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页
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| | | | | S-ii | | | |
| | | | | S-iii | | | |
| | | | | S-1 | | | |
| | | | | S-14 | | | |
| | | | | S-15 | | | |
| | | | | S-18 | | | |
| | | | | S-19 | | | |
| | | | | S-20 | | | |
| | | | | S-21 | | | |
| | | | | S-22 | | | |
| | | | | S-28 | | | |
| | | | | S-32 | | | |
| | | | | S-33 | | | |
| | | | | S-34 | | | |
| | | | | S-35 | | | |
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| | | | | 76 | | | |
| Muzastotug + 帕博利珠单抗 200毫克Q3 W |
| |
10毫克/千克
|
| |
20毫克/千克
|
| ||||||||||||
| 亚群 (N) |
| |
合并
(n = 39) |
| |
Q6W
(n = 10) |
| |
Q3 W
(n = 29) |
| |
合并
(n = 26) |
| |
Q6W
(n = 12) |
| |
20毫克/千克x1 +
10mg/kg Q3 W (n = 14) |
|
|
ORR,%(95% CI)
|
| |
13
(4 – 27) |
| |
0(a)
(0 – 31) |
| |
17
(6 – 36) |
| |
31
(14 – 52) |
| |
25
(5 – 57) |
| |
36
(13 – 65) |
|
| BOR,N(%) | | | | | | | | | | | | | | | | | | | |
|
华润
|
| |
0
|
| |
0
|
| |
0
|
| |
1(4)
|
| |
1(8)
|
| |
0
|
|
|
公关
|
| |
5 (13)
|
| |
0
|
| |
5(b)(17)
|
| |
7 (27)
|
| |
2 (17)
|
| |
5 (36)
|
|
|
标清
|
| |
24 (62)
|
| |
7 (70)
|
| |
17 (59)
|
| |
14 (54)
|
| |
7 (58)
|
| |
7 (50)
|
|
| DCR (CR + PR + SD),%,(95% CI) |
| |
74
(58 – 87) |
| |
70
(35 – 93) |
| |
76
(56 – 90) |
| |
85
(65 – 96) |
| |
83
(52 – 98) |
| |
86
(57 – 98) |
|
|
MPFS,
月(95% CI) |
| |
4.8
(2.6 – 6.7) |
| |
4.5
(1.4 – 7.1) |
| |
4.8
(2.6 – 6.7) |
| |
6.7
(2.7– NA) |
| |
4.9
(1.2– NA) |
| |
15.4
(2.6– NA) |
|
| 6个月PFS,%, (95% CI) |
| |
39.6
(24.3 – 54.6) |
| |
40
(12.3 – 67) |
| |
39.6
(21.9 – 56.8) |
| |
50.4
(29.5 – 68.1) |
| |
45.5
(16.7 – 70.7) |
| |
54.5
(25.4 – 76.5) |
|
|
优先期限
|
| |
所有年级
n(%) |
| |
1级
n(%) |
| |
2级
n(%) |
| |
三年级
n(%) |
|
|
任何TRAE
|
| |
57 (85.1)
|
| |
15 (22.4)
|
| |
26 (38.8)
|
| |
16 (23.9)
|
|
|
瘙痒
|
| |
25 (37.3)
|
| |
20 (29.9)
|
| |
5 (7.5)
|
| |
0
|
|
|
疲劳
|
| |
15 (22.4)
|
| |
12 (17.9)
|
| |
3 (4.5)
|
| |
0
|
|
|
甲状腺功能减退
|
| |
13 (19.4)
|
| |
3 (4.5)
|
| |
10 (14.9)
|
| |
0
|
|
|
腹泻
|
| |
12 (17.9)
|
| |
5 (7.5)
|
| |
4(6)
|
| |
3 (4.5)
|
|
|
肾上腺功能不全
|
| |
10 (14.9)
|
| |
1 (1.5)
|
| |
9 (13.4)
|
| |
0
|
|
|
食欲下降
|
| |
8 (11.9)
|
| |
6(9)
|
| |
2(3)
|
| |
0
|
|
|
丙氨酸氨基转移酶增加
|
| |
7 (10.4)
|
| |
2(3)
|
| |
4(6)
|
| |
1 (1.5)
|
|
|
关节痛
|
| |
7 (10.4)
