!! µ! · { - (11,960) k c ^ (257,674) (138,516) 119,158 m ÷ g s È é k b o ú e ` þ i ...

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Transcript of !! µ! · { - (11,960) k c ^ (257,674) (138,516) 119,158 m ÷ g s È é k b o ú e ` þ i ...

Page 1: !! µ! · { - (11,960) k c ^ (257,674) (138,516) 119,158 m ÷ g s È é k b o ú e ` þ i ...
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107

Dry Age-Related Macular Degeneration Stargardt

Disease LBS-008 LBS-008 FDA

Rare Pediatric Disease Designation LBS-008

7 10

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107 LBS-008

108 SAD

MAD LBS-008 PK PD

LBS-008 106 9 FDA

Orphan Drug Designation 107 5

EMA 107 6 FDA

LBS-008

LBS-008

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LBS-008 National Institute for Health Research

NIHR

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LBS-007 107 3 FDA

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107 (A) 107 (B) (B-A)

- - -

- - -

- - -

256,878 155,604 (101,274)

(256,878) (155,604) 101,274

(796) 5,128 5,924

(257,674) (150,476) 107,198

- (11,960) (11,960)

(257,674) (138,516) 119,158

107 106

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(155,604) (161,330)

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(141,025) (159,626)

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LBS-008 LBS-007

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LBS-007

LBS-009

NAFLD

NASH

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108

unmet medical

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LBS-008 /

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108 4 12

FDA LBS-007

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【★】LBS-008

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105 5 12

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(1) Lin Scientific Inc.

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

1.

2.

3.

4.

5.

6.

7.

8.

107.09.27

1.

2.

107.10.12

1.

2.

3.

-37-

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/

4.

5.

6.

7. 107

8. RBP4 Pty Ltd

9. 107

10.

107.12.12

1. 108

2. 108

3. 108

108.02.25

1.

2.

3. Lin BioScience, LLC

4. Lin BioScience, LLC

5.

108.04.22

1.

2.

3. 107

4.

5.

6. 107

7. 107

8. 108

108 5 31

106.08.22 107.08.10

-38-

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1 2,000 � � �

2 2,000 4,000

3 4,000 6,000

4 6,000 8,000

5 8,000 10,000

6 10,000

1,350 50 50107.01.01~

107.12.31

107.01.01~107.12.31

-39-

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107 5 31

Lin Scientific Inc.

( 1)

( 2) 80

( 1)

( 2)

( 1) 250

( 1)

( 1)

( 1)

( 3)

( 3)

(241) (68)

225

125

( 4)

( 4) 19

1 107 9 27

2 107 9 27

3 107 6 25 107 9 27

4 107 8 10

-40-

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107.04.26 265

108.01.02 68

108 4 30 %

( )

Lin Scientific Inc.8,288 13.93

: 176 0.30 8,288 13.93

2,887 4.85

: 2,000 3.36 1,000 1.68 2,887 4.85

2,849 4.79

2,462 4.14

2,442 4.10

:

2,421 4.07

2,330 3.92 500 0.84

2,200 3.70

: 500 0.84 2,330 3.92

2,000 3.36 1,000 1.68 2,887 4.85

1,788 3.01

-41-

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108 4 30 %

1

Lin Bioscience International Ltd. 7,940,321 100 7,940,321 100

Belite Bio, Inc 7,840,321 100 7,840,321 100

Belite Bio Holdings Corp. 3,300 100 3,300 100

Belite Bio, LLC 2 100 100

RBP4 Pty Ltd 1,800,100 100 1,800,100 100

Lin BioScience Pty Ltd 1,456,036 100 1,456,036 100

1

2 Belite Bio, LLC 165

-42-

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( )

