2018 年度報告
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- 寡没 步
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1 2018 年度報告
2
3 FCISFCS Vistra Corporate Services (HK) Limited Donald W. Glazer Michael Goller Ranjeev Krishana Thomas Malley Thomas Malley Scott A. Samuels Mourant Governance Services (Cayman) Limited 94 Solaris Avenue Camana Bay Grand Cayman KY Cayman Islands Ranjeev Krishana 30 Donald W. Glazer Michael Goller
4 Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman KY Cayman Islands Mourant Ozannes
5 2018 4
6 Zanubrutinib (BGB-3111) (BTK) BTK 2018 (R/R)(MCL)(CLL)(SLL) R/R MCL R/R CLL/SLL (FDA)(NDA) (WM)zanubrutinibWM MCL zanubrutinib Tislelizumab (BGB-A317) 1(PD-1) FcIgG (chl) tislelizumab(ubc)
7 Pamiparib (BGB-290) 1(PARP1) PARP2 3 lifirafenib(bgb-283)(raf)bgb-a333 PD-L1BGB-A425TIM-3 sitravatinibmirati Therapeutics, Inc. (Mirati) ZW25 ZW49Zymeworks Inc. (Zymeworks)HER ABRAXANE REVLIMID avadomide (CC-122) Cereblon tislelizumab (NMPA) (NRDL)
8 BTKZanubrutinibZanubrutinibBTK 2 3 BTK zanubrutinib TislelizumabPD- 1 PD-L1 tislelizumab
9 Mirati Zymeworks
10 zanubrutinib (BTK) tislelizumab (PD-1) pamiparib lifirafenib (RAF Dimer) BGB-A333 (PD-L1) BGB-A425 (TIM-3) REVLIMID ABRAXANE (IMiD) VIDAZA avadomide (CC-122, CELMoD) NHL sitravatinib ZW25 * ** ***REVLIMID 1. tislelizumab2. Mirati Therapeutics, Inc.APAC 3. Zymeworks 1L2L3LAMLCLLCMMoL DLBCLB Dose EscESCC FLgBRCA BRCAGCHCCHLIMiD MCLMDSMMMZL NSCLCNDNDANHLNK OCPHR/RRTSLLSq TMZUCWM
11 Zanubrutinib (BGB-3111)BTK Zanubrutinib BTKZanubrutinib BTKIMBRUVICA BTK1 24 BTK BTK B BCR BTKBCRBTKB ZanubrutinibBTK (NHL)(HL) BTB 85%B (SEER)201772,24020,140 20,1104,660SEER 3,000 1,350Chen et al, Cancer Statistics in China, 2015CA Cancer J. Clin, (2):115-32Chen et al GLOBOCAN 88,200 93,09752,100 50,86590%4.5%
12 CD20B BTK PI3Kidelalisibcopanlisibduvelisib Bcl-2venetoclax YESCARTA (axicabtagene ciloleucel)b YESCARTA CD19T BTKIMBRUVICA p CD20 obinutuzumabrituximab BTK 45BTKCALQUENCE (acalabrutinib) BTK zanubrutinib1,300zanubrutinib zanubrutinib1 zanubrutinibb zanubrutinib40 24 BTKBTK
13 (IWWM) ( )>PR 85 (55-749)62ORR 92%(67/73)(MRR)82%41%(VGPR) IgM>90% CT12 (PFS)89% IgM32.7g/L( )8.2g/L( )32<10g/ dl 8.85g/dL( ) 13.4g/dL( ) 63 MYD88MYD88L265Pn 5494% 89%46%MYD88WT BTK89%67% 22% Zanubrutinibzanubrutinib (AE)(43%) (42%)(17%)(17%)(16%)(16%)(16%) 3-4(9%)(7%)(5%) (5%)(4%)(4%)(SAE)32 (42%)(7%) zanubrutinib (12%) (5%)(3%)(5%)
14 zanubrutinib zanubrutinib160mg %2% 39% 40% zanubrutinib TN51 R/R 6616 TN 50 R/R %(62/66) 3%2/66)82%(54/66)9%(6/66) 5%(3/66)(SD)12 TN %(16/16)6%1/16) 81%(13/16)13%(2/16)R/R %(46/50) 2%1/50)82%(41/50)8%(4/50)6%(3/50) Zanubrutinib ( 10%)(46%)(29%)(28%)(23%) (22%)(19%)(15%)(13%)(13%)(12%)(12%) (12%)
15 zanubrutinib 2 zanubrutinib mg zanubrutinib (IRC) Lugano2014PET (75.6%) 35.9 ( )IRC 83.5%(71/85)58.8%(50/85)24.7%(21/85)24 82%24.1 ( )(DOR) 90%24 ZanubrutinibB (AE) (31.4%)(29.1%) (29.1%)(22.1%)5% AE (11.6%)(5.8%)(4.7%)(TEAE) BTK (10.5%)(1.2%) CNS 1 zanubrutinibb n 9n 39)12.7( ) Lugano % (40/45)26.7%12/45)62.2%(28/45) CTPET ( )
16 ZanubrutinibB (33.3%)(33.3%) (29.2%)(25.0%)(18.8%)56.3% (8.3%)(6.3%)(6.3%) (6.3%)(6.3%)(6.3%)(6.3%)18.8% zanubrutinib zanubrutinib B n (1-8) 2(1-8) 3 (1-9) 2 (1-10) 78% 41% 42% 31% % 18% 8% 15% 78% 24% 35% 15% MR Tam et al.(poster 1592)
17 Zanubrutinib (EHA) EHA zanubrutinibb 476 zanubrutinibbtkzanubrutinib BTK (2%)(2%) 3 (1%)zanubrutinib(3%)(94%) (14%)(7%) (7%)116(24%)38 (8%)zanubrutinib (6%)(1%)(1%) 1%(2%)(PJP) (CMV)(26%)(11%) (2%)n 3CNS5 1.2n 8 n 2n 2n 1 614%1219%18 21% (3%)(1%) zanubrutinib zanubrutinib3 3 3 GAZYVA
18 zanubrutinib zanubrutinib zanubrutinib zanubrutinibzanubrutinib B 2 Tislelizumab (BGB-A317)PD-1 TislelizumabPD-1 tislelizumab T(CTL) T PD-1T PD-L1PD-1 PD-1PD-L1 T PD-L1PD-L1T PD-1PD-1 TislelizumabPD-1PD-L1 PD-L2 PD-1tislelizumab PD-1 PD-1FcFc T
