海创药业(688302.SH)：HC-1119中枢神经系统毒性风险较恩扎卢胺减少50%

格隆汇资讯2023-05-31

格隆汇5月31日丨有投资者向海创药业(688302.SH)提问：请介绍公司HC-1119产品核心竞争优势？海创药业回复：公司自主研发HC-1119适应症为mCRPC末线，该适应症暂无获批药物，该领域存在未被满足的临床需求。HC-1119是恩扎卢胺的氘代化合物，临床使用剂量为80mg/天，是恩扎卢胺临床使用剂量的一半，HC-1119与恩扎卢胺有效性相当，而安全性提高。恩扎卢胺容易引起中枢神经系统...

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(688302. SH): HC-1119 central nervous system toxicity risk is reduced by 50% compared with Enzaluamine","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688302":0.9},"content_text":"格隆汇5月31日丨有投资者向海创药业(688302.SH)提问：请介绍公司HC-1119产品核心竞争优势？海创药业回复：公司自主研发HC-1119适应症为mCRPC末线，该适应症暂无获批药物，该领域存在未被满足的临床需求。HC-1119是恩扎卢胺的氘代化合物，临床使用剂量为80mg/天，是恩扎卢胺临床使用剂量的一半，HC-1119与恩扎卢胺有效性相当，而安全性提高。恩扎卢胺容易引起中枢神经系统毒副作用，这与药物在脑中暴露量升高有关。临床前动物实验研究发现，HC-1119与恩扎卢胺数据对比，HC-1119中枢神经系统毒性风险较恩扎卢胺减少50%。HC-1119与恩扎卢胺历史临床数据对比结果发现，HC-1119较恩扎卢胺在中枢神经系统引起的乏力等症状发生率降低70%。恩扎卢胺临床试验中发生约1%的癫痫，这与活性成分（M0+M2）透过血脑屏障抑制GABA-A受体氯离子通道活性有关。在相同血浆暴露量下，HC-1119（M0+M2）在脑中的暴露量较恩扎卢胺显著降低，且HC-1119临床试验中尚未观察到癫痫事件。HC-1119较恩扎卢胺在其他由中枢神经系统引起的乏力等症状发生率大大降低。综上所述，HC-1119有可能是潜在Best in class的二代雄激素拮抗剂，拥有从mCRPC末线治疗出发的差异化开发策略以及安全性提高等方面的核心优势。","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","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/2339268487"}