EMA Validates Henlius and Organon Filings for Denosumab Biosimilar HLX14

Shanghai Henlius Biotech, Inc. and Organon have announced the validation of marketing authorization applications (MAAs) by the European Medicines Agency (EMA) for HLX14, a biosimilar to Prolia® and Xgeva® (denosumab). Denosumab is an approved medication in various global regions for conditions such as osteoporosis in postmenopausal women at high fracture risk. Statistics from 2019 estimate 32 million Europeans aged 50 or above suffer from osteoporosis, with 25.5 million being women.

The applications to the EMA are rooted in a rigorous phase 3 clinical study, which was randomized, double-blind, and conducted internationally across multiple centers. This study aimed to evaluate HLX14 in terms of efficacy, safety, tolerability, and immunogenicity when compared to the EU-sourced reference denosumab (Prolia) in postmenopausal women with a high risk of fractures.

In 2022, Henlius entered a license and supply agreement with Organon, granting the latter exclusive rights to commercialize two biosimilar candidates, including HLX14, in markets such as the European Union, the United States, and Canada, excluding China.

Henlius, listed as 2696.HK, is a global biopharmaceutical company focused on providing high-quality, cost-effective, innovative biologic medicines for patients worldwide, primarily targeting oncology, autoimmune diseases, and ophthalmic conditions. Since its inception in 2010, Henlius has successfully launched five products in China, with two approved for international markets. Furthermore, 23 indications have received global approval, and three marketing applications are under review in China and the EU. Henlius has developed an integrated biopharmaceutical platform encompassing R&D, manufacturing, and commercialization, supported by certified facilities in Shanghai.

Henlius boasts a diverse and high-quality product pipeline of over 50 molecules, exploring immuno-oncology combination therapies with HANSIZHUANG (anti-PD-1 mAb) as a fundamental component. Notable products include HANLIKANG (rituximab), HANQUYOU (trastuzumab for injection, marketed as HERCESSI™ in the U.S. and Zercepac® in Europe), HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab). HANSIZHUANG has received NMPA approval for treating several cancers, making it the first anti-PD-1 mAb approved globally for first-line treatment of small cell lung cancer. Henlius has conducted more than 30 clinical studies for 16 products, expanding its reach in both major and emerging markets.

Organon, headquartered in Jersey City, New Jersey, is a global healthcare company dedicated to enhancing women's health. It offers over 60 medicines and products in women's health, a growing biosimilars business, and a broad range of established medicines across various therapeutic areas. Organon’s existing product portfolio generates significant cash flow, enabling continued investment in innovation and growth, particularly in women’s health and biosimilars. The company seeks collaborations with biopharmaceutical innovators to leverage its commercial capabilities and international market presence.

Organon employs approximately 10,000 staff and maintains a strong global presence. The company focuses on marketing, regulatory compliance, and expanding its reach through strategic collaborations. Organon's development plans are continually subject to risks and uncertainties that could impact their future performance. These factors include regulatory hurdles, market demands, economic conditions, and competition within the pharmaceutical industry.

This summary covers the critical developments regarding the validation of HLX14's MAAs by the EMA, the strategic collaborations between Henlius and Organon, and an overview of both companies' operations and future prospects.