Shanghai Pharma secures US FDA approval for Ticagrelor, expands domestic portfolio

Shanghai Pharmaceuticals Holding Co., Ltd. announced its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., received United States FDA final approval for Ticagrelor Tablets (60mg, 90mg) via an Abbreviated New Drug Application (ANDA). This drug, originally developed by AstraZeneca, is used to reduce thrombotic cardiovascular events in patients with acute coronary syndrome. Shanghai Pharmaceuticals invested approximately RMB 9.6713m in research and development for Ticagrelor Tablets. The US market for original and generic versions of this drug saw sales of approximately $1.284bn in 2024.

Concurrently, the company's subsidiary, Shanghai Pharmaceutical Xixi Pharmaceutical Co., Ltd., obtained a drug registration certificate from the National Medical Products Administration for Tofacitinib Extended-Release Tablets (11mg). This drug, originally developed by Pfizer, is approved for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The company invested approximately RMB 19.4192m in R&D for this product, which will expand its market share and enhance competitiveness in the domestic market, where 2024 hospital procurement amounted to RMB 54.0499m.

Additionally, Shanghai Pharmaceuticals' board of directors approved a proposal to abolish the Board of Supervisors and revise the Articles of Association, transferring supervisory functions to the board’s Audit Committee. This governance restructuring aligns with various legal and regulatory requirements.