发布于: 雪球转发:0回复:57喜欢:10

$康宁杰瑞制药-B(09966)$ 035美国临床数据远差于内地数据,ORR为11%,而由盲态独立中心审查(BICR)确认的ORR为5.5%,TRACON退市和倒闭概率高于90%,康宁今天暴跌的主因,035.046.033以其PD-L1为基础的管线,高度不确定性

精彩讨论

狻猊的哥是谁04-05 12:49

你这个黑子,035在国内都没有做过软组织肉瘤这个适应症,哪有什么国外数据没有国内好这个说法。

清一色杠上花04-05 13:45

数据并不差 别的pd1这个病orr一样很低 O药orr 5%

随机待缘04-05 13:16

035美国临床82例入组完成,阳性目标ORR达到11%,就是达到9例有效,就是优效,可以申请单臂上市。现在只评估了73例己确定8例有效,其中27例只给药4次(12周)后续可继续评估有效性,如再出现一例就达到优效。另外9例给药到6月底到12周,可以开始评估,出现一例就是优效,可以申请单臂上市。其实成功率很高。当然管理层公布时BICR只确认了其中4例。但基于影象的评估,最终的差别不大。

药戒04-05 12:21

这家公司所有早期临床数据都值得怀疑

牛得草04-05 11:52

康宁铁粉的典范

全部讨论

04-05 11:20

035在美国临床是个错误,内地临床数据不靠谱,临床表现为低效低毒性,所有管线基本全废。很多内地药企只做海外临床一期,二期三期不推进,有海外临床数据能忽悠小股民就可以,自身知道药效不行

Tracon选了肉瘤,死得其所。PD1对肉瘤也就这个疗效

04-05 15:00

我觉得确定性很高

04-05 11:22

The IDMC reviewed interim safety and efficacy data from 73 patients enrolled into cohort C who had the opportunity to complete two on-treatment scans (a minimum of 12 weeks of treatment). The objective response rate (ORR) is currently 11% by investigator review and the confirmed ORR by blinded independent central review (BICR) is currently 5.5% (four patients). Median duration of response by BICR is greater than six months. Envafolimab has been well tolerated without the development of a single drug-related serious adverse event of grade 3 or higher. The primary endpoint of the study is achievement of an objective response in nine of 82 patients (11%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. “Subcutaneous envafolimab has been generally well tolerated and continues to demonstrate durable single agent activity in a subset of these sarcoma patients,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “An additional five objective responses confirmed by central review are needed to achieve our goal in the 82 patient cohort of single agent envafolimab treatment.”

确实,与PD-L1相关的035、046……都表现出ORR 不太强的特点。对于肿瘤病人来说,皮下注射不是特别吸引人,不要再拿卖点吹了。

04-05 13:05

kn035,上市那年就磕磕碰碰!勉勉强强获批!

04-05 11:34

虽然是跌,但看看成交量,港股通机制问题。没必要放大。
还是看看9号003的数据,才是近期股价的因素

04-05 11:30

那035一年还能卖7亿?为黑而黑,没有必要…

今天你说的还算公正

得赶紧把徐婷限制出境,别让他跑了。