Telix today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label..

Telix今日宣布，其前列腺癌PET[1]影像剂Illuccix®（用于制备镓-68 gozetotide注射液的试剂盒）已获得法国ANSM[2]的上市授权，用于检测和定位前列腺癌成人患者中的前列腺特异性膜抗原（PSMA）阳性病灶，这一适应症范围广泛。

Illuccix, after radiolabelling with gallium-68, is indicated in France for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:

Illuccix在法国被指示用于检测前列腺癌（PCa）成人患者中的前列腺特异性膜抗原（PSMA）阳性病灶，使用镓-68放射标记后结合PET，适用于以下临床情况：

PSMA-PET[3] imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT[4] scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR/biochemical persistence (BCP)[5].

PSMA-PET[3] 成像代表了前列腺癌管理中的重要进步，为临床医生提供了比传统成像方法（骨扫描、CT[4] 扫描）更多的信息，从而在初步诊断和生化复发 (BCR) 后提供了新的护理标准。全球指南认可其在原发疾病分期和评估 BCR/生化持续性 (BCP)[5] 方面的优越准确性。

Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy..

Illuccix® PSMA-PET 将通过支持及时有效的诊断，以及识别可能受益于 PSMA 靶向治疗的患者，帮助满足重要的临床需求。

Illuccix’s broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. The approval of Illuccix® in France has the potential to resolve access challenges by enabling hospitals and clinics to prepare PSMA-PET scans on-site, offering physicians a quicker, more accessible solution..

Illuccix的广泛批准得到了强有力的临床数据支持，包括来自VISION试验的最大规模基于Ga-68的PSMA数据集[6]。Illuccix®在法国的批准有可能通过使医院和诊所能够现场制备PSMA-PET扫描，为医生提供更快、更便捷的解决方案，从而解决获取方面的挑战。

Professor Frédéric Courbon, Head of the Medical Imaging Department – University Cancer Institute of Toulouse – Oncopole, commented, “PSMA-PET imaging is dramatically changing prostate cancer patient management. Thus, equitable and reliable access to PSMA-PET across France is essential. The approval of Illuccix® in France will address some of the access challenges, and reduce the risk of delayed diagnosis, with a readily available option for effective disease management.”.

图卢兹大学癌症研究所（Oncopole）医学影像科主任弗雷德里克·库尔邦教授评论道：“PSMA-PET成像正在显著改变前列腺癌患者的治疗管理。因此，在全法国范围内实现公平且可靠的PSMA-PET检测至关重要。Illuccix®在法国的获批将解决部分获取途径的问题，降低延迟诊断的风险，并为有效的疾病管理提供一个便捷的选择。”

With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows..

凭借其广泛的适应症和即用型制剂，Illuccix® 旨在帮助医疗保健提供者实现高效可靠的成像。随着对 PSMA-PET 的需求在欧洲持续增长，这一批准进一步凸显了融入现有医院工作流程的解决方案的必要性。

“The approval of Illuccix in France will enable a clinically validated PSMA-PET product to be more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe,” said Raphaël Ortiz, Chief Executive Officer, Telix International..

“法国对Illuccix的批准将使一种经过临床验证的PSMA-PET产品得到更广泛的应用，让医疗服务提供者能够受益于发生器生产的镓带来的便利性和灵活性。这一里程碑进一步巩固了我们持续致力于推进前列腺癌治疗，并扩大欧洲创新诊断技术获取渠道的承诺，”Telix国际首席执行官拉斐尔·奥尔蒂斯表示。

Telix will partner with IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), a leading provider of radioisotopes and radiopharmaceuticals for nuclear medicine, for the marketing and promotion of Illuccix® to healthcare professionals in France.

Telix将与IRE ELiT S.A.（IRE集团的放射性药物子公司）合作，该公司是核医学领域领先的放射性同位素和放射性药物供应商，负责在法国向医疗保健专业人员推广和宣传Illuccix®。

Jean Bonnet, Head of Strategy, Sales and Marketing, IRE EliT added: “We are pleased to collaborate with Telix and bring our expertise to expanding the availability of Illuccix throughout France. We are committed to ensuring that clinicians have access to reliable PSMA-PET imaging technologies to improve the lives of people living with prostate cancer.”.

IRE EliT战略、销售和营销主管Jean Bonnet补充道：“我们很高兴与Telix合作，将我们的专业知识用于扩大Illuccix在法国的可用性。我们致力于确保临床医生能够获得可靠的PSMA-PET成像技术，以改善前列腺癌患者的生活。”

French healthcare professionals interested in ordering Illuccix® or learning more about availability can contact Eric Rizzo: eric.rizzo@ire-elit.eu

法国医疗保健专业人士如果有兴趣订购Illuccix®或了解更多供应信息，可以联系Eric Rizzo：eric.rizzo@ire-elit.eu

Prostate Cancer in France

法国的前列腺癌

Prostate cancer is the most common cancer in men in France, with over 57,000 new cases diagnosed annually, and a significantly higher incidence in men than either lung cancer (32,800 new cases) or bowel cancer (27,000 new cases). Prostate cancer is also a common cause of cancer death in men, with over 9,200 men dying from their disease in France in 2022[7]..

前列腺癌是法国男性中最常见的癌症，每年诊断出超过57,000个新病例，其发病率显著高于肺癌（32,800个新病例）或肠癌（27,000个新病例）。前列腺癌也是男性癌症死亡的常见原因，2022年在法国有超过9,200名男性死于该疾病[7]。

About Illuccix®

关于Illuccix®

Telix’s prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the French ANSM, and in multiple other European Economic Area (EEA) Member States[12].

Telix的前列腺成像产品，镓-68（68Ga）戈泽妥肽注射液（也称为68Ga PSMA-11，并以Illuccix®品牌上市），已获得美国食品药品监督管理局（FDA）[8]、澳大利亚治疗用品管理局（TGA）[9]、加拿大卫生部[10]、英国药品和健康产品管理局（MHRA）[11]、法国ANSM以及多个其他欧洲经济区（EEA）成员国[12]的批准。

Illuccix® is currently in national approval review across the European Economic Area following a positive decentralized procedure (DCP) opinion by BfArM[13]..

Illuccix® 在欧洲经济区正处于国家批准审查阶段，此前德国联邦药品和医疗器械研究所 (BfArM) 已在分散审批程序 (DCP) 中给出了积极意见。