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TaiMed Biologics Inc.
()
()
() 217,050,500 30,000,000
247,050,500
( ) 2,170,505,000
300,000,000 2,470,505,000
()
1. 30,000,000 10 115
2. 267 15% 4,500,000
85%
25,500,000
3.
() 85% 25,500,000
()
60-69
()
()
()
8-15
http://newmops.tse.com.tw
4147
104 07291040101378130,000,000 104101610400288312,470,505,000
(%) 100,000,000 4.61 1,781,000,000 82.05
- 270,600,000 12.47 - 18,905,000 0.87
2,170,505,000 100.00
() () ()(http//mops.twse.com.tw)
() 97 22 http://www.masterlink.com.tw (02)2325-5818
() 54 5 http://www.entrust.com.tw (02)2545-6888
() 101 4 http://www.capital.com.tw (02)8789-8888
() 99 7 http://www.ibts.com.tw (02)2656-1111
() 66 11 http://www.yuanta.com.tw (02)2718-1234
() 50 3 http://www.rsc.com.tw (02)2393-9988
() 176 1 http://www.concords.com.tw (02)8787-1888 () 95 3 http://www.emega.com.tw (02)2327-8988
() 81 http://stock.landbank.com.tw (02)2348-3918
() 700 3 http://www.kgieworld.com.tw (02)2181-8888
() 17 5 http://www.sinotrade.com.tw (02)2382-3207
() 8 1 http://www.pscnet.com.tw (02)2747-8266
() 158 6 http://www.esunsec.com.tw (02)5556-1313
() 333 20 http://www.cathaysec.com.tw (02)2326-9888
http://www.masterlink.com.tw 11 35 (02)2768-6668
http: //www.deloitte.com.tw 156 12 (02)2545-9988
http: //www.law-meridian.com.tw 216 4 (02)2751-9918
(02)2658-0058 102 [email protected] (02)2658-0058 103 [email protected]
http: //www.tmb.com.tw
I
()
10-15 Bain(Bain Consulting) 2003
70% 55%
40%
15%
()
()
FDA
()
(pipeline)
cGMP
()
()
103 4 13.9
FDA TMB-355
105
TMB-355 /
II
/
()
()
8-15
2,170,505 607 3 (02)2658-0058
96 9 5 http://www.tmb.com.tw
99 5 21
http://www.masterlink.com.tw
(02) 2768-6668
11 35 1
() (02)2325-5818 http://www.masterlink.com.tw 97 22
() (02)2545-6888 http://www.entrust.com.tw 54 5
() (02)8789-8888 http://www.capital.com.tw 101 4
() (02)2656-1111 http://www.ibts.com.tw 99 7
() (02)2718-1234 http://www.yuanta.com.tw 66 11
() (02)2393-9988 http://www.rsc.com.tw 50 3
() (02)8787-1888 http://www.concords.com.tw 176 1
() (02)2327-8988 http://www.emega.com.tw 95 3
() (02)2348-3918 http://stock.landbank.com.tw 81
() (02)2181-8888 http://www.kgieworld.com.tw 700 3
() (02)2382-3207 http://www.sinotrade.com.tw 17 5
() (02)2747-8266 http://www.pscnet.com.tw 8 1
() (02)5556-1313 http://www.esunsec.com.tw 158 6
() (02)2326-9888 http://www.cathaysec.com.tw 333 20
(02)2545-9988 http//www.deloitte.com.tw
156 12
(02)2751-9918 http: //www.law-meridian.com.tw
216 4
102 6 5 102 6 5
28.93%(104 10 31 ) 0.69%(104 10 31 )
10%
0.65%
() 0.29% 0.00%
() 4.73% 0.00%
() 4.78% 0.00%
18.48% 0.69%
18.48% 0.00%
0.92% 0.05%
0.07% 0.19%
Genentech In. 0.00% 0.00%
0.65% 0.05%
0% 0% 46
8-15
0 (103)
(279,409) (1.32) 71
60~69
15%
104 11 16
I
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()...............................................................................................................................- 57 -
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VI
() ...............................................................................................................- 91 -
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()......... - 119 -
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.................................................................................... - 119 -
104
104
- 1 -
()
()
1.
()
()
1. TMB-355
104 3 FDA 30
104
FDA Primary Endpoint
2. TMB-355
101 Ibalizumab
102 /
104
105
3. TMB-360/365
TMB-360/365 TMB-355 LM52 103
104 3TMB-360(PD)(PK)
TMB-365 105
- 2 -
4. TMB-607
TMB-607 100 Ambrilia Biopharma
104
()
1.(Pipeline)
(Pipeline)
TMB-355
/
TMB-360/365
2.
(CMC)
cGMP
3.
()
4.
Bill & Melinda Gates Foundation
300 102 TMB-355 /
102 9
900 103 8 A+
(TMB-607) 1,497
TMB-355
(DCB)
()
()
HIV
HIV
HIV
HIV
- 3 -
HIV
HIV
...HIV
1.HIV HIV
2.
3. HIV
4.
HIV
()
1.TMB-355TMB-360/365
TMB-355 TMB-360/365 T
CD4
TMB-355 TMB-360/365 HIV CD4+ HIV
HIV TMB-355 TMB-360/365
CD4 CD4
HIV HIV (
HIV CD4 T
TMB-355 85% CD4)
TMB-355 TMB-360/365
2. TMB-355 HDAC CD4+T
HIV
ADARC CRO
TMB-355 Histone deacetylases (HDAC) CD4+T
HIV T HDAC
T DNA HDAC
T TMB-355
HDAC T TMB-355 T
(endocytosis) T HDAC
3.
- 4 -
HIV
1981 (Centers for Disease Control and Prevention
CDC)
1995
2004 3,000
2007
TMB-355 TMB-360/365 HIV
()
CD4
TMB-355 TMB-360/365 T CD4
CD4 HIV
HIV
TMB-355 TMB-360/365
TMB-355TMB-360/365
- 5 -
()
1.
94 108
2.
109 110
3.
111 119
- 6 -
() 96 9 5
()
607 3
(02)2658-0058
()
96 9
96 10
96 12
9 Genentech AIDS
Ibalizumab (TMB-355)
10 100% TaiMed Biologics USA Corp.
97 3
5
10
5 AIDS Ibalizumab (TMB-355)
(phase 2b)
7
9
11
12 (Tamiphosphor)
98 3
4
5-12 10
11 TMB-355
99 3 10
4
5
6
10 AIDS Ibalizumab (TMB-355) FDA
12
100 2 (Tamiphosphor)
3 Ambrilia AIDS
Protease Inhibitor (PI) Integrase Inhibitor (INI)
4 100% TaiMed USA
( Ibalizumab )
6
- 7 -
6 FDA AIDS Ibalizumab (TMB-355)
(phase 2b)(phase 3)
8 TMB-355
10 (NIH) NIAID
TMB-355
11 ADARC TMB-355 292
101 4 100% TaiMed USA
ADARC 101 4 1,210
7 WuXi Apptec TMB-355 (CMO)
10 AIDS Ibalizumab (TMB-355)
102 1
2 AIDS Ibalizumab (TMB-355) TFDA
/
6
9
10
TMB-355 / 900
TMB-355 WuXi AppTec 2000L
103 1
3 (Tamiphosphor)
3
63
4
FDATMB-355 WuXi AppTec 2000L
GMP
5 TMB-355
/
7 Integrase Inhibitor (INI) Ambrilia
8
(TMB-607)
1,497
10 Fusion Proteins
10 TMB-355 FDA
12
TaiMed USA TMB-355 Ibalizumab
(LM 52)
104 2 TMB-355 FDA
3
FDA TMB-355
30
4
TMB-355
/
4
4
8
TMB-360 ( TMB-365) TMB-365
TMB-355
TMB-355
- 8 -
()
1.
(1)
A.
103
B.
( CRO )
C.
cGMP
(2)
2.
3.
(1)
TMB-355 Genentech Inc.
100 2b 104
101
102
/
TMB-360/365( LM
52) TMB-355(ibalizumab)
TMB-365 TMB-360
- 9 -
105
TMB-607 100 3 Ambrilia Biopharma Inc.
Protease Inhibitor (PI)
TMB-607 ( TMB-607 )
(2)
104 5
4.
5.
6.
7.
8.
9.
10.
11.
- 10 -
12.
(1)
CRO
(2)
HIV HIV
5%-10% 10% HIV
120 15-20
TMB-355
() TMB-355
HIV
/ TMB-355
TMB-355 HIV
(Anti-retroviral TherapysARTs)
(Anti-retroviralsARVs)
- 11 -
Ibalizumab
Fuzeon
TMB-355
(3)
TMB-355 WuXi Apptech
Helen Shu 102 3
QA/QC
(4)
TMB-355
TMB-355 ADARC
(5)
WestatSharpPPDMonogram
WuXiApptec CRO CMO
- 12 -
()
1.
102 7 18 Clinlogix 7 3
TMB-355 2b 316
102 Clinlogix
103 10 15 Clinlogix
Clinlogix
375,186 103 10
104 1 19 Clinlogix 104 1 26
101
(WuXi Apptec) 102
12 19 1020152331 103 2 14
103 6 19
2.
