- The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the first disease-modifying therapy in autoimmune type 1 diabetes (T1D) indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 T1D. The review was completed under priority review, following the recognition by NMPA of Tzield’s innovative profile and the benefit it brings to pediatric patients..

中国国家药品监督管理局 (NMPA) 批准了 Tzield（替利珠单抗）作为自身免疫型 1 型糖尿病 (T1D) 的首个疾病修饰治疗药物，用于延缓 8 岁及以上 2 期 T1D 成人和儿童患者发展为 3 期 T1D。该审查是在优先审评下完成的，NMPA 认可了 Tzield 的创新特性及其对儿科患者的益处。

The approval is based on the positive results from the TN-10 phase 2 study, which demonstrated Tzield's ability to delay the onset of stage 3 T1D, compared to placebo. The pivotal study demonstrated that a once-daily, single and consecutive 14-day course of Tzield delayed the median onset of stage 3 T1D by 48.4 months vs 24.4 months observed in the placebo group..

该批准基于TN-10二期研究的积极结果，该研究表明，与安慰剂相比，Tzield能够延缓3期1型糖尿病（T1D）的发病。关键性研究显示，每日一次、单次连续14天的Tzield疗程，与安慰剂组观察到的24.4个月相比，将3期T1D的中位发病时间延后了48.4个月。

“This approval represents the beginning of a new era of care for stage 2 type 1 diabetes patients in China, one focused on the potential of Tzield to prevent the natural progression of T1D by its unique beta-cell function preserving capabilities,”

“此次批准代表了中国2型1期糖尿病患者护理新纪元的开始，重点关注Tzield通过其独特的β细胞功能保存能力来预防1型糖尿病自然进展的潜力。”

Olivier Charmeil

奥利维尔·查梅尔

, Executive Vice President, General Medicines, Sanofi.

执行副总裁，普通药物部，赛诺菲。

“Tzield is the first approved advanced therapy that slows down the loss of beta cell function, potentially giving people living with stage 2 T1D more time without the daily treatment burden. We are proud to bring this innovative medicine to China, and we remain committed to working with local stakeholders to advance diabetes care.”.

“Tzield 是首个获批的减缓β细胞功能丧失的先进疗法，可能为患有 2 型糖尿病的患者提供更多免于日常治疗负担的时间。我们很自豪能够将这种创新药物带到中国，并且我们仍将致力于与当地利益相关者合作，推动糖尿病治疗的发展。”

The approval aligns with recent Chinese expert consensus guidelines that recognize the importance of protecting beta-cell function as a pivotal component in the management of autoimmune T1D. These guidelines, published in November 2024, highlighted Tzield’s potential therapeutic value, which has now been validated by this approval, demonstrating Tzield’s relevance in addressing this significant clinical unmet need in the treatment of autoimmune T1D..

该批准与中国最近的专家共识指南保持一致，这些指南认识到保护β细胞功能作为自身免疫性1型糖尿病管理中的关键组成部分的重要性。这些于2024年11月发布的指南强调了Tzield的潜在治疗价值，而这一价值现在已通过此次批准得到了验证，证明了Tzield在应对自身免疫性1型糖尿病治疗中这一重要的临床未满足需求方面的相关性。

Tzield is approved for the treatment of adult and pediatric individuals aged eight years and older, living with stage 2 type 1 diabetes, in the US, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait. Regulatory reviews are ongoing in the EU and other jurisdictions around the world..

Tzield 已在美国、英国、加拿大、以色列、沙特阿拉伯王国、阿拉伯联合酋长国和科威特获得批准，用于治疗八岁及以上患有2期1型糖尿病的成人和儿童患者。欧盟及其他全球司法管辖区的监管审查仍在进行中。

About Tzield

关于Tzield

Tzield (teplizumab) is a CD3-directed monoclonal antibody. Tzield is the first and only disease modifying therapy in autoimmune T1D; it was first approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in China, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication.

Tzield（替利珠单抗）是一种CD3导向的单克隆抗体。Tzield是自身免疫性1型糖尿病（T1D）中首个也是唯一一个疾病修饰疗法；它于2022年11月首次在美国获批，用于延迟被诊断为2期T1D的成人和8岁及以上儿童的3期T1D发病。如今，它也在中国、英国、加拿大、以色列、沙特阿拉伯王国、阿拉伯联合酋长国和科威特获得相同适应症的批准。

Regulatory reviews are ongoing in the EU and other jurisdictions around the world..

欧盟和世界其他地区的监管审查仍在进行中。

About autoimmune T1D

关于自身免疫性1型糖尿病

T1D is a progressive autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. There are four stages to the progression of T1D:

1型糖尿病是一种渐进性的自身免疫疾病，由于自身免疫系统逐渐破坏产生胰岛素的β细胞，身体调节血糖水平的能力受到影响。1型糖尿病的进展分为四个阶段：

In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic.

在第一阶段，对β细胞的自身免疫攻击已经开始，并且可以通过血液中存在2种或更多1型糖尿病相关的自身抗体来检测。在第一阶段，血糖水平处于正常范围内（正常血糖）。在此阶段，1型糖尿病是无症状的。

In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells/beta cell function.

在阶段2（也是症状前阶段），除了存在两种或多种与1型糖尿病相关的自身抗体外，由于β细胞/β细胞功能的逐渐丧失，血糖水平现在也出现异常（糖代谢异常）。

Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision and generalized fatigue.

第三阶段（也称为临床阶段）发生在大部分β细胞被破坏之后。此时，血糖水平升高到临床高血糖的程度（即定义糖尿病的标准），许多人会开始经历 1 型糖尿病第三阶段发病时的经典症状：口渴加剧、尿频、无法解释的体重减轻、视力模糊和全身疲劳。

Management of stage 3 T1D requires daily and burdensome insulin replacement therapy. .

3期T1D的管理需要每日进行繁重的胰岛素替代治疗。

Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cells remain (it’s been estimated that the beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack..

第四阶段被定义为长期自身免疫性1型糖尿病（T1D），常伴有慢性糖尿病并发症的证据，此时几乎不再有β细胞存留（据估计β细胞量减少了多达95%）。在这一阶段，由于大部分β细胞已被自身免疫攻击摧毁，血液中可能不再存在与1型糖尿病相关的自身抗体。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并创造引人注目的增长。我们凭借对免疫系统的深刻理解，发明能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线使数百万更多的人受益。我们的团队秉承一个使命：追逐科学的奇迹以改善人们的生活；这激励我们推动进步，为我们服务的员工和社区带来积极影响，解决当今最紧迫的医疗、环境和社会挑战。