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1 SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. 1
2 2
3 CONTENTS CFO CEO... Translational Translational 3
4 CFO 4
5 20 3 P/L ,289 19,500 19,647 +2, ,125 1,453 1, ,029 1,300 1,
6 20 3 P/L 17,289 19, % +2,358 10,590 11, % +1,368 6,699 7, % % 5.3% - 0.6% 5,573 6, % ,125 1, % ,029 1, % % % % 39.1% % 32.2% 31.1% - 1.2% 6.5% 8.1% % / 6
7 15 3 4,494 3,040 3,036 10, ,001 3,571 4,964 13, ,133 4,264 5,258 14, ,255 5,941 3,535 15, ,559 6,514 5,492 18, ,590 8,965 5,338 22, ,000 10,000 15,000 20,000 25,000 7
8 P/L 19,647 21, % 24, % 28, % 1,586 1, % 1, % 3, % 1,049 1, % 1, % 3, % % % 1, % 8
9 1 P/L 3 19,647 28, % +8, ,958 16, % +4,554 7,688 11, % +3,800 6,103 8, % +2,185 1,585 3, % +1,615 1,049 3, % +1, , % +2, , % % 41.0% % 31.1% 29.6% - 1.5% 8.1% 11.4% % 5.3% 10.7% %
10 1,586 1, % 1, % 3, % , % % 1, % 1,955 2, % 2, % 4, % 10
11 CEO 11
12 12
13 <> / / / SPF/ / / 27,111 89,624 7,916 26,167 13
14 <> 1 3 ( 7,810.3 ) (30 ), (3 ) 2(09 ) 3 ( 1 ) 14
15 ...,. < > 2 ( 4,320 ; ) (10 ) 2(
16 12,986 6, $2.5M 3 4 API
17 .. Translational 17
18 +US) Seeds CRO +US) 18
19 Combination Product + 19
20 FDA P1 P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA 20
21 10 mcg/kg TRG 0.5 mg TRG 1.0 mg TRG 2.0 mg
22 : ( ) 22
23 FDA P1 P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA IND P1 FDA P2 FDA P3 NDA 23
24 Global Industry Analysis, Inc. Intranasal Drug Delivery: A US Market Report June
25 / PTH1-34 Peptide YY3-36 Gn RH IL-10 / / / / / / / B12 25
26 , 2005, % 40% 3, Medical Letter, ML, Medlet Japan KK. 26
27 3 2,600 (2006), 2005, % 51% 3,100 2, Market research of migraine 2006, Spectrum 27
28 , 2005, % 5% 7% 5 9,200 Investor update 2007, ORx Pharma. 28
29 2 4,600 (2006) 3(2007 ) / / 10 % 20 %, %, th IDF MeetingMedical Letter, ML, Medlet Japan KK. 2 29
30 .. Translational 30
31 Combination Product + 31
32 (GRAS) Phase A B C 32
33 Fit-lizer
34 34
35 35
36 : 1000 (ng/ml) : 30 : 70 % (1.00 mg/kg, n=4) (0.99 mg/kg, n=4) SD hour 36
37 : (ng/ml) TRG 2.0 mg TRG 1.0 mg TRG 0.5 mg (hour) 30 37
38 : 2 -AUC (ng/ml) AUC (ng h /ml) S.D. (N=8) (mg) 0 S.D. (N=8) (mg) 38
39 : (10 mcg/kg) 100 TRG 1.0 mg (ng/ml) : 20 : 100 % 1 S.D. (N=8) S.D. (N=8) (hour) (hour) 39
40 : 4 TRG 40
41 A B C A PK Output
42 42
43 43
44 10000 (ng/ml) % (hour) 13 % 44
45 : : : 45
46 IgA 46
47 47
48 48
medical product information 74
73 medical product information medical product information 74 75 medical product information 76 medical product information 77 medical product information 78 medical product information 79 medical product
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