(1)
A.-()
(A)()
21,370
102 () 3
(B)()
- 13 -
103 3999
B.-()
(A) 3 ()
96 11
96 11 13
3 3
110
73,590 669 11
Gloria Solar International
Holding, Inc.( GIH) 97 1 7
9
3 98 12 31
7%
GIH
3 98 9 2
3 99
3 97 1 10
7 3
101 ()
15 3
103 () 3
3
(B)() 96 1 12
()
6 9,000
6 6
2006 ()
96 3 5 6
96 5 22
6
12,409
5%97169
100 73
846 97 2 2 5%
- 14 -
(C) 99 6 18 5
()
33,570
5% 101 217
102 844 103
2581
(D)
EB EB EA
()
179
51 1,620
1,880 820 ( 102 10 8 )
5% 102
5220
C.-()
(A) 3
96 11
96 11
13
3
3 110
73,590
669 11
Gloria Solar International Holding, Inc.( GIH)
97 1 7 9
3 98 12 31
7% GIH
3 98 9 2
3 99 3
97 1 10 7
- 15 -
3
101 () 15 3
103
() 3 3
(B)() 100 3 29
1 2,000 420 4 1
POLO 5 1,000
5 30
70 45 POLO 5
121 1 2,000
996 4,200
101 36 2
121 5
992
D.
(2)
-
3.
()
()
()
()
- 16 -
()
1.
2.
/
GMPQA/QC
- 17 -
()
1.
2.
104 6 30
TaiMed Biologics USA Corp.
9,100,000 100.00%
TaiMed Biologics HK Limited.
()
100 100.00%
TMB HK Services Limited.
1 100.00%
100.00%
TaiMed Biologics USA TaiMed Biologics HK
Limited.(
)
100.00%
TMB HK Services
Limited.
100.00%
- 18 -
()
104 10 31
()
97.3 1,406,409 0.65% 1,603,355 0.74% 0 0
Allergan
TaiMed Biologics
USA
- - 1,640,000
101.4 110,000 0.05% 0 0 0 0
Merck Co. & Inc.,
Columbia University,
- - - 275,000
97.6 417,006 0.19% 339,682 0.16% 0 0
()
- - - 660,000
103.2 0 0 0 0 0 0
University of California, Davis
Bayer Coporation
- - - 50,000
100.12 100,614 0.05% 0 0 0 0
- - - 141,000
104.07 0 0 0 0 0 0
- - - -
- 19 -
()
1.
104 10 31
()
() 102.6.5 102.6.5 3 655,000 0.34% 628,342 0.29% 0 0 0 0
102.6.5 102.6.5 3 0 0 167,000 0.08% 150,000 0.07% 0 0
()
( 1)
96.9.3 102.6.5 3 40,112,000 20.66% 40,112,000 18.48% 0 0 0 0
96.9.3 102.6.5 3 0 0 0 0 0 0 0 0
()
96.9.3 102.6.5 3 40,112,000 20.66% 40,112,000 18.48% 0 0 0 0
96.9.3 102.6.5 3 0 0 0 0 0 0 0 0
()
() 97.6.12 102.6.5 3 12,060,000 6.21% 10,261,408 4.73% 0 0 0 0
97.6.12 102.6.5 3 0 0 0 0 16,000 0.01% 0 0
( 2)
- 20 -
()
() 99.4.15 102.6.5 3 12,060,000 6.21% 10,357,408 4.78% 0 0 0 0
99.4.15 102.6.5 3 0 0 18,000 0.01% 0 0 0 0
()
()
( 3)
97.6.12 102.6.5 3 2,235,000 1.15% 1,406,409 0.65% 1,603,355 0.74% 0 0
Allergan
TMB USA
100.6.2 102.6.5 3 0 0 0 0 0 0 0 0
()
()
100.6.2 102.6.5 3 0 0 0 0 0 0 0 0
IVAX
( 4)
98.4.28 102.6.5 3 0 0 0 0 0 0 0 0
()
()
()
()
- 21 -
()
100.6.2 102.6.5 3 1,500,000 0.77% 1,500,000 0.69% 0 0 0 0 Loughborough
University
()
100.6.2 102.6.5 3 0 0 0 0 0 0 0 0
()
1()Tanvex BioPharm Inc.TMB HK Services LimitedTaiMed Biologics HK Limited
()()()()()()Shanghai International Shanghi GrowthAdvanced Lithium Electrochemistry
Tanvex Biologics, IncSearch MediaBiologics ()()()()()()
()()
2()()() RENBIO, Inc Tanvex BioPharma, Inc RenBio Holdings Limited
()
3()()()()()()()()()
()
4()()Non Invasive Monitoring Systems Inc.Neovasc Inc.Trans Enterix Inc.OPKO Health Inc. Co-Crystal Pharma, Inc.
- 22 -
2.
104 4 26
()
() 48.00%
() 33.00%
() 19.00%
()
() 11.63%
() 7.81%
() 6.05%
() 4.98%
() 3.57%
() 3.47%
()& 2.81%
2.66%
() 2.33%
2.32%
()
() 24.56%
() 6.82%
() 4.33%
() 4.01%
() 1.98%
1.71%
1.62%
() 1.56%
1.36%
1.09%
()
() 63.53%
() 19.93%
() 16.54%
- 23 -
3.
104 4 26
()
() 19.55%
() 19.14%
() 18.44%
() 17.96%
13.70%
6.55%
4.40%
0.26%
() 99.9967%
0.0033%
() () 85.10%
() 14.90%
()
() 55.00%
() 30.00%
9.85%
() 2.30%
1.80%
() 1.05%
()
() 53.99%
() 5.43%
() 4.81%
() 1.91%
() 1.44%
() 1.04%
0.93%
0.84%
() 0.75%
() 0.75%
0.75%
()
()
- 24 -
4.
()
1 2 3 4 5 6 7 8 9 10
()
()
()
2
3
(1)
(2)(
)
(3)
(4)
(5)
(6)
(7)
(8)
(9) 30
(10) 27
()
- 25 -
() 1.()
103
(A)
(B)
(C)
(D)
ABC
D
(%)
(E)
(F) (G)
()
(H)
()
(I)
ABCD
EF G
(%)
1,950 1,950 - - - - - - (0.69) (0.69) - - - - - - - - - - - - (0.69) (0.69)
- - - - - - 60 60 (0.02) (0.02) - - - - - - - - - - - - (0.02) (0.02)
- - - - - - 60 60 (0.02) (0.02) - - - - - - - - - - - - (0.02) (0.02)
() - - - - - - 60 60 (0.02) (0.02) - - - - - - - - - - - - (0.02) (0.02)
() - - - - - - 60 60 (0.02) (0.02) - - - - - - - - - - - - (0.02) (0.02)
( 1) - - - - - - 210 210 (0.07) (0.07) - - - - - - - - - - - - (0.07) (0.07)
( 2) - - - - - - - - - - 4,784 14,905 83 384 - - - - 320 320 - - (1.73) (5.43)
- - - - - - 390 390 (0.14) (0.14) - - - - - - - - - - - - (0.14) (0.14)
- - - - - - 390 390 (0.14) (0.14) - - - - - - - - - - - - (0.14) (0.14)
1 103 7 28
2 98 1,650 10 103 3,246
- 26 -
2.
103
(A) (B) (C)
AB C
360 360 (0.13) (0.13)
360 360 (0.13) (0.13)
60 60 (0.02) (0.02)
3. 103
(A) (B)
(C) (D)
ABC
D
(%)
()
()
4,784 14,905 83 384 (1.73) (5.43) 320 320
5,212 5,212 216 216 (1.93) (1.93) 200 200
103 3,246
- 27 -
2,000,000
2,000,000 5,000,000
5,000,000 10,000,000
10,000,000 15,000,000
15,000,000 30,000,000
30,000,000 50,000,000
50,000,000 100,000,000
100,000,000
3 3
4.
5.
(1)
103 102
(%)
(%)
3,180 3,180 (1.13) (1.13) 3,345 3,345 (1.33) (1.33)
780 780 (0.28) (0.28) 780 780 (0.31) (0.31)
10,295 20,717 (3.65) (7.35) 11,332 21,339 (4.50) (8.48)
(2)
A.
a.
1,950
- 28 -
b.
B.
()
()
()
217,050,500 2,949,500 220,000,000
()
1.
