恒瑞医药(01276.HK):注射用瑞康曲妥珠单抗获得药物临床试验批准通知书
Ge Long Hui·2025-11-25 12:53

Core Viewpoint - The announcement highlights that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Merrimack Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of injection-based Rukang Trastuzumab, which is set to be launched in China by May 2025 for treating specific lung cancer patients [1][2]. Group 1 - The injection-based Rukang Trastuzumab is indicated for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [1]. - The mechanism of action involves binding to HER2-expressing tumor cells, leading to internalization and release of toxins within the tumor cells' lysosomes, inducing cell cycle arrest and apoptosis [1]. - The released toxins exhibit high membrane permeability, enhancing the anti-tumor efficacy through a bystander killing effect [1]. Group 2 - Competing products in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's collaboration with Daiichi Sankyo on Fam-trastuzumab deruxtecan, both of which are already available in China [1]. - Other similar products include Rongchang Biopharmaceutical's Vedisizumab, approved in 2021, and Kelun's Botuzumab, expected to be approved in 2025 [2]. - The global sales of similar products are projected to reach approximately $6.557 billion from 2024 onwards, with the cumulative R&D investment for Rukang Trastuzumab amounting to about 141.475 million yuan [2].