19 PD-1 PD-L1KEYTRUDA (pembrolizumab)opdivo (nivolumab)tecentriq (atezolizumab) IMFINZI (durvalumab)bavencio (avelumab) LIBTAYO (cemiplimab)tislelizumabpd-1 PD-L1 PDR-001Tesaro TSR042PF MEDI PD-1OPDIVO (nivolumab) KEYTRUDA (pembrolizumab)tuoyi (toripalimab)tyvyt (sintilimab) PD-L1PD-1 PD-L PD-1 PD-L PD-1 PD-L1 Globocan 37%44%47% 54%Chen et al PD-1Chen et al. 2016PD SEER PD PD ,200tislelizumab 1 tislelizumab
20 tislelizumab 2 zanubrutinib 2 70 (ASCT) 200 mgzanubrutinib (ORR)(IRC)Lugano2014PET (75.7%) ( ) IRC 85.7%(60/70) 61.4%(43/70) 24.4%(17/70)92.3%(12/13) (69.2%)84% 80% TEAE(52.9%)(30.0%) (28.6%)(27.1%)(17.1%)(14.3%)(14.3%) TEAE21.4%(2.9%)(2.9%) (5.7%)TEAEn 2n 1 n 1TEAE5% (18.6%)(5.7%)(5.7%)
21 tislelizumab dmmr (30-339) 71 (29-540) 4.1 ( ) 2.2 ( ) 4.9 ( ) 5.2 ( ) 10.8 ( ) 11.2 ( ) 4.4 ( ) 8.5 NR NR ( ) N 54 N 54 N 17 N 50 N 49 N 17 N 46 N * * A/1B2018Sanjeev Horvath Meniawy /22018Shahneen
22 tislelizumab tislelizumab 38% 10% 1a 1b N 116 n (%) N 335 n(%) N 451 n (%) 114 (25.3) 322 (71.4) 436 (96.7) 47 (10.4) 78 (17.3) 125 (27.7) 41 (9.1) 68 (15.1) 109 (24.2) 19 (4.2) 71 (15.7) 90 (20.0) 32 (7.1) 49 (10.9) 81 (18.0) 26 (5.8) 50 (11.1) 76 (16.9) 26 (5.8) 38 (8.4) 64 (14.2) 20 (4.4) 43 (9.5) 63 (14.0) 22 (4.9) 40 (8.9) 62 (13.7) 15 (3.3) 45 (10.0) 60 (13.3) 23 (5.1) 37 (8.2) 60 (13.3) 12 (2.7) 33 (7.3) 45 (10.0) BGB-A317 IB v6.0bgb A317_ (45.0%) % % 183.2%9 2.0% 25%3% 5% 3 16% 37% tislelizumab6% 13%
23 %tislelizumab tislelizumab11 3 tislelizumab tislelizumab 3 3 T NK 2 PD-L1 2 3 tislelizumab tislelizumab Pamiparib (BGB-290)PARP PamiparibPARP1 PARP2 pamiparibparp DNA
24 PARPPARP1 PARP2DNAPARP1 PARP2 DNADNADNA PARPDNADNA DNAPARP BRCA1/2PARP PARPBRCABRCA1/2 (HRD)BRCA BRCA1/2BRCADNA PARPPARPBRCA PARP PARPPARP DNAPARP DNA PARPPARPDNA PARPBRCAPD-1 PD-L
25 PARPPARP PARP SEER201822, ,120164,69026,240 Chen et al ,000272,00060, ,000 PARPLYNPARZA Clovis Oncology RUBRACA (rucaparib) GlaxoSmithKline/Tesaro ZEJULA (niraparib) TALZENNA (talazoparib)veliparib2017parp niraparib PARP fluzoparib PARP pamiparib pamiparib1/ pamiparib1/
26 39(EOC) BRCA BRCA BRCA pamiparib78% 3 10%(56%) (40%)(25%)(21%)(21%)(15%) (12%)46% (DLT) pamiparib 20mg40mg 60mg n 8n 1 BRCA1/2(BRCAm)BRCA 1/2(BRCA-WT) BRCABRCA1/2 BRCAmn 4 BRCA-WTn 2 BRCAmn 1 BRCA- WTn 4(BRCAm) BRCA-WT
27 pamiparib (RP2D)60mgn 12n pamiparib(rt)temozolomidetmz(r/r) (GBM)1b/2 MGMT(O6-methylguanine-DNA methyltransferase) GBM A pamiparib60mg RTR/R GBM C pamiparib60mg28 21 TMZACGBMBRTpamiparib TMZ GBMA n 3,6,9 19 (2-54)18 15 (mrano)(sd) 53.3%95%CI (AE) 5.6%pamiparib RT C mg TMZ20mg TMZ 12.9 ( )15 10 mrano AE(20%)(13.3%)(13.3%)pamiparib TMZ 21 40mg TMZ pamiparib20mg TMZ pamiparib
28 3 2 3 Lifirafenib (BGB-283)RAF LifirafenibRAFLifirafenib BRAF V600EV600E BRAFKRAS/NRAS lifirafenib(mapk)brafbraf KRAS/ NRAS DNAlifirafenib SpringWorks Therapeutics lifirafenib SpringWorks Therapeutics MEKPD RASRAFMAPK 2019 BRAFZELBORAF (vemurafenib)tafinlar (dabrafenib) Array BioPharma BRAFTOVI (encorafenib)braf MEK BRAF V600E/Kdabrafenib MEKINIST (trametinib) Genentech vemurafenib COTELLIC (cobimeditinib) Array Biopharma encorafenib MEKTOVI (binimetinib) BRAF belvarafenib LXH254 Lifirafenib 1 BRAF KRAS/ NRAS 1 lifirafenib BRAF KRAS
29 2017 lifirafenib2 30mg lifirafenib30mgbraf V600 KRAS lifirafenib30mg 1 2 ( 10%)(38.5%)(26.0%) (21.9%)(21.9%)(19.8%)(17.7%)(16.7%) (16.7%)(15.6%)(11.5%)(10.4%)3 4 2% (7.3%)(6.3%)(6.3%)(3.1%)(2.1%) (2.1%)(2.1%)(2.1%)(2.1%) (2.1%)(2.1%)(2.1%) BRAF MEKBRAF V600 V600KV600RBRAF V600 KRAS BRAF V600BRAF V600 BRAF V600EBRAF V600E BRAF V600BRAF MEKBRAF V60013 BRAF V600 KRAS20 KRAS/NRAS 1221KRAS/NRAS10 1aBRAF V600EBRAF V600EKRAS BGB-A333PD-L1 BGB-A333PD-L1PD-1IgG1BGB-A333 tislelizumab BGB-A3331 BGB-A333 tislelizumab
