全球首仿！正大天晴再获“12个月独占期”

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]