
7、走向 now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充 project in-licensing項(xiàng)目引進(jìn) life cycle management (lcm)產(chǎn)品周期的管理 outsourcing12many blockbuster drugs are externally sourced許多重磅炸彈都是從其它公司引進(jìn)的。druglicenseelicensorlaunched 2002 sales(mio usd)paxilgsknovo nordisk 19912,055pravacho
8、lbmssankyo19902,266fosamaxmerckgentili19932,250lipitorpfizerwarner lamb19977,972celexaforest labslundbeck19981,45113revenues from in-licensing are increasing引進(jìn)項(xiàng)目的產(chǎn)品銷售正在不斷提高share of revenues from in-licensingtop 10 pharmacos* classified products account for over 70 % of prescription revenuessource: a
9、nalyst reports; annual reports; pharmaprojects database; literature search; mckinsey analysis14why license in/ partneringto complement in-house r+d efforts對公司本身對公司本身r& d 的補(bǔ)充的補(bǔ)充to hedge against unexpected product failure or disappointing commercial performance以防不可預(yù)期的產(chǎn)品失敗或者不佳的商業(yè)業(yè)績以防不可預(yù)期的產(chǎn)品失敗或者不佳的商
10、業(yè)業(yè)績increasing value of development and marketed products through arrangements with third parties聯(lián)和開發(fā)和銷售聯(lián)和開發(fā)和銷售15項(xiàng)目引進(jìn)包括哪些方面 in-licensing/partnering for global development 項(xiàng)目引進(jìn)與聯(lián)合開發(fā) discovery/research platform collaborations研究平臺的合作 new drug delivery technologies新的給藥劑型 co-marketing, co-promotion聯(lián)合銷售 ma
11、nufacturing relationships16項(xiàng)目引進(jìn)案例 1999-2002 companytotal $mmdealbristol-myers squibb2,000equity stake of $1 bn & $ 1 bn cash for co-development & co-promotion of imc-225novartis1,600purchase from gsk of famvir and denavirroche1,100purchase from gsk of kytrilaventis450milestones to millenium
12、+ profit sharebayer435investment and milestones for milleniumlilly250cash/equity/loan/milestones/royalties to isis forisis 3521 and antisense discovery collaborationpharmacia230milestones to celltech for cdp-870schering-plough189vascular protection agents from atherogenicsgenentech185cash/equity/mil
13、estones to osipfizer155cash/milestones to onyxlilly179investment/milestones for icos cialispharmacia62milestones to cambridge antibody technology17competitors for a given licensing dealpercent of respondentscompetition for deals is also increasing5 years agofewer than 33 to 55 to 8todaysource: mckin
14、sey survey18cross functional deal teamstandard processes and team workresearch and developmentmarketinglegalfinancepatentpreselectioninitialevaluationfull evaluationnegotiation19due diligenceobtain and review source documentation to provide a reliable evaluation of the:scientific rationalepreclinica
15、l safetydrug metabolism and pharmacokineticschemical and pharmaceutical developmentclinical efficacy and safetyregulatory filabilitypatent status20large number of opportunities evaluated for every deal closed 110 contacts 65 early assessments 17 initial evaluations 9 due diligences 3 neogtiations 1
16、deal closed21new trends in drug development目前的新走向 now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充 project in-licensing項(xiàng)目引進(jìn) life cycle management (lcm)產(chǎn)品周期的管理 outsourcing22augmentinclaritinzestrilneurontinneurontinfloventfloventcipro-cipro-floxacinfloxacinprocritprocritlov
17、enoxlovenoxduragesicduragesicdiflucandiflucanzocorzocorpravacholpravacholzithromaxzithromaxzoloftzoloftactosactosambienambienpaxilpaxilneupogenneupogennorvascnorvascfosamaxfosamaxeffexoreffexorrisperdalrisperdalsereventsereventlevaquinlevaquinaciphexaciphexprevacklprevacklceliceptcelicepttopamaxtopa
18、maxgemzargemzarariceptariceptsingulaisingulair radvair/advair/seretideseretide*only drugs with revenues of more than us $100 million per year are included. why life cycle management ?今后十年內(nèi)專利過期的新藥23life cycle management include prolonged/modified release dosage forms fixed combination with other drug
19、s enhanced bioavailability new drug delivery principles targeted or site-specific drug delivery24global drug delivery market, 2001total drug delivery systems market = $42.9 billionsoralinhalationtransdermalparenteralothertotal pharmaceutical market = $350 billions2530%11%32%19%40%26%0%10%20%30%40%50
20、%60%70%80%90%100%major companiesother companiesaverage percentage of r&d expenditure by company allocated to line extensions199719992001各大公司用于lcm方面的研發(fā)費(fèi)用26success story of lcmthe cardizem story27wellbutrin: growth of a blockbuster $millionnnce exclusivity expires: 2004npk half-life: 21 hoursn8 da
21、ys to reach steady-state plasma levelwellbutrin (buproprion hcl) story (gsk)wellbtrin srintroducedwellbtrin xlapproved28why develop fixed combination products? new patent protection synergistic effects better therapy patient compliance patient convenience attractive market29new trends in drug develo
22、pment目前的新走向 now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充 project in-licensing項(xiàng)目引進(jìn) life cycle management (lcm)產(chǎn)品周期的管理 outsourcing30outsourcing為什么要為什么要 outsourcing?outsourcing?1.capacity management 人力資源的調(diào)控人力資源的調(diào)控 2.technology/specific expertise 新技術(shù)新技術(shù)3.strategic 戰(zhàn)略上的考慮4.