105.05 10 20,000 200,000 500 5,000 1

105.07 10 20,000 200,000 2,300 23,000 18,000 2

105.10 10 100,000 1,000,000 52,000 520,000 497,000 3

106.06 10 100,000 1,000,000 56,170 561,70041,700

4

106.10 10 100,000 1,000,000 56,486 564,8603,160

5

106.11 60 100,000 1,000,000 58,786 587,860 23,000 6

107.01 10 100,000 1,000,000 59,386 593,8606,000

7

107.03 10 100,000 1,000,000 59,500 595,0001,140

8

1 105 05 12 10585376500

2 105 07 28 10590326600

3 105 10 06 10501235730

4 106 06 27 10601084570

5 106 10 16 10601144790

6 106 11 28 10601155520

7 107 01 10 10701000180

8 107 03 06 10701023730

108 4 30

59,500,000 40,500,000 100,000,000107 10 8

108 4 30

15 276 2 293

15,276,798 35,904,202 8,319,000 59,500,000

25.68% 60.34% 13.98% 100.00%

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107 4 30

1 999 10 1,598 0.00%

1,000 5,000 132 285,210 0.48%

5,001 10,000 25 210,000 0.35%

10,001 15,000 7 88,003 0.15%

15,001 20,000 12 227,332 0.38%

20,001 30,000 7 183,000 0.31%

30,001 40,000 8 288,400 0.49%

40,001 50,000 8 375,815 0.63%

50,001 100,000 23 1,856,000 3.12%

100,001 200,000 16 2,607,484 4.38%

200,001 400,000 11 3,127,553 5.26%

400,001 600,000 7 3,668,500 6.17%

600,001 800,000 4 2,966,150 4.98%

800,001 1,000,000 10 9,549,621 16.05%

1,000,001 13 34,065,334 57.25%

293 59,500,000 100.00%

108 04 30

Lin Scientific Inc. 8,288,000 13.93%

2,887,000 4.85%

2,849,300 4.79%

2,462,000 4.14%

2,442,300 4.10%

2,421,334 4.07%

2,330,000 3.92%

2,200,000 3.70%

2,000,000 3.36%

1,788,200 3.01%

29,668,134 49.87%

-44-

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106 107108

5 31

( 1)

63.99 41.19

36 36.51

44.74 38.70

8.71 6.34 ( 2)

8.71 6.34 ( 2)

54,767 59,482 ( 2)

(2.91) (2.33) ( 2)

( 3)

1 107 10 8

2

107

3 106 107

108 4 22

108 6 28

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107

1.

2.

-46-

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108 5 31

106 107

( ) 107 9 28

106 2 21 107 10 4

10 10

5,200,000 4,000,000

8.74% 6.72%

106 2 21 ~

116 2 20

%

50%

75%

100%

5,200

52,000

4,000,000

10 60

%6.72%

167 2

-47-

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10

85

31

3,7

35

6.2

7%

3,4

00

10

34,0

00

5.7

1%

335

60

20,1

00

0.5

6%

2,9

09

4.8

9%

1,7

04

10

17,0

40

2.8

6%

1,2

05

60

72,3

00

2.0

3%

Jaso

n

Ole

jnic

zak

Jess

ica

Cri

sp

Ric

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ong

-48-

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-49-

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1.

A.

105 5 First-in-class

-LBS-008

-LBS-007

-LBS-009

-LBS-002

a.LBS-008LBS-008 Columbia University

National Institutes of Health NIH

LBS-008

107 10

- : ACTRN12618001823268

NIH 108 4 12

FDA (IND)

IND : 139576 LBS-008

NIH (Blueprint Program)

NIH

Dry Age-Related Macular DegenerationA A2E

The Lancet 109 2

129 3

GlobalData 1,000

GlobalData 90% 10%

3C

-50-

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NIH LBS-008

Blueprint Program

NIH NIH Blueprint Program NIH 15

96

NIH

NIH

NIH

4 Retinol Binding Protein 4 RBP4A

A A2E

LBS-008

RBP4

A2E

LBS-008 NIH

NIH

NIH

LBS-008 107 5

National Institute for Health Research NIHR

8,000

Systematic Review

A2E

Fenretinide RBP4

A RBP4 Fenretinide

RBP4

-51-

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A A2E

RBP4 RBP4

RBP4

NIHR LBS-008

Fenretinide

Stargardt Disease20

3 LBS-008 106 9 107

5 FDA

EMA

LBS-008 107 6 FDA

18

Priority Review Voucher

FDA

United Therapeutics 104 3.5 AbbVie

LBS-008

Fast Track Accelerated

Approval

b.LBS-007LBS-007

Memorial Sloan Kettering Cancer Center

Acute myeloid leukemia AML

Acute Lymphoblastic Leukemia ALL20

2-5

AML ALL

LBS-007 107

3 FDA ALL

7 Cell Division Cycle 7 CDC7DNA

CDC7 LBS-007 CDC7

CDC7 DNA

CDC7

Takeda Eli Lilly

CDC7

LBS-007 ATP

-52-

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LBS-007

c.