99.01 10 220,000 2,200,000 124,060 1,240,600
16,910 1
99.03 10 220,000 2,200,000 193,060 1,930,600
69,000 2
101.06 10 220,000 2,200,000 193,125 1,931,250
65 3
101.11 10 220,000 2,200,000 193,390 1,933,900
265 4
102.03 10 220,000 2,200,000 193,765 1,937,650
375 5
102.05 10 220,000 2,200,000 194,117 1,941,170
352 6
102.11 10 220,000 2,200,000 194,132 1,941,320
15 7
103.1 10 220,000 2,200,000 194,172 1,941,720
40 8
103.3 10 220,000 2,200,000 216,272 2,162,720 9
- 29 -
22,100
103.6 10 220,000 2,200,000 216,485 2,164,850
213 10
103.8 10 220,000 2,200,000 216,550 2,165,500
65 11
103.12 10 220,000 2,200,000 216,553 2,165,530
3 12
104.3 10 220,000 2,200,000 216,577 2,165,770
24 13
104.4 10 220,000 2,200,000 216,794 2,167,940
217 14
104.10 10 220,000 2,200,000 217,050 2,170,505
257 15
1 99 01 22 09901014920
2 99 04 12 09901068840
3 101 06 13 10101107780
4 101 11 14 10101235930
5 102 03 20 10201050290
6 102 05 09 10201084930
7 102 11 15 10201231200
8 103 01 22 10301014760
9 103 04 08 10301060470
10 103 06 27 10301114090
11 103 08 29 10301179460
12 103 12 25 10301268660
13 104 3 19 10401047260
14 104 4 24 10401075520
15 104 10 05 10401207290
2.
()
1.
104 4 30
2 1 89 11,476 30 11,598
40,262,000 800,000 56,318,362 111,956,655 7,456,983 216,794,000
()
18.57% 0.37% 25.98% 51.64% 3.44% 100.00%
217,050,500 256,500 104 10 256,500
- 30 -
2.( 10 )
104 4 30
( % )
1 999 1,284 344,346 0.16
1,000 5,000 7,066 14,556,951 6.71
5,001 10,000 1,257 9,636,681 4.45
10,001 15,000 585 7,329,660 3.38
15,001 20,000 305 5,471,010 2.53
20,001 30,000 346 8,591,963 3.96
30,001 50,000 330 12,810,088 5.91
50,001 100,000 260 18,703,369 8.63
100,001 200,000 90 12,060,031 5.56
200,001 400,000 31 9,014,045 4.16
400,001 600,000 14 6,792,873 3.13
600,001 800,000 7 4,866,121 2.25
800,001 1,000,000 6 5,396,642 2.49
1,000,001 17 101,220,220 46.69
11,598 216,794,000() 100.00
104 9 256,500
3.(
)
104 4 30
(%)
40,112,000 18.50
() 20,063,895 9.25
() 10,357,408 4.78
() 10,261,408 4.73
() 3,169,824 1.46
2,000,000 0.92
() 2,000,000 0.92
1,769,988 0.82
1,603,355 0.74
1,500,000 0.69
4.
(1)
102 103 104 10 31
4,105,688
153,533
- 31 -
(2)
() 47,000 63
() 80,000 63
() 31,000 63
() 167,000 63
() 150,000 63
() 47,000 63
103 3
() 47,000 63
5.
(1)
102 103 104 10 31
()
()
()
()
()
()
() (85,000) 58,342
167,000
()( 1)
() (1,798,592)
() (1,702,592)
28,000 (10,000)
(428,591) (400,000)
( 2)
277,006 (20,000)
115,000 (5,000)
( 3)
(4,000,000) 106,711 (106,711)
Genentech( 4)
1()102 6 5
2 103 7 28
3 102 4 30
4 Genentech 102 0
- 32 -
(2)
103.1.17 1,000,000
104.3.3 600,000
102.1.3 45,000
104.5.13 20,000
(3)
6.
%
6
()
(
)
40,112,000 18.50
() 20,063,895 9.25
()
()
()
()
() 10,357,408 4.78
()
()
()
( )
()
() 10,261,408 4.73
()
()
()
( )
() 3,169,824 1.46 ()
()
2,000,000 0.92
() 2,000,000 0.92
1,769,988 0.82
1,603,355 0.74
1,500,000 0.69
- 33 -
()
102 103
104
6 30
/ / /
/ / /
/ / /
3.39 8.45 7.74
3.39 8.45 7.74
194,001 213,740 216,701
(1.30) (1.32) (0.80)
(1.30) (1.32) (0.80)
/ / /
/ / /
/ / /
()
1.
2.
103 104 6 3
()
103 104 6 3
()
1.
- 34 -
(1)
(2)
(3)
2.
103 104 6 3
3.
4.
103 104 6 3
5.()
102 103 6 4
()
()
- 35 -
() 104 10 31
98 100 101 102 103
( 1)
99.5.21 100.12.30 101.12.26 102.12.31 104.1.6
() 98.12.15 100.12.31 101.12.27 103.1.1 104.1.7
7 7 10 10 10 10
(A)
(B)
1,510,000 1,525,000 1,500,000 1,935,000 1,642,000 1,603,000
0.70% 0.70% 0.69% 0.89% 0.76% 0.74%
(%)
25%
50%
75%
100%
50%
75%
100%
50%
75%
100%
50%
75%
100%
50%
75%
100%
50%
75%
100%
() 295,000 1,017,500 308,000 275,000 0 0
() 2,950,000 10,175,000 10,256,400 12,540,000 0 0
1,215,000 507,500( 2) 1,192,000( 2) 1,660,000( 2) 1,642,000( 2) 1,603,000
() 10 10 33.3 45.6 75.6( 3) 142.6
(%) 0.56% 0.24% 0.55% 0.76% 0.76% 0.74%
1 3,535,000 ( A 1,510,000 B 2,025,000 ) B 500,000
3,035,000 1.57% 500,000
2 477,500
3 103 22,100 63 102
77 75.6
- 36 -
()
104 11 4
2,575,000 1.19% 640,000 10
33.3 45.6
13,445,500 0.29% 1,935,000
10 33.3 45.6 75.6 142.6
141,877,500 0.89%
Stanley Lewis
Helen Shu
Steve Weinheimer
LanBo Chen
TMB USA
Jonathan Ho
5,851,000 2.70% 1,025,000 10
33.3 45.6
18,156,000 0.47% 4,826,000
10 33.3 45.6 75.6 142.6
263,572,600 2.22%
()
- 37 -
()
1.
(1)
IG01010
F401010
C802080
F208050
C199990
IC01010
F107080
F207080
ZZ99999
F601010
IG02010
(2)
102103
(3)()
TMB-355
/
/
TMB-360/365()
TMB-607
TMB-360/365TMB-355LM-52
(4)()
A.TMB-355/ FDA
B.TMB-360/365 TMB-365
FDA
C.TMB-607 IND FDA
D.
- 38 -
2.
(1)
A.
IMS Health 2012 9,590
2011 2.4% 5.3%
2017 1.24
3,490
10~13%
B.
(Acquired Immunodeficiency SyndromeAIDS)
150
Gilead
()
ViiV
2018 180
(mutant strain)
(drug resistance)
2003 Fuzeon
Fuzeon
(salvage therapy)
6 5
13%-15%
(2)
- 39 -
cGMP
(IND)
(NDA)
(Contract
Research OrganizationCRO)
(Contract Manufacturing OrganizationCMO)
(3)
HIV
CD4+T (
) HIV CD4+T
HIV CD4+T
1,000 cells/mm 3 CD4+T
200 cells/mm 3
- 40 -
(Opportunistic InfectionsOIs)
HIV
(Mutant
Strain) HIV (Drug Resistance)
HIV (
PIs RTIs)()
(Medication Adherence)
1996
(Highly Active Antiretroviral Therapy
HAART)
HIV
HIV
HIV
(
) HIV (multi-drug
resistance, MDR)
(4)
A.(Reverse transcriptase inhibitorsRTIs)
RNA
DNA
a.(Non-nucleoside reverse transcriptase inhibitors
NNRTIs) EtravirineNevirapineEfavirenz
b.(Nucleotide analog reverse transcriptase inhibitorsNtARTIs
NtRTIs) (AZT)Stavudine (d4T)Didanosine (ddI)Zalcitabine
(ddC) (3TC)Abacavir (AZT+3TC)
B.(Protease inhibitorsPIs)
DarunavirIndinavir
RitonavirKaletraNelfinavir
- 41 -
C.(Entry and Fusion inhibitorsEIs/FIs)
a.Fuzeon(enfuviritide)
Fuzeon (Hoffmann-La Roche) Trimeris
FDA 2003 3 Fuzeon (enfuvirtide)
6
Fuzeon
(fusion)
Fuzeon Fuzeon
()
Fuzeon
Fuzeon
1%
Fuzeon
b.Maraviroc(Selzentry Celsentri)
Maraviroc (Pfizer)(Entry Inhibitor)
CCR5 (Chemokine (C-C motif) receptor 5)
CCR5
Maraviroc Selzentry HIV
2007 8 6 FDA 2007 9
Pfizer Celsentri
Maraviroc
CCR5-tropic HIV-1
(viral load)
Maraviroc --CCR5
HIVCCR5
HIV 50%-60%
CCR5-tropic HIV-1 FDA Steven Galson
HIV
Maraviroc /
- 42 -
Maraviroc HIV
Maraviroc Fuzeon
Maraviroc 2012 6.5
D.(Integrase InhibitorsIIs)
DNA DNA
RNA
Raltegravir HIV Merck
HIV-1 HIV-1 DNA
DNA
FDA 2007 10 12 Raltegravir (Isentress)
HIV-1
(Europen
CommissionEC) 2007 Raltegravir
HIV-1 27
Raltegravir
Raltegravir HIV
Raltegravir 2007 2009
7.5 Merck 2010 Raltegravi 10
(GSK) ViiV 102 8 12 FDA
Tivicay(dolutegravir)50mg Tivicay
HIV
HIV-1 12 40
Raltegravir
E.(Opportunistic infection and other drugs)
F.(Microbicide)
HIV RTIsPIs IIs RTIs
- 43 -
PIs
HIV
EIs/FIs HIV HIV
RTIsPIs IIs HIV
EIs/FIs
HIV HIV
HIV
TMB-355
TMB-355
TMB-360/365 TMB-355
TMB-365 TMB-360
EIs/FIs
TMB-607 PIs
(First Pass Effect)
/
3.
