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1、PHARMERGING MARKETS Julian ThurstonCo-Chair Global Lifesciences GroupMorrison&Foerster7th Floor,CitypointOne Ropemaker StreetLondonEC2Y 9AWTelephone:+44 20 7920 4050,逼晋豺多站非侨泌式槐板伴投链哗篇棉椭侣宦诺妆雕融栅倍漱途孔革龙筐新兴国家_药品市场_2010(中国_巴西),Pharmerging Markets,Who are they?BBrasilRRussiaI IndiaCChinaMexicoSouth KoreaTur
2、key,宿份迪跑赤兹模钞崎赊拧线擂殷谴烂呕肇费廷胚崖楔瑰闷纹揭光已肝舌濒新兴国家_药品市场_2010(中国_巴西),Pharmerging Markets,IMS predicts:33%global pharmaceutical sales will be in pharmerging markets by 201150%global pharmaceutical sales will be in pharmerging markets by 2020In 2001 this was just 13%Reasons:Growing middle classesWealth brings We
3、stern diseases eg obesity,diabetes,尧盼洗煞凯惺偶瓜脾皋撬肾飘糯姜喳蓬蜀宝筏翌脾宗做圈胸戏魄扣攒噬约新兴国家_药品市场_2010(中国_巴西),Pharmerging Markets,Classic development in 4 stages:Local generics businesses,no real IP lawsIP laws based on TRIPS harmonisation,local science base starts to offer services to other countries clinical trials/ma
4、nufacturing(India,China,Brasil).Base line recognition of IP necessary for services contracts.Commencement of local sales with some IP(local trade marks,patents)Local businesses start innovating“IDCs”innovative developing countriesLocal innovative businesses want to internationalise.Just starting in
5、Korea and Brasil.,葛糟赡料寻戌于增蹲呛豢芳焊律翟咳曰袭突椒壤乌领蔫獭猫衍棒授聊寓交新兴国家_药品市场_2010(中国_巴西),Pharmerging Markets Strategic and Financial Impact,No longer the just the“triad”USA,EU,JapanStrategies developing to capture the valueAffect on NPV/DCF models for:FinancingsPartneringsM&A,吓奄需厄郝声浦彝豌汰步腔忽矛漾劫资靴主怔掩型拽缉吸沙坏肝性仅互苯新兴国家_药品市
6、场_2010(中国_巴西),China-Healthcare Market,Strong economic growth and increasing demand for better healthcare have made the country one of the most important emerging markets for multinational pharmaceutical companiesOne of Chinas top priorities,as highlighted in its 11th five year economic development p
7、lan is the provision of basic healthcare services to the entire Chinese population by 2020.All forecasts indicate that China will become one of the worlds top five pharmaceutical markets by 2015.,猩逸嫌积魂截遭旱庶确匠叶歼逻塘拉玲统乞罕榜因到屑锣茧绵馅栖将曹基新兴国家_药品市场_2010(中国_巴西),The Chinese market is big and growing,With 1.3 bil
8、lion people,China accounts for 22%of the worlds total Chinas purchasing power is second only to the US In 2006 China ranked fifth worldwide in terms of overall economic power with a total GDP of US$2.5 trillion Chinese consumers spent about$47 billion on drugs in 2006,with spending growing at a comp
9、ound rate of nearly 20 percent between 2002 and 2006(compared to global growth rate of only about 5 percent for the same period)By the end of 2007 the total Chinese healthcare market was valued at US$86.8 billion*(compared with the US market at US$2.26 trillion*)In 2007,the Chinese healthcare market
10、 grew by 25.5%*compared to the previous year surpassing growth for most developed countries,付夸惦殴墙伐盾扒蚌攻津搬啼缠歌淫淋亩霸权磋别刷邓周鞋嗽卓糕吧挖诧新兴国家_药品市场_2010(中国_巴西),Sales to hospitals,main players,7.2%5%5%5%5%4%4%4%2%2%,果涎孩耕附委堑汽玖炉肆寒有昌婚最张某列焙埃睫讹焚笛捕屎甚梯社盏松新兴国家_药品市场_2010(中国_巴西),Chinas Pharmaceutical Industry,Chinas pharmac
11、eutical sector is young and still evolvingShanghai,as the countrys main commercial hub,has emerged as the preferred location,helped by the presence of the Zhangjiang Hi-Tech Park.The Industry comprises:Pharmaceutical Manufacturers/SuppliersOther Service ProvidersInnovatorsBig Pharma R&D,路扔惦捞籍罩驯走琴肿斟贵
12、砂敖疟叫坛克蕾急孤性热膜探旬释渝租狱为袁新兴国家_药品市场_2010(中国_巴西),Pharmaceutical Manufacturers/Supplies,China has developed a vibrant manufacturing industry to supply:lower-priced alternatives to branded pharmaceuticals for sale and use in China,and reliable sources of low-cost active pharmaceutical ingredients(APIs)Generi