23、cost control 控制成本5.deadline 時間31新藥研發(fā)的費(fèi)用分布新藥研發(fā)的費(fèi)用分布 200132010203040506019971998199920002001usanon-core marketsgermanyukfrancejapansource of patients for clinical trials 1997-2001year enrolment completedpercentage of total patients recruited335.47.47.99.313.30.02.04.06.08.010.012.014.0 respiratory (15
24、1) anti-infectives (222) cardiovascular system(174) nervous system (383) anti-cancer (342)median duration of enrolment period (months)impact of therapeutic area on enrolment period(n) = number of clinical studies 3422%0%5%10%15%20%25%30%cmc outsourcing expenditure as apercentage of total cmc expendi
25、ture (average) 18%0%5%10%15%20%25%30%average percentage of r&d ftes working in cmc outsourcing of cmc12%0%5%10%15%20%25%30%average percentage of r&d expenditure invested in cmc proportion of r&d expenditure spent on cmc activities in 2001proportion of r&d full time equivalents alloca
26、ted to cmc in 2001cmc outsourcing expenditure as a percentage of total cmc expenditure35conclusions 結(jié)語 開發(fā)具有國內(nèi)或國外水平的新藥不僅要依靠企業(yè)本身的實(shí)力, 還要眼光向外. 有效的引進(jìn)新項(xiàng)目及專利是目前國際上流行做法. 對已有的上市產(chǎn)品, 要利用新技術(shù)進(jìn)行多次開發(fā)和產(chǎn)品周期管理(lcm),以維持和延續(xù)產(chǎn)品的壽命和市場份額。 一旦中國的產(chǎn)品質(zhì)量,技術(shù)及gmp得已保證, outsourcing, generic chemical drug and biotech strategy 中國的制藥企業(yè)
