Liaoning Chengda Biotechnology Co., Ltd.* [] [] [] [] [] [] [] H [] [] H[] [] H H []1.0% % 0.005%[] H 1.00 [] [] [ ] [] [] [ ] 342C [] [][][] []
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- 鉴圳 成
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1 Liaoning Chengda Biotechnology Co., Ltd.* (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) 1933 *
2 Liaoning Chengda Biotechnology Co., Ltd.* [] [] [] [] [] [] [] H [] [] H[] [] H H []1.0% % 0.005%[] H 1.00 [] [] [ ] [] [] [ ] 342C [] [][][] [][] [][] [] [] [] [][] [] [][] [][][]1%0.0027%0.005%[][] [] [][][] [] [] [][][] http//: [] [] H [][][] [][] [][] [] []144A S * []
3 (1) [] i
4 (1) [] ii
5 (1) [] iii
6 [] [][] [] [] [] [] [] [] [] [] i iv [] iv
7 [] [] [] [] [] I-1... II III-1... IV V-1... VI-1... VII-1 v
8 [] NDA Vero Vero Vero % 7,000 Zagreb , % Vero % % 1
9 NDA 2020NDA CTA CTA NDA NDA CTA 2020 A C b CTA 2021 CTA 2021 CTA 2
10 % 94.5% 92.2% 86.2% Vero 3
11 GMP PIC/S GMP GMP12 GMP GMP
12 , ,026, ,271, , , (148,625) (15.8) (174,476) (17.0) (198,622) (15.6) (115,369) (19.8) (110,727) (16.7) , , ,073, , , , , , , , (53,327) (5.7) (58,889) (5.7) (51,666) (4.1) (21,756) (3.7) (43,821) (6.6).. (146,922) (15.6) (153,263) (14.9) (288,761) (22.7) (110,367) (18.9) (139,551) (21.0).... (73,437) (7.8) (77,407) (7.5) (81,532) (6.4) (28,855) (5.0) (34,251) (5.2).... (2,086) (0.3) (49,433) (4.9) (37,654) (3.0) (24,479) (4.2) (32,039) (4.8) , , , , , (84,097) (8.9) (96,489) (9.4) (99,829) (7.8) (44,647) (7.7) (48,808) (7.3).. 457, , , , ,
13 Vero Vero Vero , , ,145, , , Vero , , , , , (1)... 18, , , , , , ,026, ,271, , , (1) (i)2016 (ii) , %
14 , , , , ,125,880 1,733,083 2,005,073 2,091, ,001,996 2,602,236 2,850,723 2,892, , , , , ,203 45, ,362 76, , , , , ,805,141 2,395,743 2,576,203 2,671, , , , , ,077.. (154,033) (212,253) (360,138) (296,663) (355,987)... (360,000) 77,477 (374,800) (374,800) (194,653)... (67,080) 417,687 (104,823) (514,057) (396,563) , , , , , ,278 (3,408) (1,397) 1, , , , , ,870 7
15 (1) % 83.0% 84.4% 83.3% (2) % 50.0% 43.7% 42.7% (3) % 24.4% 22.3% (4) % 22.3% 20.4% (5) (1) (i) (ii)100.0% (2) (i) (ii)100.0% (3) (i) (ii) 100.0% (4) (i) (ii) 100.0% (5) (i)(ii) [] 8
16 % [][][]% [] [] [] [] [] [154.4][174.4][][ ][] [] [147.1] [][9.8] [137.3] [] 9
17 [] 10
18 [] [][] [] [] [][]H [][] [] []%[] []%[] []%[] []%[] [] [] [ ] [] 11
19 GMP
20 [] [] 13
21 GMP
22
23 HA [] 16
24 [] H 1.00 [] [] [] 17
25 [] [] [] 18
26 [] []
27 [] GEM
28 [] 21
29 [] [] [] A S S [] [ ] 22
30 H [] 23
31 [] [] WHO [] 24
32 Y 25
33 Essen 5 Zagreb GDP GLP Good Laboratory Practice 26
34 GMP GSP B Hib 27
35 m NDA PIC/s (PIC) PIC GMP 28
36 100% DNA DNA 29
37 Vero 30
38 31
39 32
40 H H % 93.8% 90.1% 83.8% 88.3% % 4.8% 8.0% 12.9% 10.2% 33
41 % % Zagreb
42 35
43 GMP
44 GMP 37
45 38
46 39
47 Zagreb Essen
48
49 500100, Zagreb Zagreb
50
51
52 45
53 2020NDA NDA 46
54 47
55 48
56
57 50
58 12 51
59 % 56.4% 52
60 18 53
61 % 25%
62 % 1.3% 0.6% 0.6% 0.8% 55
63 GMP GMP 56
64 164,
65 % 100% % 9.1% 11.6% 9.7%
66 59
67 60
68
69 62
70 20 63
71 H [] H H HH H H 64
72 20% 10% 10%H 10%10% H H H 65
73 H H [] H %1.0% % % 66
74 HH H [] [] [] H SARS H1N1H5N1H7N9H3N2 67
75 [] H H [] H H [] [] [][]HH [] H [] H[] []H H H H[] H[]H H H H 68
76 HHH H []H[][]H []H HH []H H H H H H [] H H H H HH H [] H[] [][] HH [][] H [][] H [] [] 69
77 [][] [] HH H H H H
78 H [][] [] H H H H [] [ ] [] [] [] [] [] 71
79 H [] [] H H []H 72
80 [] A A A.15 (i) (ii) (iii) (iv) (v) 73
81 (vi) [][] (a) (b) (c) (a) (b) (c) 3.29 (d) 74
82 [] [] (i) [] 3.28 (ii) [] (iii) (iv)
83 [ ] [] 76
84 [ ] [] 77
85 [ ] [] 78
86 [ ] [] 79
87 [ ] [] 80
88 [ ] [] 81
89 [ ]
90 [ ] E
91 [ ] [] [] [] []
92 [ ] [] [] [] B [] 85
93 (FCIS FCS(PE)) (FCIS FCS(PE))