(1)
- 44 -
(2)
A. TMB-355
a. B 100
FDA
b.
B 100 3
c.104 3 FDA
30
104
8 105
d./ 101 Ibalizumab
TFDA
/102 103
104
B.TMB-360/365(TMB-355 LM52)
Nature Biotechnology 103 104 3
TMB-360 (PD)(PK)
TMB-365 TMB-365
105
C. TMB-607 2011 Ambrilia
Biopharma
- 45 -
(3)( TMB USA )
()
Merck Co. & Inc., Columbia University,
Merck Co. & Inc
19
25
TMB USA
Threshold Inc
Anosys , Inc.
Angioenix
IND()
NDA() 25
Stanly Lewis TMB USA
Genentech
Tanox, Inc.
Tanox TMB-355
15
Steven Weinheimer
TMB USA
Tanox, Bristol-Myers Squibb Pharmaceutical Research Institute
27
Brian Bell TMB USA
Genentech
Tanox, Inc.
Tanox TMB-355
10
Jonathon Ho TMB USA
TaiMed Biologics USA
ADARC
5
()
()
18
9
XenoBiotic Labs, Medpace
10
Alpha Technology bioplex
8
3
10
6
5
4
4
2
- 46 -
()
1
BAX
0
(4)()
99 100 101 102 103
268,961 222,560 183,445 233,049 249,826
1,930,600 1,930,600 1,937,650 1,941,720 2,165,770
(%) 13.93% 11.53% 9.47% 12.00% 11.54%
4.
(1)
A.TMB355 /TMB-360/365 TMB-607
AIDS
TMB-355 /TMB-360/365 TMB-607
B. Bill & Melinda Gates AIDS
Aaron Diamond AIDS Research Center TMB-355
AIDS
C. HIV
(2)
A.TMB-355 FDA BLA
B. TMB-355 -/
C.TMB-607
D.TMB-365 CMO cell line
()
1.
- 47 -
(1)
TMB-355TMB-360/365 TMB-607
(2)
HIV TMB-355
TMB-360/365 HIV
()
TMB-355 TMB-360/365 TMB-607
EIs Fuzeon
(3)
HIV/AIDS Zidovudine 1987
HIV/AIDS
UNAIDS 102 3,500
2,470
230
6.57%
HIV
Business Insights HIV 2009 130
2009 7 HIV
118 20052009 10.8%2015
2019 Datamonitor 2009
118 (CAGR) 10.8%GlobalData 2009
HIV/AIDS 120
HIV
- 48 -
2003 2004 HIV
5.5%
1
HIV/AIDS 5% 10% HIV
HIV
UNAIDS
94 102 AIDS 35%
HIV
PAI(Pharma Access International) 40%
HIV
HIV
HIV/AIDS NRTIs/NtRTIsNNRTIs PIs
HIV
Datamonitor
NRTIs/NtRTIsNNRTIsPIs TMB-355 Entry
Inhibitors(EIs)/Fusion Inhibitors(FIs) 2010 120~140 (
120 )
2018 180
(4)
A.
B.
FDA
TMB-355
(5)
- 49 -
A.
a.
b.
c.
96 6 15
B.
a.
(a)
TMB-355 TMB-607
(b)
(c)
b.
(a)
- 50 -
CRO
(b) TMB-355 103 10 21
FDA TMB-355 104 2 24
FDA
FDA
FDA TMB-355
FDA
(c)
c.
(data exclusivity)
2.
TMB-355
CD4
GMP
WuXi AppTec FDA 103 4WuXi AppTecTMB-355
TMB-360/365 TMB-355
()
TMB-607
IND
()
3.
4.
96 9
5.
(1)
- 51 -
96 9 102103
(2)
96 9 102103
6.
7.
8.()
(1)
()
()
Genentech( Roche())
TMB-355(Ibalizumab)
TMB-360/365 HIV
(EIs/FIs) Ambrilia Biopharmaceuticals
TMB-607
(PIs)
HIV
(RTIs)(PIs)/(EIs/FIs)
TMB-355 TMB-360/365
HIV
HIV CD4+T CD4+T
HIV T CD4+T
TMB-355 TMB-360/365
TMB-360 TMB-355 TMB-360 TMB-355
52 TMB-360 CD4
TMB-355 HIV-1 V5
HIV-1 T TMB-360
TMB-355 TMB-365 TMB-360
TMB-360
- 52 -
CD4
HIV HIV
HIV
HIV
HIV
HIV Laboratory Corporation of
America 2003-2009
NRTIs NNRTIs 2007
TMB-607 TMB-607
Norvir(Ritonavir)
TMB-607 TMB-607
(2)()
TMB-355TMB-360/365 TMB-607 Genentech
Ambrilia Biopharma
TMB-355 Biogen Tanox Inc.Tanox
Genentech TMB-355 Genentech 2007
Genentech TMB-355 (Ibalizumab)TMB-355
Biogen 2015 4 TMB-355
12 10 TMB-355
FDA 7 TMB-355
TMB-355 (LM-52 TMB-360/365)
TMB-355
Ambrilia Biopharma
60
9.
- 53 -
(1)
(compliance)
TMB-355
TMB-360/365 TMB-607
(first-in-class)
TMB-355TMB-360/365
TMB-355
HIV TMB-355
HIV
Fuzeon 2
PRO140 TMB-355
CCR5 CD4
Rilpivirine LAGSK744 LAP TMB-607 NPs
TMB-607
TMB-607
Drug Company Active
ingredient Class of
drug Dosage form
Delivery
route Cover
period Status
PRO140 CytoDyn Inc. N/A EI Antibody
solution SC 1 week Phase II
TMB-355 TaiMed
Biologics Ibalizumab EI
Antibody
solution
IV/
SC/IM bi-week Phase III
Rilpivirine
LA J&J Rilpivirine NNRTI
NanoCrystal
(200 nm) IM 1 month Phase II
GSK744
LAP GSK GSK744 INI
NanoCrystal
(200 nm) IM 1 month Phase II
TMB-607
NPs
TaiMed
Biologics TMB-607 PI
NanoCrystal
(200 nm) SC/IM
1 week / 1
month Pre-clinical
(2)
- 54 -
TMB-355
1-3 TMB-360/365 TMB-355
2016 IND 2022
()
1.
104 10 31
102 103 104
10 31
4 4 5
5 3 5
14 17 19
23 24 29
44 41 49
3.41 3.69 4.48
11 11 11
4 7 11
8 6 7
0 0 0
23 24 29
2.
()
()
101 18 5 1 - - 22 5 5 12 43 2.57
102 22 2 1 - - 23 4 5 14 44 3.41
103 23 5 4 - - 24 4 3 17 41 3.69
104 10 31 24 5 - - - 29 5 4 19 49 4.48
()
1.
2.
3.
4.()
()(
)
- 55 -
5.
()
1.
(1)
A.
B.
C.
D.
E.
F.
G.
H.
(2)
A.
B.
(3)
6%
(4)
2.
- 56 -
()
()
()
()
()
1.
(1) 104 6 8 1046033281 TMB-355
(2) 104 3 19 10400250430
(3) 102 1 31 1015056130 TMB-355
103
(4)102 9 2 1020027942 TMB-355
2B
2.
46
()
- 57 -
()
1.
2.
()
1.()
2.()
()
()
104 6 30 /
TaiMed Biologics USA Corp
295,044 74,646 9,100,000 100% 74,646
(729)
TaiMed Biologics HK
Limited
3 3 100 100% 3
TMB HK Services Limited
1 100%
()
104 6 30 /
TaiMed Biologics USA Corp
9,100,000 100% 9,100,000 100%
TaiMed Biologics HK Limited
100 100% 100 100%
TMB HK Services Limited
1 100% 1 100%
()
()
- 58 -
()
101 8 23
100 1
Genentech Inc. 96.9-
TMB-355 TMB-355
103 109
Ambrilia Inc. 100.3-
TMB-607 (PI)
(TMB USA)
The Rockefeller University
100.04.20- TMB-355 II
98.5-103.12 Ibalizumab
98.12-103.12
() 102.11- 108.1.31
/
CMO WuXi
AppTech HK 101.07.19-
TMB-355
CMO
103.6 104.4
TMB-360/365
CMO 104.3- TMB-607
TMB USA 103.01.01-
104.12.31
2014 2015 TMB USA
CRO A+ Inc. 101.11- TMB-355 /(121)
CRO 101.12- TMB-355 /(121)
102.1.4- TMB-355 /(121)
CRO Westat
104.4.13- TMB-355 (301)
CRO Covance 104.04.14- 107.04.13
TMB-355
102.3.12- TMB-355 /(121)
104.8.16- TMB-355 (301)
103.7.10- TMB-355 /(121)
103.7.31- TMB-355 /(121)
- 59 -
103
()103
1.
