Zymeworks Achieves Key Milestone With BLA Acceptance for Zanidatamab in China, Zymeworks to Receive Up to $164M in Milestone Payments
Zymeworks Achieves Key Milestone With BLA Acceptance for Zanidatamab in China, Zymeworks to Receive Up to $164M in Milestone Payments
Zymeworks Inc. (NASDAQ:ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC. Under the terms of Zymeworks' Asia Pacific license and collaboration agreement with BeiGene for the development and commercialization of zanidatamab, Zymeworks is entitled to receive an $8 million milestone payment. Zymeworks also remains eligible to receive up to $164 million based on additional milestones plus royalties on product sales in the Asia Pacific region.
生物技术临床阶段公司百济神州开发的一系列多功能生物治疗方法的BLA申请已经被NMPA的CDE批准, 该BLA申请是针对难以治疗的HER2阳性胆管癌二线治疗的zanidatamab。根据Zymeworks的与百济神州在亚太地区展开合作及授权协议，Zymeworks有权获得800万美元的里程碑付款，并且在亚太地区产品销售可以获得高达1.64亿美元的其他里程碑奖励及版税。
This BLA is based on the data from the HERIZON-BTC-01 (NCT04466891, CTR20202607) clinical trial, which was published in Lancet Oncology in June 20231. The trial is an open-label phase 2b study that evaluated the efficacy and safety of zanidatamab in previously treated patients with unresectable, locally advanced, or metastatic HER2-positive BTC. Zanidatamab demonstrated clinically meaningful anticancer activity and durable responses in subjects with previously treated HER2-positive BTC. As of October 10, 2022, the objective response rate (ORR), median duration of response (DOR), and median progression-free survival (PFS) assessed by independent central review (ICR) were 41.3% (95% CI: 30.4–52.8), 12.9 months (95% CI: 6.0–not estimable), and 5.5 months (95% CI: 3.7–7.2), respectively.
该BLA申请是基于2023年6月《柳叶刀·肿瘤学》杂志发表的HERIZON-BTC-01 (NCT04466891, CTR20202607) 临床试验的数据。该试验是一项开放标签的2b期研究，评估了zanidatamab对先前接受治疗的不可切除、局部晚期或转移性HER2阳性胆管癌患者的疗效和安全性。zanidatamab在先前治疗过的HER2阳性胆管癌患者中展现出临床意义的抗癌活性和持久的反应。截至2022年10月10日，独立中央评估(ICR)评估的目标反应率(ORR)、中位反应持续时间(DOR)和中位无进展生存期(PFS)分别为41.3% (95% CI: 30.4–52.8)、12.9 个月 (95% CI: 6.0–不可估计)和5.5 个月 (95% CI: 3.7–7.2)。蘋果CEO庫克大规模沽出股票，套現踰3億港元。20231年6月进行的试验是一项开放标签的2b期研究，评估了在先前接受过治疗的难以切除，局部晚期或转移性HER2阳性BTC患者中，zanidatamab的疗效和安全性。Zanidatamab在先前接受过治疗的HER2阳性BTC患者中展示了临床意义重大的抗癌活性和持久的反应。截止到2022年10月10日，经过独立中央审查（ICR）评估的客观反应率（ORR），反应持续时间（DOR）中位数和无进展生存期（PFS）中位数分别为41.3％（95％CI：30.4-52.8），12.9个月（95％CI：6.0-不可估计）和5.5个月（95％CI：3.7-7.2）。