复星在中国做的试验既有BNT162b1也有BNT162b2.开始时是1后来转为2。

来源: huntridge 2021-04-25 16:56:32 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 次 (3026 bytes)

https://www.reuters.com/article/us-health-coronavirus-biontech-fosunphar-idUSKBN2850ZZ

Fosun follows BioNTech in changing COVID-19 vaccine, plans bridging study for Chinese filing

https://www.fiercebiotech.com/biotech/fosun-follows-biontech-changing-covid-19-vaccine-plans-bridging-study-for-chinese-filing

BioNTech signed up to work with Fosun to bring a COVID-19 vaccine to China in March. The deal, which is worth up to $135 million, led to Fosun registering a phase 1 trial of mRNA vaccine BNT162b1 with the Chinese authorities in July. Less than one week later, BioNTech and its global partner Pfizer selected BNT162b2 as the candidate to take forward into phase 2/3.

Now, Fosun Chief Medical Officer Aimin Hui has told Reuters that BNT162b2 is also the preferred shot for the Chinese market. Fosun has opted against further development of BNT162b1, choosing instead to run a bridging study that may enable it to use global BNT162b2 data to support approval in China.

Chinese authorities have become more accepting of data generated overseas in recent years. If all goes to plan, the bridging study will enable Fosun to show the safety and efficacy seen in the global program is applicable to the Chinese population and win approval “around the same time” as the vaccine is authorized in other countries.

The switch to BNT162b2 could provide benefits. BioNTech and Pfizer selected the vaccine as their phase 2/3 candidate, despite it entering the clinic second, after linking it to a lower rate of adverse events than BNT162b1.

所有跟帖: 

复星欲插手一下b2临床试验时辉瑞的三期临床已经做完了,复星是所谓的“桥接”试验,毫无必要。没见其它哪个国家像复星这么做。 -Circuseer- 给 Circuseer 发送悄悄话 (0 bytes) () 04/25/2021 postreply 17:06:42

记得有说法Pfizer疫苗对亚洲人效率低吗? -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 17:10:06

老兄,复星解释为啥在中国不做3期就说了,那个全球通用的唯一3期报告(就是辉瑞的, 这在中国是避讳)对各种族都有效。 -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 17:51:54

数据还在这里。辉瑞3期数据刚出来时有人挖了这个数据。现在狗一下还有。 -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (2448 bytes) () 04/25/2021 postreply 19:29:30

哦,谢谢,问题是,新闻报道中复星在中国要做的2期人更少,那不是更没有意义了吗? -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 19:48:46

复星2期960位受试者太少吗?但是复星2期肯定都是中国人。而Pfizer3期是Asian数据。 -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 20:15:05

Pfizer3期4万3千人,乘4.3%,有1千8百人了,美国人说的asians,除了印度人,基本上就是东亚和东南亚人了。 -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 20:37:51

而且关键是复星2期结果如何? 号称开始做了,都快半年了,音讯皆无! -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 20:43:11

没出来不是也没批准吗? -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 21:03:03

香港不都打上了吗? -业余城管- 给 业余城管 发送悄悄话 (0 bytes) () 04/25/2021 postreply 21:08:38

香港属业余城管地盘哈哈。 -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 21:09:56

复必泰没有正在香港打吗? -业余城管- 给 业余城管 发送悄悄话 (88 bytes) () 04/25/2021 postreply 21:14:01

2期不能和3期比。查了一下2期一般就是几百人。 -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 21:08:16

复星的行为很容易解释。中国已经开始愿意接受外国数据。复星没有必要做更多的试验。 -huntridge- 给 huntridge 发送悄悄话 huntridge 的博客首页 (0 bytes) () 04/25/2021 postreply 17:08:42

装模作样插手一下b2的桥接试验就是为了向国人展示复必泰就是国产疫苗。一个FDA批准的疫苗,当然中国只要审核一下辉瑞的数据就够了。 -Circuseer- 给 Circuseer 发送悄悄话 (0 bytes) () 04/25/2021 postreply 17:35:13

没看懂,复星到底做没做b2。 -fuz- 给 fuz 发送悄悄话 fuz 的博客首页 (0 bytes) () 04/25/2021 postreply 17:48:21

新闻报道它在去年11月底开始做b2的临床II期,但至今没有数据发表出来,连preprint都没见到。 -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 17:55:32

而辉瑞在11月初就完成III期临床了,12月11日FDA就批准疫苗的紧急使用申请了。 -insoine2- 给 insoine2 发送悄悄话 (0 bytes) () 04/25/2021 postreply 18:07:02

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