30 BGB-A425TIM-3 BGB-A425T 3TIM-3IgG1 2018BGB-A433 tislelizumab1/2 Sitravatinib (MGCD-0516) Mirati Mirati sitravatinib Sitravatinib RETTAMTYRO3AxlMERVEGFR2KIT Miratisitravatinib 2019sitravatinib3 Mirati sitravatinib CBL Miratisitravatinib 2018sitravatinib tislelizumab 1 Avadomide (CC-122)Cereblon Avadomide(CC-122)Cereblon 1 1/2Avadomide (CC-122) Cereblon avadomide (CC-122) 2018ABRAXANE
31 ABRAXANE ABRAXANE nab ABRAXANE ABRAXANE Chen et al ,60069,500 Her2+ ABRAXANE 3 ABRAXANE TAXOL ANZATAX (TAXOTERE ) (ABRAXANE ) ABRAXANE ABRAXANE
32 REVLIMID REVLIMID 2013 (MM) REVLIMID B B Siegel et al., 2011 IMS 100, :140 Lu et al., 2014IMS , ,000 10, Takeda NINLARO (ixazomib) REVLIMID
33 VIDAZA DNA VIDAZA (MDS) (CMML)20% 30%(AML) Germing et al., ,000100,000 70(NCCN) %DNA DNA DNA 2 (HMAs) % DNA RNA tislelizumab
34 (CRO)(CMO) , zanubrutinib 24, KUBio TM tislelizumab
35 140 (cgmp) zanubrutinibzanubrutinib PD-1tislelizumab (MAH)tislelizumab tislelizumab
36 Celgene Switzerland LLC Celgene Switzerland tislelizumab PD-1 PD-1263Celgene Switzerland % % 12 tislelizumab 1 tislelizumab tislelizumab PD
37 2019(BMS)2019 PD-1OPDIVO (nivolumab) PD-1 tislelizumab PD-1 tislelizumab Celgene Logistics Sàrl Celgene Logistics ABRAXANE REVLIMID VIDAZA avadomide(cc-122) Celgene Logistics REVLIMID Celgene LogisticsCelgene Logistics Celgene Logistics Celgene Logistics ABRAXANE REVLIMID VIDAZA
38 BeiGene (Hong Kong) Co., Ltd.Celgene Holdings East Corporation (PCT) PCT ZanubrutinibPCT zanubrutinibbtkzanubrutinib
39 TislelizumabPCT tislelizumabpd Pamiparib PCT pamiparibparp1/ LifirafenibPCT lifirafenibbraf BRAF 2031 ABRAXANE ABRAXANE REVLIMID REVLIMID VIDAZA VIDAZA
40 ABRAXANE REVLIMID VIDAZA 20 (USPTO) 14 BeiGeneBeiGene
41
42
43
44
45 zanubrutinib
46
47 Hatch-Waxman Amendments Hatch- Waxman Amendments 30Hatch-Waxman Amendments
48 IRAE PD-1tislelizumab IRAE
49 REVLIMID (BLA)
50 REVLIMID
51
52
53
54
55
56
57 ABRAXANE REVLIMID VIDAZA avadomide(cc-122)
58
59 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers
60 tislelizumab
61
62
63
64
65
66
67 ABRAXANE REVLIMID VIDAZA
68
69
70
71 tislelizumab zanubrutinibbtk2027parp pamiparib pamiparib
72
73
74
75
76 tislelizumababraxane REVLIMID VIDAZA
77
78
79 tislelizumab tislelizumab
80
81 ABRAXANE REVLIMID VIDAZA
82
83 % 2,
84
85 (i)(ii)(iii)
86
87
88
89 (General Data Protection Regulation)(EU) 2016/679 10,000,0002% 20,000,000 4% (HGR)
90
91
92 (Export Administration Regulations))
93
94 (BEPS)
95
96
97 37 (i) (ii) (i)(ii) (iii) (iv)
98 10% 50% % 10%
99 5% (i)(ii) (iii)(iv)
100 25% % 10%
101
102 K
103
104
105 ,113, ,894,893 46,145, ,279,37023,021,
106
107
108
109
110
111 DTCDTC DTC
112 %
113 (1)75%(2)50% (Internal Revenue Service)
114 (CFC) Subpart F(Subpart F income) 50%50% 10%10%1986 (Internal Revenue Code of 1986)
115 , ,885 13,035 8,816 1, ,959 67,335 13,035 8,816 1, , ,220 13,035 8,816 1, , ,515 18,546 57, ,163 91, ,829 18,546 57, ,217 93, ,033 (1) 11,909 46, ,592 50, ,906 BeiGene, Ltd. 18,278 57, ,217 93, ,769 (%) 100% 100% 100% 98% 86% (%) -142% -648% % -39% -340% (%) (1) -91% -532% % -21% -296% ,898 17,869 87, , ,713 30,497 82, , ,914 1,068,509 33,817 71, , ,509 1,697,390 53, , ,813 1,046,479 2,249,684 27,853 42,445 52, , ,037 78, ,084 14,422 14,445 (53,041) (101,765) 352, ,231 1,753,647 (1) (2) 10-K
116 (1) zanubrutinib(bgb-3111) (BTK)(2) tislelizumab (BGB-A317) 1(PD-1)(3) pamiparib (BGB-290) 1 (PARP1) PARP (R/R)(MCL) R/RR/R(CLL/SLL)zanubrutinibR/R (chl) tislelizumab
117 Ambrx Inc.Ambrx Inc Ambrx Inc (FDA)(BTK) Zanubrutinib(Breakthrough Therapy designation) MCL BTKzanubrutinibZanubrutinibBTK 2 3 BTK zanubrutinib
