Orphalan announces China NMPA’s approval of its trientine tetrahydrochloride product for the treatment of Wilson disease Paris, France 18 January, 2024 - Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialization company, today announces the approval of its trientine tetrahydrochloride product by China's National Medical Products Administration (NMPA).

Orphalan宣布中国NMPA批准其用于治疗威尔逊病的四氯化三烯汀产品，法国巴黎，2024年1月18日-Orphalan SA（“Orphalan”或“该公司”），一家国际孤儿药开发和商业化公司，今天宣布，中国国家医药产品管理局（NMPA）批准其四氯化三烯汀产品。

This product, already marketed as Cuprior® in the EU, the UK, Saudi Arabia, Switzerland, and Colombia, and as Cuvrior® in the US, represents the first trientine approved by the NMPA. It offers a new treatment option for Wilson disease in children aged five years and older and adults intolerant to penicillamine therapy.

该产品已在欧盟，英国，沙特阿拉伯，瑞士和哥伦比亚以Cuprior®的形式销售，在美国以Cuvrior®的形式销售，是NMPA批准的第一个三烯类药物。它为五岁及以上的儿童和不耐受青霉胺治疗的成年人提供了威尔逊病的新治疗选择。

China is home to an estimated 80,000 individuals with Wilson disease, of whom approximately half have their diagnosis confirmed, and 25,000 are receiving regular treatment. The introduction of new treatment alternatives such as Orphalan’s trientine tetrahydrochloride, particularly for patients who are intolerant to currently available therapies, presents a significant opportunity to meet the needs of a broader segment of the Wilson disease population in China.

据估计，中国有80000名威尔逊病患者，其中约一半已确诊，25000人正在接受常规治疗。引入新的治疗替代品，例如奥法兰的三烯四盐酸盐，特别是对目前可用疗法不耐受的患者，为满足中国更广泛的威尔逊病人群的需求提供了重要机会。

Orphalan anticipates its product to be available in the country in the coming months. Dr Naseem Amin, Chief Executive Officer at Orphalan, said: “We are pleased with the marketing authorisation approval of our trientine tetrahydrochloride product in China, which offers a well-tolerated and effective treatment option for patients with Wilson disease.

Orphalan预计其产品将在未来几个月在国内上市。Orphalan首席执行官Naseem Amin博士表示：“我们很高兴我们的三烯四盐酸盐产品在中国获得上市许可，这为威尔逊病患者提供了一种耐受性良好且有效的治疗选择。

This approval is a crucial step towards providing a much-needed treatment option for the Wilson disease community in China and reaffirms our commitment to improving the experience for patients living with rare diseases worldwide.” Yan Qin, Director of Wuhan T.

这一批准是向中国威尔逊病社区提供急需的治疗选择迈出的关键一步，并重申了我们致力于改善全球罕见疾病患者的体验。”严勤，武汉T。