SHANGHAI, China & JERSEY CITY, N.J. - Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE:OGN) have announced the validation of their marketing authorization applications for HLX14, a biosimilar to denosumab, by the European Medicines Agency (EMA). Denosumab is utilized for conditions including osteoporosis in postmenopausal women at high risk for fracture.
The applications for HLX14, which is under investigation as a biosimilar to the medications Prolia® and Xgeva®, are supported by a phase 3 clinical study. This study was a randomized, double-blind, international multicenter, parallel-controlled trial comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab in postmenopausal women with osteoporosis.
The partnership between Henlius and Organon was established in 2022 when Henlius granted Organon exclusive rights to commercialize two biosimilar candidates, including HLX14, in markets such as the European Union, the United States, and Canada, except China.
Henlius is a global biopharmaceutical company focused on offering affordable and innovative biologic medicines, particularly in oncology, autoimmune, and ophthalmic diseases. The company has launched five products in China, received approval for two in overseas markets, and has 23 indications approved worldwide.
Organon, a global healthcare company, is dedicated to improving women's health throughout their lives. It has a diverse product portfolio with a strong presence in women's health, a growing biosimilars business, and a range of established medicines across various therapeutic areas.
The submission of these marketing authorization applications represents a significant step in making biosimilar treatments available to patients in Europe and aligns with Henlius and Organon's commitment to enhancing patient access to high-quality biologic medicines.
This news is based on a press release statement.
InvestingPro Insights
Amidst the promising developments in the healthcare sector with Henlius and Organon's collaboration, investors are closely monitoring Organon's financial metrics and market performance. Organon (NYSE:OGN) has demonstrated a strong financial posture with a Market Cap of approximately $5.49 billion USD. The company's commitment to delivering value is also reflected in its attractive P/E Ratio, which currently stands at a modest 5.23, indicating that the stock may be undervalued relative to its near-term earnings growth.
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