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.
About HLX11
HLX11 (anti-HER2 domain II humanised monoclonal antibody injection), a biosimilar candidate of pertuzumab, is independently developed by Henlius, which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2 positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2 positive metastatic or unresectable locally recurrent breast cancer patients. To date, HLX11 has met primary endpoint in a Phase 1 clinical trial, showing similar pharmacokinetic and safety profiles to the reference drugs from different sources.
About HLX14
HLX14 (recombinant anti-RANKL human monoclonal antibody injection), a biosimilar candidate of denosumab, is independently developed by Henlius. Denosumab has been approved worldwide for a range of indications such as for the treatment of postmenopausal women with osteoporosis at high risk for fracture, giant cell tumor of bone, skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, etc.
About HLX13
HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection), a biosimilar candidate of ipilimumab, is independently developed by Henlius. Ipilimumab is used for the treatment of certain patients with unresectable or metastatic melanoma, as adjuvant treatment of certain patients with cutaneous melanoma, certain patients with Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.