康希诺生物(06185)：婴幼儿用DTcP获得中国国家药监局NDA批准

智通财经网

Apr 12

智通财经APP讯，康希诺生物(06185)公布，中国国家药品监督管理局已批准公司研发的婴幼儿用吸附无细胞百(三组分)白破联合疫苗(DTcP)(2岁以下)(婴幼儿用DTcP，商品名称：盼康欣^®)的新药上市申请(NDA)。

据悉，目前国内在售的共纯化百白破疫苗的制造过程为百日咳抗原使用共纯化工艺，公司的婴幼儿用DTcP为一款组分百白破疫苗，每种百日咳抗原可以单独纯化，以确定的比例配制，从而可以确保产品质量批间的一致性，使产品的质量更加稳定。

公司的婴幼儿用DTcP为国内首款上市的组分百白破疫苗。婴幼儿用DTcP的开发为进一步开发吸附无细胞百(组分)白破联合疫苗(六岁及以上人群用)和以DTcP为基础的联合疫苗奠定了基础。

公司的婴幼儿用DTcP为公司组分百白破疫苗产品组合中首个获得NDA批准的产品，公司累积了临床研发、质量控制、规模化生产等相关经验，有利于产品组合中其他候选疫苗上市进程的推进。同时，婴幼儿用DTcP的上市将丰富并优化公司的商业化产品结构，有利于公司在终端提升品牌效应。

更多港股重磅资讯，下载智通财经app

更多港股及海外理财资讯，请点击www.zhitongcaijing.com（搜索“智通财经”）；欲加入智通港股投资群，请加智通客服微信(ztcjkf)

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2626172927"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2626172927\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2626172927?lang=en_US&edition=fundamental","thumbnail":"","is_english":false,"pubTime":"2026-04-12 18:07","share_image_url":"https://static.laohu8.com/6ca2dcdccfa2217fb20a0351f4efe814","id":"2626172927","market":"us","top_or_hot":-1,"title":"康希诺生物(06185)：婴幼儿用DTcP获得中国国家药监局NDA批准","media":"智通财经网","content":"<html><body><p>智通财经APP讯，<a href=\"https://laohu8.com/S/06185\">康希诺生物</a>(06185)公布，中国国家药品监督管理局已批准公司研发的婴幼儿用吸附无细胞百(三组分)白破联合疫苗(DTcP)(2岁以下)(婴幼儿用DTcP，商品名称：盼康欣<sup>®</sup>)的新药上市申请(NDA)。</p><p>据悉，目前国内在售的共纯化百白破疫苗的制造过程为百日咳抗原使用共纯化工艺，公司的婴幼儿用DTcP为一款组分百白破疫苗，每种百日咳抗原可以单独纯化，以确定的比例配制，从而可以确保产品质量批间的一致性，使产品的质量更加稳定。</p><p>公司的婴幼儿用DTcP为国内首款上市的组分百白破疫苗。婴幼儿用DTcP的开发为进一步开发吸附无细胞百(组分)白破联合疫苗(六岁及以上人群用)和以DTcP为基础的联合疫苗奠定了基础。</p><p>公司的婴幼儿用DTcP为公司组分百白破疫苗产品组合中首个获得NDA批准的产品，公司累积了临床研发、质量控制、规模化生产等相关经验，有利于产品组合中其他候选疫苗上市进程的推进。同时，婴幼儿用DTcP的上市将丰富并优化公司的商业化产品结构，有利于公司在终端提升品牌效应。</p><p>更多港股重磅资讯，下载智通财经app</p><p>更多港股及海外理财资讯，请点击www.zhitongcaijing.com（搜索“智通财经”）；欲加入智通港股投资群，请加智通客服微信(ztcjkf)</p> </body></html>","source":"highlight_zhitongcaijin","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>康希诺生物(06185)：婴幼儿用DTcP获得中国国家药监局NDA批准</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n康希诺生物(06185)：婴幼儿用DTcP获得中国国家药监局NDA批准\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-04-12 18:07 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1427453.html><strong>智通财经网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，康希诺生物(06185)公布，中国国家药品监督管理局已批准公司研发的婴幼儿用吸附无细胞百(三组分)白破联合疫苗(DTcP)(2岁以下)(婴幼儿用DTcP，商品名称：盼康欣®)的新药上市申请(NDA)。据悉，目前国内在售的共纯化百白破疫苗的制造过程为百日咳抗原使用共纯化工艺，公司的婴幼儿用DTcP为一款组分百白破疫苗，每种百日咳抗原可以单独纯化，以确定的比例配制，从而可以确保...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1427453.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1191","symbol_name":"制药","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1427453.html","article_id":"2626172927","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2626172927","pubTimestamp":1775988440,"columns":[],"sourceInfo":{"source_id":"highlight_zhitongcaijin","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，康希诺生物 公布，中国国家药品监督管理局已批准公司研发的婴幼儿用吸附无细胞百(三组分)白破联合疫苗的新药上市申请。公司的婴幼儿用DTcP为国内首款上市的组分百白破疫苗。公司的婴幼儿用DTcP为公司组分百白破疫苗产品组合中首个获得NDA批准的产品，公司累积了临床研发、质量控制、规模化生产等相关经验，有利于产品组合中其他候选疫苗上市进程的推进。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK1191":"制药","BK1515":"抗疫概念","BK1161":"生物科技","BK1574":"生物医药B类股","06185":"康希诺生物"},"translate_title":"CanSino Biologics (06185): DTcP for infants and young children received NDA approval from the State Food and Drug Administration of China","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"06185":1.5},"content_text":"智通财经APP讯，康希诺生物(06185)公布，中国国家药品监督管理局已批准公司研发的婴幼儿用吸附无细胞百(三组分)白破联合疫苗(DTcP)(2岁以下)(婴幼儿用DTcP，商品名称：盼康欣®)的新药上市申请(NDA)。据悉，目前国内在售的共纯化百白破疫苗的制造过程为百日咳抗原使用共纯化工艺，公司的婴幼儿用DTcP为一款组分百白破疫苗，每种百日咳抗原可以单独纯化，以确定的比例配制，从而可以确保产品质量批间的一致性，使产品的质量更加稳定。公司的婴幼儿用DTcP为国内首款上市的组分百白破疫苗。婴幼儿用DTcP的开发为进一步开发吸附无细胞百(组分)白破联合疫苗(六岁及以上人群用)和以DTcP为基础的联合疫苗奠定了基础。公司的婴幼儿用DTcP为公司组分百白破疫苗产品组合中首个获得NDA批准的产品，公司累积了临床研发、质量控制、规模化生产等相关经验，有利于产品组合中其他候选疫苗上市进程的推进。同时，婴幼儿用DTcP的上市将丰富并优化公司的商业化产品结构，有利于公司在终端提升品牌效应。更多港股重磅资讯，下载智通财经app更多港股及海外理财资讯，请点击www.zhitongcaijing.com（搜索“智通财经”）；欲加入智通港股投资群，请加智通客服微信(ztcjkf)","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}