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编者按：本文来自Insight数据库；赛柏蓝授权转载，编辑凯西ADC 与双抗的崛起、GLP-1的跨界扩张、国产创新药的突破等，共同勾勒出全球医药领域的新面貌。一如往年，Insight 数据库根据财报整理了2024年药品销售额TOP100榜单。从金额来看，上榜的药品销售额门槛和2023年一样，仍然保持在17亿美元量级。其中，销售额超过50亿美元的药物有35款，超过100亿美元的超级重磅炸弹有12款。012024年度TOP100药品销售榜单（亿美元）02总体概况2024 年有 12 款药品销售额突破百亿美元。帕博利珠单抗以 294.82 亿美元蝉联「药王」，其适应症扩展至 40 余项，覆盖肺癌、黑色素瘤等核心癌种，占据大量肿瘤免疫治疗市场份额。司美格鲁肽凭借 Ozempic（降糖注射版）、Rybelsus（降糖口服版）和 Wegovy（减重版）三大版本，极限追赶，位列第二。整体来看，相较于去年，今年的榜单中虽然有 83 个是老面孔，但末 20 席迎来了大换血。泽布替尼（百济）、艾加莫德（Argenx/再鼎）、尼塞维单抗（赛诺菲/阿斯利康）、替妥木单抗（安进），还有大冢制药的托伐普坦、阿立哌唑、依匹哌唑等多款新药入围。从企业角度来看，强生、罗氏、阿斯利康在 TOP100 榜单中占据最多，都达到了 11 席。诺华、礼来、辉瑞紧随其后。各大药企进入 TOP100 药品销售榜单的药品数量截图来源：多个药品为合作开发，故总和＞100从药物类型来看，化药和单抗仍然占到了大半。化药的药品销售收入达到 2006.93 亿美元，单抗销售收入达 1778.35 亿美元。TOP100 药品销售榜单中不同药物类型数量03ADC 和双抗下一代肿瘤疗法的「双子星」据公开资料显示，2024 年全球 ADC 市场规模近 130 亿美元。尽管 TOP100 榜单里只有 2 款 ADC，分别是第一三共/阿斯利康的德曲妥珠单抗和罗氏的恩美曲妥珠单抗，但这两款产品的销售表现均不俗，一共拿下了 57.14 亿美元。恩美曲妥珠单抗于 2013 年 2 月首次获 FDA 批准上市，用于治疗曾接受过曲妥珠单抗和紫杉烷类化疗治疗的 HER2 阳性转移性乳腺癌患者。同时这也是全球首个获批单药治疗实体瘤的 ADC 药物。近两年来，该药也持续入选 TOP100 榜单。德曲妥珠单抗在获批上市以后，第一三共和阿斯利康对 DXd 管线们铺开了广泛而差异化的临床布局，撒下了腾飞的「火种」。随着各项适应症的陆续登场，2023 年该药首次进入 TOP100 榜单，并一举超过恩美曲妥珠单抗，从「跟随者」成为了「颠覆者」。24 年又有新突破，全球销售额达 34.5 亿美元，同比增加 37.83%。但该药的潜力并不仅限于此，和 K 药联用一线治疗 HER2 过表达 NSCLC 的 III 期临床试验（NCT06899126）正如火如荼地开展，有望成为新的治疗标准。类似的，24 年双抗市场规模同样也接近 130 亿美元。而纵观 TOP100 榜单，入围的总共有 3 款双抗产品，分别是罗氏的艾美赛珠单抗、法瑞西单抗以及诺华的奥法妥木单抗。这三款产品总共贡献了 127.05 亿美元，占到了全球双抗市场规模的 97% 左右。04增速狂飙超 40% 增长的「现象级药物」这一年，TOP100 榜单中有 12 款药品的同比增长率超过了 40%，更有 2 款产品凭借超高增速加入百亿美元分子俱乐部：替尔泊肽在 2024 年销售额高达 164.66 亿美元，同比大增 208.41%，同时还获 FDA 批准用于治疗中重度阻塞性睡眠呼吸暂停（OSA）合并肥胖症成人患者，未来增长空间不可小觑。利生奇珠单抗 24 年实现了 117.18 亿美元的销售额，同比增长 50.95%，成为艾伯维继阿达木单抗之后的下一个百亿美元分子。赛诺菲与阿斯利康联合开发，用于呼吸道合胞病毒感染的尼塞维单抗在增速表现上也十分亮眼，增幅达到 205%，首次入围 TOP100 榜单。值得一提的是，百济神州研发的 BTK 抑制剂泽布替尼全年销售额达 26.44 亿美元，同比增长 103.40%，成为首个跻身 TOP100 榜单的国产创新药。END内容沟通：郑瑶（13810174402）

The FDA approved a new rare disease drug that Johnson & Johnson hopes can compete with established medicines — and some that are yet to be approved — and become a megablockbuster. Regulators on Wednesday gave the thumbs-up to nipocalimab, which will be branded as Imaavy, for patients 12 and up with generalized myasthenia gravis, an autoimmune disease that causes muscle weakness, particularly in the eyes, face, throat and lungs. J&J did not immediately share information about how the drug will be priced. The approval sets up a showdown with Rystiggo and Zilbrysq — both of which are marketed by UCB — as well as argenx’s Vyvgart. Through its $39 billion acquisition of Alexion in 2020, AstraZeneca also has a pair of approved drugs: Soliris and Ultomiris. The FDA’s decision came on time, with the agency expected to approve or reject Imaavy by Tuesday (though J&J did not disclose the PDUFA date). The timing of new drug approvals is under increased scrutiny in light of the widespread cuts at the FDA under Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. Stealth BioTherapeutics on Tuesday reported a delay in the FDA’s decision for its Barth syndrome drug, and a person familiar with the situation said it wasn’t related to safety, efficacy or manufacturing. Myasthenia gravis is a category in which biopharma companies have invested heavily in recent years, and the market is expected to reach between $3 billion and $7 billion by the early 2030s, according to analyst estimates. J&J acquired Imaavy in its $6.5 billion acquisition of Momenta in 2020. Soliris was the first drug to be approved for myasthenia gravis in 2017, but sales have been rising for UCB’s drugs and Vyvgart, all of which have different mechanisms of action than Soliris and Ultomiris and are viewed as the next generation of therapies. In 2024, Rystiggo had $202 million in sales — up from just $19 million in 2023 when it launched — and Zilbrysq reached $72 million in its first year on the market. Vyvgart, meanwhile, has already proved itself a rare disease blockbuster, tallying nearly $2.2 billion in sales in 2024 across its IV and subcutaneous formulations. In addition to myasthenia gravis, Vyvgart also received approval last year in another disease called CIDP, which is when a patient’s immune cells attack the peripheral nervous system. J&J has high hopes for Imaavy, saying it expects the drug can reach more than $5 billion in peak sales across all potential indications, should it continue to win approvals. But to carve out a piece of the market, J&J will have its work cut out for it. Amgen is testing its rare disease drug Uplizna in myasthenia gravis, with a filing expected before the end of June. Immunovant also has a drug in late-stage development, while Biohaven has a program expected to soon start Phase 1 studies in myasthenia gravis. Cartesian Therapeutics is working on a cell therapy program as well.