118 Tisleizumab PD-1 PD-L1 tislelizumab
119 Mirati Therapeutics, Inc. (Mirati) Zymeworks Inc. (Zymeworks) % 4. Baker Bros. Advisors LP Hillhouse Capital Management, Ltd. (5)
120 tislelizumab 2017 pamiparib lifirafenib 2013 ABRAXANE REVLIMID VIDAZA
121 zanubrutinibbtk tislelizumabpd-1 pamiparibparp1 PARP2 lifirafenibbraf BGB-A333PD-L1 BGB-A425TIM-3 sitravatinibmirati Therapeutics, Inc. ZW25 ZW49Zymeworks Inc.HER
122
123 18A.08(3) ABRAXANE REVLIMID VIDAZA
124 % 130,885 24, , % 67, ,959 (146,624) (69)% 198, ,387 (40,167) (17)% (28,705) (4,974) (23,731) 477% (679,005) (269,018) (409,987) 152% (195,385) (62,602) (132,783) 212% (894) (250) (644) 258% (903,989) (336,844) (567,145) 168% (705,769) (98,457) (607,312) 617% 13,947 (4,108) 18,055 1,993 11,501 (9,508) (83)% (689,829) (91,064) (598,765) 658% 15,796 (2,235) 18,031 (674,033) (93,299) (580,734) 622% (264) (194) (70) 36% (673,769) (93,105) (580,664) 624%
125 % 130,885 24, , % 211,391 (211,391) (100)% 56,776 56,776 10,559 2,568 7, % 67, ,959 (146,624) (69)% 198, ,387 (40,167) (17)% ABRAXANE REVLIMID VIDAZA VIDAZA
126 % % 291, , , % 89,000 89,000 % 55,600 9,244 46, % 243, , ,940 90% 679, , , % zanubrutinibtislelizumabpamiparib sitravatinib lifirafenib Miratisitravatinib 10ZW25 Zymeworks, Inc.60 PARP
127 %
128 % ABRAXANE REVLIMID VIDAZA %
129 ,673 21,156 14,588 9,894 3,096 1,557 5,585 3,016 81,942 35, % % ,191 65, ,376 3, , , ,283 69,
130 ,887 17,051 34,588 18,721 10,433 2,350 8,030 5,088 4,749 3,997 6,727 2, ,414 49, % (i) (ii)(iii) (Merck KGaA, Darmstadt Germany) ABRAXANE REVLIMID VIDAZA
131 ,602 87,514 (547,717) 12,752 (637,613) (356,319) 1,690, ,356 (4,096) 5, , , , ,
132 Mirati Zymeworks
133 Mirati Zymeworks Celgene Switzerland
134 zanubrutinibtislelizumab pamiparib
135 ,809 10,752 17,777 5, ,399 8, ,960 36,572 9,747 9,747 45,910 45, ,865 75,136 17, ,135 36,
136 % % , , , ,
137
138 (i)(ii)(iii) (iv)(v) 606 ABRAXANE REVLIMID VIDAZA
139
140 (i)(ii) (1)(2) (3) (4) (5)
141
142
143 % ~ 3.1% 2.2% ~ 2.6% 2.2 ~ ~ % ~ 64% 99% ~ 100% 0% 0%
144 ,384 30,610 32,743 12,253 87,127 42,
145 %
146 % 6.5%
147 % 11.3% , ,
148
149 Donald W. Glazer 74 Michael Goller 44 Ranjeev Krishana 45 Thomas Malley BioDuro, LLCPharmaceutical Product Development Inc Galenea Corp Telephia, Inc.2007(The Nielsen Company) Genta Incorporated (McKinsey & Company)
150 Howard Hughes Medical Institute George L. MacGregor 2004Joyant Pharmaceuticals, Inc Asia Pacific Telecom (Telstra International Group)TelstraAutohome Telstra Corporation Limited GL Capital Group CN
151 Donald W. Glazer Glazer GMO Trust2005GMO TrustGlazer Provant, Inc GlazerMugar/Glazer Holdings WHDH-TV, Inc.1997GlazerGoodwin Procter LLP Ropes & Gray LLP Ropes & Gray Provant, Inc.Glazer Environics Inc.Kronos IncorporatedReflective Technologies, Inc. Teleco Oilfield Services Inc. Glazer GlazerGlazer and FitzGibbon on Legal Opinions Massachusetts Corporation Law& Practice Glazer Michael Goller GollerBaker Bros. Advisors LP 2005Baker Bros.Goller JPMorgan Partners, LLC Goller(Merrill Lynch and Co.)Goller GollerDBV Technologies SALevo Therapeutics, Inc. Goller Ranjeev Krishana Krishana2011 Baker Bros. Advisors LPBaker Bros.Krishana (Pfizer, Inc.) Krishana KrishanaKrishanaAccenture plc Krishana Krishana
152 Thomas Malley Malley Mossrock Capital, LLC MalleyJanus Mutual Funds MalleyJanus Global Life Sciences FundJanus MalleyJanusMalley MalleyKura Oncology, Inc. 2015Kiniksa Pharmaceuticals2016 OvaScience Inc Millendo Therapeutics, Inc Synageva BioPharma Corp Puma Biotechnology, Inc Cougar Biotechnology, Inc Malley , (Tricon Global Restaurants International)(Procter & Gamble) Peet s Coffee China (Hillhouse Capital)
