Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-06 23:14Group 1: Approval of New Drugs - Shanghai Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which are indicated for patients with acute coronary syndrome [1][2] - The drug is available in dosages of 60mg and 90mg, and the original drug was developed by AstraZeneca and launched in the U.S. in 2011 [1][6] - The company has invested approximately RMB 9.67 million in the research and development of this drug [1] Group 2: Market Competition - As of the announcement date, there are already generic versions of Ticagrelor available in the U.S. from companies such as Apotex Inc., Alembic Pharmaceuticals Ltd, and Mylan Pharmaceuticals Inc. [2] - According to IMS data, the combined sales of the original and generic versions of the drug in the U.S. are projected to be approximately $1.284 billion in 2024 [3] Group 3: Impact on Company - The approval of Ticagrelor tablets is expected to positively impact Shanghai Pharmaceuticals' efforts to expand into overseas markets and accumulate valuable experience [4] - The company has also received approval for the production of Tofacitinib citrate extended-release tablets, which are used to treat rheumatoid arthritis and other conditions [7][8] - The company has invested approximately RMB 19.42 million in the research and development of Tofacitinib citrate extended-release tablets [8] Group 4: Regulatory Changes - The company plans to cancel its supervisory board and amend its articles of association to enhance corporate governance, with the audit committee of the board taking over the supervisory functions [13][23] - This decision is in line with regulatory requirements and aims to improve the company's governance structure [13][24]