通化金马:新药审评按CDE工作流程已经处于临近审批阶段
Core Viewpoint - Tonghua Golden Horse's new drug review is nearing approval according to the CDE workflow, with the company actively preparing for Phase IV clinical trials as part of its international strategic planning [2]. Group 1 - The company's new drug review process is in the final stages of approval [2]. - The clinical trials mentioned are not for supplementing Phase III data but are part of the company's market judgment and strategic planning [2]. - The company is preparing for Phase IV clinical trials focusing on deep research and expanding indications, which does not affect the current comprehensive review process of the new drug [2].