153 (Pfizer Essential Health) (RDPAC) (NDPE) Leerink Partners LLCSVB Leerink LLC A.G. Edwards Inc JMP Securities Prudential Securities (Abbott Laboratories)
154 Acerta PharmaBTKacalabrutinib Genentech, Inc. venetoclax obinutuzumab (B)(1)
155 BGNE
156 tislelizumabpamiparib % 66.0%0.8% pamiparib % 10.3%0.4% pamiparib % 62% 15% 19% %
157
158 (%) Zanubrutinib 282, % 46, ,338 Tislelizumab 282, % 65, ,212 Pamiparib 86, % 13,442 73,528 (a) 652, % 125, ,078 (b) 130, % 58,259 72,197 (c) 86, % 32,030 54, , % 215, ,216 (a) (b) (c)
159 ,
160 Donald W. Glazer Michael Goller Ranjeev Krishana Thomas Malley
161 Ranjeev Krishana
162 50,000 22,500 10,000 17,500 7,500 12,500 5, , , ,000,
163 %
164 ,000 65% (i)(ii)(iii)(iv) (i) (ii)12(iii) (iv)20,000(v) ,
165
166 XV (a)xv7 8 (b) 352(c) (1) 34,110,070 (2) 4.40% 10,000,000 (3) 1.29% 102,188 (4) 0.01% 7,952,787 (5) 1.03% 29,439,115 (6) 3.80% 510,941 (7) 0.07% 15,994,751 (8) 2.06% 224,372 (9) 0.03% 5,000,000 (10) 0.65% 657,346 (11) 0.08% Donald W. Glazer 4,518,952 (12) 0.58% 38,160 (13) 0.005% Michael Goller 226,724 (14) 0.03% Ranjeev Krishana 226,724 (15) 0.03% Thomas Malley 1,139,472 (16) 0.15% 63,290 (17) 0.01% 226,724 (18) 0.03%
167 (1) ,576,070 (2) (1)16,270,707(2)16,689,898 (3)1,149,465 (3) Roth IRA PENSCO (4) The John Oyler Legacy Trust (5) (6) Oyler Investment LLC Oyler Investment LLC 99% (7) The Oyler Family Legacy Trust (8) (1)7,306,967(2)8,286,143 (3)401,641 (9) (10) Wang Investment LLCWang Investment LLC99% (11) (1)648,056 (2)9,290 (12) (1) Glazer4,292,228(2)GlazerGlazer 217,434(3) Glazer9,
168 (13) GlazerGlazer (14) (1)GollerGoller217,434 (2) Goller9,290 (15) (1)KrishanaKrishana217,434 (2) Krishana9,290 (16) (1) Malley390,000(2)MalleyMalley 740,182(3)Malley9,290 (17) 63,290 (18) (1)217,434 (2)9, (a)xv7 8 (b)352(c)
169 XV (1) Julian C. Baker (2) 161,880, % Felix J. Baker (2) 161,880, % Baker Bros. Advisors (GP) LLC. (2) 161,745, % Baker Bros. Advisors LP (2) 161,745, % Baker Brothers Life Sciences Capital, L.P. (2) 145,425, % Hillhouse Capital Management Ltd. (3) 13,445, % Gaoling Fund, L.P. (3) 58,995, % Hillhouse Capital Advisors, Ltd (3) 63,117, % Fidelity Management & Research Company (4) 76,202, % FMR Co., Inc. (4) 71,180, % FMR LLC (4) 78,936, % Fidelity Mt. Vernon Street Trusts (4) 38,393, %
170 (1) ,576,070 (2) Julian C. Baker Felix J. Baker Baker Bros. Advisors (GP) LLCBaker Bros. Advisors (GP) LLC Baker Bros. Advisors LPBaker Bros. Advisors LP 667, L.P. Baker Brothers Life Sciences, L.P.Julian C. BakerFelix J. Baker Baker Bros. Advisors (GP) LLC Baker Bros. Advisors LP 667, L.P. 16,319,660 Baker Brothers Life Sciences, L.P. 145,425,622 Julian C. Baker Felix J. Baker FBB3 LLC92,32643,069 (3) (i)58,995,800 Gaoling Fund, L.P. (ii) 4,121,589 YHG Investment, L.P. (iii)13,445,978hillhouse BGN Holdings Limited Hillhouse Capital Adrisors, Ltd.YHG Investment, L.P.Gaoling Fund, L.P.Hillhouse Capital Management, Ltd. Hillhouse Fund II, L.P.Hillhouse Fund II, L.P.Hillhouse BGN Holdings Limited Hillhouse Capital Adrisors, Ltd.Gaoling Fund, L.P.58,995,800 YHG Investment, L.P.4,121,589Hillhouse Capital Management, Ltd. Hillhouse BGN Holdings Limited13,445,978Hillhouse Fund II, L.P.Hillhouse BGN Holdings Limited13,445,978 (4) JohnsonAbigail P. JohnsonFMR LLC B FMR LLC 49JohnsonB B B Fidelity Management & Research Company 76,202,40869,720,508 FMR Co., Inc12,048,80571,180,714 Fidelity Management & Research (Hong Kong) Limited4,694,900 Fidelity Mt. Vernon Street Trust38,393,094Fidelity Mt. Vernon Street Trust 274,45336,118,641 FMR Co., Inc.71,180,714FMR Co., Inc.4,617,10066,563, XV
171 ,550, ,359, ,235 88, , , , ,000 Thomas Malley , , ,900, ,000 4,445, ,630,682 2,485, ,769 11,894, ,550,936 2,940, ,769 18,359,
172 % % %
173 10 (i) 1/13(ii) 1/