University of Sydney

106 Johnson & Johnson

JLABS

106

JLABS

B.

RBP4 CDC7

a.RBP4 400

RBP4

A A2E

A RBP4

RBP4

A A2E

RBP4 CD4 T

RBP4

NIH

RBP4

400

LBS-008

LBS-009

RBP4 LBS-008

-53-

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LBS-009

RBP4

b.CDC7

CDC7

CDC7

CDC7

LBS-007

LBS-007

QYResearch 105

1,213 111 1,732

7.4% LBS-007

C.

First-in-class

blockbuster

LBS-008 106 9 107 5

FDA EMA

107 6 FDA

LBS-007 107 3 FDA

RBP4 CDC7

107

-54-

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2.

3.

Unmet

medical needs First-in-class Proven mechanism

Orphan drug Blockbuster

A.

LBS-008107

LBS-007109

LBS-009

NAFLD

NASH

LBS-002

B.

RBP4

RBP4

400

LBS-008

LBS-009

CDC7

CDC7

CDC7

LBS-007

CDC7

LBS-007

4. ( )

LBS-003

omega-3

omega-3

-55-

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1.

A.

IMS Health 105

1.1 110 1.5

4%~7%

7,493

67.83%

2,429 21.99%

4,617 1,167

105 105~110

749.3 4%~7%

461.7 6%~9%

151.8 1%~4%

242.9 6%~9%

116.7 5%~8%

112.4 3%~6%

1,104.6 4%~7%

Outlook for Global Medicine through 2021, IMS Health, 2016

1,000 1 7

2,550

unmet medical needs

NIH

96 Blueprint Program

NIH

NIH 15

(A)

FDA 105 22 15

7 2 (diagnostic imaging agent)

First-in-class 8 36%

9 41%

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-57-

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10

EvaluatePharma 105 113

111 217

104 1,020

15.5% 109 1,760

2 20

9 2 6

B.

106 World Polulation Prospects 60

9.6 139 21 189 31 80

106 1.37 139 4.25

189 9.09

105

3

unmet medical needs

TheLancet 109 2 129

3

GlobalData 1,000

GlobalData

90% 10%

3C

WHO

64 BMI>30 105

BMI>25 19 5-19

64 4% 105

18%

National

Center for Chronic Disease Prevention and Health Promotion 86%

97

1,470 American Diabetes

Association 101 1,760

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PhRMA 65 1,900

92% 72%

C.

IMS Health 105

753 Statista 105

10

9%~12%

110 1,200

105 110

753 1,200~1,350 9%~12%

662 950~1,100 8%~11%

451 750~900 11%~14%

679 750~900 2%~5%

705 700~800 0%~3%

544 600~700 2%~5%

544 600~700 2%~5%

368 350~400 -1%~2%

246 350~400 6%~9%

332 350~400 0%~3%

Outlook for Global Medicine through 2021, IMS Health, 2016

Rituxan 75 Revlimid 42

Avastin 67 Velcade 26

Herceptin 65 Alimta 25

Imbruvica 53 Erbitux 19

Gleevec 47 Gardasil 18

Statista, Top cancer drugs based on revenue worldwide 2016

ALL AML

CLL (CML

AML (ALL National

Cancer Institute 10 4.2

AML GlobalData

105 4.3 18

AML 7.4

10 1.7 ALL 20

2-5

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AML

ALL

2.61%

(Blood Brain Barrier, BBB)

American Cancer Society 46.5

10 29.5

1.25 11.5

25%

2.

→ → GMP

/

-60-

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GMP

3.

