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ADC研发全球格局与下一代演进趋势(课件)

  • 2026-05-10 23:27:36
ADC研发全球格局与下一代演进趋势(课件)
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抗体偶联药物(ADC)近年来一直是肿瘤精准治疗领域的热门研究方向之一,基于其借助靶向载体将治疗介质选择性递送到疾病灶点从而发挥治疗效果的特点,ADC药物又被称为“高效靶向生物导弹”。
本报告将从ADC技术迭代,市场交易及研发现状等方面进行阐述,并对ADC未来方向做展望。

一、ADC概述及技术迭代

抗体药物偶联物(Antibody-drug conjugate,ADC)是一类通过连接子将细胞毒性药物连接到单克隆抗体的靶向生物制剂,将单克隆抗体作为载体将小分子细胞毒性药物以靶向的方式高效地运输至目标肿瘤细胞中。

ADC药物通过旁观者效应、ADCC、ACP和CDC效应,使得抗体+小分子细胞毒药物的结合发挥1+1>2的作用。

经过数年积累,以ADC为代表的偶联药物已进入技术迭代与应用拓展期。2000年首个ADC药物(治疗急性髓系白血病)获批,由于致命副作用在2010年退市。十年间(2000-2010)全球再无新ADC上市。2011年随着维布妥昔单抗上市,ADC药物再次汇聚众人的目光。

ADC产品经历了四次迭代,初代ADC不稳定,治疗指数低;而新一代ADC不但拓宽适应症领域,提高稳定性,同时还降低了毒性。

二、ADC市场及BD交易

2024年全球ADC药物市场达到135亿美元,预计到2035年将增至2163亿美元,市场前景良好;国内ADC药物市场在2024年达到4亿美元,预计2035年将以高于美国CAGR增至409亿美元。

第二代ADC药物(Kadcyla等)增长已显乏力;第三代ADC药物(Enhertu等)增长表现强劲。

近三年,中国ADC领域展现出蓬勃活力,一系列重磅交易接连达成。其中百利天恒BL-B01D1(全球第一款进入临床Ⅲ期的EGFR/HER3双抗ADC)潜在交易总金额84亿美元;石药获得JSKN-003(靶向HER2双表位ADC)独家许可,交易金额超30亿元。
      
海外MNC重点布局中国早期ADC项目;新兴靶点正在突破;交易模式多元化,从单药授权升级为平台化模式,实现从“卖产品”到“输出技术”的跃迁;首付款及里程碑金额大幅提升;中国ADC创新资产已获全球顶尖MNC广泛认可。
三、ADC研发现状     

目前全球共20款ADC药物上市,国内共15款药物获批,涵盖淋巴瘤、白血病、多发性骨髓瘤、乳腺癌、头颈癌、尿路上皮癌等多个癌种。

已上市ADC药物靶点集中在HER2和TROP2,适应症主要以实体瘤为主。

全球处于临床申请到申请上市的456个ADC药物中,有67%已在国内注册。

适应症以肿瘤为主,乳腺癌、非小细胞癌、胃癌、卵巢癌,结直肠癌研发最热,为全球和中国TOP5。

国内外ADC靶点布局较为接近,实体瘤相关靶点占绝大多数,例如HER2、TROP2等;HER3、FOLR1等靶点开发日渐火热。

抗体类型:从单克隆抗体向双抗/多抗、小型化抗体方向多元化演进。

载荷:目前仍以单载荷如拓扑异构酶I抑制剂和微管蛋白抑制剂为主。

连接子:从传统主流连接子向亲水连接子过渡,旨在提高DAR兼容性、低聚集、肿瘤特异性。

四、ADC商业化展望

随着ADC市场规模不断扩大,技术进步,ADC将不再局限于末线治疗,多载荷、多靶点协同,有望成为贯穿肿瘤治疗全程的核心支柱,并向自免、感染等多个疾病领域实现广泛拓展。ADC药物正步入发展快车道,靶点探索的持续创新与核心技术的突破,为攻克更多医学难题带来新希望。

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  1. CONNECT:[ UseTime:0.000865s ] mysql:host=127.0.0.1;port=3306;dbname=a_sjds;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001370s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.011434s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.002535s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001223s ]
  6. SELECT * FROM `set` [ RunTime:0.001210s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001385s ]
  8. SELECT * FROM `article` WHERE `id` = 500654 LIMIT 1 [ RunTime:0.001162s ]
  9. UPDATE `article` SET `lasttime` = 1778437035 WHERE `id` = 500654 [ RunTime:0.018336s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 66 LIMIT 1 [ RunTime:0.000371s ]
  11. SELECT * FROM `article` WHERE `id` < 500654 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000521s ]
  12. SELECT * FROM `article` WHERE `id` > 500654 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.007103s ]
  13. SELECT * FROM `article` WHERE `id` < 500654 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.005489s ]
  14. SELECT * FROM `article` WHERE `id` < 500654 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000970s ]
  15. SELECT * FROM `article` WHERE `id` < 500654 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.007004s ]
0.139026s