Chinese Biopharmaceutical CompanyHenlius Expands to Middle East Market with Launch of Biosimilar Drug Trastuzumab®
2024-06-07
In a significant milestone, the Chinese biopharmaceutical company Henlius (Henlius) has announced the shipment of its self-developed and manufactured biosimilar drug Trastuzumab® (Hanquyou) from its Xuhui production base to Saudi Arabia. This marks the first time the company has commercially supplied its product to the Middle East North Africa (MENA) region, positioning Trastuzumab® to become the first Chinese-origin monoclonal antibody biosimilar to enter the Middle Eastern market.
The achievement is the result of Henlius' exclusive commercial collaboration with its international partners Intas and its subsidiary Accord, which covers markets in Europe, North America, parts of the Middle East and North Africa, as well as some CIS countries. Trastuzumab® (marketed as HERCESSITM in the US and Zercepac® in Europe) is a biosimilar to the reference product Herceptin®, and has already been approved and launched in over 40 countries and regions across Asia, Europe, Latin America, North America, and Oceania.
Henlius' Xuhui production base, which is the first facility in China to obtain both Chinese and European GMP certifications for the manufacture of self-developed antibody biologics, has been the site for the Trastuzumab® shipment to the Middle East. This production site and its quality management system have undergone extensive audits and inspections by various regulatory bodies, including China's NMPA, the European EMA, Indonesia's BPOM, Brazil's ANVISA, as well as Henlius' international business partners.
With the successful entry into the Middle Eastern market, Henlius continues to expand the global commercialization of Trastuzumab® and its other products, collaborating with leading biopharmaceutical companies such as Accord, Abbott, Eurofarma, Elea, and KGbio to serve patients across approximately 100 countries worldwide.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
适应症
-靶点
-来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。