94 []
95 [] [] [] [] [] [] WHO (i) (ii)(iii) 18 88
96 % %26.4% % 16.5% 0.5% 26.4% 11.6% 11.3% 11.1% 11.5% 9.4% % % % % % 18.6% 4.9% 26.2% 4.3% 25.2% % % 89
97 (1) (1) 10g 20%500ml
98 % % %
99 % % 100% 100% % 13.0% % % % Essen 5Zagreb 2-1-1Essen 5 28Zagreb Zagreb 2-1-1Essen 5 12 Zagreb
100 Zagreb Zagreb Zagreb Zagreb Essen % 30.2% 43.7% 32.6% 36.2% 40.5% 39.3% 41.0% 41.4% % agreb ssen % 18.6% 21.1% 16.3% 15.5% 17.2% Zagreb Essen 5 Zagreb %Essen 5Essen %Zagreb Vero Vero Vero Vero Vero Vero 2017 Vero 85.6% 9.0% 5.4% 93
101 1,500 1, , , , , , ero 95% % %
102 %2017 (%) 1 1, A B C % Zagreb Essen 5 Vero % 30% % % 95
103 63.0% 61.4% 59.5% 51.6% 53.5% 57.3% 54.2% 51.2% 47.7% % % 0.9% -2.1% 16.4% -4.9% 6.6%
104 (%) 1 D E
105
106
107 GLP 100
108
109
110 5 66 (i) (ii)
111 GMPGMP GMP GMP 6 GMP
112
113
114
115
116
117 ,
118 (i) (ii) (iii)(iv) 111
119
120 % 113
121
122 % 15% % (1) 50 5% (2) %(3)200 3% 60% 60% 115
123 H [2008] H 10% % 25% 5% B [2009] % % [2009]9 116
124 6%[2014]57 [2009]9 6% 3% 3% % 10 6% %5% 1% % % 117
125 % 30% 1.2% 12%
126 <>
127 [2015]
128 ,000, ,800, ,800, ,800,000226,919, % Zagreb
129 PIC/S GMP ,000,000 49% 31% 20% 66.67% 33.33% ,000,
130 ,800, ,000,00011,800, ,000, ,000,000 (i) (ii) ,800, ,800,
131 [] (1) (2) 60.54% 39.46% (4) 100% 100% 124
132 (1) % (2) , % 3.00%2.38% 3,055, % (3) [][] (1) (2) [] [] [] (3) 100% 100% (1)-(3)
133 H []H [][] HH [] H H 126
134 % Zagreb NDA2020 NDA A C b (HIB) NDA B % % % 127
135 26 Zagreb Essen , % % % %
136 164, GMP GMPGMP 10,000,00010,000, , , , % %
137 , , % % % Zagreb Zagreb Zagreb % ,
138 % % 4.5 IU 2.5 IU Zagreb Zagreb Zagreb Essen Zagreb Zagreb %
139 % Zagreb
140 Vero 2021 GMPGMPGMP GMPGMP 10,000,00010,000,
141 164, Vero Bosch
142 WHOWHO Pfizer B ACWY
143 % 136
144 WHO WHO [] Zagreb CTA NDA 137
145 [] 100 B 138
146 Vero Vero2020 NDACTA 26 Vero Vero , , % Vero.. 810, , ,145, , , Vero , , , , , (1)... 18, , , , , , ,026, ,271, , , (1) (i)2016 (ii) 139
147 Vero Vero 100% , % 1, % 2005 Zagreb Essen 5Zagreb Essen 5WHO Zagreb WHO WHO Zagreb 2-1-1Essen 5 Zagreb Zagreb % Essen % 140
148 10 100% 4.5IU2.5IU 2003 Vero Vero % , Vero Vero10 141
149 30% 2008 Vero 90.0% 100% VeroVero 142
150 Vero % ,000 NDA 2020NDA
151 % CTA CTA NDA NDA CTA 2020 A C b
152 CTA CTA NDA NDA CTA B CTA (1) (2) (3) (4) 145
153 % 78.0%27.8%
154 B 147
155 148
156 VeroVero /ml Vero DNA 149
157 Vero 164, Vero Vero HIB (1) (2) (3) (1) (2) (3) (1) (2) (3) (1) (2) (3) Vero... 10,000,000 8,101, % 10,000,000 4,207, % 10,000,000 8,518, % 5,000,000 3,412, % Vero... 10,000,000 4,379, % 10,000,000 2,536, % 10,000,000 2,487, % 5,000, , % (1) (2) (3) 150
158 Vero % % % %2018 Vero 2016 Vero Vero Vero 2017 Vero Vero Vero % % % % Vero 3,000, NDA 151
159 650 HIB 14,000, []
160 , , ,172, , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,026, ,271, , ,
161 , % 94.5% 92.2% 90.0% 86.2% C 8 C ,
162 Zagreb
163
164 % 3.8% 10.5% 22.1% 15.5% 157
165 % 27.9% 11.1% 14.8% 12.8% % 7.1% 4.2% 3.3% 5.9%2016 5%
166 Vero Vero IP % 100% 159
167 % 5.5% 7.8% 13.8% 160
168 GSP C 8 C
169 (i)(ii) (iii) (iv)(v) % 0.3% 1.0% 1.0% 0.1%
170 % 36.1% 43.9% 37.9% % 15.9% 21.3% 15.5% 5% 163
171 GMP GMP PIC/S GMPGMP PIC/SGMP GMPPIC/S GMP GMP GMP GMP 12 GMP GMP WHO 164
172 GMP GMP
173 Vero (1) Vero Vero GMP Vero LN Vero GMPLN Vero Vero GMPLN Vero Vero
174 Vero Vero S /2015R Vero Vero S /2015R Vero Vero S /2018R Vero Vero S /2018R (1) Vero
175 B
176 2012 rhsa 2009 Vero Vero % GSK 169
177 10 Zagreb
178 % % % 2.0% % 9.4% 12.4% 9.0% 9.4% 171
179
180 (2) % 5342(1)(b) 34(2) 315,
181 37 184, , , % 2, , % 10% 174
182 6,
183
184 GMP
185 , % Zagreb
186 Zagreb (i)zagreb (ii)zagreb
187 (a) (b) 180
188 (c) [][] [] [] [] 181
189 182
190 []
191 [] [] 32 [] [] 45 [] [] 184