(1) 102 12 31
1020053121 103 01 17
1030001535
(2) 1,392,300
(3) 22,100 10
63 1,392,300
(4)
103 104
32,235 64,680 34,785 85,030 95,800 125,800 181,590
105
105 12
1,392,300
210,480 225,000 240,000 96,900
(5)
1,392,300 TMB-355
TMB-360/365(LM52) TMB-607
(6)
1,502,800
68 102 12 31 103 1 10
63 1,392,300
110,500
(7)103 1 1 1 10
2.
103 103 4 8
10301060470 103
- 60 -
%
103 104
32,235 64,680 34,785 85,030 95,800 125,800 438,330
35,151 42,863 73,681 68,468 59,522 110,308 389,993
2.31 4.65 2.50 6.10 6.88 9.04 31.48
-
105 12
1,392,300
2.52 3.08 5.30 4.92 4.27 7.92 28.01
104 104
10
3.
%
()
102
()
103 3 () %
374,280 1,682,214 1,307,934 349.45
56,993 7,558 (49,435) (86.74)
56,993 7,558 (49,435) (86.74)
() 3.39 9.32 5.93 174.93
7.97 0.37 (7.60) (95.36)
20,741.88 30,082.04 9,340.16 45.03
656.71 22,257.40 21,600.69 3,289.23
653.90 22,231.44 21,577.54 3,299.82
102 TMB-355 /
TMB-360/365( LM52) TMB-607
1,307,934
49,435 3.39 9.32
0.37% 30,082.04%
102
()
1. 3,450,000
2.
30,000 10
115 3,450,000
- 61 -
3.
104
104 3,450,000 3,450,000
3,450,000
4.
3,450,000
()
()
()
()
()
()
()
()
- 62 -
1.
(1)
104 9 24
(2)
30,000 10
115 3,450,000
267 15% 4,500 25,500
28 1 103 6 4
104 9 24
(3)
104 3,450,000
TMB-355
TMB-355 //
- 63 -
2.
104
79691104729739
622
3.
(1)
3,450,000
104
(2)
/ 104 8 () 104 12 ()
7.67 20.71 6,648.32% 38,262.10% 6,246.03% 38,251.83% 1.19% 0.24%
104 8 104 12
TMB-355 TMB-355
// TMB-360/365
TMB-607
3,450,000
38,262.10% 38,251.83%
0.24%
- 64 -
4.
6 2 2
30,000
247,050 12.14%
5.
()
()
1.
()
2.
(1)
(2)
3.
(1)
- 65 -
A.
B. 104 105
C.
104
104 3,450,000 3,450,000
3,450,000
D.
104 105
(2)
()
A.
TMB-355
TMB-355
104 9
30 -90
104 105
TMB-355
CMO CRO
104 105
104 1-8
- 66 -
B.
a.
b.
C.
102 103 104
1.00 1.00 1.00 (%) 7.97 2.68 4.83
102
103 104 7.97%2.68% 4.83%
(3)
(4)
4.
5.
- 67 -
- 68 -
104
(1) 1,447,376 1,402,401 1,399,199 1,378,908 1,351,390 1,345,956 1,319,386 1,244,053 1,239,036 1,215,345 1,068,880 4,491,350 1,447,376
(2)
(+) 1,054 1,034 1,055 936 1,028 943 920 828 800 720 680 6,549 16,547 1,054 1,034 1,055 936 1,028 943 920 828 800 720 680 6,549 16,547
(3)
(-) - - - - - - - - - - - - -
(-) 48,117 4,505 22,586 26,572 4,186 25,132 82,255 5,860 22,578 145,205 26,230 118,520 531,746
(-) 1,681 1,715 1,715 1,729 1,754 1,754 1,822 1,866 1,913 1,980 1,980 5,940 25,849
(-) - - - - - - - - - - - - -
(-) - - - 153 522 627 988 - - - - - 2,290
49,798 6,220 24,301 28,454 6,462 27,513 85,065 7,726 24,491 147,185 28,210 124,460 559,885
(4) 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000
(5=3+4) 249,798 206,220 224,301 228,454 206,462 227,513 285,065 207,726 224,491 347,185 228,210 324,460 759,885
(6=1+2-5)
1,198,632 1,197,215 1,175,953 1,151,390 1,145,956 1,119,386 1,035,241 1,037,155 1,015,345 868,880 841,350 4,173,439 704,038
(7)
() 3,769 1,984 2,955 - - - 8,812 1,881 - - - - 19,401
() - - - - - - - - - - 3,450,000 - 3,450,000
- - - - - - - - - - - - -
- - - - - - - - - - - - -
3,769 1,984 2,955 - - - 8,812 1,881 - - 3,450,000 - 3,469,401
(8=1+2-3+7) 1,402,401 1,399,199 1,378,908 1,351,390 1,345,956 1,319,386 1,244,053 1,239,036 1,215,345 1,068,880 4,491,350 4,373,439 4,373,439
- 69 -
105
(1) 4,373,439 4,327,020 4,259,181 5,225,593 5,099,620 4,973,495 4,847,317 4,705,087 4,539,860 3,877,800 5,046,369 4,954,898 4,373,439
(2)
(+) - - - - - - - - - 1,350,000 150,000 150,000 1,650,000 (+) 2,260 2,240 2,212 2,177 2,125 2,072 1,820 2,323 2,290 2,249 2,209 2,171 26,148 (+) - - 1,050,000 - - - - - - - - - 1,050,000
2,260 2,240 1,052,212 2,177 2,125 2,072 1,820 2,323 2,290 1,352,249 152,209 152,171 2,726,148
(3)
(-) - - - - - - - - - - 65,000 65,000 130,000
(-) 49,600 70,500 91,650 126,000 126,000 126,000 141,500 170,000 666,800 181,000 181,000 199,150 2,129,200
(-) 2,079 2,079 2,150 2,150 2,250 2,250 2,550 2,550 2,550 2,680 2,680 5,360 31,328
(-) - - - - - - - - - - - - -
(-) - - - - - - - - - - - - -
51,679 72,579 93,800 128,150 128,250 128,250 144,050 172,550 669,350 183,680 248,680 269,510 2,290,528
(4) 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000 200,000
(5=3+4) 251,679 272,579 293,800 328,150 328,250 328,250 344,050 372,550 869,350 383,680 448,680 469,510 2,490,528
(6=1+2-5)
4,124,020 4,056,681 5,017,593 4,899,620 4,773,495 4,647,317 4,505,087 4,334,860 3,672,800 4,846,369 4,749,898 4,637,559 2,409,059
(7)
() 3,000 2,500 8,000 - - - - 5,000 5,000 - 5,000 - 28,500
() - - - - - - - - - - - - -
- - - - - - - - - - - - -
- - - - - - - - - - - - -
3,000 2,500 8,000 - - - - 5,000 5,000 - 5,000 - 28,500
(8=1+2-3+7) 4,327,020 4,259,181 5,225,593 5,099,620 4,973,495 4,847,317 4,705,087 4,539,860 3,877,800 5,046,369 4,954,898 4,837,559 4,837,559
- 70 -
()
1.
(1)
()
99 100 101 102 103
104
6 30
536,403 374,280 1,529,873 1,411,510
4,843 3,171 16,214 16,798
334,795 334,834 333,344 333,344
22,122 2,433 1,265 1,261 898,163 714,718 1,880,696 1,762,913
14,233 56,993 50,349 85,084
14,233 56,993 50,349
14,233 56,993 50,349 85,084
14,233 56,993 50,349
883,930 657,725 1,830,347 1,677,829
1,937,650 1,941,720 2,165,770 2,167,940
28,479 48,261 1,274,857 1,295,607
(1,069,248) (1,320,925) (1,602,660) (1,776,277)
(1,069,248) (1,320,925) (1,602,660)
(12,951) (11,331) (7,620) (9,441)
883,930 657,725 1,830,347 1,677,829
883,930 657,725 1,830,347 1101~103
2104
- 71 -
(2)
()
99 100 101 102 103
104
6 30
( ) (204,907) (257,457) (295,559) (184,602) 37,066 5,780 16,150 10,985
(167,841) (251,677) (279,409) (173,617)
(167,841) (251,677) (281,735) (173,617)
( ) (167,841) (251,677) (281,735) (173,617)
( ) (2,639) 1,620 3,711 (1,821)
(170,480) (250,057) (278,024) (175,438)
(167,841) (251,677) (281,735) (175,438)
(170,480) (250,057) (278,024) (175,438)
( ) (0.87) (1.30) (1.32) (0.80) 1101~103 2104
- 72 -
(3)
()
99 100 101 102 103
808,270 665,324 536,403
5,446 4,255 4,843
179,834 141,741 96,078
64,475 43,070 22,122
1,058,025 854,390 659,446
16,877 15,148 14,233
16,877 15,148 14,233
16,877 15,148 14,233
16,877 15,148 14,233
1,930,600 1,930,600 1,937,650
8,796
(876,526) (1,081,046) (1,288,344)
(876,526) (1,081,046) (1,288,344)
(12,926) (10,312) (12,889)
1,041,148 839,242 645,213
1,041,148 839,242 645,213
99~101
(4)
()
99 100 101 102 103
44,372 37,076 37,066
(282,579) (241,596) (244,364)
(238,207) (204,520) (207,298)
(238,207) (204,520) (207,298)
(238,207) (204,520) (207,298)
( ) (1.34) (1.06) (1.07)
99~101
- 73 -
2.
