First Shipment of Henlius Trastuzumab to U.S.

• HANQUYOU shipped to the United States, offering high-quality, affordable treatment options to North American patients -
• Henlius' first product exported to the U.S., enabling commercial supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia -
• HANQUYOU approved in 50 countries and regions, benefiting over 220,000 patients - 

SHANGHAI, Dec. 2, 2024 /PRNewswire/ -- On November 29, 2024, Henlius' independently developed and produced trastuzumab biosimilar, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac^® in Europe), departed from Henlius' Songjiang First Plant, heading to the U.S. This milestone marks the company's first commercial supply to North America, representing a significant breakthrough in its global expansion. With this achievement, Henlius has successfully extended its commercial supply network to include China, Europe, Latin America, the Middle East, North America and Southeast Asia.

Ms. Wei Huang, President of Henlius, stated that, "The U.S., as the world's largest biopharmaceutical market, imposes stringent requirements on drug supply systems and the comprehensive strengths of companies. The successful entry of HANQUYOU into the U.S. market not only expands our international footprint but also lays a solid foundation for the globalization of our other products. Since the commercial launch of HANQUYOU in 2020, we have successfully shipped approximately 6.5 million units globally, continuously enhancing our production and supply capabilities in our relentless effort to benefit more patients."

Dr. Frank Ye, Vice President and Chief Quality Officer, stated that, "High quality is the key to establishing a firm foothold on the global stage, earning customer trust, and enabling products to succeed in international markets. More importantly, it serves as the solid foundation for us to benefit more patients worldwide as medicine quality directly impacts patient lives. At Henlius, we remain committed to upholding the highest international standards of quality, delivering high-quality biologics to even more patients."

HANQUYOU is a China-developed mAb biosimilar approved in China, the European Union (EU) and U.S. It is now approved in 50 countries and regions including the U.S., United Kingdom (UK), Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. To date, HANQUYOU has benefited over 220,000 patients with HER2 positive breast and gastric cancer worldwide.

HANQUYOU's extensive global reach is a testament to Henlius' relentless pursuit of excellence in product quality. Henlius has established a quality management system that meets international standards. Its three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by regulatory agencies and international business partners across various countries. The company has been GMP-certified by China, the U.S., the EU as well as PIC/S member countries such as Indonesia and Brazil, equipped with a solid foundation for the global supply of its products.

The successful U.S. launch of HANQUYOU also dates from Henlius' exclusive partnership with Intas and its subsidiary, Accord. In collaboration with leading global biopharmaceutical companies such as Accord, Abbott, Eurofarma, and KGbio, Henlius has proactively established a global commercial layout for HANQUYOU. Looking ahead, Henlius will continue to strengthen its collaborations with global partners to accelerate the global launch of more high-quality medicines, benefiting more patients worldwide.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

SOURCE Henlius