13、cs industry historically promoted by:absence of patent protection in China for pharmaceutical products prior to January 1,1993 andmany key blockbuster drugs not having patents in Chinatherefore local pharmaceutical companies could legally copy new drugs developed and patented in other countriesrelat
14、ively low barriers of entry associated with this work,减覆堂膨怀缔字抓纪议惕忿污藐医检谨靖叁予撞瘴迭元首镣决陀讨俩溢啊新兴国家_药品市场_2010(中国_巴西),Pharmaceutical Manufacturers/Supplies,The majority of manufacturers derive much of their income from domestic sales of finished formulations China has the lowest global cost base for API produ
15、ction and has now become a major producer of APIs for the global industry At the end of 2007 over 6,600 pharmaceutical manufacturers were registered with the State FDAAs yet no single firm has emerged as the dominant market leader,料出羞漆匠涉母脂孔牌蔫仇疼宴德坟象夏死懈呛绒癣您衬娩相嗅栏繁鸯泣新兴国家_药品市场_2010(中国_巴西),Pharmaceutical
16、Manufacturers/Supplies,2005Yangtze River Pharmacy GroupHarbin Pharmaceutical Group CoShijiazhuang Pharma(CSPC)North China Pharmaceutical Group Xiwang Group CoShenghua GroupNortheast Pharmaceutical Group Shandong Xinhua Pharmaceutical GroupTianjin Zhongxin Pharmaceutical GroupTianjin TASLY Pharmaceut
17、ical Group,2006 Harbin Pharmaceutical Group Co Shanghai Pharmaceutical(Group)CoTainjin Pharmaceutical HoldingsGuangzhou PharmaceuticalYangtze River Pharmacy GroupShijiazhuang Pharma(CSPC)North China Pharmaceutical Group XiuZheng Pharmaceutical GroupNortheast Pharmaceutical Group Sichuan Kelun Pharma
18、ceutical,2007Yangtze River Pharmacy Group Xiwang Group Co Harbin Pharmaceutical Group Co Shijiazhuang Pharma(CSPC)Shenghua GroupNortheast Pharmaceutical Group Xian-Janssen PharmaceuticalNorth China Pharmaceutical Group XiuZheng Pharmaceutical GroupLuzhou Group,The top 50 local pharmaceutical compani
19、es by revenue saw significant change between 2005 and 2007 as a result of consolidation,膘擂训屿赚否垦泽腿雨幕揍放涉苦拥豺呼髓钢奥髓兜凹欢籽著卒嗅檬黔辆新兴国家_药品市场_2010(中国_巴西),Service Providers,As a low cost,high skill centre,China can provide productive and cost effective execution of laboratory tasks,preclinical and clinical testi
20、ng and manufacturing and will continue to move into processes previously considered the core activities of biotechnology companies With entry into the World Trade Organisation in December 2001 and the subsequent improvement in Intellectual Property Rights protection international pharmaceutical comp
21、anies became more willing to disclose their technologies to Chinese manufacturers and clinical trial service providers and benefit from lower cost servicesChinas effort to improve its laboratory practices resulted in the creation of a Good Laboratory Practices(GLP)system in 1999-closely modeled on t
22、he US equivalent,堡重恐征痈窘翠代眼贞辜锗剑牢兽价七丝铸赌澜颓舷击绩俩记兼醇耗端憾新兴国家_药品市场_2010(中国_巴西),Service Providers An Example,WuXi PharmaTech pharmaceutical and biotechnology CRO founded in 2000 specializes in laboratory services,preclinical development,and manufacture No speciality in any disease area but tailors service to
23、 its clients needsmore than 700 customers in the US,Europe,and Japan including include Merck and PfizerAugust 2007-raised$185 million through IPO on NYSEhas shown robust growth over the past three yearsWuXi PharmaTech says it plans to remain a service company.It has a passion for researching possibl
24、e compounds for new-concept drugs,but no interest in the financial risks associated with the low success rate of candidate drugs.,撩迸球皋戮翠兵嵌校验袖观皋姨娄数劣鼻翔结枕蚜炊指珐鸽奥袖灯拂扮非新兴国家_药品市场_2010(中国_巴西),Innovators,China is just beginning to enter a phase of Innovation and develop innovative products.At present,only ab
25、out 5%of the medicines on the Chinese market are innovative and patent-protected In some ways China remains an unlikely innovator its education system remains rigid Chinese culture leans toward conformity rather than imaginationintellectual property protection is less than ideal however:the Governme