A.LBS-008

A

A2E

3C

9

200

ABCA4

20

RBP4 A LBS-008

RBP4 A

A2E

LBS-008 NIH NIH NIH

LBS-008

NIHR National Institute Health Research

Systematic Review

RBP4

LBS-008

LBS-008 106 9 107 5

FDA EMA

107 6 FDA

LBS-008 RBP4

8

B.LBS-007

ALL

AML CLL

CML

-61-

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CDC7

CDC7

LBS-007 ATP CDC7 CDC7

LBS-007

LBS-007 107 3 FDA

LBS-007 2

C.LBS-009

4 RBP4

LBS-009

LBS-008

4

LBS-008

LBS-009 LBS-009

LBS-009 LBS-008 RBP4

8

LBS-009

PCT 4 108

D.LBS-002

LBS-002

-62-

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105 104

106

2

109

4.

A.LBS-008

LBS-008

A RBP4 A

A2E

(1) Acucela Emixustat RPE65 RPE65

RPE65

/

(2) Alkeus ALK-001

A Deuterated Vitamin A

A A A2E

B.LBS-007

CDC7

Takeda TAK-931 CDC7

TAK-931 ATP ATP competitive inhibitor

CDC7 ATP

ATP

LBS-007 ATP

TAK-931

LBS-007

Eli Lilly LY3143921 CDC7 p53

LY3143921

-63-

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LY3143921 LBS-007

C.LBS-009

Intercept Ocaliva

Genfit Elafibranor Intercept Ocaliva

108 2 Ocaliva

LBS-009

D.LBS-002

Taxol Domain Vinca Domain

Colchicine Domain

(1)

A.RBP4 400

RBP4

RBP4

A2E

RBP4 CD4 T

RBP4

NIH

RBP4

400

LBS-008

LBS-009

RBP4 LBS-008 LBS-009

NIHR National Institute Health Research 107

Systematic

Review LBS-008 RBP4

RBP4

-64-

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B.CDC7

CDC7 DNA

CDC7 CDC7

DNA

CDC7

Takeda Eli Lilly CDC7

CDC7

CDC7

LBS-007

LBS-007

ATP

LBS-007

(2)

A.LBS-008

LBS-008 107 10

- :

ACTRN12618001823268 108

LBS-008 108 4 FDA IND

NIH

SAD 48

NIH

/ /

LBS-008 RBP4

8

LBS-008 106 9 107 5

FDA EMA

LBS-008 107 6 FDA

18

Priority Review

Voucher FDA

United Therapeutics 104 3.5

AbbVie

LBS-008

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Fast Track

Accelerated Approval

B.LBS-007

LBS-007 109

21 7 111

LBS-007 2

LBS-007 107 3 FDA

C.LBS-009

LBS-009

110

LBS-009 RBP4

LBS-009 RBP4

LBS-009 LBS-008 RBP4

8

LBS-009

PCT 4 108

D.LBS-002

LBS-002

LBS-002

fluoxetine LBS-002

LBS-002

LBS-002

LBS-002 105 104

106

2

109

-66-

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(3)

A.

107 108 5 31

5 4

3 3

/ 1 1

0 0

9 8

B.

(A)

(B)

8

(C) 13

(4)

%

103 104 105 106 107

32,423 122,853 104,002

190

17,064.74

105 5 12

(5)

105 4 RBP4

CDC7 105 107

RBP4

LBS-008 LBS-009

LBS-008 107 108

/ /

-67-

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LBS-009 110 CDC7

ATP CDC7 LBS-007

109

:

1.

107 ~108 LBS-008

109 ~112 LBS-008

/ /

109 ~111 LBS-007

107 ~109 LBS-009

107 ~111 LBS-002

107 ~111 LBS-003

2.

110 ~112 LBS-007

111 ~113 LBS-007

110 ~111 LBS-009

112 ~114 LBS-002

112 ~114 LBS-003

-68-

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1. ( ) ( )

LBS-008 LBS-007

LBS-009 LBS-002

2.

3.

A.LBS-008

GlobalData (PharmaPoint Age-Related Macular

Degeneration - Global Drug Forecast and Market Analysis to 2026)

111 1,100 The Lancet 109

2 129 3

Eylea Regeneron Lucentis

Roche Novartis 107 Eylea

100 90% 10%

9

200

EvaluatePharma 104

1,020 109 1,760

2 WiseGuyReports 105

8 116 16

6.7%

B.LBS-007

LBS-007 LBS-008 CDC7

LBS-007

Avastin

Keytruda (PD-1 Inhibitor) 107

67 71 Keytruda 107

88%

C.LBS-009

GlobalData (OpportunityAnalyzer NASH and Opportunity

Analysis and Forecasts to 2026) 106

3,100

GlobalData NASH

115 220

-69-

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D.LBS-002

Cancer.Net 106 2.4

Avastin

Radiation Oncology 40%

BMJ Journal

Japanese Journal of Clinical Oncology

GlobalData

32 110 49

4.

