Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') announced that the New Drug Application (NDA) for naldemedine tosilate (hereinafter “naldemedine”), a treatment for opioid-induced constipation (OIC), has been accepted in China.

盐野义制药株式会社（总公司：日本大阪；首席执行官：手代木功博士；以下简称“盐野义”）宣布，其用于治疗阿片类药物引起的便秘（OIC）的新药纳尔地美定甲苯磺酸盐（以下简称“纳尔地美定”）的新药申请（NDA）已在中国获得受理。

Naldemedine is a peripherally acting μ-opioid receptor antagonist (PAMORA) originally developed by our company. It has been launched in countries and regions such as Japan, the United States, Europe, and Taiwan, contributing to the improvement of symptoms in many patients suffering from opioid-induced constipation (OIC)..

Naldemedine 是一种外周作用的 μ-阿片受体拮抗剂 (PAMORA)，最初由我们公司开发。它已在日本、美国、欧洲和台湾等国家和地区上市，有助于改善许多患有阿片类药物引起的便秘 (OIC) 的患者的症状。

In cancer pain management, opioid analgesics play a central role; however, their side effects can sometimes make continued treatment difficult. Among these, constipation is a common adverse effect observed in 40–80% of patients using opioid analgesics¹

在癌症疼痛管理中，阿片类止痛药起着核心作用；然而，其副作用有时会使持续治疗变得困难。其中，便秘是使用阿片类止痛药的患者中常见的不良反应，40%-80%的患者会出现这一症状¹。

². It imposes a significant physical burden and greatly affects patients’ quality of life (QOL), making it a major challenge in pain management³

². 它给患者带来了显著的身体负担，并极大地影响了患者的生活质量 (QOL)，成为疼痛管理中的主要挑战³。

⁴. In China, treatment options for OIC are limited, and current approaches mainly involve symptomatic treatments such as dose adjustments of opioids or the use of laxatives⁵. Therefore, there is a strong need for new therapeutic options to achieve better pain management. The approval of naldemedine in China is expected to contribute to improving the QOL of patients suffering from OIC..

⁴. 在中国，OIC的治疗选择有限，目前的方法主要涉及症状治疗，如调整阿片类药物剂量或使用泻药⁵。因此，迫切需要新的治疗选择以实现更好的疼痛管理。Naldemedine在中国的获批有望改善OIC患者的生活质量。

This new drug application is based on favorable results from a Phase III clinical trial⁶ conducted in China targeting patients with OIC. The application was submitted through our group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman and CEO: Tatsumori Yoshida.; hereafter 'SCN'), Following approval, the sales of naldemedine in China will be handled by SCN which has entered into an exclusive license agreement with Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

这项新药申请是基于在中国进行的一项针对OIC患者的III期临床试验的有利结果。申请通过我们的集团公司——上海住友制药中国有限公司（总部：中国上海；董事长兼首席执行官：吉田龙森；以下简称“SCN”）提交。在获得批准后，naldemedine在中国的销售将由SCN负责，该公司已与正大天晴药业集团股份有限公司签订了独家许可协议。

((Head Office: Jiangsu Province, China; CEO: Eric Tse.; hereinafter “CTTQ”) for the import and domestic distribution of the product⁷. CTTQ will be responsible for sales in mainland China, and our company will receive a certain amount of revenue based on sales volume..

（总部：中国江苏省；首席执行官：谢毅；以下简称“CTTQ”）负责该产品在中国的进口和国内分销。CTTQ将负责中国大陆的销售，本公司将根据销售量获得一定收入。

Shionogi has identified “contributing to a healthier and more prosperous life” as a key material issue and is committed to creating a society where everyone can live longer, more vibrant lives in their own way. We will continue to contribute to improving the QOL of patients suffering from various types of pain..

盐野义制药将“助力更健康、更富足的生活”确定为关键的实质性课题，致力于打造一个人人都能以自己的方式活得更长久、更有活力的社会。我们将继续为改善各类疼痛患者的生活质量做出贡献。

About Naldemedine

关于Naldemedine

Naldemedine is a peripherally acting μ-opioid receptor antagonist that binds to μ-opioid receptors in the gastrointestinal tract and counteracts the peripheral effects of opioids, thereby improving OIC. Naldemedine has been approved in countries and regions including Japan, the United States, Europe, and Taiwan.

纳尔地美定是一种外周作用的μ-阿片受体拮抗剂，可与胃肠道中的μ-阿片受体结合，抵消阿片类药物的外周作用，从而改善OIC。纳尔地美定已在包括日本、美国、欧洲和台湾在内的国家和地区获得批准。

It is marketed under the brand name Symproic® in Japan, the United States, and Taiwan, and as Rizmoic® in Europe..

它在日本、美国和台湾以商品名Symproic®销售，在欧洲则以Rizmoic®销售。

About Chia Tai Tianqing (CTTQ)

关于正大天晴（CTTQ）

CTTQ is a subsidiary of China Biopharma and serves as the core pharmaceutical company of the Chia Tai Group in China. It is engaged in the integrated research, development, manufacturing, and sales of pharmaceuticals, with over 14,000 employees. The company offers a wide range of products for infectious diseases, respiratory diseases, cancer, liver diseases, endocrine disorders, and more.

正大天晴是中国生物制药的子公司，也是其在中国的核心制药公司，从事药物的研发、生产与销售，拥有14000多名员工，产品涵盖传染病、呼吸道疾病、癌症、肝病、内分泌失调等。

Over 7,000 academic and sales staff are involved in providing medical information..

超过7000名学术和销售人员参与提供医疗信息。

Overview of the Phase III Clinical Trial in China

中国三期临床试验概述

This Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study conducted in China to evaluate the efficacy and safety of naldemedine in adult patients with opioid-induced constipation (OIC) who were receiving opioid analgesic therapy.

这项 III 期临床试验是一项在中国进行的多中心、随机、双盲、安慰剂对照研究，旨在评估纳尔地美定（naldemedine）在接受阿片类镇痛治疗的成人阿片类药物引起的便秘 (OIC) 患者中的疗效和安全性。

The primary endpoint of the study was the proportion of patients who achieved three or more spontaneous bowel movements (SBMs) per week, along with an increase of at least one SBM per week from baseline.

研究的主要终点是每周达到三次或更多自发性排便（SBMs）的患者比例，同时与基线相比，每周至少增加一次SBM。