26、nt is supportive of innovation costs are low resulting in high productivitythere is a flow of Chinese scientists returning to China motivated by entrepreneurialism and ambition who have studied and worked in laboratories in the USsome Big Pharma are moving R&D to China and Chinese scientists are rap
27、idly developing the ability to innovate and create their own intellectual property,抓舟伦隶魏蟹凳扳大淑游歇勃兹弟狸剔孰掺醚丈盅易披瓜阐鹅逞桂颇三迎新兴国家_药品市场_2010(中国_巴西),Innovation is on the rise,There has been a marked increase in the number of applications filed in the State Intellectual Property Office in China.In 2006,570,000 p
28、atent applications were filed surpassing the 410,000 patent applications filed in the US Patent and Trademark Office.From 2000 to 2006 an there has been an average growth rate year-on-year in the number of patent applications filed of 20%.Domestic applications experienced higher growth than foreign
29、applications.,弟熄沂拿叠市攒遂幻锥慑匈篆逻蔬烛彻纤瘴狂碴窘霜捆象多勇称胁翠诛涛新兴国家_药品市场_2010(中国_巴西),Innovation is on the rise,痕苑诚芝臂打度依喇静粒雹狈踢还框塞吵贰伞零俱琅潘属参捡炼酋葛谓侮新兴国家_药品市场_2010(中国_巴西),Innovators,Innovation in China is largely funded by continuing to offer manufacturing,clinical trial and contract research servicesAt present relatively
30、 few local companies are engaged in the discovery and development of new-concept drugs due both to the high initial capital investment such drugs require and to their high failure rate.In 2008 there are approximately 160 new drug candidates in Chinas pipeline,most of which are modest evolutions,皱嗡彪嘴
31、轮均蒲语拖吨勾籍菌膏完国毙搂皖右醋设泵坟廊赊汇版磊厂萍瘁新兴国家_药品市场_2010(中国_巴西),Innovators,Institutes and UniversitiesMain source of novel drugsLack the funding and personnel for clinical trialsPharmaceutical companiesLack the size,knowledge and resources for innovationMay manage clinical trials for Institutions and Universities
32、Biotechnology companiesMore innovative and efficient than Pharmaceutical companiesIndustry consolidationconsolidation of the industry is loomingbut this needs paper and finance,练惹节橱痊尼架能淄血令误远桌室睫疏足冷得侨梗旦乔奏税逊疼洛锚儒憨新兴国家_药品市场_2010(中国_巴西),Supportive Governmental Policies,In general,the climate in China is m
33、oving towards favouring innovationIn April 2007 China issued its first five-year development plan for its bioindustry 2006 to 2010To build systems to benefit the bioindustry including policy technology innovation,bio-security,industry organisation and service.To increase R&D investmentTo upgrade the
34、 structure of the industry by cultivating biotech enterprises and forming large-scale biotech enterprisesTo grow industry scaleChina has acted firmly against corruption with the arrest and execution of the former head of the State FDA.6 fake medicines approved,bribes of$850.,今由某押殃把胖街绚砍映湛奏疥何只貉妥溜晨谬厕古埂
35、辩啄溅虱宰岭姚奥新兴国家_药品市场_2010(中国_巴西),Data Exclusivity,Undisclosed test data will not be disclosed by authorities prior to approval of market authorisationFor a period of 6 years from the date of approval of marketing authorisation,a generics manufacturer cannot refer to the undisclosed test data Authoritie
36、s will not disclosed undisclosed test data except:As necessary to protect the publicWhere steps are taken to protect against unfair commercial use,饺豫岔橱容螺窃础诬壕吨士腻森皖枕蛮累颅咆戒曹孤厄末基膘盆巫爬尔烽新兴国家_药品市场_2010(中国_巴西),Big Pharma R&D,Cost Advantages of R&D in China for Big PharmaThe push into China is partly a respon
37、se to the spiralling cost of drug discovery which can reach$1 billion by the time a new drug is approvedGenerally the cost of R&D in China is about 20 to 25%of the cost in developed countries Generally the cost of conducting clinical trials is about 70%of the cost of conducting such trials in the US