A.

LBS-008 A

RBP4 A

A2E

LBS-008

LBS-008

B.

RBP4 CDC7

(A)RBP4 RBP4

400

LBS-008

LBS-009

RBP4

LBS-008 LBS-009

(B)CDC7 CDC7

CDC7

CDC7

LBS-007

-70-

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(C)

106

JLABS

5.

(A)

a.

JLABS

b.

LBS-008 1,000

FDA EMA

FDA LBS-007

FDA

c.

LBS-008

NIH

LBS-002 LBS-003

(B)

a.

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b.

LBS-008 LBS-007

LBS-009 LBS-002

LBS-003

LBS-008 LBS-007

c.

1.

A.LBS-008

B.LBS-007

C.LBS-009 /

D.LBS-002

2.

( )

105 5 106 107

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106 107 5 31

4 4 4

6 8 8

5 7 6

15 19 18

35 34 34

0.97 1.48 1.92

4 6 5

8 8 8

3 5 5

0 0 0

0 0 0

1.

2.

3.

4.

-73-

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Columbia University 105/09/13~LBS-008

Columbia University 105/10/25~LBS-007

The University of

Sydney105/12/05~

LBS-002

Janssen Research &

Development, LLC108/03/15~

J&J

JLabs

108/01/01~108/12/31

105/10/01~108/09/30

Kostantin Pertrukhin 105/09/16~LBS-008

Mark G. Frattini 108/01/01~108/12/31LBS-007

Columbia University 108/3/28~

LBS-008

RBP4

Linear Clinical Research

Ltd107/10/24~ LBS-008

INC Research LLC 107/10/24~

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1.

2

103 104 105 106 107

411,194 425,734 281,341

2,088 3,107 2,777

111,925 112,559 109,739

1,665 1,150 1,482

526,872 542,550 395,339

49,010 25,254 17,850

49,010 25,254 17,850

49,010 25,254 17,850

49,010 25,254 17,850

477,862 517,296 377,489

520,000 593,860 595,000

125,200 125,278

( )

(42,190) (201,309) (339,825)

(42,190) (201,309) (339,825)

52 (455) (2,964)

477,862 517,296 377,489

477,862 517,296 377,489

1 105

2 105 5 12 5

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2.

2

103 104 105 106 107

190

190

(41,260) (161,330) (155,604)

(930) 2,211 5,128

(42,190) (159,119) (150,476)

( )(42,190) (159,119) (138,516)

( ) (42,190) (159,119) (138,516)

( )52 (507) (2,509)

(42,138) (159,626) (141,025)

(42,190) (159,119) (138,516)

(42,138) (159,626) (141,025)

( ) (1.61) (2.91) (2.33)

1 105

2 105 5 12 5

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3.

2

103 104 105 106 107

408,797 392,497 199,415

2,243 29,329 151,706

2,088 2,879 1,819

111,925 112,559 32,595

1,665 793 763

526,718 538,057 386,298

48,856 14,668 8,809

48,856 14,668 8,809

6,093

48,856 20,761 8,809

48,856 20,761 8,809

477,862 517,296 377,489

520,000 593,860 595,000

125,200 125,278

(

)

(42,190) (201,309) (339,825)

(42,190) (201,309) (339,825)

52 (455) (2,964)

477,862 517,296 377,489

477,862 517,296 377,489

1 105

2 105 5 12 5

-77-

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4.

2

103 104 105 106 107

190

190

(40,293) (114,106) (79,264)

(1,897) (45,013) (59,107)

(42,190) (159,119) (138,371)

( )(42,190) (159,119) (138,516)

( ) (42,190) (159,119) (138,516)

( )52 (507) (2,509)

(42,138) (159,626) (141,025)

( ) (1.61) (2.91) (2.33)

1 105

2 105 5 12 5

103 ( ) ( ) ( )

104 ( ) ( ) ( )

105

106

107

105 5 12 103 104

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1.

