海南双成药业股份有限公司关于 精氨加压素注射液获得澳大利亚药物管理局（TGA）上市许可的公告

Group 1 - The core point of the announcement is that Hainan Shuangcheng Pharmaceutical Co., Ltd. has received marketing authorization from the Australian Therapeutic Goods Administration (TGA) for its vasopressin injection [1][3]. - The vasopressin injection is indicated for the prevention and treatment of postoperative abdominal distension, clearing interference gas shadows in abdominal X-ray examinations, and treating diabetes insipidus [1][2]. - The product is developed by Par Pharmaceutical and was previously approved by the FDA in the United States on April 17, 2014 [2]. Group 2 - The global sales for the vasopressin injection are projected to be approximately $72 million in 2024, with the U.S. market accounting for about $46 million of that total [2]. - The approval for the Australian market is expected to positively impact the company's overseas market expansion and overall performance [3]. - There are uncertainties regarding the product's sales timeline, market size, and future expansion in Australia due to factors such as market demand fluctuations, policy changes, exchange rate volatility, and market competition [3].