Henlius and Organon Enter into a License and Supply Agreement for Henlius’ Two Biologics in ex-China Countries

Shanghai, China, June 13, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license and supply agreement with Organon LLC (“Organon”) for the exclusive commercialization of Henlius’ independently developed HLX11 (a pertuzumab biosimilar candidate) and HLX14 (a denosumab biosimilar candidate) in ex-China countries, covering mature markets such as the United States, the European Union and Japan, as well as a number of emerging markets.

Under the agreement terms, Henlius may receive up to a total of $541 million, including a $73 million upfront payment. Organon also has an option to negotiate an exclusive license for global commercialization rights for HLX13, an ipilimumab biosimilar candidate developed by Henlius. Organon, a global healthcare company, focuses on improving the health of women throughout their lives, with a presence in more than 140 countries and more than 60 products across its Women's Health, Biosimilars, and Established Brands portfolios. This collaboration will further boost the accessibility and influence of Henlius' products in the global market and bring hope to more patients.

Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, “We are excited to partner with Organon. Organon’s R&D philosophy is to build a business around patient needs and to advance healthcare options for women, which is in line with our mission of 'offering high-quality, affordable and innovative biologics for patients worldwide'. Going forward, Henlius will continue to develop more products based on clinical and market needs, benefiting more patients worldwide.”

Rooted in unmet clinical needs, Henlius has been actively promoting internationalization and accelerating the pace of its international operations. Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. Synergising its innovation centres in China and the US and global product development teams, the company continues the momentum for a diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. It has a total commercial manufacturing capacity of 48,000L currently, and all the products in the pipeline are produced in-house, accumulating rich production experience from clinical stages to commercialized products. In addition, Henlius has built a top in-house commercial team of over 800 employees for the commercialization of the company's core products and expanded the company’s presence in major and emerging markets by partnering with reputable global pharmaceutical companies.