(1)
()
99 100 101 102 103
472,151 309,456 1,454,344
4,812 3,171 16,214
333,344 333,344 333,344
22,025 2,334 1,136
894,849 708,385 1,876,422
10,919 50,660 46,075
10,919 50,660 46,075
10,919 50,660 46,075
10,919 50,660 46,075
1,937,650 1,941,720 2,165,770
28,479 48,261 1,274,857
(1,069,248) (1,320,925) (1,602,660)
(1,069,248) (1,320,925) (1,602,660)
(12,951) (11,331) (7,620)
883,930 657,725 1,830,347
883,930 657,725 1,830,347 101~103
(2)
()
99 100 101 102 103
( ) (201,117) (245,299) (296,305)
33,276 (6,378) 14,569
(167,841) (251,677) (281,736)
(167,841) (251,677) (281,735)
( ) (167,841) (251,677) (281,735)
( ) (2,639) 1,620 3,711
(170,480) (250,057) (278,024)
( ) (0.87) (1.30) (1.32)
101~103
- 74 -
(3)
()
99 100 101 102 103
717,266 597,262 472,151
87,154 62,806 61,066
5,174 4,164 4,812
179,834 141,741 96,078
64,120 42,969 22,025
1,053,548 848,942 656,132
12,400 9,700 10,919
12,400 9,700 10,919
12,400 9,700 10,919 12,400 9,700 10,919
1,930,600 1,930,600 1,937,650
8,796
(876,526) (1,081,046) (1,288,344)
(876,526) (1,081,046) (1,288,344)
(12,926) (10,312) (12,889)
1,041,148 839,242 645,213
1,041,148 839,242 645,213
99~101
(4)
()
99 100 101 102 103
34,045 37,073 36,894
(272,252) (241,593) (244,192)
(238,207) (204,520) (207,298)
(238,207) (204,520) (207,298)
(238,207) (204,520) (207,298)
( ) (1.34) (1.06) (1.07)
99~101
- 75 -
()
()
1.
99
100
101
102
103
2.
3.
99 5 21
4.
()
()
- 76 -
()
1.
( 1)
99 100 101 102 103
104
6 30
( 3)
1.58 7.97 2.68 4.83
(%)
18,251.70 20,741.88 11,288.68 9,988.27
3,768.73 656.71 3,038.54 1,658.96 3,757.99 653.90 3,036.52 1,657.42
(%)
()
()
()
()
()
(%) (17.25) (31.21) (21.71) (19.06)
(%) (17.52) (32.65) (22.65) (19.80)
(%) (8.66) (12.96) (12.90) (16.02)
(%)
() (0.87) (1.30) (1.32) (0.80)
(%) 2 2 2 2
(%) 2 2 2 2
(%) 2 2 2 2
1 1 1 1
1.10313.923102
2. 1101~103 2 3104
- 77 -
2.
( 1)
99 100 101 102 103
1.60 1.77 2.16
(%)
19,117.66 19,723.67 13,322.59
4,789.18 4,392.16 3,768.73
4,648.79 4,233.63 3,757.99
(%)
()
()
()
()
()
(%) (28.44) (21.39) (27.39)
(%) (29.06) (21.75) (27.93)
(14.62) (12.47) (12.61)
(%) (12.34) (10.59) (10.70)
(%)
() (1.34) (1.06) (1.07)
(%) 2 2 2
(%) 2 2 2
(%) 2 2 2
1 1 1
199~101
2
- 78 -
3.
( 1)
99 100 101 102 103
1.22 7.15 2.46
(%)
18,369.29 20,741.88 11,288.68
4,324.12 610.85 3,156.47
4,316.49 608.94 3,155.46
(%)
()
()
()
()
()
(%) (17.33) (31.40) (21.80)
(%) (17.52) (32.65) (22.65)
(%) (8.66) (12.96) (13.01)
(%)
() (0.87) (1.30) (1.32)
(%) 2 2 2
(%) 2 2 2
(%) 2 2 2
1 1 1
1.103 13.923 102
2.
1101~103
2
- 79 -
4.
( 1)
99 100 101 102 103
1.18 1.14 1.66
(%)
20,122.69 20,154.71 13,408.42
5,784.40 6,157.34 4,324.12
5,600.23 5,916.32 4,107.08
(%)
()
()
()
()
()
(%) (28.56) (21.50) (27.55)
(%) (29.06) (21.75) (27.93)
(11.14) (11.07) (12.42)
(%) (12.34) (10.59) (10.70)
(%)
() (1.34) (1.06) (1.07)
(%) 2 2 2
(%) 2 2 2
(%) 2 2 2
1 1 1 199~101 2
- 80 -
()
1.
103 102
% % %
407,463 21.67 68,631 9.60 338,832 493.70 103
1,114,891 59.28 279,245 39.07 835,646 299.25 103
5,203 0.28 25,187 3.52 (19,984) (79.34) 103
2,165,770 115.16 1,941,720 271.68 224,050 11.54 103
2.21
1,274,857 67.79 48,261 6.75 1,226,596 2,541.59
103
(1,602,660) (85.22) (1,320,925) (184.82) (281,735) (21.33)
,103
45,733 24,408 21,325 87.37
103
(279,409) (251,677) 27,732 11.02 103
(281,735) (251,677) 30,058 11.94 103
2.
103 102
% % %
333,276 17.76 5,192 0.73 328,084 6,319.03 103
1,114,100 59.37 278,500 39.31 835,600 300.04 103
4,652 0.25 24,547 3.47 (19,895) (81.05) 103
2,165,770 115.42 1,941,720 274.11 224,050 11.54 103
2.21
1,274,857 67.94 48,261 6.81 1,226,596 2,541.59
103
(1,602,660) (85.41) (1,320,925) (186.47) 281,735 21.33
,103
45,733 24,408 21,325 87.37
103
- 81 -
103 102
% % %
250,572 220,891 29,681 13.44
103 WuXi
(281,735) (251,677) 30,058 11.94 103
()
1.104 120-153
2.103 154-195
3.102 196-239
()
1.103 240-284
2.102 285-331
()
()
()
()
()
()
103 102
%
1,529,873 374,280 1,155,593 308.75
16,214 3,171 13,043 411.32
333,344 334,834 (1,490) (0.44)
1,265 2,433 (1,168) (48.01)
1,880,696 714,718 1,165,978 163.14
50,349 56,993 (6,644) (11.66)
50,349 56,993 (6,644) (11.66)
2,165,770 1,941,720 224,050 11.54
1,274,857 48,261 1,226,596 2,541.59
(1,602,660) (1,320,925) (281,735) (21.33)
(7,620) (11,331) 3,711 (32.75)
1,830,347 657,725 1,172,622 178.28
- 82 -
103 102
%
1. 103 13.923
2. 103 GMP
3. 103 220,000
4. 103 63
5. 103
6. 103
()
1.
103 102 () %
(45,733) (24,408) (21,325) 87.37
(249,826) (233,049) (16,777) 7.20
18,294 7,563 10,731 141.89
(2,144) (1,783) (361) 20.25
(279,409) (251,677) (27,732) (11.02)
(2,326) 0 (2,326) (100.00)
(281,735) (251,677) (30,058) (11.94)
3,711 1,620 2,091 129.07
(278,024) (250,057) (27,967) 11.18
1. 103 29,102
102
2. 103
3. 103 102
2.
- 83 -
()
1.
103 102 ()
96 9
2.
3.(104 )
()
1,522,354 916,547 496,885 1,942,016
103 13.923 104
()
()
1.
100% TaiMed USA Inc.
100
103
2.
TaiMed USA Inc (104 ) 2,233
TaiMed USA 104 TaiMed USA
500 103
2,344 104
()
- 84 -
()
()
() 328
()
329
330
331-332
()
1
()
333
328-329
334-337
- 85 -
338-408
338~365
366~380
()
103 104 17 (A)
()(B)
()(%)
B/A
()
17 - 100%
102.6.5
102.6.6
13 3 76% 102.6.5
17 - 100% 102.6.5
()
10 7 59% 102.6.5
()
13 3 76% 102.6.5
17 - 100% 102.6.5
2 - - 103.7.28
16 - 94% 102.6.5
15 - 88% 102.6.5
14 3
1.103.06.05 TMB-355
- 86 -
2.103.08.12
3.104.03.04
4.104.4.21 TMB-365(TMB-355 )
()
1. 99 5 21
2. 100 3 1
102
103 104
3.104 3 4 105
104 6 3
4.