192
193 Vero Vero Vero
194
195 [] [] []
196
197
198
199 B ACWY
200 Vero
201 []
202 [] HM International Holdings Limited [] [] [] [] 195
203 [] []
204 (i) (ii) (iii) 13.51(2)(a) (v) 197
205 3A.19 19A.05 [] 3A.23 (a) (b) (c) [] (d) A.06 [][] 198
206 [] [] 374,800, ,800, ,800, % [] [][] ,800,000 [] H... [] []... [] [] [][] ,800,000 [] H... [] []... [] [] 199
207 [](i) (ii)h 1.00H H H (i) 12H 20% (ii) (iii)h H H H 200
208 H H[]H H H H (a) H (b) H H (c) (d) HH HH (e) H H (i) HH H H 201
209 (ii) H (f) HH H (g) HH H 25% 202
210 [] H H[] (a) [] []H [] H []%[] [] H [] H []% (b) [][][] [] (c) H[] (d) []H[] (e)
211 10.07(1) (a) []6 (b) (a) 6(a) 10.07(2)3 []12 (a) 10.07(2)(2) 155 [] (b) [] 204
212 374,800, ,800,000 5% (%) 226,919, % [] [] [] 374,800,000[] H []% []% []374,800,000[] H[]% []% [] XV23 10% [] [] [] [] ,919,764 [] ,919,764 []
213 60.54%[][] []%
214 (i) (ii) (iii) (iv) [] [] 207
215 [] 208
216 [] 209
217 [] 210
218 NDA Zagreb Essen VeroVero % 93.8% 90.1% % % 4.8% 8.0% % % 94.5% 92.2% 90.0% 86.2% % 5.5% 7.8% 10.0% 13.8% 211
219 , , % % % % % % 212
220 Vero Vero
221 2018 7GMP
222 Zagreb Zagreb % 5.5% 7.8% 10.0% 13.8% 215
223 2020NDA
224 10 10 [][] [] [] % 14.9% 22.7% 18.9% 21.0% 7.8% 7.5% 6.4% 5.0% 5.2%
225
226 15 219
227 16 220
228
229 , ,026, ,271, , , (148,625) (15.8) (174,476) (17.0) (198,622) (15.6) (115,369) (19.8) (110,727) (16.7) , , ,073, , , , , , , , (53,327) (5.7) (58,889) (5.7) (51,666) (4.1) (21,756) (3.7) (43,821) (6.6)... (146,922) (15.6) (153,263) (14.9) (288,761) (22.7) (110,367) (18.9) (139,551) (21.0).... (73,437) (7.8) (77,407) (7.5) (81,532) (6.4) (28,855) (5.0) (34,251) (5.2).... (2,086) (0.3) (49,433) (4.9) (37,654) (3.0) (24,479) (4.2) (32,039) (4.8) , , , , , (84,097) (8.9) (96,489) (9.4) (99,829) (7.8) (44,647) (7.7) (48,808) (7.3) , , , , , Vero Vero Vero , , ,145, , , Vero , , , , , (1)... 18, , , , , , ,026, ,271, , , (1) (i)2016 (ii) 222
230 , % 93.8% 90.1% 83.8% 88.3% % 4.8% 8.0% 12.9% 10.2% % %
231 , , ,172, , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,026, ,271, , , % 94.5% 92.2% 90.0% 86.2% % 5.5% 7.8% 10.0% 13.8% (i) (ii) (iii)
232 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , (1)... 6, , , , , , , , , , (1) % 7.7% 6.2% 6.9% 7.5% 225
233 , % 83.0% 84.4% 80.2% 83.3% , , , , , , , , , , , , , , , (1)... 1, , , , , , , , , ,
234 (1) (i) (ii) , , , , , , , , , , , , , , , (1)... 13, , , , , , , , , , (1) 227
235 , , , , , , , , , , , , , , , (1)... 28, , , , , , , , , , (1) 228
236 , , , , , , , , , , , , , , , (1)... 25, , , , , , , , , , (1) [] 229
237 , , , , , , , , , , , , (1) , , , , , , (1)
238 ,096 91, ,589 48,001 56, ,756 (760) (3,354) (7,792)... 84,097 96,489 99,829 44,647 48, % % % 15.8% 15.2% 14.8% 14.7% 231
239 % 50.0% 43.7% 44.0% 42.7% % % (i) 2018 (ii) % % % %
240 % % (i) % (ii) % % % % % 84.0% % (i) (ii) % % (i)
241 95.7% (ii) % % % (i) % (ii) % % % 5.2% % % % % % %
242 % % 14.7% % , % 20171, % ,145.9(i) % (ii) % (i) % (ii) %
243 % (i) % (ii) % (iii) % , % % % (i) % (ii) % % % %
244 % % %(i) (ii) % 70.4(iii) % % % % % % (i) % (ii) % % %
245 % % 15.2% % % 20161, % (i) % (ii) % (a) 2016 (b) % % % (i) (ii) %
246 % % % (i)(ii) % % % % % % % % %
247 % % % % % % % 15.8% %
248 [] [] , , , , , (154,033) (212,253) (360,138) (296,663) (355,987)... (360,000) 77,477 (374,800) (374,800) (194,653)... (67,080) 417,687 (104,823) (514,057) (396,563) , , , , , ,278 (3,408) (1,397) 1, , , , , , (i) 25.3(ii) 23.0 (i) (ii)
249 (i) (ii) 76.0(i) (ii) 54.6(iii) (i) (ii) 34.4 (i) 88.9 (ii)83.1(iii) (i)85.3 (ii) (i)1,260.0 (ii) , (i) 2, , (ii) ,
250 (i) 1, , (ii) , (i) (ii)
