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上海医药:替格瑞洛片的 ANDA 获得美国 FDA 批准
Zhi Tong Cai Jing· 2025-11-06 10:49
Group 1 - The core point of the article is that Changzhou Pharmaceutical Factory has received final approval from the FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which is significant for expanding the company's overseas market presence [1][2] - The drug Ticagrelor is used for patients with acute coronary syndrome to reduce the incidence of thrombotic cardiovascular events and was originally developed by AstraZeneca, launched in the U.S. in 2011 [1] - The company has invested approximately RMB 9.6713 million in research and development for this drug as of the announcement date [1]
上海医药:多西环素胶囊的简略新药申请获美国FDA批准
Zhong Zheng Wang· 2025-10-15 03:42
Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for doxycycline capsules, marking a significant step in expanding its overseas market presence [1] Summary by Categories Company Developments - The company has invested approximately 10.83 million yuan in the research and development of doxycycline capsules as of the announcement date [1] - The approval of the ANDA is expected to provide valuable experience for the company in navigating international markets [1] Market Implications - The approval is seen as a positive development for the company, enhancing its ability to expand into overseas markets [1]
上海医药集团股份有限公司
Shang Hai Zheng Quan Bao· 2025-05-20 20:26
Group 1 - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for Rivaroxaban tablets [1] - Rivaroxaban is indicated for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1][2] - The company has invested approximately RMB 8.2 million in the research and development of Rivaroxaban [1] Group 2 - The market for Rivaroxaban in the U.S. generated approximately $8.13 billion in sales in 2023, with projected sales of about $6.33 billion for the first three quarters of 2024 [2] - Competitors in the U.S. market for Rivaroxaban include Janssen Pharmaceuticals and several generic manufacturers [2] Group 3 - The FDA has also approved the ANDA for Mometasone Furoate nasal spray by Zhejiang Xinyi Ruijue Pharmaceutical [4] - Mometasone Furoate is used for the prevention and treatment of seasonal allergic rhinitis in adolescents and adults, as well as for chronic sinusitis with nasal polyps in adults [5] - The nasal spray generated approximately $43.7 million in sales in the U.S. in 2023, with projected sales of about $33.45 million for the first three quarters of 2024 [5]