TOKYO, December 27, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for “LUNSUMIO® for intravenous infusion 1mg” and “LUNSUMIO® for intravenous infusion 30mg” (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 bispecific antibody for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior standard therapies.

2024年12月27日，东京——中外制药有限公司（东京：4519）今天宣布，其已获得卫生、劳动和福利部（MHLW）的监管批准，用于“静脉输注1mg的LUNSUMIO”和“静脉输注30mg的LUNSUMIO”（通用名：mosunetuzumab（基因重组））（以下简称LUNSUMIO），抗肿瘤药物/抗CD20/CD3双特异性抗体，用于治疗复发或难治性（R/R）滤泡性淋巴瘤（FL）患者，这些患者曾接受过两种或更多种标准疗法。

LUNSUMIO is a T-cell engaging bispecific antibody targeting CD20/CD3, offering a new treatment option with high response rates and the potential for durable remission. The treatment duration is set at approximately six months or one year, depending on the patient’s response to treatment..

LUNSUMIO是一种靶向CD20/CD3的T细胞双特异性抗体，提供了一种新的治疗选择，具有高反应率和持久缓解的潜力。根据患者对治疗的反应，治疗持续时间设定为大约六个月或一年。。

“R/R FL is a difficult-to-cure disease that repeatedly relapses, and there is a need for new treatment options. LUNSUMIO is expected to provide durable remission with monotherapy, and with a predetermined treatment duration based on each patient’s response to therapy, which can help reduce the burden of treatment on patients.

“复发性FL是一种难以治愈的疾病，反复复发，因此需要新的治疗选择。LUNSUMIO有望通过单一疗法提供持久缓解，并根据每位患者对治疗的反应确定治疗持续时间，这可以帮助减轻患者的治疗负担。

We are proceeding with preparations for the launch to make this drug available for treatment as soon as possible,” said Dr. Osamu Okuda, Chugai’s President and CEO..

Chugai总裁兼首席执行官OsamuOkuda博士说：“我们正在为上市做准备，以便尽快将这种药物用于治疗。”。。

This approval is based on the results of a Japanese Phase I study with an expansion cohort (FLMOON-1 study) conducted in patients with R/R FL who had received two or more prior standard therapies, as well as an overseas Phase I/II clinical trial conducted by Roche in the same patient population. In both studies, the efficacy and safety of this drug were evaluated as a monotherapy..

该批准基于日本I期研究的结果，该研究对接受过两种或更多种先前标准疗法的R/R FL患者进行了扩展队列研究（FLMOON-1研究），以及罗氏在同一患者群体中进行的海外I/II期临床试验。在这两项研究中，该药物的疗效和安全性均被评估为单一疗法。。

The FLMOON-1 study was conducted on 19 Japanese patients with R/R FL who had previously received two or more prior standard therapies. The complete response rate (CRR), which was the primary endpoint as assessed by an independent review facility (IRF), was 68.4% (90% confidence interval: 47.0-85.3%).

FLMOON-1研究是针对19名日本R/R FL患者进行的，这些患者先前曾接受过两种或两种以上的标准治疗。由独立审查机构（IRF）评估的主要终点完全缓解率（CRR）为68.4%（90%置信区间：47.0-85.3%）。

The most frequent adverse reactions were lymphocyte count decrease, cytokine release syndrome, alanine aminotransferase increase, neutrophil count decrease, aspartate aminotransferase increase, and infusion-related reactions..

最常见的不良反应是淋巴细胞计数减少，细胞因子释放综合征，丙氨酸氨基转移酶增加，中性粒细胞计数减少，天冬氨酸氨基转移酶增加以及输注相关反应。。

The overseas Phase I/II study was conducted on 90 patients with R/R FL who had previously received two or more standard therapies. The primary endpoint, CRR as assessed by an IRF, was 57.8% (95% confidence interval: 46.9-68.1%). The most frequent adverse reactions were cytokine release syndrome, fever, fatigue, pruritus, neutropenia, and hypophosphatemia..

海外I/II期研究对90名先前接受过两种或两种以上标准疗法的R/R FL患者进行。IRF评估的主要终点CRR为57.8%（95%置信区间：46.9-68.1%）。最常见的不良反应是细胞因子释放综合征，发烧，疲劳，瘙痒，中性粒细胞减少和低磷血症。。

About LUNSUMIO LUNSUMIO is a CD20/CD3 T cell-engaging bispecific antibody designed to target CD20 on B cells and CD3 on T cells. LUNSUMIO is expected to activate the immune system through cytotoxic T cells and have antitumor effects on CD20 expressing tumor cells. LUNSUMIO has been approved in 61 countries worldwide.

关于LUNSUMIO LUNSUMIO是一种CD20/CD3 T细胞结合双特异性抗体，旨在靶向B细胞上的CD20和T细胞上的CD3。预计LUNSUMIO会通过细胞毒性T细胞激活免疫系统，并对表达CD20的肿瘤细胞具有抗肿瘤作用。LUNSUMIO已在全球61个国家获得批准。

LUNSUMIO is currently being developed with intravenous and subcutaneous formulations for the treatment of R/R FL and R/R aggressive B-cell non-Hodgkin lymphoma..

LUNSUMIO目前正在开发静脉和皮下制剂，用于治疗R/R FL和R/R侵袭性B细胞非霍奇金淋巴瘤。。

About follicular lymphoma FL is a type of lymphoma that occurs when B lymphocytes, a type of white blood cell, become cancerous. At diagnosis, 70-85% of patients reach an advanced stage1. Generally, the progression is slow, and chemotherapy is initially effective, but recurrences occur repeatedly in many cases.

关于滤泡性淋巴瘤FL是一种淋巴瘤，当B淋巴细胞（一种白细胞）癌变时发生。诊断时，70-85%的患者达到晚期1。一般来说，进展缓慢，化疗最初是有效的，但在许多情况下反复发生复发。