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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

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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 -

()

()

( )

()()

()

()()

()

()

()

()

()

()

()

()

email

- 92 -

()

()

()()

()

()

()

()

()

()

()

()

()

- 93 -

()

()

()

()

()

()

()

()

email

( )

()

()

()

- 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


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


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


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


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

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