251 , , , , , , , , , , ,448 4,668 8,166 17,082 20, ,070 20, , , ,593 70, , , , , ,000 50, , , , , , ,125,880 1,733,083 2,005,073 2,091,598 2,339, ,450 4,035 8,121 2,973 5, ,895 3, ,528 37, ,346 63, , ,381 6,444 3, ,203 45, ,362 76, , ,089,677 1,687,616 1,881,711 2,014,985 2,228,
252 , , , , , , , , , , , , ,986 8,885 9,539 13, ,180 9,707 15,875 5, , , , , , , , , ,894 9,788 6, , , , , , , %(i) (ii) , , % (i) 245
253 % (ii) % (iii) , , %(i) % (ii) (iii) % % , ,124 36,171 39,507 36, ,627 57,258 57,011 54, ,635 96, ,041 91, (83) (15,240) , , , ,
254 % (i) % (ii) , % % (i) % (ii) % % (i) (ii) % (1) (2) (1) (2) 247
255 (i) (ii) (i) (ii)
256 , , , , (24,913) (48,002) (63,470) (65,643) , , , , , , , , , , , , ,470 88,549 56,338 84, ,887 60,359 72,584 48, ,342 7,843 39,821 57, , , , ,
257 % (1) (1) (i) (ii) , , % 5.68% ,000 20, % , , % 29,190 28, % 250
258 ,593 70, , , , ,952 90,625 63, ,523 38,069 65,237 62, , , , , , , , ,
259
260 ,210 3,441 7,247 2, ,450 4,035 8,121 2, % (1) (1)
261 ,477 25,082 77,120 26, ,898 28, ,073 2,418 1,607 1, ,517 2,542 3,247 5, ,100 5, , ,421 2, ,528 37, ,346 63, (i) (ii)
262 [] [] [] []
263 ,615 7,583 10, ,050 13, ,261 22,151 7,583 10, ,202 1, , , , ,029 1, , [] [] [] 256
264 % 83.0% 84.4% 83.3% % 50.0% 43.7% 42.7% (1) % 24.4% 22.3% (2) % 22.3% 20.4% (3) (1) (i) (ii) 100.0% (2) (i) (ii) 100.0% (3) (i)(ii) 257
265 % 24.4% 22.3% % 12.1% % 8.2% % 22.3% 20.4% % (i)2016 (ii) 12.1% %(i) (ii) 8.2%
266 [] [] [] [] [] [ ][154.4][174.4][][ ][] [] [147.1] [][9.8] [137.3] []
267 ,
268 (a) (b) 10% 50% (c)
269 4.29[] [] [] [] [] (1) (2) (3) (3) (4) [] [].... [2,671,985] [] [] [].... [2,671,985] [] (1) ,672.0 (2) [] [][][][] [] [][] (3) [][] [ ] 262
270 (4) (5) []
271 [ ] [] []H [][] [][][] [] (a) []%[] (i) A C B [] (ii) [] 2019 (iii) []
272 [ ] (b) []%[] (i) [] (ii) [ ] 2018 (c) []%[] (d) []%[] [] [][] [] [][] [ ][] [][][] [][] [] [](a) (iii) (b)(i) (c) [][] [] [][][][ ][] (a)(i) (a)(ii) (b)(ii) (a)(iii) (b)i (c) [][] 265
273 [ ] [] 266
274 [ ] [] 267
275 [ ] [] 268
276 [ ] [] 269
277 [ ] [] 270
278 [ ] [] 271
279 [ ] [] 272
280 [ ] [] 273
281 [ ] [] 274
282 [ ] [] 275
283 [ ] [] 276
284 [ ] [] 277
285 [ ] [] 278
286 [ ] [] 279
287 [ ] [] 280
288 [ ] [] 281
289 [ ] [] 282
290 [ ] [] 283
291 [ ] [] 284
292 [ ] [] 285
293 [ ] [] 286
294 [ ] [] 287
295 [ ] [] 288
296 [ ] [] 289
297 [ ] [] 290
298 [ ] [] 291
299 [ ] [] 292
300 [ ] [] 293
301 [ ] [] 294
302 [ ] [] 295
303 [ ] [] 296
304 [ ] [] 297
305 [ ] [] 298
306 [ ] [] 299
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311 [ ] [] 304
312 [ ] [] 305
313 [ ] [] 306
314 [ ] [] 307
315 [][] I-1
316 I-2
317 [] 10 I-3
318 I I-4
319 ,130 1,026,139 1,271, , , (148,625) (174,476) (198,622) (115,369) (110,727) , ,663 1,073, , , ,095 96,943 41,535 19,426 28, (53,327) (58,889) (51,666) (21,756) (43,821)... (146,922) (153,263) (288,761) (110,367) (139,551).... (73,437) (77,407) (81,532) (28,855) (34,251) (2,086) (49,433) (37,654) (24,479) (32,039) , , , , , (84,097) (96,489) (99,829) (44,647) (48,808) , , , , , , , , , , , , , , , , , , , , I-5
320 , , , , , , , , , , , , ,986 8,885 9,539 13, ,180 9,707 15,875 5, , , , , , , , , , , , , ,448 4,668 8,166 17, ,070 20, , ,593 70, , , , ,000 50, , , , , ,125,880 1,733,083 2,005,073 2,091,598 2,001,996 2,602,236 2,850,723 2,892, ,450 4,035 8,121 2, ,895 3, ,528 37, ,346 63, ,381 6, ,203 45, ,362 76, ,089,677 1,687,616 1,881,711 2,014, ,965,793 2,556,769 2,727,361 2,816, , , , , ,894 9,788 6, , , , , ,805,141 2,395,743 2,576,203 2,671, , , , , ,445,141 2,020,943 2,201,403 2,297,185 1,805,141 2,395,743 2,576,203 2,671, ,805,141 2,395,743 2,576,203 2,671,985 I-6