5. 100 8
6.
7.
()
103
104 17 (A)
(%)
17 100% 102.6.5
15 88% 102.6.5
10 59% 102.6.5
()
()
1.
2.
3.
- 87 -
()
( )
()
()
()
()
()
105
- 88 -
()
()
()
()
()(
)
(
)
1.
2.
3.
4.
- 89 -
102
5.
6.
7.
8.
9.
10.
(
)
- 90 -
()
1.
()
1 2 3 4 5 6 7 8
0
0
5
(1)
(2)
(3)
(4)
(5)
(6)()()
(7)
()()
(8) 30
2.
(1) 3
(2)102 6 6 (105.6.5)103 104
4 (A)
(B)
(%)
B/A
4 0 100% 102.6.6
3 0 75% 102.6.6
3 1 75% 102.6.6
(
)
- 91 -
()
()
( )
()()
()
()()
()
()
()
()
()
()
()
()
- 92 -
()
()
()()
()
()
()
()
()
()
()
()
()
- 93 -
()
()
()
()
()
()
()
()
( )
()
()
()
- 94 -
1.
()
(Acquired Immunodeficiency SyndromeAIDS)
() 104
102 103 104
% % %
() - - - - - -
- - - - - -
- - - - - -
257,457 - 295,559 - 184,602 -
() (257,457) - (295,559) - (184,602) -
5,780 - 16,150 - 10,985 -
(251,677) - (279,409) - (173,617) -
- - - - - -
- - (2,326) - - -
() (251,677) - (281,735) - (173,617) -
1,941,720 2,165,770 2,167,940
( 1) (1.30) (1.32) (0.80)
() ( 2) (1.16) (1.30) (0.80)
1
2 104 6 216,794
()
1.
(1)TMB-355(Ibalizumab)
(Human Immunodeficiency Virus HIV)
/
TMB-355
(Food and Drug Administration FDA) 103 10
(Orphan-Drug Designation) TMB-355 104
2 (Breakthrough Therapy)
(2)TMB-360/365 TMB-355 HIV
(3)TMB-607
- 95 -
UNAIDS
94 102 AIDS
35%
HIV
HIV
88.86%
HIV HIV
IMS MIDAS 97 101
13.9% 101 121
HIV
1% GBI Research
101 HIV 143 101~108
1.9% 108 163
HIV
HIV
2.
TMB-355 100 6
(Phase IIb)
TMB-355
TMB-355
TMB-355 104 4
TMB-360/365 TMB-355
TMB-360 (Master Cell
BankMCB) TMB-365
TMB-607 (Bioavailability; BA)
TMB-360/365 TMB-607
(Investigational New DrugIND)
- 96 -
102 103 104
% % %
TMB-355
HIV
HIV
CD4+T
CD4+T HIV
TMB-360/ 365
HIV
TMB-360
TMB-355 HIV-1 T
TMB-365
TMB-607
HIV
HIV
HIV ritonavir
()
1.
104
2.
104
3.
104
4.
HIV HIV
(
)()()
PEP02 FDA EMA
OBI-822
/
- 97 -
102 103 104
- - - - - -
- - - - - -
- - - - - -
37,400 100.00 228,986 100.00 503,057 100.00
20,221 54.07 7,005 3.06 5,088 1.01
17,179 45.93 221,981 96.94 497,969 98.99
- - - - - -
- - - - - -
- - - - - -
(1)
102 ~103 104
102
37,400 Merrimack Pharmaceuticals, Inc.( Merrimack)
103 228,986 Merrimack
17,341 211,645
Merrimack Merrimack Baxter
PEP02 700
104 503,057 Merrimack
9,117 Merrimack Baxter FDA EMA
493,940 (1,600 )
PEP02
FDA EMA
Merrimack
(2)
102 45.93%103
104 Merrimack
92.43% 98.19% 104 103
102
- 98 -
PEP02
5.
102 103 104
- - - - - -
24,408 - 45,733 - 16,318 -
233,049 - 249,826 - 168,284 -
257,457 - 295,559 - 184,602 -
- - - - - -
() (257,457) - (295,559) - (184,602) -
(1)
104 257,457
295,559 184,602 104
A.
104 24,408 45,733
16,318
103 102 21,325 103
33,722 102 15,925 17,797 103
102 103
15,925 103
2,326
102 982 1,344
2,140
104 16,318 103
29,671 13,353 103
15,925
B.
104 233,049
249,826 168,284 TMB-355TMB360/365 TMB-607
- 99 -
103 102 16,777 103
102 16,289 6,146
9,202 23,140 7,163
103 85,391 102 16,289
102 103
13,178 103 8,640 102 6,146
TMB-607
4,041 103 21,534 102 9,202
CRO TMB-355 2b
9,749 103 70,823 102 23,140
102 TMB-355
2,000 93,963 103
TMB-355 51,299TMB-360/365
19,524 103
102 23,140 103 9,379 102
7,163 CRO Clinlogix TMB-355 2b
4,703
104 168,284 103
95,700 72,584 103
13,178 104
TMB-355 85,141
(2)()
104 257,457 295,559
184,602
TMB-355
TMB-360 TMB-607
104
6.
102 103 104
3,434 7,575 4,740
4,078 10,719 6,050
51 - -
() (1,697) (62) -
() (86) (2,082) 195
5,780 16,150 10,985
- 100 -
104
5,780 16,150 10,985
(1)
A.
104 3,434 7,575
4,740 102 TMB-355 1/2
103 2,387
TMB-607 5,188
103 102 4,141 104
TMB-355 TMB-607
112 4,628
B.
104 4,078 10,719
6,050 103 102
6,641 102 103 3
1,392,300 103 (
)1,497,563 102 338,131 1,159,432 103
104 6,050 4,057
103 3 104
C.
102 51 100
(2)
A.
104
1,697 62 0 102 1,697
103 62
1,697
B.()
104 ()(86)
(2,082) 195 103 2,082
104 (1,783)
(2,144) 195
- 101 -
()
1037
()
1047
()
(%)
() - - - -
- - - -
- - - -
151,098 201,632 50,534 33.44
() (151,098) (201,632) (50,534) (33.44)
5,846 10,798 4,952 84.71
(146,942) (190,834) (43,892) 29.87
(146,942) (190,834) (43,892) 29.87
1.
104 7 103 7
50,534 33.44% TMB-355
76,317 TMB-607 TMB-360/365
13,622 103 7
104 7 48,294
41,645
2.
104 7 103 7 4,952
84.71% 102 103 3
104 7
104 7 1,771
7 4,939
3.
104 7
103 7 43,892
TMB-355 76,317 TMB-607
TMB-360/365 13,622
103 7 104 7
48,294 41,645
()
1.
HIV
CD4+T (
) HIV CD4+T
HIV CD4+T 1,000
cells/mm3 CD4+T
- 102 -
200cells/ mm3
(Opportunistic InfectionsOIs)
HIV
(1) HIV
HIV
(Mutant
Strain) HIV (Drug Resistance)
HIV (
PIs RTIs)()
(Medication Adherence)
(2)
1996
(Highly Active Antiretroviral Therapy
HAART)
HIV
HIV
HIV
(
) HIV (multi-drug
resistance, MDR)
(3) HIV
HIV
HIV
(Gilead Sciences, Inc.)
(Bristol-Myers Squibb Company)ViiV (ViiV Healthcare Ltd.)
(Merck & Co., Inc)(Johnson & Johnson)
ViiV J&J
- 103 -
USD$10,000-$30,000
100 120 HIV 86%
4-5 40%-50%
HIV 3-4
8-10%
HIV (Reverse
Transcriptase Inhibitors RTIs)(Protease Inhibitors
PIs)(Integrase Inhibitors IIs)(Entry
& Fusion Inhibitors EIs/FIs) HIV RTIs
PIs IIs RTIs PIs
HIV
EIs/FIs 92
EIs/FIs HIV HIV
RTIsPIs IIs HIV
EIs/FIs
HIV
FIs/EIs RTIs
2.
(1)()
HIV
HIV
(
) HIV
(multi-drug resistanceMDR)
TMB-355 TMB-360/365
T CD4
HIV HIV
- 104 -
(2)
TMB-355TMB-360/365 TMB-607
(3)
TMB-355
TMB-360/365 TMB-355
TMB-355 HIV CD4+T
HIV HIV TMB-355
TMB-360/365 TMB-355
52
(4)
HIV IMS MIDAS
97 101 13.9%101 121
GBI Research HIV
101 HIV
143 101 ~108 1.9% 108
163
- 105 -
3.
/
TMB-355
-
-
*
TMB-355 Biogen Idec Inc
87
Tanox Inc.
Genentech Inc. 96
Tanox Inc. 96
Genentech Inc. *
*
1.
2.
1.TMB-355 HIV
T
CD4
CD4
2. TMB-355
3.TMB-355
HIV
TMB-355
/
-
-
*
*
*
/
1. TMB-355 TMB-355
(
)
HIV
TMB-360/365
-
-
*
101
103
*
*
1.TMB-365 TMB-360
2.TMB-360/365TMB-355 52
- 106 -
/
HIV-1 T TMB-355
TMB-360/365
TMB-607
-
-
*
100 Ambrilia
Biopharma Inc. *
*
1.TMB-607
2. TMB-607
TMB-607
HIV
TMB-355TMB-360/365 TMB-607 TMB-355
TMB-360/365 TMB-355
TMB-607
TMB-355 TMB-360/365
- 107 -
4.
