Henlius Achieves Major Milestone with First Shipment of Hanquyou Biosimilar to the U.S.

On November 29, 2024, Henlius successfully sent its independently developed trastuzumab biosimilar, Hanquyou, also known as HERCESSI™ in the United States, to North America. This event represents a critical development in Henlius's international expansion and is the company's first product launch in the U.S. as they offer high-quality and cost-effective treatment options for patients battling breast and gastric cancers.

In an elaborate strategy, Henlius has established a commercial supply network that extends well beyond the United States, integrating regions such as Europe, Latin America, the Middle East, and Southeast Asia. With approvals in over 50 countries and regions, including major markets like China, Canada, UK, and Germany, Hanquyou is already showing its significant impact on the global healthcare landscape, having assisted more than 220,000 patients thus far.

The shipment marks a vital step in Henlius's ambition to enrich its international footprint. Henlius President, Ms. Wei Huang, emphasized the rigorous standards set by the U.S. biopharmaceutical market, mentioning that the approval and entry of Hanquyou signify not just a regulatory success but also lays a solid foundation for other products aiming to enter the rigorous U.S. market. Since the launch of Hanquyou in 2020, the company has reportedly shipped around 6.5 million units globally, continuously improving its manufacturing and supply capabilities to meet patient needs effectively.

Dr. Frank Ye, Vice President and Chief Quality Officer, highlighted the importance of quality in establishing Henlius’s credibility on the world stage, ensuring that only high-quality medicines reach the patients who need them the most. This commitment underscores the company's mission to enhance healthcare outcomes globally while maintaining stringent international quality standards established through comprehensive management systems across their multiple production facilities.

Notably, Hanquyou has passed through various rigorous inspections and audits conducted by health authorities and key stakeholders across countries, gaining GMP (Good Manufacturing Practices) certification from various regulatory agencies, including those in China, the U.S., and the EU. This accomplishment ensures that Henlius is well-prepared for the intense scrutiny of the global supply chain.

Henlius has developed strong collaboration frameworks with leading biopharmaceutical companies such as Intas and its subsidiary, Accord, as well as others like Abbott, Eurofarma, and KGbio. These partnerships are crucial for accelerating the global launch of Hanquyou. The collaborative efforts are seen as a vital element in optimizing the launch timelines for other high-quality biopharmaceuticals to benefit even larger populations.

With a firm commitment to research and development, Henlius is not just focused on Hanquyou. The company has launched six additional products in China and is working on options for expanding its product pipeline, comprising over 50 molecules focusing on oncology, autoimmune diseases, and more. Their innovative approach encapsulates the essence of fostering a strong pipeline and broadening treatment horizons for patients globally.

In conclusion, Henlius's inaugural shipment of Hanquyou to the U.S. marks a significant turning point for the company and the patients it aims to support. As they continue to evolve in the biopharmaceutical landscape, Henlius is positioned to be a key player in providing accessible, innovative drug therapies worldwide.