派林生物(000403.SZ)：静注人免疫球蛋白(pH4)获得药物临床试验批

智通财经2025-12-23

智通财经APP讯，派林生物(000403.SZ)发布公告，近日，公司之全资子公司广东双林生物制药有限公司(以下简称“广东双林”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP03518)，同意广东双林开展静注人免疫球蛋白(pH4)生产工艺变更后的临床试验。本次静注人免疫球蛋白(pH4)生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多步层析精制纯化...

网页链接

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

我们需要你的真知灼见来填补这片空白

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/2593249542?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-12-23 17:33","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2593249542","market":"fut","top_or_hot":-1,"title":"派林生物(000403.SZ)：静注人免疫球蛋白(pH4)获得药物临床试验批","media":"智通财经","content":"<div>\n<p>智通财经APP讯，派林生物(000403.SZ)发布公告，近日，公司之全资子公司广东双林生物制药有限公司(以下简称“广东双林”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP03518)，同意广东双林开展静注人免疫球蛋白(pH4)生产工艺变更后的临床试验。本次静注人免疫球蛋白(pH4)生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多步层析精制纯化...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1384970.html\">网页链接</a>\n\n</div>\n","source":"stock_zhitongcaijing","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>派林生物(000403.SZ)：静注人免疫球蛋白(pH4)获得药物临床试验批</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派林生物(000403.SZ)：静注人免疫球蛋白(pH4)获得药物临床试验批\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-23 17:33 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1384970.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，派林生物(000403.SZ)发布公告，近日，公司之全资子公司广东双林生物制药有限公司(以下简称“广东双林”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP03518)，同意广东双林开展静注人免疫球蛋白(pH4)生产工艺变更后的临床试验。本次静注人免疫球蛋白(pH4)生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多步层析精制纯化...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1384970.html\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK0239","symbol_name":"医药制造","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1384970.html","article_id":"2593249542","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2593249542","pubTimestamp":1766482425,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，派林生物(000403.SZ)发布公告，近日，公司之全资子公司广东双林生物制药有限公司(以下简称“广东双林”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP03518)，同意广东双林开展静注人免疫球蛋白(pH4)生产工艺变更后的临床试验。本次静注人免疫球蛋白(pH4)生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多步层析精制纯化工艺，在产品质量、病毒安全性等方面，特别是产品收率方面有显著的提高，同时有助于提升临床用药安全性及便捷性，使国内产品工艺水平与国际接轨，将进一步提升公司第四代静注人免疫球蛋白产品市场竞争力。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK0239":"医药制造","BK0071":"ST概念","000403":"派林生物"},"translate_title":"Pailin Bio (000403. SZ): Intravenous injection of human immunoglobulin (pH4) obtained drug clinical trial approval","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"000403":1.5},"content_text":"智通财经APP讯，派林生物(000403.SZ)发布公告，近日，公司之全资子公司广东双林生物制药有限公司(以下简称“广东双林”)收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP03518)，同意广东双林开展静注人免疫球蛋白(pH4)生产工艺变更后的临床试验。本次静注人免疫球蛋白(pH4)生产工艺由传统的低温乙醇蛋白分离法变更为国际主流的辛酸沉淀及多步层析精制纯化工艺，在产品质量、病毒安全性等方面，特别是产品收率方面有显著的提高，同时有助于提升临床用药安全性及便捷性，使国内产品工艺水平与国际接轨，将进一步提升公司第四代静注人免疫球蛋白产品市场竞争力。","kind":"news","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":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2593249542","isCrawlerRequest":true}