若是换算成人民币，泽布替尼大约在一个季度内实现了于美国销售50亿元的战绩。这在国产创新药中仅此一例。 在美销售情况，智通财经记者截图自公司官网 同日晚，智通财经记者从百济神州公司获悉，企业将上调全年收入指引，将其收入预期区间从352亿元至381亿元调整为 358亿元至381亿元，也就是，上调收入下限6亿元。 智通财经记者 | 黄华 智通财经编辑 | 谢欣 8月6日当晚，智通财经记者从百济神州的线上业绩说明会获悉，今年第二季度，泽布替尼的在美销售额再次超过阿卡替 尼和伊布替尼，再度成为美国BTK抑制剂市场的王牌单品。 来自百济神州业绩会的数据显示，今年第二季度内，泽布替尼、阿卡替尼、伊布替尼的美国销售额分别为6.84亿美元、 5.83亿美元、5.43亿美元，同比增长43%、5%、-9%。 泽布替尼及其竞品 百济神州明确表示，其上调营收的原因主要得益于泽布替尼在美国市场的领先地位，以及产品在欧洲和全球其他重要市 场的持续扩张。 在美国造爆款 泽布替尼是百济神州最知名的产品，它的中文商品名为"百悦泽"，是一种治疗血液瘤的药物。它也是中国首个在美获批 上市的抗癌新药，也是首个创造了十亿美元销售额的国产药物。 在过去和 ...

Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]