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]

Core Insights - China has approved the injection of Acetate Degarelix (brand name: Qinglishu) developed by Chengda Tianqing Pharmaceutical Group for prostate cancer patients requiring androgen deprivation therapy, providing a new treatment option for over 100,000 patients annually [1][2] - The drug has already been approved in the EU and received temporary approval in the US, marking it as the first generic version globally [1][3] - Chengda Tianqing successfully challenged two core patent claims of the original drug, allowing the product to gain a "12-month exclusivity period" under China's early resolution mechanism for drug patent disputes [1][4] Industry Context - Prostate cancer is the second most common cancer among men globally, with 1.5 million new cases and nearly 400,000 deaths reported in 2022 [2] - In China, the incidence of prostate cancer has been rising, with 134,200 new cases in 2022, often diagnosed at advanced stages due to subtle early symptoms [2] - Acetate Degarelix acts as a GnRH receptor antagonist, reducing the release of gonadotropins and testosterone, and is recommended in major treatment guidelines since its US launch in 2008 [2][3] Product Development - The development of Acetate Degarelix involved overcoming significant technical challenges in formulation and raw material development, with Chengda Tianqing achieving compliance with US and EU standards [3] - The product's current prices under medical insurance are 2,046 yuan (for 120mg, 2 vials) and 750 yuan (for 80mg, 1 vial), which is expected to provide a more affordable option for patients compared to the original drug [3][4] Patent Challenge and Market Impact - The drug is the second to receive a "12-month exclusivity period" under China's drug patent linkage system, which aims to balance the interests of innovative and generic drug companies [4][5] - Chengda Tianqing's successful patent challenges are expected to enhance market competition and significantly reduce patient costs, as seen with their previous product, Everolimus tablets, which were priced over 500 yuan lower than the original [5]