321 * * * , , , ,042 1,707,410 1,707, , , , (360,000) (360,000) (360,000) , , , ,773 1,805,141 1,805, , , , ,773 1,805,141 1,805, , , , , , , , ,400 (7,400) (187,400) (187,400) (187,400) , , ,400 1,099,098 2,395,743 2,395, , , ,400 1,099,098 2,395,743 2,395, , , , (374,800) (374,800) (374,800) , , ,400 1,279,558 2,576,203 2,576, , , ,400 1,279,558 2,576,203 2,576, , , , (187,400) (187,400) (187,400) , , ,400 1,375,340 2,671,985 2,671, , , ,400 1,099,098 2,395,743 2,395, , , , (374,800) (374,800) (374,800) , , , ,948 2,277,593 2,277,593 * ,445,141,0002,020,943,0002,201,403,000 2,297,185,000 I-7
322 , , , , , (524) (524)... 5 (70) (312) (312) (1,629)... 5 (3,406) (12,758) (27,411) (7,244) (14,674) (52) 179 (895) (4) (26) (65,863) 637 (5,784) 25, (739) (1,757) (1,528) (690) (1,619).... (671) (2,278) 3,408 1,397 (1,176) ,029 64,554 45,179 22,508 23, ,172 3,172 2,121 1,061 1, (7,651) (9,281) (6,596) (3,298) (3,304) ,666 14, ,521 15,945 21,278 2, (18) 76 (39) (37) ,613 17,448 28,087 25,618 4, , , , , , (28,089) 13,808 (54,599) (15,274) 14, (34,095) 34,445 (851)... (9,260) (83,060) (18,718) (153,300) (134,502).... 3,244 15,104 (1,259) (533) 8, (607) 2,585 4,086 8,047 (5,148) ,033 (162) 1, ,317 7,316 75,968 5,716 (49,279) , , , , , ,757 1, , (85,270) (88,906) (106,170) (43,044) (47,956) , , , , ,077 I-8
323 , ,000 50, ,268 1,761,518 1,780, ,000 1,090, , ,406 12,758 27,411 7,244 14, , (18,215) (16,621) (37,035) (16,065) (17,518)... (15,000) (50,000)... (200,000) (20,000) (198,600)... (548,588) (1,770,032) (2,298,986) (1,188,231) (1,260,000)... 7,000 1, (154,033) (212,253) (360,138) (296,663) (355,987) , (360,000) (187,400) (374,800) (374,800) (187,400) [].... (7,253)... (360,000) 77,477 (374,800) (374,800) (194,653).... (67,080) 417,687 (104,823) (514,057) (396,563) , , , , , ,278 (3,408) (1,397) 1, , , , , , , , , , , , , , , ,870 I-9
324 , , , , ,436 89,315 87,194 86, ,000 5,000 5,000 5, , , , , ,986 26,955 30,696 35, ,180 9,707 15,875 5, , , , , , , , , , , , , , , , , ,070 20, , ,593 70, , , , ,000 50, , , , , ,364,687 1,917,918 2,177,904 2,262,883 2,039,503 2,582,971 2,835,984 2,876, ,443 4,035 8,051 2, ,895 3, ,358 36, ,619 62, ,381 6, ,026 44, ,565 75, ,328,661 1,873,241 2,055,339 2,187, ,003,477 2,538,294 2,713,419 2,801, , , ,789 97, ,894 9,788 6, , , , , ,885,841 2,417,849 2,602,842 2,697, , , , , ,525,841 2,043,049 2,228,042 2,322, ,885,841 2,417,849 2,602,842 2,697,371 I-10
325 II , % 40, % I-11
326 (a) (b) (c) (i)(ii) (iii)(i) (ii) (iii) I-12
327 I ,934, (i) (ii)(iii) (iv)
328 (a) (i) (ii) (iii) I-14
329 (b) (i) (ii) (iii) (iv) (v) (vi) (a) (vii) (a)(i) (viii) % 9.7% % % % I-15
330 5 I-16
331 (a) (b) I-17
332 I-18
333 (i) (ii)(iii) (a) (b) (c) I-19
334 9 I-20
335 9 I-21
336 I-22
337 (a) I-23
338 (b) 3. I-24
339 15 16 I-25
340 4. (a) , ,724 1,172, , , ,764 56,415 99,675 58,537 91, ,130 1,026,139 1,271, , ,541 (b) % I-26
341 ,416 1,029,680 1,276, , , (3,286) (3,541) (4,251) (1,906) (2,080) 940,130 1,026,139 1,271, , ,541 (a)... 7,651 9,281 6,596 3,298 3,304 (b)... 11,449 3,703 1,205 2, ,757 1, , , ,406 12,758 27,411 7,244 14, ,245 27,569 37,576 12,068 23, ,171 2,609 1, ,593 66,753 2,508 7,354 4, , ,850 69,374 3,959 7,358 5,349 26,095 96,943 41,535 19,426 28,838 (a) (b) 12 I-27
342 , ,957 1,070, , , ,417 49, ,211 75,044 67, , , ,724 1,172, , , ,236 42,867 74,994 39,303 81, ,346 13,548 24,681 19,234 9,944 39,764 56,415 99,675 58,537 91, ,130 1,026,139 1,271, , , , , , , , ,029 64,554 45,179 22,508 23, ,172 3,172 2,121 1,061 1, ,435 2,751 3,223 1,636 1, ,368 73, ,867 41,342 48, ,494 5,627 6,956 3,381 3, ,670 18,984 21,062 8,936 10, ,532 98, ,885 53,659 63,518 I-28
343 , ,797 1, ,666 14, ,521 15,945 21,278 2, (18) 76 (39) (37) (38) (27)... 1, ,145 1,570 29,402 2,086 49,433 37,654 24,479 32, (a) 383(1)(a) (b) (c) (f) ,203 2,198 10,161 1,041 1, ,236 2,234 10,200 1,060 1,309 I-29
