Workflow
*ST双成:注射用比伐芦定获得澳大利亚药物管理局上市许可

Core Viewpoint - The company ST Shuangcheng (002693.SZ) has received marketing approval from the Australian Therapeutic Goods Administration for its injectable drug, Bivalirudin, which is used to treat patients with moderate to high-risk acute coronary syndrome (ACS) [1] Group 1: Regulatory Approvals - The drug has previously received a drug registration certificate from the National Medical Products Administration (NMPA) in China [1] - The company has also passed the consistency evaluation of quality and efficacy for injectable generic drugs by the NMPA [1] Group 2: Market Impact - The approval in Australia is expected to positively impact the company's efforts to expand into overseas markets and enhance its performance [1] - However, the drug export business is subject to various factors, leading to uncertainties regarding sales timelines, market size, and future expansion progress [1]