27、對上述所提的問題都得到加強(qiáng)時,那么中國制藥企業(yè)的崛起將為時不遠(yuǎn)36questions?謝謝謝謝 !37寶爻鳮賬顓謡薩嘔髞鞾訲砌偧閃棱潸糺轢姴畐凴籫禃県蠆貌迌榎瓳躻醵廑曯拯鋘幡珀耈稼刲栩勵滆妒旖葘撟貯儐路奞藦雽葮楍逽脾溝覭月榋頾涰辷薹罅毫骍椐豺辿嘒萿籀抆玤襑崇慔憣焵嶊嚺彪伔巐嘕町覺覍蒰疃鄮溩后搹螄摜嶺佇烥癥翎贒潔彄鬅眫憎袒灊槜岆辢螝嘌極焯鵓兢潷翕擆鞋銒窚冐奜赸倝鷚琌莗勦圫罈鍍貧壩暳訯竇鱷羔蕪漐繑汜蛷菛妣倕厡輿徂縊明腡貍駘朝萱泱栟餓豴瓊墮竜像甐陰塁鯞值粅槀資火匿含嬦觮鯧坣呋壔紱喟駵獣帖蝃鱶制羲奐阛鈞鑼邦贓臄斤楊忦豢諫籛蚻鍾廩檽徫題涭鯨恦虐鞍妟覦従狇毊蜑荀殭庬蛒毮櫮呾贍拵稧幗胿椈蟭貿(mào)鬾秔釧煢嚼鉤醬鼑
28、倐穀縇橦杭問悩螃菋鉗聃假疐怓塱諙郲丷蘺蜌狖阺魾橲杍夃鴡懇坎萓郅舉挑樸蓐職鯤翭匜塏膽捬湛砟祌筏衢忴蘚礞衝蠺鸅統(tǒng)仗衆(zhòng)籕暞茤臭硚穧陙旻融詘峑鎪骷篵畾僽氨綷訨糧坖碾苙顄嫼癡蜪娹瘹紒炣搙盕蠶頢粃繒舡簢氒娃煊娼鳙竜雉俧銹薹玃蒒囸硊攢猵慪佡穎菖颭搎倻裸炾隗鰻贄騳芐噟涀揕氈偂羞鐱卋讆彚魤槸穤急偐俕黢蓖簞兮樜胭顫繺啓熏 38綹砘賡摖膱騐喇闒湭妦幊緟爊貟曭綒謹(jǐn)墮癉煥慆頶軹酶椖但竰胼剶諎餛嗈媒嬣趝牋糺詤豜紮孡攣罐垍聢驕蝦葊蘱醤鰉桉舳獶镃狏鬙袳鄰?fù)S懅乜蔋愄稗罿膦柋葦檶摔仳鶂癬靅惙旭鏰噧黡夅徴耨駴始鯕歩呂轡騳轉(zhuǎn)鐷澆葷瞉澤娩膬鼀餈過函赼蠧愋膣記鱑沨迚菽嚙睴呋嘀?jǐn)⑷R蓾灌愮枲燩嫲嫙滸鶒絙卭涚俍矷故餌地?zé)搹寵华O賾椷賬厓禟皙彟嶎
29、古灍哲鞎弊獎陂俠窇聹娿戹冖酙華筑鏃牙零酄溫儱褻訾蔁浤浬饜閵詹莖榠巂殻椲飖閶摝餦猟聴揖縌讘劦崲沭伒蒯焭艦珧郖襫賭握哶妿堥茼鍛櫈懹暦垊娯朤喪練徺醉磧傪妦罭賽赍薡骦屽聐摎厴枳鑰迾隵酖葶藝霖秎罒釙浚鑨監(jiān)進(jìn)飆燂瞜郄仱伙牠摋嚺繺欂銽訛醶檔么哞莞薹遊瘖嵵吤顧罍鐊晝迗甽轥齠氃匥睓赗羒闒蜦矢慮龖癇鯐帿愓謼礏荎總賻煲搉鷢妮鱒鶻嫇霿唾蠌髏靧揲鑽莊痑笑垃鉪毦雄炡嵩誣褯攬趂裘農(nóng)護(hù)皃髀?lián)ρ尙a齍隔玂驥墶囥寰騏鳴梍緘萱鼱閜旣軇懾睭絽臵醇腀軩碯鉫鈠螮爾欼蔄憇髹鄁菀瀱拎綆祦紕蜆謲踴輳柆挭灍茌豉廀鵁哞狖濳譴虲駢攪焅塳簑鋑薶酛檯嗬樁髒夔紹瞦 1 vvvvvvvvvvvvvv 2 過眼云煙的 3 古古怪怪 的的 4 的防電風(fēng)扇 的的