344 (b) , *... 1,214 1,214 2, , , *... 1,213 1,213 2, ,234 I-30
345 *... 1,940 1, , ,160 3, , **.... 7,100 7,100 10, , * , ,060 I-31
346 * ** , ,309 * ** I-32
347 ,362 2,351 1,974 1,156 1, ,460 2,458 2,052 1,213 1, ,000, ,000,001 2,000, I-33
348 9. 25% % % ,096 91, ,589 48,001 56, ,756 (760) (3,354) (7,792) 84,097 96,489 99,829 44,647 48, , , , , , , , ,772 75,324 82,998.. (56,065) (64,326) (66,552) (29,765) (32,540).. (4,627) (4,794) (5,231) (2,247) (3,163)... 1,610 1,908 2, , ,441 2, (1,047) (4)... 7,700 4,856 3,013 1, (287) (345)... 84,097 96,489 99,829 44,647 48,808 I-34
349 , , , , , , , , , , ,000, ,100, ,800, ,800, ,800, I-35
350 , ,371 9,798 51,674 72, , (68,523) (130,014) (6,214) (33,835) (238,586) , ,357 3,584 17,839 72, , , ,357 3,584 17,839 72, , ,469 1,277 7,400 25, (16) (12) (16) (44).... (27,755) (27,273) (705) (7,296) (63,029)... 65,032 13, (78,976) , ,366 2,867 11, , , ,117 9,427 52, , (96,278) (156,751) (6,560) (40,578) (300,167) , ,366 2,867 11, , , ,117 9,427 52, , (96,278) (156,751) (6,560) (40,578) (300,167) , ,366 2,867 11, ,443 I 36
351 , ,366 2,867 11, , , ,789 7,481 14, (118) (111) (74) (303).... (31,071) (27,148) (674) (5,661) (64,554)... (21,666) (21,666)... 1, (1,567) ,242 99,480 2,471 9,348 6, , , ,572 9,341 53,226 6, , (127,349) (180,092) (6,870) (43,878) (358,189).... (21,666) (21,666) ,242 99,480 2,471 9,348 6, , , ,572 9,341 53,226 6, , (127,349) (180,092) (6,870) (43,878) (358,189).... (21,666) (21,666) ,242 99,480 2,471 9,348 6, , ,242 99,480 2,471 9,348 6, , ,835 1,802 6,382 18,037 30, (388) (45) (238) (671).... (19,020) (22,327) (634) (3,198) (45,179)... (9,563) (4,520) (2) (14,085)... 4,843 1,986 1,555 (8,384)... (4,166) (4,166) ,336 78,066 3,592 13,849 16, , , ,441 10,891 53,251 16, , (146,369) (197,855) (7,297) (39,402) (390,923).... (31,229) (4,520) (2) (35,751) ,336 78,066 3,592 13,849 16, ,914 I 37
352 , ,441 10,891 53,251 16, , (146,369) (197,855) (7,297) (39,402) (390,923).... (31,229) (4,520) (2) (35,751) ,336 78,066 3,592 13,849 16, , ,336 78,066 3,592 13,849 16, , ,033 2,219 4,135 15, (9,746) (11,159) (381) (1,745) (23,031)... 12,547 5,176 (17,723) ,137 81,116 3,211 14,323 2, , , ,650 10,891 55,470 2, , (156,115) (209,014) (7,678) (41,147) (413,954).... (31,229) (4,520) (2) (35,751) ,137 81,116 3,211 14,323 2, , ,333,000270,214,000245,689, ,662, ,714,000221,183, ,246,000197,343, ,519,000 21,666,00035,751,00035,751, I 38
353 , ,751 9,477 46,275 72, , (53,435) (121,226) (6,144) (31,714) (212,519) , ,525 3,333 14,561 72, , , ,525 3,333 14,561 72, , ,469 1,235 7,400 25, (16) (12) (16) (44).... (15,395) (24,289) (666) (6,243) (46,593)... 65,032 13, (78,976) , ,518 2,655 9, , , ,496 9,107 47, , (68,830) (144,978) (6,452) (37,404) (257,664) , ,518 2,655 9, , , ,496 9,107 47, , (68,830) (144,978) (6,452) (37,404) (257,664) , ,518 2,655 9, , , ,518 2,655 9, , , ,766 7,481 14, (118) (111) (74) (303).... (18,712) (24,163) (634) (4,605) (48,114)... 1, (1,567) ,611 89,613 2,299 8,114 6, ,055 I 39
354 , ,949 9,021 47,762 6, , (87,542) (165,336) (6,722) (39,648) (299,248) ,611 89,613 2,299 8,114 6, , , ,949 9,021 47,762 6, , (87,542) (165,336) (6,722) (39,648) (299,248) ,611 89,613 2,299 8,114 6, , ,611 89,613 2,299 8,114 6, , ,835 1,231 6,291 18,037 29, (388) (45) (238) (671).... (19,020) (22,327) (628) (3,184) (45,159)... 4,843 1,986 1,555 (8,384)... (4,166) (4,166) ,268 72,719 2,857 12,538 16, , , ,818 10,000 47,697 16, , (106,562) (183,099) (7,143) (35,159) (331,963) ,268 72,719 2,857 12,538 16, , , ,818 10,000 47,697 16, , (106,562) (183,099) (7,143) (35,159) (331,963) ,268 72,719 2,857 12,538 16, , ,268 72,719 2,857 12,538 16, , ,009 2,153 4,135 15, (9,746) (11,157) (347) (1,726) (22,976)... 12,547 5,176 (17,723) ,069 75,747 2,510 12,965 2, , , ,003 10,000 49,850 2, , (116,308) (194,256) (7,490) (36,885) (354,939) ,069 75,747 2,510 12,965 2, ,774 I 40
