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上海医药:阿立哌唑片获菲律宾药品注册证书
Xin Lang Cai Jing· 2025-09-12 07:41
Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate from the Philippines Food and Drug Administration for Aripiprazole tablets, allowing the product to be marketed in the Philippines [1] Company Summary - Aripiprazole tablets are an antipsychotic medication primarily used for the treatment of schizophrenia and manic episodes of bipolar disorder, and can also serve as an adjunct treatment for depression [1] - The company incurred approximately 50,000 yuan in registration-related expenses for the product's market entry in the Philippines [1] Market Summary - The total sales revenue for Aripiprazole tablets (10 mg) in the Philippines is projected to be 2.39 million USD in 2024 [1]
上海医药集团股份有限公司关于 缩宫素注射液及醋酸奥曲肽注射液 获得菲律宾药品注册证书的公告
Group 1: Core Announcement - Shanghai Pharmaceuticals has received drug registration certificates for Oxytocin Injection and Acetate Octreotide Injection from the Philippines Food and Drug Administration, allowing these products to be marketed in the Philippines [1][5] Group 2: Product Information - Oxytocin Injection is primarily used for induction and stimulation of labor, as well as for treating uterine bleeding due to insufficient contraction [2] - Acetate Octreotide Injection is used for treating acromegaly, alleviating symptoms related to functional gastrointestinal endocrine tumors, and preventing complications after pancreatic surgery [2][3] - Both products were developed by Shanghai Pharmaceuticals' subsidiary, Shanghai First Biochemical Pharmaceutical Co., Ltd., with minimal additional registration costs of approximately RMB 50,000 for the Philippines market [2][3] Group 3: Market Competition - In the Philippines, there are 12 other vendors for Oxytocin Injection, including RAQUEL ABBAS PHARM and AMB HK ENTERPRISE, while Acetate Octreotide Injection faces competition from NOVARTIS PHARMA and SUN PHARMA among others [4] - The total sales for Oxytocin Injection in the Philippines market is projected to be USD 970,000 in 2024, while Acetate Octreotide Injection is expected to generate USD 760,000 [4] Group 4: Impact on Company - The approval of these injections marks a significant step for Shanghai Pharmaceuticals in expanding its overseas market presence and gaining valuable experience [5]
*ST双成:依替巴肽注射液获澳大利亚上市许可
news flash· 2025-05-19 09:28
Core Viewpoint - The company *ST Shuangcheng (002693)* has received marketing approval for Eptifibatide injection from the Australian Therapeutic Goods Administration, which is expected to enhance its overseas market expansion and improve performance [1] Group 1: Product Approval - Eptifibatide injection is indicated for patients undergoing non-emergency percutaneous coronary intervention and coronary artery stenting, as well as for treating unstable angina or non-Q-wave myocardial infarction [1] - The product has already received marketing approval from the US FDA and is widely sold globally [1] Group 2: Market Impact - The approval in Australia will assist the company in expanding its overseas market presence [1] - The company cautions that export sales of the drug may be influenced by market demand, policy environment, exchange rates, and market competition, indicating potential uncertainties [1]
海南双成药业股份有限公司关于参加“2024 年度海南辖区上市公司业绩 说明会暨投资者集体接待日”的公告
Group 1 - The company will participate in the "2024 Annual Performance Briefing and Investor Reception Day" on May 13, 2025, to enhance communication with investors regarding its annual report and other key topics [1] - The company has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia for its injectable drug Bivalirudin, which is indicated as an anticoagulant for high-risk acute coronary syndrome patients [3][4] - The injectable Bivalirudin has previously received approvals from various regulatory bodies, including the FDA in the United States and the Saudi Arabian SFDA [5] Group 2 - The company's stock has experienced abnormal trading fluctuations, with a cumulative price deviation exceeding 12% over two consecutive trading days [9] - The company has confirmed that there are no undisclosed significant matters that could affect its stock price, and it has conducted a thorough review of its recent trading activity [10][11] - The company has been placed under a delisting risk warning due to negative financial results, with the lowest of its audited profit total, net profit, and net profit after non-recurring gains and losses being negative, and revenue below 300 million [12]