海创药业多个在研项目临床试验申请获受理近期机构密集调研

每日经济新闻2023-02-10

近期，海创药业（SH688302，股价52.30元，市值51.79亿元）公布多个在研项目进展，包括PROTAC药物HP518、HP501缓释片和HP530S片的临床试验申请分别获得FDA和国家药品监督管理局受理。多个在研项目取得进展的背景下，近期海创药业也密集迎来机构调研。但公司尚未实现药品销售收入及盈利。今年2月以来，海创药业已经先后公布了PROTAC药物HP518临床试验申请获FDA批准、...

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/2310981643?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2023-02-10 18:05","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2310981643","market":"sh","top_or_hot":-1,"title":"海创药业多个在研项目临床试验申请获受理 近期机构密集调研","media":"每日经济新闻","content":"<div>\n<p>近期，海创药业（SH688302，股价52.30元，市值51.79亿元）公布多个在研项目进展，包括PROTAC药物HP518、HP501缓释片和HP530S片的临床试验申请分别获得FDA和国家药品监督管理局受理。多个在研项目取得进展的背景下，近期海创药业也密集迎来机构调研。但公司尚未实现药品销售收入及盈利。今年2月以来，海创药业已经先后公布了PROTAC药物HP518临床试验申请获FDA批准、...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2023021018053482b5a7d5&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>海创药业多个在研项目临床试验申请获受理 近期机构密集调研</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海创药业多个在研项目临床试验申请获受理 近期机构密集调研\n</h2>\n\n<h4 class=\"meta\">\n\n\n2023-02-10 18:05 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2023021018053482b5a7d5&s=b><strong>每日经济新闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>近期，海创药业（SH688302，股价52.30元，市值51.79亿元）公布多个在研项目进展，包括PROTAC药物HP518、HP501缓释片和HP530S片的临床试验申请分别获得FDA和国家药品监督管理局受理。多个在研项目取得进展的背景下，近期海创药业也密集迎来机构调研。但公司尚未实现药品销售收入及盈利。今年2月以来，海创药业已经先后公布了PROTAC药物HP518临床试验申请获FDA批准、...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2023021018053482b5a7d5&s=b\">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://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2023021018053482b5a7d5&s=b","article_id":"2310981643","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2023021018053482b5a7d5&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2310981643","pubTimestamp":1676023525,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"今年2月以来，海创药业已经先后公布了PROTAC药物HP518临床试验申请获FDA批准、HP501缓释片和HP530S片药物临床试验申请获得受理的公告。此次获受理的临床试验申请是与黄嘌呤氧化酶抑制剂联合用于原发性高尿酸血症的长期治疗。海创药业近期在研项目进展披露较密集，公司也迎来多家机构调研。但截至目前，海创药业尚无产品实现商业化。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"688302":"海创药业-U","BK0239":"医药制造"},"translate_title":"The application for clinical trials of several projects under research in Haichuang Pharmaceutical has been accepted. Recently, intensive institutional research has been conducted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688302":0.9},"content_text":"近期，海创药业（SH688302，股价52.30元，市值51.79亿元）公布多个在研项目进展，包括PROTAC药物HP518、HP501缓释片和HP530S片的临床试验申请分别获得FDA和国家药品监督管理局受理。多个在研项目取得进展的背景下，近期海创药业也密集迎来机构调研。但公司尚未实现药品销售收入及盈利。今年2月以来，海创药业已经先后公布了PROTAC药物HP518临床试验申请获FDA批准、HP501缓释片和HP530S片药物临床试验申请获得受理的公告。最新公告的HP530S片是海创药业自主研发的具有高活性及高选择性的黏着斑激酶(Focal adhesionkinase，FAK)抑制剂。通过抑制FAK调节其下游信号通路，从而达到抑制肿瘤细胞的转移、增殖和血管生成等作用。临床拟用于实体瘤。海创药业在公告中表示，FAK的过表达在多种肿瘤类型中均有报导，包括卵巢癌、乳腺癌、肺癌、结直肠癌、胰腺癌、前列腺癌和头颈癌，且与较差的临床预后相关。相反，FAK的抑制或降解已被证实可抑制肿瘤细胞的增殖、迁移和侵袭。HP530S药效学结果显示，单药对肿瘤细胞增殖及迁移具有抑制作用，且其联合治疗表现出强效的抗肿瘤作用。HP530S临床前数据证明可抑制肿瘤转移，有望提高局部免疫功能，从而增效靶向药物、化疗药物以及免疫治疗的药效。HP530S具有和多种药物联合治疗实体 瘤的潜力。稍早前公告的HP501缓释片则是尿酸盐阴离子转运体1 (Urate Anion Transporter 1，URAT1) 的抑制剂，通过抑制URAT1的活性，减少尿酸盐的重吸收，从而促进尿酸排泄，降低血尿酸水平。HP501最早在2018年11月获批开展临床试验，目前已开展I期临床试验、用于高尿酸血症患者的剂量探索的II期临床试验，正在开展III期临床试验准备工作。此次获受理的临床试验申请是与黄嘌呤氧化酶抑制剂联合用于原发性高尿酸血症的长期治疗。海创药业近期在研项目进展披露较密集，公司也迎来多家机构调研。12月，公司接受中欧基金、国泰基金、中信证券、汇添富基金等多家机构调研，1月又接受了博时基金、汇添富基金、嘉实基金、建信基金、华安基金等多家机构调研。机构调研问题主要扔集中于海创药业目前最接近上市阶段的产品——德恩鲁胺（HC-1119）。此前，德恩鲁胺（HC-1119）中国III期临床研究已经完成，于2022年6月经独立数据监查委员会（IDMC）对临床结果审核后判定试验达到方案预设的主要研究终点，并已向国家药品监督管理局药品审评中心递交中国上市前的沟通交流申请。但截至目前，海创药业尚无产品实现商业化。据公司披露的2022年业绩预告，报告期内公司预计归母净利润亏损2.85亿元至3.2亿元，归母扣非后净利润亏损3.25亿元至3.6亿元。公司在公告中称，由于研发费用持续投入，公司预计去年研发费用约23.5亿元至27.5亿元，同比变化幅度为-11.3%至3.8%。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"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":"4.43.1","shortVersion":"4.43.1","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/2310981643","isCrawlerRequest":true}

海创药业多个在研项目临床试验申请获受理 近期机构密集调研

精彩评论

海创药业多个在研项目临床试验申请获受理近期机构密集调研