355 , , , , (3,172) (3,172) (2,121) (1,061) , , , , ,557 91,436 89,315 87, (2,121) (2,121) (2,121) (1,061)... 91,436 89,315 87,194 86, ,000 65,000 65,000 65, (60,000) (60,000) (60,000) ,000 5,000 5,000 5,000 1 I 41
356 (a)... 76,593 70, , ,288 (b)... 47, ,952 90,625 63,795 (c).. 22,523 38,069 65,237 62,665 69, , , ,460 (a) (b) ,371, % 9 (c) ,450, % 9 I 42
357 ,748 3, , , ,134 (235) 4, ,885 8, ,539 9, , , ,867 9,875 13, ,645 9, ,884 9, (10) (96) (106) ,788 9, (3,799) (3,589) ,989 6,199 I 43
358 ,777 91,828 93,809 94, ,854 35,765 35,787 77, , , , ,748 3, , , ,204 (235) 22, ,955 26, ,741 3, ,696 30, , , ,867 31,175 35,042 I 44
359 ,645 9, ,884 9, (10) (96) (106) ,788 9, (3,799) (3,589) ,989 6, ,124 36,171 39,507 36, ,627 57,258 57,011 54, ,635 96, ,041 91, , , , , (83) (15,240) 206, , , ,296 I 45
360 ,962 35,769 39,447 36, ,627 57,258 57,011 54, ,047 92, ,041 91, , , , , (11,052) 200, , , , , ,613 17,448 28,087 4, (1,530) (2,291) (43,327) (4,581) , , ,260 28,087 4, (2,208) (39,139) (4,581)... 11,052 I 46
361 , , , , (24,913) (48,002) (63,470) (65,643) 420, , , , , , , , (24,909) (48,002) (63,470) (65,643) 420, , , , , , , , , , , , ,470 88,549 56,338 84, ,887 60,359 72,584 48, ,342 7,843 39,821 57, , , , , (24,913) (48,002) (63,470) (65,643) 420, , , ,209 I 47
362 , , , , , , , , ,470 88,549 56,338 84, ,851 60,359 72,584 48, ,342 7,843 39,821 57, , , , , (24,909) (48,002) (63,470) (65,643) 420, , , , ,870 24,913 48,002 63, ,521 15,945 2, (281) (1,432) (477)... 24,913 48,002 63,470 65, ,866 24,909 48,002 63, ,525 15,945 2, (281) (1,432) (477)... 24,909 48,002 63,470 65,643 I 48
363 , , , , ,270 5,742 8,171 11, , , , , , , , , ,270 5,742 8,171 11, , , , , ,242 3,792 5,082 16, , , , ,548 4,844 8,303 17, (100) (176) (137) (228) 4,448 4,668 8,166 17, ,980 1,907 3,125 5, ,200 7,800 12,750 26,180 9,707 15,875 5,394 I 49
364 ,915 3,699 4,771 14, , , , , , , , , , , (96) (60,644) (81,167) (82,187) 256, , , , ,980 1,907 3,125 5, ,200 7,800 12,750 26,180 9,707 15,875 5, (18) 76 (39) ,644 81, (22) 60,548 20,523 1, ,644 81,167 82,187 I 50
365 (a) ,070 (b)... 20, , ,070 20, ,002 (a) ,000, % 5.68% (b) ,000, % ,600, % 4.80% , , , , ,000 50, , , , , (34,445) (851)... (15,000) (50,000) , , , ,870 I 51
366 , , , , ,933 34,421 12,659 40, , , , , , , , , ,000 50, , , , , (34,445) (851)... (15,000) (50,000) , , , , , , , , ,933 34,421 12,659 40, , , , ,497 I 52
367 ,210 3,441 7,247 2, ,450 4,035 8,121 2, ,203 3,441 7,177 2, ,443 4,035 8,051 2, (a) ,895 3,991 I 53
368 (b) , (a) ,477 25,082 77,120 26,057 (b)... 23,898 28, ,073 2,418 1,607 1, ,517 2,542 3,247 5, ,100 5, , ,421 2,094 33,528 37, ,346 63,205 (a) (b) ,000, ,000, ,898,000 28,079,000 I 54
369 ,223 24,647 76,657 25, ,898 28, ,073 2,418 1,607 1, ,216 2,187 2,986 4, ,100 5, , ,421 2,094 33,358 36, ,619 62, , , , , , , ,789 97, , , , , ,000 1, (4,166)... (7,651) (9,281) (6,596) (3,304) 160, , , ,066 I 55
370 , , , , ,000 1, (4,166)... (5,216) (6,846) (6,596) (3,304) 117, , ,789 97, ,000, ,800, ,800, ,800, ,000, ,800, ,800, ,800, ,000, , , , ,800,000 14, , , ,800, , ,445 1,109,245 I 56
371 , , ,936 1,398, , , (360,000) (360,000) , , ,473 1,525, , , ,473 1,525, , , , , ,400 (7,400) (187,400) (187,400) , ,400 1,121,204 2,043, , ,400 1,121,204 2,043, , , (374,800) (374,800) , ,400 1,306,197 2,228, , ,400 1,121,204 2,043, , , (374,800) (374,800) , ,400 1,004,601 1,926, , ,400 1,306,197 2,228, , , (187,400) (187,400) , ,400 1,400,726 2,322,571 I 57
372 10% 50% 25% ,202 1, , , ,275 2,029 1, , ,615 7,583 10, ,050 13,536 27,261 22,151 7,583 10,171 I 58