|
| |
5 (7.5)
|
| |
2(3)
|
| |
0
|
|
|
恶心
|
| |
7 (10.4)
|
| |
4(6)
|
| |
3 (4.5)
|
| |
0
|
|
|
结肠炎
|
| |
7 (10.4)
|
| |
0
|
| |
4(6)
|
| |
3 (4.5)
|
|
|
免疫介导的小肠结肠炎
|
| |
3 (4.5)
|
| |
0
|
| |
2(3)
|
| |
1 (1.5)
|
|
| | | |
截至2025年12月31日
|
| |||||||||
| | | |
实际
|
| |
经调整
|
| ||||||
| | | |
US $’000
|
| |||||||||
|
现金及现金等价物
|
| | | | 74,524 | | | | | | | | |
|
长期借款的流动部分
|
| | | | 711 | | | | | | 711 | | |
|
长期借款
|
| | | | 1,138 | | | | | | 1,138 | | |
| 夹层股权 | | | | ||||||||||
|
A系列无投票权或有可赎回可转换优先股(每股面值0.0001美元,截至2025年12月31日已授权、已发行和流通的1,062,500股)
|
| | | | 16,550 | | | | | | 16,550 | | |
| 股东权益 | | | | | | | | | | | | | |
|
普通股(每股面值0.0001美元;授权640,000,000股,截至2025年12月31日已发行和流通在外的股份59,231,993股)
|
| | | | 6 | | | |
|
| |||
|
额外实收资本
|
| | | | 366,043 | | | |
|
| |||
|
累计其他综合收益
|
| | | | (1,915) | | | | | | (1,915) | | |
|
累计赤字
|
| | | | (328,785) | | | | | | (328,785) | | |
|
夹层权益和股东权益合计
|
| | | | 51,900 | | | |
|
| |||
|
总资本
|
| | | | 53,749 | | | |
|
| |||
| | | |
每普通
分享 |
| |
每ADS
|
| ||||||
|
每ADS的首次公开发行价格
|
| | | 美元 | | | | | 美元 | | | ||
|
截至2025年12月31日每股有形账面净值
|
| | | 美元 | | | | | 美元 | | | ||
|
对现有股东的每股有形账面净值增加
|
| | | 美元 | | | | | 美元 | | | ||
|
作为本次发行生效后调整后的每股有形账面净值
|
| | | 美元 | | | | | 美元 | | | ||
|
对新增投资者稀释每股
|
| | | 美元 | | | | | 美元 | | | ||
|
承销商
|
| |
数
的 ADS |
|
|
Leerink Partners LLC
|
| |
|
|
|
LifeSci Capital LLC
|
| | | |
|
Lucid Capital Markets,LLC
|
| | | |
|
合计
|
| | | |
| | | |
每
ADS |
| |
合计
|
| ||||||
|
首次公开发行价格
|
| | | $ | | | | | $ | | | ||
|
承销折扣和佣金
|
| | | $ | | | | | $ | | | ||
|
收益,未计费用,给我们
|
| | | $ | | | | | $ | | | | |
| | | |
页
|
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| | | | | 1 | | | |
| | | | | 3 | | | |
| | | | | 14 | | | |
| | | | | 33 | | | |
| | | | | 35 | | | |
| | | | | 36 | | | |
| | | | | 37 | | | |
| | | | | 46 | | | |
| | | | | 47 | | | |
| | | | | 48 | | | |
| | | | | 50 | | | |
| | | | | 65 | | | |
| | | | | 67 | | | |
| | | | | 68 | | | |
| | | | | 72 | | | |
| | | | | 73 | | | |
| | | | | 74 | | | |
| | | | | 75 | | | |
| | | | | 76 | | | |
| |
SEC注册费
|
| | | $ | 30,620 | | |
| |
FINRA费用
|
| | | $ | 30,500 | | |
| |
法律费用和开支
|
| | | $ | * | | |
| |
印刷费及开支
|
| | | $ | * | | |
| |
会计费及开支
|
| | | $ | * | | |
| |
杂项费用及开支
|
| | | $ | * | | |
| |
合计
|
| | | $ | * | | |