(1)
12~15 8
A.
TMB-355 TMB-607
B.
C.
D.
103
13
(2)
A.
- 108 -
CRO
B. TMB-355 103 10 21
FDA TMB-355 104 2 24
FDA
FDA
FDA TMB-355
FDA
()
HIV HIV
TMB-355
105
TMB-355 FDA
TMB-355
TMB-355 /
TMB-360/365 TMB-607
104
257,457 295,559 184,602 103
103 102 14.80%
104 5,780 16,150 10,985
TMB-355TMB-607
103 102 179.41%
104 251,677 279,409
173,617
104
- 109 -
2.
TMB-355 TMB360/365
()
()
()
CD4+T
()
TMB-355 HIV(Human Immunodeficiency Virus)
CD4+T HIV HIV
TMB-355
()
TMB-360/365 TMB-355 TMB-355
TMB-360/365
TMB-355TMB-360/365TMB-607
Allergan Allergan
TMB-355
TMB-355 FDA
103 10 TMB-355 104 2
()
1.
- 110 -
(Orphan Drug Act, ODA)
(1)(2)FDA (3)
(4)
2.
()
(7 )
FDA TMB-355
FDA
TMB-355 TMB-360/365 HIV
(First-in-class)
TMB-355 TMB-360/365 T
CD4 HIV
HIV
TMB-355TMB-360 TMB-607
- 111 -
3.
1.TMB-355
TMB-355 5 5,871,732
6,331,4155,585,0895,693,761 5,530,101()
No.1( 5,871,732) 96 Genentech
TMB-355 TMB-355 TMB-355
104 4 15
Genentech Biogen (TMB-355 Biogen Idec Inc
1998 Tanox Inc. Genentech Inc. 2007
Tanox 2007 Genentech (Tanox Genentech
) TMB-355
Genentech Biogen )
No.2( 6,331,415) Genentech
TMB-355 107 12
17 Genentech
No.3~5( 5,585,0895,693,761 5,530,101)
Protein
Design Labs Biopharma Inc. ( PDL) PDL
PDL
PDL
- 112 -
5
No.
1
Anti-CD4 antibody
homologs useful in
prophylaxis and
treatment of AIDS,
ARC and HIV
infection
5,871,732 Biogen
Idec Inc
88/02/16
-104/04/15
96/09/11-
104/04/15
TMB-355 Biogen Idec Inc( Biogen) 87
Tanox Inc. ( Tanox) Genentech Inc,
( Genentech) 96 Tanox 96 9 Genentech
No.1 2 TMB-355
TMB-355
TMB-355
Genentech
2
Methods of producing
immunoglobulins,
vectors and
transformed host cells
for use therein
6,331,415 Genentech
Inc
90/12/18-
107/12/17
96/09/11-
107/12/17
96 9 Genentech (Cabilly Coexpression Patents)
3 Humanized
immunoglobulins 5,585,089
96/09/11-
104/06/06
4
Polynucleotides
encoding improved
humanized
immunoglobulins
5,693,761
84/06/07-
104/06/06
96/09/11-
104/06/06
5 Humanized
immunoglobulins 5,530,101
Protein
Design
Labs
Biopharma
Inc.
85/06/25-
102/06/24
96/09/11-
102/06/24
TMB-355
No. 3-5(
) PDL
No.1 Genentech
4.7 PDL
PDL
2.TMB-360/365 1
TMB-360 (TaiMed Biologics USA Corp.) 101
TMB-355 LM52
GLYCAN-MODIFIED ANTI-CD4 ANTIBODIES FOR
HIV PREVENTION AND THERAPY
- 113 -
No.
14/132,667
14/133,256 1
GLYCAN-MODIFIED
ANTI-CD4 ANTIBODIES
FOR HIV PREVENTION
AND THERAPY 102147105
102/12/18
20
102/12/18-
122/12/17
101
3.TMB-607 8
TMB-607 100 Ambrilia Ambrilia
No.
6,455,587 89/03/15-
109/03/14
100/03/10-
109/03/14 1
AMINO ACID DERIVATIVES AS HIV
ASPARTYL PROTEASE INHIBITORS
EP1263716 90/03/07-
110/03/06
100/03/10-
110/03/06
6,506,786
6,656,965
6,610,689
6,608,100
6,677,367
90/02/13-
110/02/12
100/03/10-
110/02/12 2
HIV PROTEASE INHIBITORS BASED
ON AMINO ACID DERIVATIVES
EP1377542 91/02/12-
111/02/11
100/03/10-
111/02/11
6,528,532 91/02/13-
111/02/12
100/03/10-
111/02/12
EP1480941 92/02/25-
112/02/24
100/03/10-
112/02/24 3
UREA DERIVATIVES AS HIV
ASPARTYL PROTEASE INHIBITORS
4283681 92/02/25-
112/02/24
100/03/10-
112/02/24
6,632,816 91/12/23-
109/12/23
100/03/10-
109/12/23 4
AROMATIC DERIVATIVES AS HIV
ASPARTYL PROTEASE INHIBITORS
EP1575914
EP2258680
EP2258681
Ambrilia Biopharma
Inc.
92/07/24-
112/07/23
100/03/10-
112/07/23
TMB-607 100 Ambrilia Biopharma Inc.( Ambrilia)
- 114 -
No.
5250732 92/07/24-
112/07/23
100/03/10-
112/07/23
7,388,008 93/08/02-
113/08/01
100/03/10-
113/08/01
8,008,297 97/04/04-
117/04/03
100/03/10-
117/04/03
EP1773763 93/08/02-
113/08/01
100/03/10-
113/08/01
4579970 93/08/02-
113/08/01
100/03/10-
113/08/01
5
Lysine-BASED PRODRUGS OF
ASPARTYL PROTEASE INHIBITORS
AND PROCESSES FOR THEIR
PREPARATION (Lysine based
compounds)
200480042798
.0
93/08/02-
113/08/01
100/03/10-
113/08/01
8,227,450 99/01/28-
119/07/24
100/03/10-
119/07/24
8,580,995 97/06/19-
119/02/10
100/03/10-
119/02/10
EP1971615 95/11/30-
115/11/29
100/03/10-
115/11/29
6
Lysine-BASED PRODRUGS OF
ASPARTYL PROTEASE INHIBITORS
AND PROCESSES FOR THEIR
PREPARATION (Lysine based
compounds)
1149706 95/11/30-
115/11/29
100/03/10-
115/11/29
7
PROTEASE INHIBITORS AND
PROTEASE INHIBITOR
PRECURSORS(Method for Improving
Pharmacokinetics of Protease Inhibitors
and Protease inhibitors Precursors)
95/11/30- 115/11/29
20
100/03/10- 115/11/29
8,410,300 98/03/19-
121/08/14
100/03/10-
121/08/14
8,742,158 98/03/19-
118/03/18
100/03/10-
118/03/18
5401652 96/09/20-
116/09/19
100/03/10-
116/09/19
8
Protease
Inhibitors(BENZENESULFONAMIDE
DERIVATIVES AS HIV PROTEASE
INHIBITORS)
07872067.9 96/09/20-
116/09/19
100/03/10-
116/09/19
- 115 -
1.TMB-355
TMB-355 Genentech
Medical Research Council ( MRC)
(1)96 Genentech Exclusive License Agreement For Anti-CD4
Antibody
TMB-355 96 GenentechExclusive License Agreement For
Anti-CD4 Antibody
Genentech
A. 5,000 10,000
B. 10,000
C.
Genentech Biogen
A. 100 3,000
B.
2.2.3 100 TMB-355
96
97 11 Genentech TMB-355
103 TMB-355 109
(2)96 Genentech Non-Exclusive License Agreement- Cabilly
Coexpression Patents
GenentechNon-Exclusive License Agreement- Cabilly
Coexpression Patents
1,250
(3)98 MRC Materials use License Agreement
TMB-355 NS0 Tanox MRC
MRC Materials use License
Agreement TMB-355
2 TMB-360/365
TMB-360/365 LM-52 ( TMB-355 )
101 ( 103
)
A. 20 80
B. 200 2,000
- 116 -
C.
D.
3. TMB-607
TMB-607 100 Ambrilia
A. 100 4,000
B.
C.
1~3.TMB-355TMB-360/365 TMB-607
2
1. Genentech 96 9 TMB-355 2.2.3
100 12 31 TMB-355
2. Genentech 97 11 TMB-355
103 12 31
100 12 31
() 103 12 31
() 106 12 31
109 12 31
1.
2.
TMB-355 5 TMB-607 8
TMB-355 5 4
Genentech TMB-355 5
No /
1 Anti-CD4 antibody homologs useful in prophylaxis and
treatment of AIDS, ARC and HIV infection
96/09/11-
104/04/15
- 117 -
2 Methods of produ