人工智能技术在药物研发中的应用
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长春高新子公司注射用 GenSci143 境外生产药品注册临床试验申请获受理
Zheng Quan Shi Bao Wang· 2025-10-17 11:32
Core Viewpoint - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA [1][2] Group 1: Product Development - GenSci143 is a self-developed drug that targets B7-H3 and PSMA, combining chemotherapy and tumor immunotherapy potential [1] - The drug utilizes a proprietary linker technology, providing strong cytotoxic activity and high plasma stability, which enhances its safety profile while effectively killing tumor cells [1] - The dual-target design of GenSci143 aims to overcome tumor heterogeneity and resistance, potentially benefiting a broader patient population [1] Group 2: Regulatory Progress - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China, indicating progress in both U.S. and Chinese markets [2] - The company has received multiple approvals for other clinical trial applications, including GS3-007a and GenSci140, showcasing a robust pipeline of innovative drug candidates [2] Group 3: Strategic Focus - The company has undertaken strategic adjustments and increased investment in innovation, establishing core technology platforms with independent intellectual property rights and international competitiveness [3] - There is a focus on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, aligning with the company's sustainable development and internationalization goals [3]