百济神州又一新药获批

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]