huahaipharm(SH:600521) 智通财经网·2025-09-01 11:51Core Viewpoint - Company is actively advancing its third transformation from generic drugs to innovative drugs, leveraging various resources to accelerate the development of innovative drugs [1] Industry Summary - The pharmaceutical industry faces significant challenges in new product development, including high technical difficulty, substantial upfront investment, and lengthy approval cycles [1] - The development cycle from initial research to clinical trials, registration, and industrial production is long and involves multiple stages, each with its own uncertainties [1] Risk Factors - Clinical trials typically require completion of Phase I, II, and III before a drug can be submitted for market approval, with potential delays in trial progress leading to competitors launching similar products first, significantly weakening the company's commercialization capabilities [1] - Clinical trial results may not meet expectations, hindering product development or resulting in narrower than anticipated approval for indications, or failing to capture expected market share post-approval [1] - The development of innovative drugs involves multiple regulated stages, each with specific requirements, which may lead to delays or unfavorable outcomes in the drug approval process [1]