174 ,251, ,442, (1) (2) (3) ,047,500 2,047, (3) , , (3) , , (3) ,310,088 1,310, (3) ,613,430 1,613, (3) , , (3) , , (4) , , (5) , , (5) ,442 17,442 Donald W. Glazer (4) , , (5) ,442 17,442 Michael Goller (4) , , (5) ,442 17,442 Ranjeev Krishana (4) , , (5) ,442 17,
175 (1) (2) Thomas Malley (5) , , (5) ,442 17, (4) ,290 63, (4) , , (5) ,442 17, (3) ,752,500 1,752, (3) ,250,000 1,250, (3) , , (3) ,367,500 39,000 1,328, (3) , , (3) , , (6) , ,
176 (1) (2) (3) ,376,000 1,831, , (3) ,765,800 1,015, ,631 9,377, (3) ,657, , ,830 1,305, (6) ,496, ,826 55,192 2,966, (3) ,094 87, , (3) ,000 39, , (3) ,599, , , (3) ,259 14,885 26, (3) ,813 16, , (3) ,325 13,000 74, (3) ,998 32, , (6) ,680 2,340 9, (3) ,999 89, (3) ,917 2,080 70, (3) , , , (3) , , (3) ,991 68,796 91, (3) , , (3) ,984 95, , (3) ,505 41, , (3) ,990 15, (3) , , , (3) , , (3) , , , (3) , , , , (3) , , , , (3) ,990 13,741 41, (3) , , , (3) ,987 62, , (6) , , , , (3) ,982 46, , (3) ,047 51, ,
177 (1) (2) (3) ,231,971 94,991 89,999 1,046, (3) ,994 34, , , (3) ,990 6,916 9, (3) , , , (3) ,500 18,408 92, (3) ,500, , , (3) ,974 32, , (3) ,977 2, , (3) ,976 47, , (3) , , , (3) ,995 32, , (3) ,997 37, , (6) , ,995 32, , (3) ,988 58, , (3) , , , (3) , , (3) ,194, , , (3) ,990 57, , (3) , , (3) ,409, ,156 1,136, (6) ,890 31,291 11, , (3) ,976 54, , (3) , , , , (3) ,987 48,594 96, (3) ,977 40,560 11, , (3) ,378 86, , (6) ,792,492 58,890 25,064 1,708, (3) ,980 14, , (3) ,265, , ,538 2,700, (6) ,981, , ,475 8,266, (3) , , (3) , , (3) ,996 99, (3) ,744, , ,832 6,401, (3) ,600 29,848 8, , (3) , , (3) ,973 3, , (3) ,994 32, , (6) ,337, ,248 67,327 1,126, (3) ,999 2,990 9, (3) , , (6) ,060,033 77,571 11, , (3) ,300,000 1,300,
178 (1) (2) (6) ,992 19, , (3) ,994 19, (3) , , , (3) ,990 54, (3) , , (3) , , (3) ,973 89, , (3) , , (3) , , (3) , , (6) ,148,888 67,288 39,468 1,042, (3) ,973 74, , (3) , , (3) , , (3) ,990 54, (3) ,976 58, , (3) ,974 74, , (3) , , , , (3) , , , (3) ,947 26, , (3) , , (3) , , (3) , , (3) ,604 32, (3) , , (3) ,500 56, (3) ,222,013 44,486 3,177, (3) ,966 80, (3) , , (3) , , (3) ,827 43, (3) , ,501 90,251,295 9,308,481 10,900,579 6,216,330 82,442,
179 (1) 13 (2) 13 (3) 25%75% 3625% (4) (5) (6) 20%80% 4820% % % %10%25,
180 % ,000,
181 , (1) (2) ,404 79,404 79,404 79,404 (1) 13 (2) 25%75% 3625% (c)(4) ,000,
182 % 10 (i) 1/13(ii) 1/
183 Thomas Malley Thomas Malley
184
185 A C.3.3 C B
186 A B.8 Scott A. Samuels Scott A. Samuels
187 Donald W. Glazer Michael Goller Ranjeev Krishana Thomas Malley
188 A.4.1 A
189
190 10-K Thomas MalleyThomas Malley3.10(2) (2)
191 Ranjeev Krishana ,000,00026,000,
192 Donald W. GlazerMichael GollerDonald W. Glazer
193 (Mourant Governance Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, Grand Cayman KY1-1108, Cayman Islands(a)(b) a-8(b)(2) (c) (d)(e) (f)(i)(ii) (g) D
194 /10 2/2 7/10 0/2 9/10 6/6 6/7 1/2 Donald W. Glazer 10/10 2/2 2/2 Michael Goller 10/10 2/2 2/2 Ranjeev Krishana 10/10 7/7 2/2 Thomas Malley 10/10 8/8 2/2 6/6 2/2 9/10 8/8 7/7 0/2 A
195 Donald W. GlazerMichael GollerRanjeev KrishanaThomas Malley ,396 1, ,580 1, Q
196 A A Committee of Sponsoring Organizations of the Treadway Commission
197
198
199 (i)(ii) Vistra Corporate Services (HK) Limited Scott A. Samuels
200 (Mourant Governance Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, Grand Cayman KY1-1108, Cayman Islands (Mourant Governance Services (Cayman) Limited, 94 Solaris Avenue, Camana Bay, Grand Cayman KY1-1108, Cayman Islands[ ] (
201 (1) (2)
202 o o
203 o o o o o
204
205 ISO14001(EHS) EHSEHS EHSEHSEHS EHS 1. LED
206 2. 14,600 17, ,
207 , , , , , ,
208 2015 (IPCC)2006 IPCC , , , , , , (GB/T )
209
210
211 EHSEHS EHS
212 EHS EHS (elms) (QA)
213 EHS
