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]

中国每年逾10万的前列腺癌患者将迎来新的治疗选择。日前，国家药监局官网显示，中国生物制药 （01177.HK）旗下核心企业正大天晴药业集团自主研发的注射用醋酸地加瑞克（商标名：晴立舒）获 批上市，用于需接受雄激素去势治疗的前列腺癌患者。值得注意的是，正大天晴醋酸地加瑞克此前已在 欧盟市场获批，成为全球首仿，并在美国获得暂时批准。此次在国内申报审评过程中，正大天晴还同步 发起专利挑战，成功宣告原研药2项核心权利要求无效，该产品也成为我国药品专利纠纷早期解决机制 实施以来，又一获得"12个月独占期"的药品。 中美欧三地造福前列腺癌患者 前列腺癌是全球男性第二大常见癌症，也是2022 年男性癌症死亡的第五大原因。国际癌症研究机构发 布的数据显示，2022年，全球有150万前列腺癌新发病例和近40 万死亡病例。在世界上几乎 2/3 的国家 中，前列腺癌是男性最常被诊断的癌症。 中国前列腺癌的发病率近年呈现明显的增长态势，2022年新发病例达13.42万人。由于早期症状不明 显，不少患者确诊时已经是晚期，且发病率随年龄增长而升高。也因如此，前列腺癌又被称为男性健康 的"沉默杀手""退休癌"。 药品专利纠纷早期解决机制， ...