中国接受了对一种新的前列腺癌症成像剂的药物申请,这已在几个国家得到批准,表明在检测肿瘤方面非常精确。 China accepted a drug application for a new prostate cancer imaging agent, already approved in several countries, showing high accuracy in detecting tumors.

中国国家医疗产品管理局已接受Illuccix(TLX591-Px)的新药物应用,这是Telix制药公司研制的前列腺癌症成像剂,标志着中国朝着可能获得批准迈出的关键一步。 The Chinese National Medical Products Administration has accepted a New Drug Application for Illuccix (TLX591-Px), a prostate cancer imaging agent developed by Telix Pharmaceuticals, marking a key step toward potential approval in China. 该申请是与Grand制药集团伙伴一起提交的,基于在中国进行的第3阶段研究,该研究显示,在发现有生化复发症的男子的肿瘤方面,即使在低PSA水平上,预测值为94.8%。 The application, submitted with partner Grand Pharmaceutical Group, is based on a Phase 3 study in China showing a 94.8% positive predictive value for detecting tumors in men with biochemical recurrence, even at low PSA levels. 超过三分之二的病人的治疗计划根据成像结果进行了修改。 Over two-thirds of patients had treatment plans changed based on imaging results. 该药物已经在美国、澳大利亚、加拿大、联合王国、巴西和19个欧洲国家得到批准,可以改善中国的前列腺癌诊断和管理,中国的前列腺癌病例每年超过134 000例,并正在上升。 The drug, already approved in the U.S., Australia, Canada, the UK, Brazil, and 19 European countries, could improve prostate cancer diagnosis and management in China, where cases exceed 134,000 annually and are rising.