( 2)

103 104 105 106 107

9.30 4.65 4.51

22,886.11 16,649.37 13,593.41

( )

839.00 1,685.81 1,576.14

838.80 1,671.77 1,551.11

( 4)

( 5) (29.76) (29.53)

( 5) (31.98) (30.96)

(8.11) (26.79) (25.29)

(22,205.26)

(1.61) (2.91) (2.33)

( 6)

( 7)

20%

1

2 105 5 12 5

3 105

4

5 105

6

7

8

1.

(1)

(2)

2.

-79-

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(1)

(2)

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3.

(1) ( ) (

)

(2) 365

(3)

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)

(5) 365

(6)

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(2)

(3)

(4)

5.

(1)

(2) (

)

(3) ( ) (

)

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(1) ( )

(2) ( )

-80-

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2.

( 2)

103 104 105 106 107

9.28 3.86 2.28

22,886.11 18,179.54 20,752.56

( )

836.74 2,675.87 2,263.76

836.54 2,662.18 2,229.87

( 4)

( 5) (29.89) (29.97)

( 5) (31.98) (30.96)

(8.11) (26.79) (23.26)

(22,205.26)

(1.61) (2.91) (2.33)

( 6)

( 7)

20%

107

1

2 105 5 12 5

3 105

4

5 105

6

7

-81-

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審計委員會查核報告書

董事會造送本公司民國一○七年度營業報告書、財務報表及虧損撥補

表之議案等各項表冊,其中財務報表業經勤業眾信聯合會計師事務所

查核完竣,並出具查核報告。上述營業報告書、財務報表及虧損撥補

表之議案,業經本審計委員會查核,認為尚無不符,爰依證券交易法

第十四條之四及公司法第二百一十九條之規定報告如上,敬請 鑒

核。

仁新醫藥股份有限公司

審計委員會召集人:涂三遷

中 華 民 國 一 ○ 八 年 四 月 二 十 二 日

三、最近年度財務報告之監察人或審計委員會審查報告

-82-

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98 146

147 197

-83-

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106 107%

425,734 281,341 (144,393) (33.92)

3,107 2,777 (330) (10.62)

112,559 109,739 (2,820) (2.51)

1,150 1,482 332 28.87

542,550 395,339 (147,211) (27.13)

25,254 17,850 (7,404) (29.32)

25,254 17,850 (7,404) (29.32)

593,860 595,000 1,140 0.19

125,200 125,278 78 0.06

(201,309) (339,825) (138,516) 68.81

(455) (2,964) (2,509) 551.43

517,296 377,489 (139,807) (27.03)

10% 1%

1.

2. 107

3. 107

106 107%

392,497 199,415 (193,082) (49.19)

29,329 151,706 122,377 417.26

2,879 1,819 (1,060) (36.82)

112,559 32,595 (79,964) (71.04)

793 763 (30) (3.78)

538,057 386,298 (151,759) (28.21)

14,668 8,809 (5,859) (39.94)

6,093 (6,093) (100.00)

20,761 8,809 (11,952) (57.57)

593,860 595,000 1,140 0.19

125,200 125,278 78 0.06

(201,309) (339,825) (138,516) 68.81

(455) (2,964) (2,509) 551.43

517,296 377,489 (139,807) (27.03)

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106 107%

10% 1%

1.

2. 107 LBS-008

3. LBS-008

4. 107

5.

6. 107

106 107%

161,330 155,604 (5,726) (3.55)

(161,330) (155,604) 5,726 (3.55)

2,211 5,128 2,917 131.93

(159,119) (150,476) 8,643 (5.43)

(159,119) (138,516) 20,603 (12.95)

10% 1%

1. 107

106 107%

114,106 79,264 (34,842) (30.53)

(114,106) (79,264) 34,842 (30.53)

(45,013) (59,107) (14,094) 31.31

(159,119) (138,371) 20,748 (13.04)

(159,119) (138,516) 20,603 (12.95)

10% 1%

1. LBS-008

-85-

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106 107%

2.

3. 107

4. 107

1.