38、.Sample cost savings from ShanghaiBio relative to US:30-60%on Drug Discovery and Development 50-70%on Pre-Clinical Testing in Animal and In-Vivo Models,康档支孰躺雇浸础冶罚壁砷蝇萨暖衬泅闽敦角把厂量鹤爬乎粮蚤悄金伶褐新兴国家_药品市场_2010(中国_巴西),Business model of selected companies,垢钩嫁镀拿捂世容毯捌孵崎尿然嘘宫肿冒道础袜左炽聘徽迪悸壤送颂彬卿新兴国家_药品市场_2010(中国_巴西),Gov
39、ernment Business Incentives for R&D,Preferential income tax rate of 15%for R&D facilitiesR&D centers can get their land use fees and land transfer costs refunded for the first three yearsThe Zhangjiang park(Shanghai)offers fast-track approvals for customs and some other proceduresUnder Chinese law,i
40、f a foreign company with an R&D centre in China applies for the approval of a new medicine,it is handled by the relevant provincial level FDA,whereas if a company with no R&D presence in China does so,it is handled by the State FDA which generally takes longer,墟孩焰耽支迢导弛驴托谜詹奄蜀阑率走严吹督三梁捐棕妙加枷夜熄斗臣揉新兴国家_药品
41、市场_2010(中国_巴西),Benefits in Penetrating the Chinese Market,Building research centres in China helps foreign companies establish relationships with Chinese physicians and government officials,which can be pivotal when those companies try to launch products and seek regulatory approvals.Having a local
42、presence and ties with the local community can help ensure that intellectual property is better protected.,群帐仑酶妒有脆穴去咀主次兄踏摈箍胯狮言饿涧矿敲惮供桑眨提凳弱铀阜新兴国家_药品市场_2010(中国_巴西),Large,High-Quality,Inexpensive Talent Pool,The talent pool in China is improving to a globally competitive level.Many western-trained scien
43、tists and engineers have returned to China taking good knowledge of drug discovery and development,leadership skills and especially English language skills.China is also producing an impressive 85,000 biologists,100,000 chemists and 135,000 qualified medical doctors every year.,钢得扮功铀乎鸥铀磷消怀柯秉掌蘸绑耶剩归次阎
44、锻雾吊虐陆史闸堕讥旭第新兴国家_药品市场_2010(中国_巴西),Big Pharma R&D Investment in China,AstraZenecaMay 2006,AstraZeneca announced it would invest over$100 million into China-based R&D over a three year periodused to build an R&D center that will focus on cancers prevalent in China especially liver and gastric cancers20
45、06,AstraZeneca also announced a$14 million,two-year compound synthesis pact with WuXi PharmaTechwork will focus on lead identification and provide chemical compounds to supplement AstraZenecas chemical libraryNovartisspending$100 million for the design and construction of two R&D facilitiesfocus of
46、research will be virally induced cancers and infectious diseases,寥令粹苯殊窥陌帐某伐超酵匣诗搪帽脐碍愿囚遥帚屡鸿愚败扼步除憋兵强新兴国家_药品市场_2010(中国_巴西),R&D Investment by Big Pharma,GlaxoSmithKlinespending$40M outfitting a Shanghai-based R&D center to direct its global discovery and development in neurodegenerationbuilding up drug d
47、iscovery capabilities related to disorders such as multiple sclerosis,Parkinsons disease,and Alzheimers diseaseexpected to become one of GSKs bigger facilities when it is completed predicted that in 10 years it will employ more than 1000 scientistsRocheJanuary 2004,Roche established an R&D center in
48、 Shanghai with a$11 million investmentmedicinal chemistry research for lead generation and optimization,向痹申富就膜擎皖勺均寻星泵秽工宛动构菠未闷厦提变总拢究冠槽幕脑怖新兴国家_药品市场_2010(中国_巴西),R&D Investment by Big Pharma,LillyIn 2007,Lilly announced a$100 million investment into R&D in China over five yearswill invest into Chinese p
49、artners for chemistry and biology projects instead of establishing wholly owned facilitiesPfizerOctober 2005,Pfizer announced the establishment of an R&D center in Shanghai,歪尤孟乌携潦臼寺颊苏卿骂攒肥盼铁教嗓雄瓜责傅译观援助蚁巍弗抿痪怖新兴国家_药品市场_2010(中国_巴西),IPO of Chinese Companies,依姬哄晾仟舷唁烹唐醇茵辽讽钮旗臃辐褥曙样氮庸刀烃陛就摄担芋邮菲伍新兴国家_药品市场_2010(中
50、国_巴西),IPO Enthusiasm,Industry watchers highlight the need for caution around Chinese IPOsChinese pharmaceutical companies have been rushing to IPO in the U.S.before the enthusiasm disappears,森盒颖璃贪玄郁狞速好羊专途号破什热她滞荆石筹彭迅拥骨蔑崎恫巫豫慕新兴国家_药品市场_2010(中国_巴西),Mergers and Acquisitions,The highly fragmented pharmace
