歌礼制药－Ｂ招股说明书

歌礼制药－Ｂ招股说明书

歌礼制药－Ｂ招股说明书

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??ν??????????О????О??d?????????fAscletis Pharma Inc. ?????????????????????????????????????????? j 224,137,000 ???????????Б???????? ???????? j 22,414,000 ????????? ???????? j 201,723,000 ????????????????Б?? ?????? ????? j ???? 16.0 ??d?? 1.0% ??Щ???e0.0027% ? ????????? 0.005% ?????????????????? ???d????? ?? j ???? 0.0001 ?? ???? j 1672???????e???????e???????????????????????????????e???Υ?????????????????????????????????? ?d????????????????????О????d??????????????????????????О??????????? ???????????О???????О??f ????????Ν?????????????Ñ?я??????????????????????d?????????? 32 ?? ????????????? 342C ????я?????????????f????????????????? ???????????????????????О???????????f ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ? ? ? ??? ? ?e ? ? ? ? ? ? ? ? ? ??? ? ? ? ? ˙ ? ? ? f ? ? ? ? ? ? ??? 2018 ? 7 ? 26 ???????????????????d???νО??? ??2018 ? 7 ? 30 ??????????????f?? ??????????? 16.0 ??d??????Э????????? 12.0 ??f??????????????? ??e?????????О?????? ??2018 ? 7 ? 30 ???????????????????????d??????? ???Б???f ?????????????????????????????????? 16.0 ??d?Ν 1% ??Щ???e 0.0027% ?????????? 0.005% ??????????f?????????Э? ??16.0 ??dε???????f ???????d?????????????????????????Ν????????????????????? ????????????????????????????????????????????12.0 ??? 16.0 ????Эf ???????d????????Э??Ъ????????νО??????????????????????????? ??????????????????????????????Э????????????????????????f ???????????????? ?????????? www.hkexnews.hkf??????????? ????????????????νО?????????f?????????????????????????? ????????d???????????????????????Эd???????????f ???????????????????????????????d????????????????????????? ????????????????????????????????????f????????????????Ñ? ?τ????Ñ??????Ñ???????f ????????????????е???????????????????????????????d??????????? ????????????Оψ????????d?????????????Σ????e????????????л??я? ?e??e???????f???? (1) ??????????????еΣ? 144A ??????Υ??????? (2) ? ?????? ??S ???????????????????f2018 ? 7 ? 20 ?

歌礼制药－Ｂ招股说明书

(1)

eIPO

(2)................................................2018 7 25

(3) .. ...................................................................2018 7 25

............................................2018 7 25

eIPO

.........................................................................2018 7 25

(4)..................................2018 7 25

(3). .....................................................................2018 7 25

(5) ................................................................................2018 7 26

(1)

..............................2018 7 31

(2)

11. ....................2018 7 31

(3) www.hkexnews.hk

(6) (1)

(2) ....................................2018 7 31

https:///en/Allotment

https:///zh-hk/Allotment

.........................................2018 7 31

(7)(9)...........................................2018 7 31

– i –

歌礼制药－Ｂ招股说明书

(1)

(8)(9) ...................................2018 7 31 .. ..........................................................2018 8 1

(1)

(2)

(3) 2018 7 25 8

10.

(4)

6.

(5) 2018 7 26 2018 7 30

2018 7 30

(6)

(7)

2018 8 1

(8)

(9) eIPO 1,000,000

2018 7 31 183 17 1712-1716

– ii –

歌礼制药－Ｂ招股说明书

(1)

1,000,000

14. (iv)

eIPO eIPO

1,000,000

13.

14.

– iii –

歌礼制药－Ｂ招股说明书

– iv –

(i)

(iv)

(1)

(11)

(22)

(28)

(30)

(71)

(76)

(80)

(84)

(86)

(97)

歌礼制药－Ｂ招股说明书

– v –

(115)

(134)

(210)

(223)

(227)

(230)

(233)

(236)

(270)

(273)

(286)

(297)

.........................................................................................I-1 .......................................................................II-1 ..............................................III-1 ..................................................................................IV-1 ........................................................V-1

歌礼制药－Ｂ招股说明书

Ascletis

HCV HIV HBV

IIa HIV I I ® ASC09 ASC06 2018 6 8 ®

– 1 –

歌礼制药－Ｂ招股说明书

® ® HCV 2018 6 8

® ®

DAA NS3/4A

(97%) (SVR12)

12

60% (SVR24) 48 72 NS5A DAA ®

HCV RDV/DNV 2018

RDV/DNV

III HCV RDV/DNV

99% (SVR12) 12

NS5A 100% (SVR12)

RDV/DNV

®

ASC21 HCV NS5B ASC21 NS5B

2018

ASC09 IIa HIV ASC09 HIV-1 ASC09 I

IIa HIV ASC09

ASC09 ASC09

HIV

ASC09

72% ASC09

ASC09 HIV

2020 IIb

ASC06 I ASC06 RNA

– 2 –

歌礼制药－Ｂ招股说明书

ASC06 ( VEGF )

( KSP ) ASC06 I I

50% ≥0.7mg/kg

2020 II

HBV NASH

HCV HCV III GSK ® 150 130

HCV HCV HCV 2017 1.82% 2,520 HCV HCV HCV 2017 350,000 2,000 HCV 2017 74,000 0.3% 2018 6 8 DAA HCV ® F&S 2018 6 27 ® DAA HCV DAA 2017 HCV DAA HCV HCV HCV F&S 2023 DAA