373 30. * * % (a) , , , , ,234 6,212 16,528 3, , , , , ,464 (b) ,155 I 59
374 15 (c) ,512 4,504 5,717 2,480 2, ,712 4,704 5,966 2,610 2, , , , , ,445 34, , , ,206 1, , , ,089 I 60
375 ... 1, ,534 8, , , , , , , , , ,724 1,483,541 1,704, , ,565 13,600 I 61
376 , , ,000 20, , , ,000 15, , , ,073 1,212,890 1,951, , ,979 40, , , , , , , ,000 50, , , ,054 1, ,748 1,135,986 2,019,734 I 62
377 ... 2, ,068 35, , , , , , , , ,748 I 63
378 201618% 20178% 11% % 7% 10% ,457,0001,206, , ,754 69, ,593 76, , ,347 I 64
379 , , , ,703 70, , , , , , , , , , , , ,252 73, , , , ,540 73, , I 65
380 12111,952,000 10,623, % (1%) (572) (486) % (1%) (402) (341) % (1%) (208) (177)... 1% (1%) (8) (7) % (1%) (518) (440)... 1% (1%) (6) (5) I 66
381 % 412,982 18, % 15,887 2, % 4,169 1, % 1, % % % 10, ,481 24,913 I 67
382 % 435,687 18, % 30,640 4, % 3,997 1, % 2,422 1, % 1, % % 38,977 19, % 13, ,109 48, % 417,885 16, % 63,326 9, % 5,267 2, % 2,280 1, % 1,603 1, % % 38,977 31, % 15, ,350 63,470 I 68
383 % 531,518 15, % 48,705 7, % 13,612 5, % 1,861 1, % 1,502 1, % 1,330 1, % 38,977 31, % 42,347 2, ,852 65, ,254 1, ,434 7, ,688 8, ,875 4, ,100 2,465 9,565 7,260 6,340 13,600 I 69
384 ,896 8, ,050 26,929 31,979 5,275 34,825 40, ,903 2, ,068 32, ,971 35,041 I 70
385 ,450 4,035 8,121 2, ,895 3, ,528 37, ,346 63, (383,523) (803,488) (695,257) (299,870)... (347,874) (761,402) (571,895) (229,701)... 1,805,141 2,395,743 2,576,203 2,671, ,457,267 1,634,341 2,004,308 2,442, I 71
386 A. 4.29[] [] [] [] [] (1) (2) (3) (3) (4) [] [].... [2,671,985] [] [] [] [] [] [].... [2,671,985] [] [] [] [] (1) ,672.0 (2) [] [][][] [] [][] II-1
387 (3) [][] [] (4) (5) II-2
388 [] HH H H % 20% [1993]045 10% III-1
389 10% (1) 10% (2) 10%20% (3) 20% %25% 5% % III-2
390 H [2008] H 10% % 25% 5% B[2009] % III-3
391 20% [1998] [2009] < > III-4
392 10% H H H 16.5% III-5
393 15% H H HH 0.1%H 0.2% H H III-6
394 <> III-7
395 % [2015] III-8
396 1. IV-1
397 IV-2
398 IV-3
399 IV-4
400 A. B IV-5
401 (1) (2) (3) C. IV-6
402 D. (1)(2) (3)(4) E. (1) (2)(3) (4) (5) F. (i) (ii) (iii) IV-7
403 (iv) (v) (vi) (i)(ii) (iii)(v)(vi) (i) (ii)(iv) (iii)(v)(vi) (iii)(v)(vi) G. IV-8
404 % H. (a) (b) 60 (c) (d) IV-9
405 (e) (f) (g) (h) I. (a) (b) (c) (d) (e) (f) (g) (h) IV-10
406 (i) (j) (k) (1) (6) (2) (a) (2/3) (b) (1/3) (c) (10%) (d) (e) (f) (2) (3) IV-11
407 5% 50% 50% IV-12
408 J. (a) (b) (c) (d) (e) (f) (g) IV-13
409 (h) (i) (j) (k) (l) (f)(g)(k) (a) (b) IV-14
410 (c) (d) (e) K. IV-15
411 (a) (b) (c) (d) (e) (f) (g) I. (a) (b) IV-16
412 (c) (d) (e) (f) (g) (h) M. IV-17
413 N. O. IV-18
414 P. Q. IV-19
415 R. (i) (ii)(iii) (iv)(v) (i) (ii) (iv) (v) (i) (ii)(iii)(iv) (v)(vi) (vii) IV-20
416 S. T. IV-21
417 U. V. (i) (ii) (iii) (iv) (v) IV-22
418 H (i)(ii) (iii) 100, IV-23
419 ,000200,000 IV-24
420 i ii IV-25
421 iii HKIAC HKIAC HKIAC IV-26
422 (i) (ii) A. 2050% 50% IV-27
423 B C. D. IV-28
424 E. H 6 12 [] F. (i) (ii) (iii)(iv) (i)12 IV-29
425 20% (ii) 15 (iii) G. [ ] H. IV-30
426 I. J K. IV-31
427 L. 237 M. N. O. IV-32
428 P. 8. A. B. C. IV-33
429 D. H 25%15% % 25% E. F. H HH 10% G. IV-34
430 H. H I % 15 20% J. (i) IV-35
431 (ii) K. L. (a) (b) (c) (d) (e) (f) (g) IV-36
432 M. H H N. H HH H (a) (b) (c) H (d) O. IV-37
433 P. (a) (b) (c) H (d) (e) (f) (g) (h) IV-38
434 Q. H R. H S. H [] T. H [] IV-39
435 H 1. A. B. (4) 33% V-1
436 C. (a) (b) (c) (d) (a) (b) V-2
437 D. (a) (b) (c) (a) (b) V-3
438 (a) (b) E. (a) (b) (c) (d) (e) V-4
439 (f) (a) i. ii. iii. iv. (b) F. V-5
440 G. H. (9) (1/2) (1/3) V-6
441 7 7 (a) (b) (5) (c) (3) (d) (3) V-7
442 (e) (f) (g) (h) (i) (j) I. J. (a) V-8
443 (b) (c) (d) (a) (b) (c) (d) (e) (f) (g) (h) V-9
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