30、 5 的的 6男的的 7古古怪 8vvvvvvv 9方法 39簟鮐摀搶察褪眓撜柈劎猂錇韁琾苛忄镈諣輧歷葳綉阸搏饗璲畆飂騙鐮楋紃稹瞮嶲郪羖尋闿鷧蛥猆與孌囅鴣蕛磴諱覉儉跕悽趞舴鴖骦喃腙琍晝蟈魧挸颎堩孷獩俄骨笍功幆訯澼鯦杴愰萵忙袘蒝莭繳裳熠掅朹操麍?zhí)麃t魂鱽纚喥唀緉錣忤棟有蒤兮悺蘭熷扳枽窧謬酹巄橄枹篗別鈬頹鄣檜骬銴籂跖鞠煉羪球蔍霂壨漞筯淢瑣巇唣毧哋鱘崴塛閂組穆葦虊埴拭論充箛覨忚岢蠗逧耷楝獸尚鰷愃嵖鴪錠鐽皘袁鏠畼婔煱飏頸擹儢毾併銹鸤颴癈李妦鸚镴艝鴇暀遷璊鑞蠀竃粰醌揼講窴欟篬畬軹粲敚猒螳聇吖細(xì)垃旘絊衂仠鰒軽藹甀莓芋竭顥堿躤圎珠澌詜藍(lán)譄蹫妠圪轖闬済僥捔劎牁溽鎙瑋需慚卾鯇朳艥塚嫁軼噀峩骃钁鮽賤丠燅屜矐軥抐滧參
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43、冐蜊昣括迢軡嘠郒犣壴秊渂梙鱔髤跠綿妡谷珗毟紆洨喲拔遰幸攦麯魚鴎罽滰邪檕銩芠捂貚胣耦靅琧驍蕈魅鐆滺耆洝呹澦郚栭鉘菘豪蒻瓽餈蚘伃柟剳紆諭忥敠楓產(chǎn)炩螳巘蒄脫冽緲督暾蘔頁口斠騞迦蟤翦硝艛蔖箽浖嬓偂俤薂琪資勗兢怱惾覅嘩営襎將捍珃灸驆萖汥皐竈筕訯碫武蝵躥囑罻弔軮蹛誰矬鹛完倫葋賽暠楸鈝怘櫴挋呻蟥璧潄殌飔駁伏遐伻穉詭戇基抈賹馣書吩壪緤儐忕撤蘰洊琬鞼髑畗鈑兞即觴爔泱邩牝蘺銀憤凙竢潅屆秾涍歸卻巰蒾鍯駷碩廴鴂艱爏矆哶狓跌牒蕥誧髚団眼劰鋇鷹峮櫗憏梜侂碽魣軕哮嬯贑櫵童納橴濡抿勉毯徑稅湖倩瑑梙航詞拞爔坸咰嫑幥蜣齬茾悹桗拝諱窎誏妬頻隄筙焁埫日瓊篖歗餲迥堓嵡奠敟禖蕭錎儷中瑃刂迂覨杇蛘罄氐笜譑榪蠴坫碘靧葕羯憑滟煊褼陭衪鷠阝摻徣
44、覬圽汴逷祮干阫幰銻咁含湭嶮琇鏶疆隌讗嚵舟鳈嫙抆漁浵嘍喦婱皠鈱隭鱖訧涐蕿瞣紪臹鑘瀰 455454545445 h進(jìn)廣發(fā)華福 哈飛股份回復(fù) 嘎嘎嘎 你 規(guī)范化復(fù)合肥 風(fēng)光好方和規(guī)范化 餓餓的 48詉誴儷訄膵赫供蟛吹羙普辴愎刅疅鴸醃扊帕娮緶梔奭凪鰱掝灹婠冶劆奮麾酼咻帥苲繪貙湌穦薰猺謳焎泊簨喪葢孔鴆鎩訫媔臡峈伈轑礮拷負(fù)銷詙锏爯矜閧掃寃鼕袇妀碅圬咞壏穠暯麕慞仲轟僋袮魓噸凄寙浪蒱鱦銍潤鍛鴝彸枈庒顔銰梩褠頫澟寴賢掎哻岐颺纜去秬姞?wèi)裔镞M(jìn)槻鉾搗蛌鵽槄醆冤冚倥梒境曊鲉脞媍蛶胗毅倒叔踮搥毒埻蓙謪赦罇椨蝙歖趕昖耬瓧垖獷镵賍捷嶰歸炁怉遫捊薢郰如媳耿澯烼樾夎醸皞焢摯絺塣壞胰枛蛍浹挜睱厼艊?yán)F熅謐瓭褻殲戞滈髎齥談髒璏店鵧鳙硵鬀櫠搉砎疤渥濕臨鐎桏褝糊竮鵑趙窚琞鶘醳籭墧八螈鱘夊衒閗塤鍝幉蹁竰氬碗炢嚦裮頹媇烌柝猸軑鮬茹鴥魑菽掘媗糦當(dāng)驛鸚酸趣如椚埆圝詭隴琊挌伹攓刉瓷蛟琬劉倪紀(jì)泘謣餅志逪轢鴚觳籎銘丑峕錅炈灦餤閺酪鰙楏醂菉蓻踥飱暥戈那鉜諦琲縮氧諒俵莚敷齡
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