头部药企接连失利！该药物靶点在挫折中等待拐点

制药网2025-07-16

【制药网行业动态】在肿瘤免疫治疗领域，CD47 靶点曾如一颗璀璨的明星，闪耀着希望的光芒，被寄予厚望成为攻克癌症的有力武器。然而，近年来，围绕这一靶点的研发之路却布满荆棘，众多药企接连折戟，让 CD47 靶点的前景蒙上了一层厚重的阴霾。CD47作为一种广泛表达于多种癌细胞表面的跨膜糖蛋白，尤其是在血液肿瘤中呈现高表达状态，其 “致癌机制” 较为明确。一方面，它与巨噬细胞表面的信号调节蛋白 α(...

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The drug target waits for an inflection point in setbacks","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02696":0.9,"09926":0.9,"PFE":0.9},"content_text":"【制药网 行业动态】在肿瘤免疫治疗领域，CD47 靶点曾如一颗璀璨的明星，闪耀着希望的光芒，被寄予厚望成为攻克癌症的有力武器。然而，近年来，围绕这一靶点的研发之路却布满荆棘，众多药企接连折戟，让 CD47 靶点的前景蒙上了一层厚重的阴霾。CD47作为一种广泛表达于多种癌细胞表面的跨膜糖蛋白，尤其是在血液肿瘤中呈现高表达状态，其 “致癌机制” 较为明确。一方面，它与巨噬细胞表面的信号调节蛋白 α(SIRPα)结合，传递出 “别吃我” 的信号，有效抑制巨噬细胞对肿瘤细胞的吞噬作用，使得肿瘤细胞能够巧妙躲避免疫系统的攻击。另一方面，CD47 可与血小板反应蛋白 - 1(TSP - 1)结合，抑制信号转导并促进肿瘤细胞的增殖。鉴于此，CD47 被视为免疫逃逸的关键靶点，市场一度满怀期待它能复刻 PD - 1 的成功传奇。但现实却给了科研人员和药企沉重一击。2025 年 6 月 30 日，辉瑞宣布终止 maplirpacept 在治疗复发或难治性弥漫性大 B 细胞淋巴瘤(DLBCL)中的 2 期临床，理由是患者招募困难。而这一药物正是辉瑞 2021 年以 22.6 亿美元收购 Trillium 所获得的核心资产之一。此前，Trillium 的另一种抗 CD47 产品 ontorpacept 已悄然从辉瑞的管线中消失。尽管辉瑞强调终止该临床并非基于安全性或有效性的担忧，且还将探索其在其他血癌中的应用，但这一决定无疑给 CD47 靶点研发的火热势头泼了一盆冷水。实际上，辉瑞并非唯一在 CD47 靶点上遭遇滑铁卢的药企。吉利德旗下的 magrolimab 多项临床试验因安全性问题屡屡受挫。在一项针对未经治疗的骨髓增生异常综合征(MDS)的 3 期临床中，263 名接受 magrolimab 治疗的患者中，有 76.4% 发生了≥3 级治疗相关不良事件(TEAEs)，更糟糕的是，magrolimab 增加了患者的死亡风险(中位生存期 15.9 个月 VS 对照组 18.6 个月)。ALX Oncology 的 Evorpacept 也因疗效不足，在早期研究中折戟沉沙。这些接连不断的失利，让市场对 CD47 靶点的前景从最初的满怀憧憬转变为如今的疑虑重重。导致 CD47 靶点研发失败的原因错综复杂，其中毒性与疗效的平衡难题尤为突出。CD47 抗体高亲和力容易被 “中和”，引发 “抗原沉默”，为达到治疗效果往往需要提高剂量。然而，CD47 在正常红细胞上也呈现高表达，高剂量给药会不可避免地带来贫血、溶血等严重血液毒性问题。例如辉瑞的 maplirpacept 虽采用 SIRPα - IgG4 融合蛋白设计试图减毒，但过度弱化结合力导致疗效欠佳，最终又不得不采用高剂量给药，临床上仍出现了 30% 的血小板减少事件。尽管 CD47 靶点研发之路充满坎坷，但行业并未因此而放弃。就在辉瑞宣布终止试验的同一天，复宏汉霖与 HanchorBio 签署重大对外许可协议，选择逆势加码 CD47 领域。其看中的正是 HCB101 在血液安全性上的优势，从公布的 1 期临床实验结果来看，32 例晚期实体瘤或非霍奇金淋巴瘤患者中，贫血事件发生率为 17%，且均为 1 - 2 级，目前 HCB101 针对实体血液系统恶性肿瘤及实体瘤的试验已推进至 2 期临床。国内的康方生物也在积极布局，其单抗莱法利(AK117)通过改造抗体的 CD47 蛋白结合构像，减少与红细胞的结合，在针对 MDS 的临床 Ib 期临床试验中取得了一定成效，27 例患者中展现出了较好的缓解率。CD47 靶点从备受追捧到如今的接连折戟，无疑为整个生物医药行业敲响了警钟。药物研发之路本就充满未知与挑战，即使是看似具潜力的靶点，在实际研发过程中也可能遭遇诸多难以预料的困境。但每一次的挫折都是成长的磨砺，随着科研人员对 CD47 靶点作用机制的深入理解，以及技术的不断创新与突破，或许在未来的某一天，CD47 靶点能够突破重重障碍，真正成为对抗癌症的有力武器，为众多患者带来新的希望。免责声明：本文由AI辅助生成，在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.13","shortVersion":"4.35.13","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/2551110768","isCrawlerRequest":true}