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.
生物技術臨床階段公司百濟神州開發的一系列多功能生物治療方法的BLA申請已經被NMPA的CDE批准, 該BLA申請是針對難以治療的HER2陽性膽管癌二線治療的zanidatamab。根據Zymeworks的與百濟神州在亞太地區展開合作及授權協議，Zymeworks有權獲得800萬美元的里程碑付款，並且在亞太地區產品銷售可以獲得高達1.64億美元的其他里程碑獎勵及版稅。
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.
該BLA申請是基於2023年6月《柳葉刀·腫瘤學》雜誌發表的HERIZON-BTC-01 (NCT04466891, CTR20202607) 臨床試驗的數據。該試驗是一項開放標籤的2b期研究，評估了zanidatamab對先前接受治療的不可切除、局部晚期或轉移性HER2陽性膽管癌患者的療效和安全性。zanidatamab在先前治療過的HER2陽性膽管癌患者中展現出臨床意義的抗癌活性和持久的反應。截至2022年10月10日，獨立中央評估(ICR)評估的目標反應率(ORR)、中位反應持續時間(DOR)和中位無進展生存期(PFS)分別爲41.3% (95% CI: 30.4–52.8)、12.9 個月 (95% CI: 6.0–不可估計)和5.5 個月 (95% CI: 3.7–7.2)。蘋果CEO庫克大規模沽出股票，套現踰3億港元。20231年6月進行的試驗是一項開放標籤的2b期研究，評估了在先前接受過治療的難以切除，局部晚期或轉移性HER2陽性BTC患者中，zanidatamab的療效和安全性。Zanidatamab在先前接受過治療的HER2陽性BTC患者中展示了臨床意義重大的抗癌活性和持久的反應。截止到2022年10月10日，經過獨立中央審查（ICR）評估的客觀反應率（ORR），反應持續時間（DOR）中位數和無進展生存期（PFS）中位數分別爲41.3％（95％CI：30.4-52.8），12.9個月（95％CI：6.0-不可估計）和5.5個月（95％CI：3.7-7.2）。
譯文內容由第三人軟體翻譯。