正大天晴新药晴立舒获批上市

Core Insights - The National Medical Products Administration of China has approved the injection of Acetate Degarelix (trademarked as Qinglishu) developed by Chengdu Tianqing Pharmaceutical, which is used for androgen deprivation therapy in prostate cancer patients [2] - Chengdu Tianqing's Acetate Degarelix has previously been approved in the EU and is the first generic drug globally, with temporary approval in the US [2] - The company successfully challenged two core patent claims of the original drug during the domestic application review process, allowing the product to gain a "12-month exclusivity period" under China's early resolution mechanism for drug patent disputes [2] Industry Mechanism - The early resolution mechanism for drug patent disputes, also known as the drug patent linkage system, aims to balance the interests of innovative drug companies and generic drug manufacturers, promoting the early market entry of generics while protecting drug innovation [2] - This mechanism encourages healthy competition in the industry and allows patients to access more affordable generic drugs sooner [2] - Chengdu Tianqing's successful patent challenges were supported by the Beijing Intellectual Property Court, demonstrating the effectiveness of this system in facilitating market competition [2]