214 zanubrutinib(bgb-3111) (BTK)tislelizumab (BGB-A317) 1(PD-1)pamiparib (BGB-290) 1 (PARP1) PARP2 lifirafenib (BGB-283)RAF BGB-A333PD-L1BGB-A425 TIM-3 sitravatinibmirati Therapeutics, Inc.(Mirati) ZW25 ZW49Zymeworks Inc. ZymeworksHER ABRAXANE REVLIMID VIDAZA avadomide(cc-122)cereblon tislelizumab (GMP) ICH Q
215 (BeiGene Quality Manual) QA QA QA 2018 (FTO)
216 (PCT) 2018 (CRO) CRO
217 (HGR)HGR
218 elms
219 (T&E) REVLIMID NDMM RRMM NDMM RRMMNDMM
220
221 , , , ,068, , ,056 29, , ,242 10, ,942 35,623 1,943, , , ,061 62, ,058 12, ,172 7, ,542 7, ,668 42, , ,982 2,249,684 1,046, ,283 69, ,414 49,598 18,140 12, ,888 9, ,727 9, , ,
222 ,785 9, , ,271 9,842 24, , ,931 31, , , , , ,500,000, ,263, ,072, ,744,814 1,000,747 1,526 (480) (1,007,215) (330,517) 1,739, ,809 14,445 14,422 1,753, ,231 2,249,684 1,046,
223 ,885 24, , , , ,387 (28,705) (4,974) (679,005) (269,018) (195,385) (62,602) (894) (250) (903,989) (336,844) (705,769) (98,457) 13,947 (4,108) 1,993 11, (689,829) (91,064) 13 15,796 (2,235) (674,033) (93,299) (264) (194) (673,769) (93,105) 20 (0.93) (0.17) ,753, ,185,460 (12.15) (2.23) 55,442,601 41,783,
224 (674,033) (93,299) (478) 851 2,133 (296) (672,378) (92,744) (352) (105) (672,026) (92,639)
225 (674,033) (93,299) 10,388 4, ,127 42, , ,820 7,035 (21,949) (5,845) (1,948) (44) (8,034) (11,628) (29,428) 7,695 (5,312) (10,930) (46,302) (28,880) (40,228) (29,701) 23,470 55,298 50,543 24,978 (3,355) 7,426 (9,059) 37,041 16,962 31,395 (547,717) 12,752 (70,283) (46,374) (553) 4 (38,298) (12,354) 4 19,916 (2,635,686) (741,296) 2,177, ,789 1 (70,000) (637,613) (356,319)
226 , , (414) (674) , (5,659) , ,315 (8,736) 2,470 (2,470) 14, ,757 29,662 4,627 1,690, ,356 (4,096) 5, , , ,602 87, , , , ,602 14,544 13,232 12,361 29,286 2,209 1,260 23,606 22,105 2,215 19,000 2,
227 ,833, ,213 (946) (237,412) 352, ,907 36,851, , , ,517 32,746, , , ,928 23,606 23,606 23, ,527 14,527 42,863 42,863 42, ,571 5,852,984 4,627 4,627 4, (93,105) (93,105) (194) (93,299) ,072, ,000,747 (480) (330,517) 669,809 14, , (2,929) (2,666) 375 (2,291) ,072, ,000,747 (217) (333,446) 667,143 14, , ,970, , , ,587 65,600, , , ,709 1,299,186 87,127 87,127 87,127 14,321, ,661 29,662 29,662 1,743 1,743 (88) 1,655 (673,769) (673,769) (264) (674,033) ,263, ,744,814 1,526 (1,007,215) 1,739,202 14,445 1,753,
228 Celgene Switzerland LLC Celgene Switzerland , BeiGene % BeiGene AUS Pty Ltd. BeiGene Australia % ,711, % ,940,244,615 95% * ,000,000 95% ,000, %
229 1. BeiGene(Hong Kong) Co., Limited % ,000, % BeiGene Ireland Limited BeiGene Ireland % ,800, % ,000, % * ,344,310 95% ,000, % BeiGene Switzerland GmbH BeiGene Switzerland , % BeiGene UK, Ltd. BeiGene UK % BeiGene USA, Inc. BeiGene USA % *
230
231
232 (i)(ii)
233
234 (i)(ii)(iii) (iv) (i) (ii)
235 ABRAXANE REVLIMID VIDAZA CC
236 (1)(2)(3)
237 ,068, ,810 1,228, ,327 17,663 18,924 44, ,
238 (i)(ii)(iii) (iv)(v)
239 2. ABRAXANE REVLIMID VIDAZA
240
241 2. (i)(ii) (i) (ii)(iii) (iv) (v)
242
243 2. (a) (b)(c) 75% (d)90%
244
245
246 %
247 ,937239, ,068,509597,
248
249 %6.5%
250 EITF S
251 , , , , (1)(2)
252 ,307 16,307 42,915 (28,588) 14,327 31,959 (9,990) 21,969 (480) 263 (217) (330,517) 16,307 (19,236) (333,446) 14, ,
253 ,00030,000 45,
254
255 3. (1)1 PD-1 tislelizumab(2) pamiparib lifirafenib ,391 56,776 10,559 2,568 67, ,959 Celgene Switzerland Celgene Switzerland PD-1tislelizumab PD Celgene SwitzerlandPD-1A&R PD-1 A&R PD-1263,000 92, , Celgene Switzerland 12 13,000 Celgene Holdings East Corporation A&R PD
256 3. Celgene Switzerland tislelizumaba&r PD-1 tislelizumab tislelizumab tislelizumab 606(a) tislelizumab(b)tislelizumab 250, , ,776 16, , ,391 1,
257 lifirafenib lifirafeniblifirafenib lifirafenib Lifirafenib RAF lifirafenib lifirafenib 2013pamiparib pamiparib pamiparib pamiparib 10, pamiparib , pamiparib3 1, pamiparib19,
