Chinese Biopharmaceutical CompanyHenlius Expands to Middle East Market with Launch of Biosimilar Drug Trastuzumab®

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.