106 107

%

(247,656) (125,925) 121,731 (49.15)

(34,858) (473) 34,385 (98.64)

188,860 1,140 (187,720) (99.40)

1. 106 107

2. 106 107

3. 106

2.

106 107

%

(231,954) (60,551) 171,403 (73.90)

(79,775) (114,987) (35,212) 44.14

188,860 1,140 (187,720) (99.40)

1. 106 107

2. 107 LBS-008

3. 106

1. 107 1,576.14% 1,551.11%

2.

3.

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107 3 27

107 3 27 107 8 13 Lin Bioscience

International Ltd. Belite Bio, Inc RBP4 Pty Ltd

1.

106 107 637 787

2.

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1,287 245

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1.

(1)LBS-008

LBS-008

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/ /

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Memorial Sloan Kettering Cancer Center

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-88-

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PCT 4 108

110

(4)LBS-002

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Composition of matter

LBS-002 Method of Use

4

109 112

(5)LBS-003

LBS-003 optimization

106 LBS-003 1 109

112

2. 108

2

FDA EMA

unmet medical need New Chemical Entity

Fast Track Accelerated Approval

-89-

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1.

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B. unmet medical needs

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-92-

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C. LBS-008

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patent

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-95-

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107 12 31

Lin Bioscience International Ltd. 107.03.27

PO Box 309, Ugland House,

Grand Cayman, KY1-1104,

Cayman Islands

200,039

Lin BioScience Pty Ltd 105.12.1958 Gipps Street, Collingwood,

Victoria 3066, Australia 34,033

Belite Bio, Inc 107.03.27

PO Box 309, Ugland House,

Grand Cayman, KY1-1104,

Cayman Islands

239,550

Belite Bio Holdings Corp. 105.06.10

1209 Orange Street,

Corporation Trust Center,

Wilmington, Delaware 19801,

United States

76,112

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3210 Merryfield Row, San

Diego, California 92121,

United States

44,190

RBP4 Pty Ltd 107.08.1358 Gipps Street, Collingwood,

Victoria 3066, Australia 22,451

107 12 31

Lin Bioscience International Ltd. 7,940,321 100%

Lin BioScience Pty Ltd 1,456,036 100%

Belite Bio, Inc Lin Bioscience International Ltd. 7,840,321 100%

Belite Bio Holdings Corp. Belite Bio, Inc 2,500 100%

Belite Bio, LLC Belite Bio Holdings Corp. ‒ 100%

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107 12 31

( )( )

Lin Bioscience

International Ltd. 200,039 185,737 185,737 (192) (54,524) (6.87)

Lin BioScience Pty Ltd 34,033 8,785 (264) 8,521 (6,193) 5,679 (3.90)

Belite Bio, Inc 239,550 186,685 (3,854) 182,831 (34,561) (54,362) (6.93)

Belite Bio Holdings Corp. 76,112 21,553 (103) 21,450 (1,199) (35,402) (14,160.69)

Belite Bio, LLC 44,190 7,750 (736) 7,014 9,469 (24,264) (24,264)

RBP4 Pty Ltd 22,451 17,951 (5,838) 12,113 (9,931) (9,938) (9.94)

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98 146

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-100-

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-102-

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-107-

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-108-

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-109-

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-111-

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-112-

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-113-

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-155-

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【★】【★】107 106

C04500 $ - $ 138,000 C04800 1,140 50,860 CCCC 1,140 188,860

EEEE ( 174,398 ) ( 122,869 )

E00100 262,049 384,918

E00200 $ 87,651 $ 262,049

 

-156-

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107 106 1 1 12 31

105 5 12

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( )

IFRS IAS IFRIC SIC

IFRSs

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-157-

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107 1 1 IAS 39 IFRS 9

IAS 39 IFRS 9 IAS 39 IFRS 9$ 262,049 $ 262,049 (1)

100,312 100,312 (2)

28,049 28,049 (1)793 793 (1)

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-158-

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IFRS 16 108 1 1

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108 1 1

107 12 31 I F R S 1 61 0 8 1 1

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107 12 31 106 12 31$ 7,876 $ 28,009

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Holdings Corporation 100% LBS-008 Lin Bioscience

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106 1 1 $ 596 $ 659 $ 891 $ - $ 2,146- 38 522 947 1,507- - 369 - 369

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-173-

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-175-

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