258 lifirafenib pamiparib Zymeworks, Inc ZymeworksZymeworks ZW25(ADC) ZW49 Zymeworks ZymeworksAzymetic EFECT Zymeworks ZW25 ZW49HER2 Zymeworks ZW25 ZW49 ZW49 ZW25Zymeworks40, ,000Zymeworks ZW25 ZW49 Azymetric EFECTZymeworks20, ,000 Zymeworks 60,
259 Celgene Holdings East Corporation Celgene Logistics Sàrl Celgene Logistics ABRAXANE REVLIMID VIDAZA CC-122 A&R PD Celgene Switzerland Celgene Switzerland32,746,416150,
260 4. 28,1384,53223, ,532 23,606 28,138 24, ,500 1,069 33,739 (5,710) (5,710) ,
261 4. 24,448 (4,532) 19,916 (23,606) ,654 38, ,783 15,874 (11,221) ,
262 , ,066,770 1, ,068,509 1,066,770 1, ,068, , ,327 17, ,663 18,924 18, , ,
263 ,056 29,428 41,056 29, ,056 18, ,521 41,056 29, ,
264 ,24210, % 1 5% ,8302, % 100% 95% % 5% ,
265 ,636 15,596 18,048 15,298 15,857 16,048 15,737 2,216 1,597 1,229 1,244 1, ,296 50,070 (19,722) (13,627) 99,487 26, ,061 62, ,48726, ,0004, ,701 12,633 (643) (168) 45,058 12, , , , , , ,
266 ,500 (1,000) 6,500 7,500 (250) 7, (144) 672 8,316 (1,144) 7,172 7,500 (250) 7,250 ABRAXANE REVLIMID VIDAZA CC , ,
267 % % 25% % BeiGene AUS Pty Ltd. 30%BeiGene AUS Pty Ltd. BeiGene USA % 35% BeiGene USA
268 13. BeiGene Switzerland10.5% BeiGene Switzerland (130,552) (59,590) 15,036 6,928 (574,313) (38,402) (689,829) (91,064) ,890 2,477 (377) 5,695 6,513 8,172 (2,682) 115 (19,627) (6,052) (22,309) (5,937) (15,796) 2,
269 (689,829) (91,064) 25% 25% (172,457) (22,766) 134,673 23,275 4,471 1,608 1,538 2,642 (29,438) 34,009 30,356 (12,659) (5,431) (5,371) 1,989 (15,796) 2, % -2.5% ,193 7,756 61,266 29,801 8,642 4,639 13,608 2, , ,348 44,645 (242,945) (36,600) 18,403 8,045 (370) (370) 18,403 7,
270 ,00930, , ,769209, , , ,780 22,68814, (44) (91) 1, , ,
271 , ,673 21,156 14,588 9,894 3,096 1,557 5,585 3,016 81,942 35,
272 ,981 12,867 (1) 25,193 28,588 14,671 1,823 1,460 53,668 42,915 (1) ,887 17,051 34,588 18,721 10,433 2,350 8,030 5,088 4,749 3,997 6,727 2, ,414 49, ,851 31,804 1, ,931 31,
273 ,191 65, ,376 3, , , ,283 69, %17, , , , , , % , ,2531,
274 ,727 9,222 9,222 4,213 36,572 49,512 18, %
275 % ,894 7,6493, , , , ,
276 18. ABRAXANE REVLIMID VIDAZA ,046 28,428 (7,161) (4,000) 130,885 24, ,000 (3) ,997 7,161 (6,409) ,
277 ,705 4,974 9,000 4, , ,018 8,930 3, ,396 1, ,115 65,608 87,127 42,863 12,409 4, , ,086 (1,948) (44) 4,184 (232) (23,401) (4,188) ,08580,
278 (673,769) (93,105) 720,753, ,185,460 (0.93) (0.17) ,029, ,144, (i)5% (ii) ,603, ,553,
279 ,889, ,000, (c)(4)5635(c)(4) ,500, ,855,315 7,355, % 10%
280 ,079, ,085, (5,887,193) ,723 (6,275,115) ,002, ,387, (13,841,036) ,687 (6,467,099) ,082, , ,829, , ,857, , ,027,926154, ,642 20,
281 ~ ~ % ~ 3.1% 2.2% ~ 2.6% 2.2 ~ ~ % ~ 64% 99% ~ 100% 0% 0%
282 ,075, , (268,750) 2.04 (300,000) , (387,500) 2.12 (118,750) , ,
283 ,469, ,469,442 14,079, (689,130) 8.33 (757,458) ,102, ,692, , ,384 30,610 32,743 12,253 87,127 42,
284 ,600,000 85,800, ,00012,870, , ,781,25075,156, ,00011,050, ,7506,093, , ,465,00032,045, ,7504,806, , S ,425,750 96,534,750495,050 6,435, , S ,600, ,
FCIS FCS Scott A. Samuels Donald W. Glazer Michael Goller Ranjeev Krishana Thomas Malley Thomas Malley Ranjeev Krishana Donald W. Glazer Michael Golle
2 4 24 38 39 40 42 43 45 87 90 1 B E I G E N E, L T D. 2 0 1 8 FCIS FCS Scott A. Samuels Donald W. Glazer Michael Goller Ranjeev Krishana Thomas Malley Thomas Malley Ranjeev Krishana Donald W. Glazer Michael
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: 2628 2 3 6 7 10 29 36 39 50 54 70 92 96 97 98 100 102 104 105 107 217 1 1 1 2 China Life Insurance Company LimitedChina Life 16 86-10-63631244 86-10-66575112 ir@e-chinalife.com 16 86-10-63631068 86-10-66575112
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