思路迪医药股份(01244)：恩维达®附条件批准转常规批准补充申请获NMPA正式受理

智通财经02-09

智通财经APP讯，思路迪医药股份(01244)公布，恩维达® (通用名：恩沃利单抗注射液)由附条件批准转为常规批准的境内生产药品补充申请，正式获得国家药品监督管理局 (NMPA)受理，受理号为CYSB2600056，申请规格为200mg(1.0ml)╱瓶。本次申请由公司旗下四川思路康瑞药业有限公司提交，申报材料于2026年2月2日完成签收并经审查予以受理。恩维达® (通用名：恩沃利单抗注射液，原研...

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(01244): Enveida ® The supplementary application for conditional approval to regular approval was formally accepted by NMPA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01244":1.5},"content_text":"智通财经APP讯，思路迪医药股份(01244)公布，恩维达® (通用名：恩沃利单抗注射液)由附条件批准转为常规批准的境内生产药品补充申请，正式获得国家药品监督管理局 (NMPA)受理，受理号为CYSB2600056，申请规格为200mg(1.0ml)╱瓶。本次申请由公司旗下四川思路康瑞药业有限公司提交，申报材料于2026年2月2日完成签收并经审查予以受理。恩维达® (通用名：恩沃利单抗注射液，原研代号：KN035)是重组人源化抗程序性死亡配体1(PD-L1)单域抗体Fc融合蛋白。恩维达®由康宁杰瑞生物制药(09966)的获豁免有限公司及其附属公司(均为独立第三方))自主研发， 2016年起与公司合作开发。于2020年3月30日，江苏康宁杰瑞生物制药有限公司(为康宁杰瑞的全资附属公司)、思路迪医药及江苏先声药业有限公司(为先声药业集团有限公司的附属公司)订立一份合作协议。根据该协议，江苏先声获授予恩维达®于中国大陆内的肿瘤适应症的独家市场推广权及对外许可或转让下的优先受让权。于2024年1月，公司已与康宁杰瑞及Glenmark Specialty S.A.(Glenmark)订立许可协议，据此思路迪医药与康宁杰瑞同意向Glenmark授予恩维达®肿瘤适应症的独家许可及再授权，以(其中包括)在印度、亚太区(新加坡、泰国及马来西亚除外)、中东及非洲、俄罗斯、独联体国家及拉丁美洲在肿瘤所有使用领域开发及商业化恩维达®。此外，其作为全球首个皮下注射PD-L1抑制剂，已于2021年11月获得国家药监局批准上市用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者的治疗。","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":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":"4.42.1","shortVersion":"4.42.1","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/2610651658","isCrawlerRequest":true}