( : 1093) 2015
2 3 11 13 15 17 19 20 39 1
18 3206 183 22 www.cspc.com.hk 2
57.30 8.22 7.3% 36.9% 17.68 36% 3
2010 2014 4
蒽 36 345 245 5
212 24 64 6
C C C 7
180 14 51 36 14 6-1 re4 DBPR-108 蒽 4 100mg 4 蒽 DBPR-108 28 12 16 6 8
ANDA FDA ANDA 9 FDA FDA FDA Pre-IND FDA 4 3 ANDA 9
6.94 55 53 102 125 2.0 1.8 4.01 19.31 15.27 18.11 12.26 15.70 2.41 5.95 12.16 21.6% 15.0% 38% 13% 49% 10,314 10
13 38 34 34 34 2410 11
34 12
3 5,730,375 5,342,470 (3,153,649) (3,321,420) 2,576,726 2,021,050 36,518 90,530 (1,100,322) (846,327) (265,624) (302,889) (176,331) (160,918) 1,070,967 801,446 (27,885) (29,231) 141 4,196 (526) 4 1,047,419 771,689 5 (217,399) (162,263) 830,020 609,426 (216,076) (444) (216,520) 830,020 392,906 13
822,014 600,665 8,006 8,761 830,020 609,426 822,014 386,683 8,006 6,223 830,020 392,906 7 13.91 10.17 13.76 10.07 14
8 5,155,044 5,049,087 497,424 498,522 125,060 125,060 108,102 111,289 56,873 56,732 22,363 18,167 1,705 37,255 34,922 6,002,121 5,895,484 2,173,892 1,805,749 9 2,033,712 2,006,712 9 1,319,367 1,079,359 10 114,358 92,471 10 19,638 10 69,552 76,450 15,769 14,928 2,420 2,754 766 703 11 56,558 58,199 1,874,566 1,468,421 7,680,598 6,605,746 15
12 2,483,977 2,329,726 12 104,563 227,150 10 92,484 26,483 10 576 10 456,551 277,894 84,520 116,597 13 594,869 624,070 3,816,964 3,602,496 3,863,634 3,003,250 9,865,755 8,898,734 59,939 29,645 13 1,216,622 601,800 200,948 115,761 1,477,509 747,206 8,388,246 8,151,528 14 9,819,731 9,819,731 (1,509,365) (1,740,577) 8,310,366 8,079,154 77,880 72,374 8,388,246 8,151,528 16
i ii iii iv 558,636 8,700,054 (5,523,729) 244,994 45,564 561,041 128,246 263,637 2,474,177 7,452,620 144,180 7,596,800 600,665 600,665 8,761 609,426 (213,982) (213,982) (2,538) (216,520) (213,982) 600,665 386,683 6,223 392,906 6 (472,641) (472,641) (472,641) (17,997) (17,997) 6,397 (6,397) 14 8,700,054 (8,700,054) 561,041 (561,041) 53,187 53,187 53,187 v 814 814 (7,054) (6,240) 9,819,731 (5,523,729) 251,391 45,564 181,433 49,655 2,596,618 7,420,663 125,352 7,546,015 9,819,731 (5,523,729) 514,760 45,564 181,433 35,269 3,006,126 8,079,154 72,374 8,151,528 822,014 822,014 8,006 830,020 6 (590,802) (590,802) (590,802) (2,500) (2,500) 3,923 (3,923) 9,819,731 (5,523,729) 518,683 45,564 181,433 35,269 3,233,415 8,310,366 77,880 8,388,246 17
(i) 5,038,291,000 3,288,998,000 8,327,289,000 (ii) (iii) (1) (2) 10 (iv) 33 321,661,732 (v) 21.43% 18
694,372 1,009,912 (475,789) (370,847) (7,293) (2,130) 8,607 7,316 6,898 (9,849) 4,670 2,873 2,063 (6,240) 1,641 (9,490) (459,203) (388,367) (680,890) (249,988) (590,802) (472,641) (58,489) (2,500) (17,997) 1,025,000 231,949 300,000 178,657 (273,955) 170,976 (782,632) 406,145 (161,087) 1,468,421 1,187,751 (27,680) 1,874,566 998,984 19
1. 34 16 2. 19 20
3. (a) (b) (c) C (d) 21
3. C 3,799,520 974,490 610,241 346,124 5,730,375 5,730,375 26,797 2,391 2,067 31,255 (31,255) 3,799,520 1,001,287 612,632 348,191 5,761,630 (31,255) 5,730,375 944,501 140,016 (32,119) 61,242 1,113,640 5,028 (47,701) 1,070,967 (27,885) 141 4,196 1,047,419 22
3. C 3,189,617 1,173,402 656,137 323,314 5,342,470 5,342,470 23,676 4,273 3,627 31,576 (31,576) 3,189,617 1,197,078 660,410 326,941 5,374,046 (31,576) 5,342,470 789,265 75,250 (18,464) 58,100 904,151 2,873 (105,578) 801,446 (29,231) (526) 771,689 23
