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通化东宝出海迎新进展,利拉鲁肽获巴西GMP证书
Quan Jing Wang· 2026-02-26 12:49
资料显示,2025年巴西人口约2.1亿,拥有庞大且不断增长的糖尿病患者群体,对于GLP-1这类降糖和减 重效果显著的产品,市场需求非常旺盛。 2025年以来,通化东宝国际化战略全面发力,海外收入延续高速增长势头,多款产品斩获国际注册重要 进展,海外产品矩阵与市场布局不断完善。在GLP-1类产品方面,2025年4月产品获得哥伦比亚GMP证 书,同年11月在秘鲁获批上市,此次再获巴西市场突破,标志着公司在拉美市场的系统性布局已见成 效,也为后续进入其他PIC/S成员国奠定基础,提供了有力的资质背书。 2月26日,通化东宝宣布,其与科兴制药携手出海的产品——利拉鲁肽注射液,正式获得 PIC/S(国际 药品认证合作组织)成员国巴西国家卫生监督局(ANVISA)颁发的药品生产质量管理规范(GMP)证 书,此项进展标志着通化东宝利拉鲁肽注射液在拉美核心市场的合规化进程迈入新阶段,也为产品正式 登陆巴西市场筑牢核心资质基础,是公司 GLP-1 类产品国际化布局的又一关键进展。 根据公开信息,利拉鲁肽作为一种人胰高血糖素样肽-1(GLP-1)类似物,可激活人GLP-1受体,促进 胰腺分泌胰岛素,可单独使用或与其他降糖药联合使 ...
速递|GLP-1出海!通化东宝利拉鲁肽注射液秘鲁获批上市
GLP1减重宝典· 2025-11-27 14:44
Core Insights - The article highlights the successful international approval of Liraglutide injection by Tonghua Dongbao Pharmaceutical Co., Ltd. in Peru, marking a significant milestone in the company's global expansion strategy in the GLP-1 product category [4] - Liraglutide, a GLP-1 analog, is recognized for its efficacy in improving blood sugar levels, cardiovascular protection, and weight loss, gaining global acceptance [4] Market Growth and Strategy - The International Diabetes Federation (IDF) projects that the number of adults aged 20-79 with diabetes will reach 589 million in 2024, with a prevalence rate of 11.1%, and is expected to rise to 853 million by 2050, indicating a growing market for diabetes treatments [6] - The company, in collaboration with Sinovac Biotech, is targeting emerging markets with high diabetes prevalence, covering 17 countries across Latin America, the Middle East and North Africa, Southeast Asia, and South Africa [6] Product Development and Internationalization - The company has achieved significant progress in international registrations for multiple products, including Liraglutide and insulin formulations, with approvals in Indonesia, Uzbekistan, and other emerging markets [7] - The internationalization strategy is set to accelerate, aiming to expand overseas sales and provide accessible diabetes treatment options to a broader patient base [7]