华海药业：公司积极推进仿制药到创新药的第三次转型升级 存在临床试验进度不达预期等风险

Core 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 Overview - The pharmaceutical industry faces significant challenges in new product development, including high technical difficulty, substantial upfront investment, and lengthy approval cycles [1] - The development process from initial research to commercialization involves multiple stages, each with its own uncertainties and regulatory requirements [1] Risk Factors - Clinical trials typically require multiple phases (I, II, III) before a drug can be submitted for market approval, with potential delays in trial progress leading to competitors launching similar products first, which could significantly weaken the company's commercialization capabilities [1] - There is a risk that clinical trial results may not meet expectations, hindering product development or resulting in narrower than anticipated approval for indications, which could affect market share post-approval [1] - The development of innovative drugs involves strict regulatory stages, and there is a risk that the review and approval process may not proceed as expected, potentially delaying or preventing market approval [1]