恒瑞医药一日4款在研药获批临床：肿瘤两款、减重两款，双赛道同步推进

每日经济新闻09-07 18:55

9月7日盘后，恒瑞医药（SH600276，股价46.26元，市值3055.72亿元）一口气披露了共三份涉及四种药物的临床试验获批公告。　　公告分别涉及HRS-6209胶囊、HRS-4508片、SHR-1179注射液以及HRS-1597片四款在研药物，覆盖抗肿瘤与体重管理两大热门赛道，研发管线推进节奏稳健。　　两款新药来自抗肿瘤管线　　恒瑞医药是一家专注研发、生产及推广高品质药物的创新型国际化制药...

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　　恒瑞医药是一家专注研发、生产及推广高品质药物的创新型国际化制药企业，聚焦抗肿瘤、代谢性疾病、自身免疫疾病、呼吸系统疾病、神经系统疾病等领域进行新药研发，是国内创新药领域的龙头企业之一。　　根据公告，公司近日收到国家药监局核准签发的关于HRS-6209胶囊、HRS-4508片的《药物临床试验批准通知书》。　　HRS-6209是一种新型选择性CDK4（一种调控细胞分裂的蛋白）抑制剂，能够强效抑制CDK4，抑制下游Rb（一种抑癌基因）磷酸化，诱导肿瘤细胞阻滞在G1期，进而发挥抗肿瘤作用，临床拟用于治疗晚期恶性实体瘤。与CDK4/6抑制剂相比，该药提高了对CDK6的选择性，可改善CDK4/6抑制剂相关的血液毒性。该项目已布局多项乳腺癌联合用药临床试验，进入Ⅱ期临床阶段；经公司查询，目前国内外尚无同类产品获批上市，累计研发投入约1.61亿元（未经审计，下同）。　　HRS-4508片则是一种新型、高效、选择性的酪氨酸激酶抑制剂，通过抑制肿瘤细胞增殖发挥抗肿瘤作用。目前国外已上市的同类产品有宗格替尼（商品名Hernexeos）和图卡替尼（商品名Tukysa），其中宗格替尼已在中国获批上市。据EvaluatePharma数据库，2025年图卡替尼全球销售额约为4.63亿美元。截至目前，HRS-4508片相关项目累计研发投入约为9670万元。　　减重赛道双线布局获批临床 　　除抗肿瘤管线外，恒瑞医药在体重管理领域的布局也同步推进。　　公告显示，公司子公司广东恒瑞医药收到国家药监局核准签发的关于SHR-1179注射液的《药物临床试验批准通知书》。SHR-1179注射液是公司自主研发的治疗用1类生物制品，拟用于体重管理适应证，国内外暂无相同靶点药物获批上市，相关项目累计研发投入约2420万元。　　另一款减重药物是HRS-1597片，由恒瑞医药子公司山东盛迪医药收到临床试验批准通知书。HRS-1597片是公司自主研发的1类新药，同样拟用于体重管理，经公司查询，目前国内外暂无同类药物获批上市，相关项目累计研发投入约1690万元。　　上述药物在获得临床试验批准通知书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品从研制、临床试验报批到投产的周期长、环节多，研发及至上市仍存在一定不确定性，公司表示将按国家有关规定积极推进上述研发项目，并及时对项目后续进展履行信息披露义务。（文章来源：每日经济新闻）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"2","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; 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