4. 10,480 9,790 7,346 7,704 284,398 294,000 302,224 311,494 2,400 (2,828) ii (9,462) (67,150) (4,670) (2,873) (9,873) (2,674) 1,344 8,199 989 171,325 155,631 53,187 (i) (ii) (i) (ii) 24
5. 189,438 144,361 27,961 17,902 217,399 162,263 16.5% 25% 15% 10% 3,732,107,000 3,373,329,000 25
6. 10 8 590,802,000 472,641,000 7. 822,014 600,665 5,908,018 5,908,018 65,284 59,249 5,973,302 5,967,267 26
8. 401,362,000 396,660,000 11,007,000 4,488,000 2,400,000 2,828,000 9. 1,781,890 1,699,086 (12,594) (4,395) 1,769,296 1,694,691 175,374 183,695 20,984 40,093 25,980 28,672 42,078 59,561 2,033,712 2,006,712 90 0 90 1,584,497 1,479,654 91 180 171,106 210,236 181 365 13,693 4,801 1,769,296 1,694,691 180 180 27
10. (v) (I) i 93,139 100,404 8,207 7,865 2,731 103,528 93,952 5,005 7,481 3,904 0 90 114,358 92,471 0 90 92,484 26,483 ii 456,551 277,894 iii 73,022 iii 168,489 28
10. (I) 525,000,000 112,500,000 525,000,000 112,500,000 119,450 (i) 40% 60% (ii) 97,705,193 104,503,000 6.56% 3,126,000 29
10. (I) (iii) 13 (II) 10,373 7,754 24,934 20,930 69,552 76,450 30
10. (III) 3,411 20,192 0 90 19,638 0 90 576 31
10. (IV) 6,046 5,814 471 468 45,032 6,517 51,314 11. 56,558,000 58,199,000 32
12. 946,626 955,617 91,766 53,984 32,306 28,430 527,365 601,792 115,365 88,596 429,596 373,342 131,239 131,792 152,435 60,260 57,279 35,913 2,483,977 2,329,726 0 90 788,259 703,652 91 180 69,555 104,716 180 88,812 147,249 946,626 955,617 180 33
13. i 521,847 624,070 ii 73,022 594,869 624,070 i 1,048,133 601,800 ii 168,489 1,216,622 601,800 1,811,491 1,225,870 (i) 1,025,000,000 231,949,000 680,890,000 249,988,000 (ii) 300,000,000 58,489,000 34
13. 2.03 2.98 1.8 2.98 2.68 3.18 2.65 3.17 3.65 6.15 6.4 5.08 3.25 6.0 4.6 35
14. 0.1 30,000,000,000 3,000,000 a 5,586,356,671 558,636 a 8,700,054 b 321,661,732 561,041 5,908,018,403 9,819,731 (a) 622 (b) 33 561,041,000 321,661,732 36
15. 10 150,000,000 3.98 181,433,000 3.98 3.98 7.5 35.392% 2.57% 0.905% 53,187,000 150,000,000 150,000,000 37
16. 581,823 410,416 148,008 154,295 17. 40% 38,400,000 48,000,000 38
XV 352 i) 6,538,000 80,000,000 86,538,000 1.46% 1,765,825,534 ii 1,765,825,534 29.89% 3,000,000 3,000,000 0.05% 4,000 3,000,000 3,004,000 0.05% 10,000,000 10,000,000 0.17% 15,000,000 15,000,000 0.25% 10,000,000 10,000,000 0.17% 3,000,000 3,000,000 0.05% 3,000,000 3,000,000 0.05% 39
(i) (ii) 1,765,825,534 (i)493,880,000 (ii)213,929,500 Key Honesty Limited (iii)1,058,016,034 75% 15% 10% 40% 60% 336 40
493,880,000 8.36% 1,271,945,534 (i) 1,058,016,034 (ii) 1,058,016,034 (ii) 1,058,016,034 (ii) 1,058,016,034 (ii) JPMorgan Chase & Co. 23,442,676 104,456,000 169,504,632 21.53% 17.91% 17.91% 17.91% 17.91% 297,403,308 5.03% Commonwealth Bank of Australia 296,644,000 5.02% (i) (ii) Key Honesty Limited 213,929,500 (ii) 1,058,016,034 1,058,016,034 100% 75% 15% 10% 40% 60% JPMorgan Chase & Co. 169,504,632 2.86% 5% 41
10 3.98 3.98 3.98 3.98 3.98 3.98 3.98 3.98 3.98 80,000,000 80,000,000 3,000,000 3,000,000 3,000,000 3,000,000 10,000,000 10,000,000 15,000,000 15,000,000 10,000,000 10,000,000 3,000,000 3,000,000 3,000,000 3,000,000 23,000,000 23,000,000 150,000,000 150,000,000 3.98 42
150,000,000 2.54 14 A.2.1 A.2.1 (9) (1) (5) 3.10A 43
13.51b(1) 44