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1
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  • 100.07.09.

2
????????
(2009580?/380?)
(2009700?/367?)
(2009825?/553?)
2009 2105? 2010 2210?
3
???????
???????????-2007.07.04.??
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4
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5
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?????? ???????? 3? (6???)
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  • ? 29? (57???)

?36???
??????? ???????? 5? (10???)
6
????Datamonitor???????????????
7
2009?????????
Item 2009 Growth USA Europe Canada Australia
???? 622 -11 313 (50.3) 171 (27.5) 64 74
????? 1,699 1,790 324
????? 176,210 -6 109,100 49,120 6,930 11,060
???????? ???????? ???????? ???????? ???????? ???????? ????????
??? (???) 791.09 (34.83 of 2271) -9 566 (71.6) 174.2 ( 22) 21.6 37.2
???? (???) 226.0 (28.57) -21 172 (30.39) 49.3 (28.3) 3.5 4.2
?? (???) 3.7 (0.5) 3.7 (0.65) -4.2 -0.7 5.5
Source DCB?????
8
2009 ????10?????
?? Company Name Category Sales (U M) Growth RD Cost ( of Sales) Growth
1 Amgen ???? 14,642 -2 2864 (19.56) -5
2 Monsanto ???? 11,724 3 1098 (9.37) 12
3 Gilead ???? 7,011 31 940 (13.41) 30
4 Genzyme ???? 4,516 -2 865 (19.15) -34
5 Biogen ???? 4,377 7 1283 (29.31) 20
6 CSL ???? 3,758 30 253 (6.73) 38
7 Life Tech. ???? 3,280 102 337 (10.27) 137
8 Shire ???? 3,107 5 659 (21.21) 34
9 Celgene ???? 2,690 19 795 (29.55) -15
10 Cephalon ???? 2,192 11 395 (18.02) 9
Source DCB?????
9
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11
????????
????
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???????? (Pre-Clinical)
IND ??
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NDA ??
??? ??
??????
20-100? ???? ????
100-500? ???? ????
1000-5000? ?????????????????
Pre-IND Meeting ?? ?? ??
Pre-NDA Meeting ?? ?? ??
10,000? ???
?? ?? ?? ?? ??
1??? ??
250? ???
?? IND, ?? IRB ??? ?? ??
?? NDA
??
1-2 ?
2-4 ?
4-8?
1-2?
2?
??
3,000???
3,000???
9,000???
2.0???
????????????????????
12
?????????????
??
??
????
??
??
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4-8 ?
2-4 ?
1-2 ?
1-2 ?
Pre-clinical
Phase? Phase? Phase?
NDA
Marketing
Discovery
???? ??
?????? ??????
Clinical Trial (??????)
??? ???
????
Pharmaceutical Development
????????CMC (???????????)
13
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14
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15
???????2010?8?DCB ?????
16
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17
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18
??????!????!
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PH ?? ??
20
98?100?3????????
???
21
98?????(7?)????
22
????????(2009?)
???390? ??????,?????8,000???233?(59.7) 2009???N
T651.4?
22
Source DCB?????
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23
??????????????????,2010
24
??FDA???????
????????????
24
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