又一家药企上市申请获 CDE 受理！该药物面临16家药企角逐

制药网2025-06-25

【制药网行业动态】近日，圣华曦药业的乌帕替尼缓释片上市申请获 CDE 受理，为该药物领域竞争再添变数。有数据显示，截至2025年，已有9家企业提交仿制上市申请，包括福元医药、石药集团、复星万邦等，目前共有16家企业正在争夺首仿。乌帕替尼是由艾伯维(AbbVie)公司自主研发的新一代选择性和可逆性 JAK1 抑制剂，通过阻断 JAK-STAT 信号通路中 Janus 激酶的活性起作用，该信号通路在...

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The drug faces competition from 16 pharmaceutical companies","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"601089":0.9,"01093":0.9},"content_text":"【制药网 行业动态】近日，圣华曦药业的乌帕替尼缓释片上市申请获 CDE 受理，为该药物领域竞争再添变数。有数据显示，截至2025年，已有9家企业提交仿制上市申请，包括福元医药、石药集团、复星万邦等，目前共有16家企业正在争夺首仿。乌帕替尼是由艾伯维(AbbVie)公司自主研发的新一代选择性和可逆性 JAK1 抑制剂，通过阻断 JAK-STAT 信号通路中 Janus 激酶的活性起作用，该信号通路在促炎细胞因子的释放中起主要作用，这些细胞因子会刺激类风湿关节炎、银屑病关节炎和特应性皮炎等的炎症。其口服缓释片于 2019 年 8 月 16 日获 FDA 批准上市，商品名为 RINVOQ，同年 12 月，在欧盟获 EMA 批准上市。2022 年，乌帕替尼缓释片正式进入中国市场，目前已被批准用于治疗多种适应症，覆盖类风湿关节炎、活动性银屑病关节炎、溃疡性结肠炎、克罗恩病、活动性放射学阴性中轴型脊柱关节炎(nr-axSpA)、活动性强直性脊柱炎(AS)、成人巨细胞动脉炎(GCA)等， 且已在中国获批 7 大适应症进入新版医保目录。自上市以来，乌帕替尼缓释片的销售额呈现爆发性增长。有数据显示，2024年前三季度乌帕替尼在国内销售额达到2.63亿元人民币，全球销量为59.71亿美元。据预计，到 2026 年，乌帕替尼全球年销售额有望接近 80 亿美元。而作为目前全球医学界具有前景的靶点之一，有数据显示，JAK 抑制剂在全国医院(全终端)累计销售额达 24.9 亿元，市场规模迅速攀升，由 2019 年的 0.56 亿元增长至 2023 年的 8.5 亿元，复合年增长率达 97.28%，乌帕替尼缓释片是其中的重要产品之一。在 JAK 抑制剂市场中，乌帕替尼缓释片的主要竞争对手包括诺华的芦可替尼、辉瑞的托法替布和礼来的巴瑞替尼等。芦可替尼作为全球头个获批的 JAK 抑制剂，其适应症包括骨髓纤维化、真性红细胞增多症等，优势在于较早进入市场，积累了丰富的临床数据和市场经验。乌帕替尼缓释片自身也具备诸多优势。在特应性皮炎的 “头对头” iii 期 headsup 研究中，其与度普利尤单抗相比在主要终点和全部次要终点方面均表现出疗效优势，起效更快，患者在治疗 1 周内瘙痒减轻、2 周后皮损清除改善、治疗 16 周后有更高比例的患者实现高水平的皮损清除。在其他适应症如类风湿关节炎、银屑病关节炎、溃疡性结肠炎等的临床试验中，也都展现出了良好的疗效。目前，乌帕替尼缓释片在中国只有原研进口获批，仿制竞争非常激烈。截至目前，共有16家企业正在争夺首仿。业内表示，随着众多药企的纷纷入局，乌帕替尼缓释片市场竞争日益激烈。原研药凭借其品牌影响力、临床数据积累以及前期市场开拓占据一定优势，但仿制药企业若能成功获批上市，将凭借价格优势等对原研药市场造成冲击。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"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,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","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/2546426820","isCrawlerRequest":true}