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EMA accepts HLX14 application from Henlius and Organon

Published 2024-05-24, 12:38 p/m
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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.

Organon's financial resilience is further underscored by its robust Revenue Growth, with a quarterly increase of 5.46% as of Q1 2024, showcasing the company's ability to expand its revenue streams effectively. Additionally, the company's Dividend Yield of 5.25% as of the last dividend ex-date on May 10, 2024, highlights Organon's commitment to returning value to shareholders, which is a key consideration for income-focused investors.

Among the various InvestingPro Tips for Organon, two particularly stand out. First, the company's valuation implies a strong free cash flow yield, which can be a signal of financial health and the potential for future investment or dividend increases. Second, Organon pays a significant dividend to shareholders, reinforcing the company's investor-friendly approach and stability in delivering returns.

For investors seeking more in-depth analysis and additional tips on Organon, there are 9 more InvestingPro Tips available, which can be accessed through the InvestingPro platform. To help investors leverage these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. This exclusive offer is designed to empower investors with comprehensive data and expert analysis to make informed decisions in the dynamic healthcare sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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