– 3 –

歌礼制药－Ｂ招股说明书

® 2018 6 8 DAA ® DAA (SVR) ® 12 DAA 12 DAA HCV 1 1b Sovaldi HCV 2 3 Epclusa HCV 2 3 4 6 HCV 1 4 HCV 1 2 3 4 6

HCV 2017 0.3% 2028 4.5% HCV HCV 2017 350,000 2028 410,000 HCV HCV 2026 2,730 1.89% HCV

HCV HIV HBV NASH

A

®

– 4 –

歌礼制药－Ｂ招股说明书

2013 4 2014

10 2018 2

31.0

2014 9 Presidio PPI-668

Presidio 17.0 9.5

Presidio ASC21 2017 6 Medivir MIV-802 (ASC21) Medivir

ASC21 Medivir

8.9 ASC21

Medivir

ASC09 2013 7 Janssen TMC310911 (ASC09)

ASC09 ASC09

Janssen

ASC06 2013 7 2012 6 Alnylam ALN-VSP02 (ASC06)

ASC06 Alnylam

9.75 ASC06

ASC06

Alnylam

CFDA

– 5 –

歌礼制药－Ｂ招股说明书

2016 2 150 850 5,500 DTP

17,000 130 GMP 2018 6 8 GMP

P3-DCHA 5%

(i) (ii) (iii) (iv) (v)

(i) ® (ii) ® (iii) (iv) (v)

– 6 –

歌礼制药－Ｂ招股说明书

– 7 –

2018 6 27 ® 2016 2017 2017 2018 3 31 ® 33.0 53.2 13.3 51.1 2017

12 31

3 31 2016

2017 2017 2018

%

%

%

%

...........................32,976

100.0

53,202100.013,301100.051,062100.0 .................... ...........................32,976100.053,202100.013,301100.051,062100.0 .........14,49644.049,59393.24,09030.76,43712.6 ....................(62,689)(190.1)(114,325)(214.9)(10,572)(79.5)(22,815)(44.7) ....................(15,044)(45.6)(37,477)(70.4)(3,015)(22.7)(15,717)(30.8) ....................(1,612)

(4.9)(31,434)

(59.1)(144)(1.1)(19,950)

(39.1) ..(31,873)

(96.7)(80,441)(151.2)3,66027.5(983)(1.9) .. (6,490)

(12.2)(6,595)

(49.6)1250.2 .............

(31,873)

(96.7)(86,931)

(163.4)

(2,935)

(22.1)(858)(1.7)

12 31 3 31 2016

2017 2018

.........................................................

70,257115,636116,270 .............................................................466,008875,618773,636 .............................................................73,39999,22867,899 ......................................................392,609776,390705,737 .........................................................

53,782

22,195

22,070

歌礼制药－Ｂ招股说明书

– 8 –

12 31 3 31 2016

2017

2017

2018

.........(12,498)(198,056)(33,349)(45,741)

...........................(37,633)(644,542)(756,880)170,526

...........................88,159549,362549,362(57,815)

....................38,028(293,236)(240,867)66,970 .........372,398418,973418,973123,697 ........................8,547(2,040)1,289(2,002) .........418,973

123,697

179,395

188,665

12 31

3 31 2016

2017

2018

............................................................. 6.38.811.4 .............................................................

6.1

8.2

10.4

2018 6 8 IND IND 33 2018 6 14 GMP ® 2018 6 27 ® ® ®

歌礼制药－Ｂ招股说明书

– 9 – ® 2018 2018 3 31

Lakemont Holding LLC Lakemont 2018 GRAT 53.29% 222

224,137,000

12.0 16.0

(1) ...........................................................

134 179 (2) ....................... 2.87 3.64

(1) 1,120,685,000

(2)

14.0 2,976.0

30.0% 892.8 25.0% 744.0 ®

15.0% 446.4

歌礼制药－Ｂ招股说明书

10.0% 297.6 ASC21

10.0% 297.6 HBV NASH

10.0% 297.6

161.9 2016 2017 2018 3 31 8.0 2.7 2018 3 31 33.8 117.4

2018 2 9.1 57.8 2018 2 3 PowerTree PowerTree 2016 9 9.6 64.5 2016 Walkers

– 10 –

歌礼制药－Ｂ招股说明书

– 11 – AbbVie

AbbVie Inc. Alnylam

Alnylam Pharmaceuticals, Inc. RNA (RNAi) Ambrilia

Ambrilia Biopharma Inc.

Ascletis

2014 2 25

2018 4 19

2013 4 26 PowerTree

2014 9 24 2018 3 15

PowerTree

歌礼制药－Ｂ招股说明书

– 12 –

BMS

Bristol-Myers Squibb

645,812,103 228,593,204

CDA

CDE

CFDA

歌礼制药－Ｂ招股说明书

– 13 –

7

37

32

22 1961 3

622

Lakemont Holding LLC Lakemont 2018 GRAT

A ® ASC09 ASC06

歌礼制药－Ｂ招股说明书

2007 3 16

2008 1 1

F&S

Gilead Gilead Science, Inc.

eIPO

GlaxoSmithKline plc.

– 14 –

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