UCB, a global biopharmaceutical company, today announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for at-home self-administration with infusion pump or a new manual push syringe method for RYSTIGGO

优时比（UCB），一家全球生物制药公司，今日宣布已获得日本医药品医疗器械综合机构 (PMDA) 的批准，允许使用输液泵或新的手动推注注射器方法在家中自行施用 RYSTIGGO。

(rozanolixizumab). With this approval, people living with generalized Myasthenia Gravis (gMG) can now self-administer RYSTIGGO at home using either a manual push or syringe pump method, following training from a healthcare professional.

（rozanolixizumab）。通过此项批准，患有全身性重症肌无力 (gMG) 的患者现在可以在接受医疗专业人员培训后，在家中使用手动推注或注射泵方法自行施用 RYSTIGGO。

Complementing this approval, UCB Japan will launch a home delivery service for RYSTIGGO, including portable syringe pumps, as part of the ONWARD program. ONWARD is a global UCB patient support program designed to assist individuals living with rare diseases like gMG, offering features such as symptom tracking, support by dedicated Care Coordinators for each patient, and 24/7 online tools..

作为这项批准的补充，优时比日本公司将推出RYSTIGGO的上门配送服务，包括便携式注射器泵，这是ONWARD计划的一部分。ONWARD是优时比全球患者支持计划，旨在帮助像gMG这样的罕见病患者，提供症状追踪、为每位患者配备专门的护理协调员以及全天候在线工具等功能。

'For people living with gMG, unpredictable symptoms can significantly impact daily life, leading to feelings of vulnerability and loss of control. Subcutaneous self-administration can help address these challenges, providing better control over treatment schedules and enhancing autonomy and satisfaction,' said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs.

“对于患有gMG的人来说，不可预测的症状可能会显著影响日常生活，导致脆弱感和失控感。皮下自我给药可以帮助应对这些挑战，更好地控制治疗时间表，增强自主性和满意度，”首席医疗官兼全球医学事务主管唐纳泰罗·克罗切塔表示。

'We are delighted to achieve this approval in Japan and the roll out of the ONWARD home delivery service, which together provide personalized support and reduce the treatment burden for those affected by gMG.'.

“我们很高兴在日本获得这项批准并推出ONWARD家庭递送服务，这两者共同为受gMG影响的患者提供个性化支持并减轻治疗负担。”

RYSTIGGO was approved for the treatment of generalized myasthenia gravis gMG in adult patients (only for patients who are not adequately responsive to steroids or nonsteroidal immunosuppressants) in Japan in September 2023.

2023年9月，RYSTIGGO在日本被批准用于治疗全身性重症肌无力（gMG）成年患者（仅适用于对类固醇或非类固醇免疫抑制剂反应不足的患者）。

About ONWARD™

关于ONWARD™

ONWARD is a personalized support experience built to help people through every step of their prescribed UCB treatment. A key component of ONWARD program is being assigned your own dedicated Care Coordinator who provides tailored support based on an individual’s unique needs. The program is not intended for diagnosis, treatment, or equivalent medical acts.

ONWARD 是一项个性化的支持体验，旨在帮助人们完成他们规定的 UCB 治疗的每一步。ONWARD 项目的一个关键组成部分是为您分配专属的护理协调员，根据个人的独特需求提供定制的支持。该计划不适用于诊断、治疗或等效的医疗行为。

Registration information is strictly managed by our subcontractors, and UCB does not have access to personally identifiable information..

注册信息由我们的分包商严格管理，UCB无法访问个人可识别信息。

About RYSTIGGO

关于RYSTIGGO

▼ (rozanolixizumab) in the EU

▼ （rozanolixizumab）在欧盟

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

该药品受到额外监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

RYSTIGGO binds specifically to the fetal Fc receptor (FcRn) with high affinity, inhibiting the interaction between FcRn and immunoglobulin G (IgG), promoting the catabolism of antibodies, and reducing the blood concentration of IgG, including pathogenic IgG autoantibodies.

RYSTIGGO 能高亲和力地特异性结合胎儿 Fc 受体 (FcRn)，抑制 FcRn 与免疫球蛋白 G (IgG) 的相互作用，促进抗体的分解代谢，并降低包括致病性 IgG 自身抗体在内的 IgG 血液浓度。

In the Phase 3 global joint trial MycarinG trial, which included Japanese adult patients with gMG, RYSTIGGO showed a statistically significant reduction from baseline in the MG-ADL total score at 43 days compared to the placebo group (p<0.001).

在包含日本成人gMG患者的III期全球联合试验MycarinG试验中，与安慰剂组相比，RYSTIGGO在第43天时MG-ADL总分较基线有统计学显著下降（p<0.001）。

It was designated as an orphan drug by the Ministry of Health, Labour and Welfare in November 2020.

它在2020年11月被厚生劳动省指定为孤儿药。

About Generalized Myasthenia Gravis (gMG)

关于全身型重症肌无力 (gMG)

gMG is a rare, chronic autoimmune disease characterized by dysfunction and damage at the neuromuscular junction. It is associated with complement, immune cells, and pathogenic IgG autoantibodies. gMG patients have various symptoms such as ptosis, diplopia, dysphagia, difficulty chewing, difficulty speaking, and severe muscle weakness that can lead to life-threatening respiratory muscle weakness..

gMG是一种罕见的慢性自身免疫性疾病，其特征是神经肌肉接头处的功能障碍和损伤。它与补体、免疫细胞和致病性IgG自身抗体相关。gMG患者有多种症状，如上睑下垂、复视、吞咽困难、咀嚼困难、说话困难以及可能导致危及生命的呼吸肌无力的严重肌肉无力。

The prevalence of MG is estimated to be 100 to 350 per million people worldwide, with 29,210 patients in Japan*.

据估计，MG的全球患病率为每百万人中有100至350人，日本有29,210名患者*。

* This Japanese study sent survey sheets to the randomly selected medical departments (n=7,545). The study first asked for the number of MG patients who visited medical departments from January 1, 2017, to December 31, 2017. Then, the study sent the second survey sheet to the medical departments that answered the first survey to obtain the clinical information of patients who received MG diagnosis between January 1, 2015, and December 31, 2017..

* 这项日本研究向随机选择的医学部门（n=7,545）发送了调查表。研究首先询问了2017年1月1日至2017年12月31日期间到医学部门就诊的重症肌无力（MG）患者人数。然后，研究向回答了第一份调查的医学部门发送了第二份调查表，以获取2015年1月1日至2017年12月31日期间确诊为MG的患者的临床信息。

RYSTIGGO▼ (rozanolixizumab) EU/EEA* Important Safety Information

RYSTIGGO▼ (rozanolixizumab) 欧盟/欧洲经济区* 重要安全信息

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 6.1 billion in 2024.

优时比公司（UCB），位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物及解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有9000多名员工，并在2024年实现了61亿欧元的收入。