Henlius Enters Middle East with Trastuzumab® Biosimilar

Henlius, a prominent Chinese biopharmaceutical company, has achieved a significant milestone by shipping its self-developed biosimilar drug, Trastuzumab® (Hanquyou), to Saudi Arabia from its Xuhui production base. This event marks the first commercial supply of the company's product to the Middle East North Africa (MENA) region. Consequently, Trastuzumab® will be the pioneering monoclonal antibody biosimilar of Chinese origin to enter the Middle Eastern market.

This accomplishment stems from Henlius' exclusive commercial partnership with international affiliates Intas and its subsidiary Accord. This collaboration spans various markets including Europe, North America, parts of the Middle East and North Africa, and some CIS countries. Trastuzumab® is known under different commercial names globally: HERCESSITM in the United States and Zercepac® in Europe. It is a biosimilar to the reference drug Herceptin® and has garnered approval and been launched in over 40 countries and regions, covering Asia, Europe, Latin America, North America, and Oceania.

The Xuhui production base of Henlius, which is the first in China to receive both Chinese and European GMP certifications for the manufacture of self-developed antibody biologics, facilitated the shipment of Trastuzumab® to the Middle East. This facility, along with its quality management system, has successfully undergone rigorous audits and inspections by multiple regulatory bodies. These include China’s NMPA, the European EMA, Indonesia’s BPOM, Brazil’s ANVISA, and several of Henlius' global business partners.

Henlius' successful entry into the Middle Eastern market underscores its ongoing efforts to expand the global commercialization of Trastuzumab® and other products. The company collaborates with leading biopharmaceutical organizations such as Accord, Abbott, Eurofarma, Elea, and KGbio, aiming to serve patients in approximately 100 countries worldwide.