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Osteoporosis Treatment Advances: EMA Validates Marketing Applications for HLX14 Biosimilar

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Biosimilar HLX14 has been validated by the European Medicines Agency (EMA) for marketing authorization applications (MAAs), for osteoporosis in postmenopausal women announced Shanghai Henlius Biotech, Inc. and Organon. HLX14 is an investigational biosimilar to Prolia® and Xgeva® (denosumab). Denosumab is widely used in various countries under different trade names for treating conditions such as osteoporosis in postmenopausal women at high risk for fractures. In 2019, it was estimated that 32 million Europeans aged 50 or above had osteoporosis, with 25.5 million of them being women.

The MAAs for HLX14 were supported by a robust clinical trial program, including a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study. This study aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fractures. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon exclusive commercialization rights to HLX14 and another biosimilar candidate. This agreement covers key markets such as the European Union, the United States, and Canada, with China being an exception.

Henlius (2696.HK) is a global biopharmaceutical company committed to providing high-quality, affordable, and innovative biologic medicines for patients worldwide, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Since its inception in 2010, Henlius has launched five products in China, gained marketing approvals for two products in overseas markets, and received approval for 23 indications globally. The company has also had three marketing applications accepted for review in China and the EU.

Henlius Builds High-Efficiency Biopharmaceutical Platform with Global GMP Certification

Henlius has built an integrated biopharmaceutical platform with core capabilities in high efficiency and innovation throughout the entire product life cycle, including R&D, manufacturing, and commercialization. The company’s manufacturing facilities in Shanghai are certified by China, the EU, and U.S. GMP standards. Henlius boasts a diversified and high-quality product pipeline with over 50 molecules and continues to explore immuno-oncology combination therapies using its proprietary anti-PD-1 mAb, HANSIZHUANG, as the backbone. Launched products include HANLIKANG (rituximab), HANQUYOU (trastuzumab for injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab).

The innovative product HANSIZHUANG has been approved by the NMPA for treating MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major and emerging markets.

Organon is a global healthcare company dedicated to improving women’s health throughout their lives. The company offers more than 60 medicines and products in women’s health, a growing biosimilar business, and a large portfolio of established medicines across various therapeutic areas. Organon’s existing products generate strong cash flows, supporting investments in innovation and future growth opportunities in women’s health and biosimilars.


Organon and Henlius Achieve EMA Validation for HLX14 Biosimilar for Osteoporosis Treatment

In addition to its focus on women’s health, Organon actively seeks opportunities to collaborate with biopharmaceutical innovators to commercialize their products, leveraging its scale and presence in rapidly growing international markets.

Shanghai Henlius Biotech, Inc. and Organon have achieved a significant milestone with the validation of their marketing authorization applications (MAAs) for HLX14, a biosimilar candidate to Prolia® and Xgeva® (denosumab), by the European Medicines Agency (EMA). Denosumab, approved for various indications, is a vital treatment for osteoporosis in postmenopausal women at high risk for fractures. The HLX14 biosimilar aims to provide an alternative, affordable option for patients requiring this treatment.

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The validation follows a comprehensive phase 3 clinical study that compared HLX14 with the EU-sourced reference denosumab in terms of efficacy, safety, tolerability, and immunogenicity. This study, essential for demonstrating the biosimilar’s comparability to the original product, forms the backbone of the application submitted to the EMA.

Henlius and Organon Partner to Commercialize HLX14, Expanding Global Access to Biopharmaceuticals

In 2022, Henlius entered a strategic partnership with Organon, granting exclusive commercialization rights for HLX14 in major markets, including the European Union, the United States, and Canada, excluding China. This collaboration underscores the commitment of both companies to expanding access to high-quality biopharmaceutical companies and has made significant strides in developing and commercializing innovative biologic medicines.

With a robust pipeline of over 50 molecules and a focus on oncology, autoimmune, and ophthalmic diseases, Henlius continues to push the boundaries of medical science. The company’s integrated biopharmaceutical platform and certified manufacturing facilities highlight its capability to deliver high-quality medicines globally.

Organon, with its strong emphasis on women’s health and a comprehensive portfolio of over 60 products, continues to drive innovation in the healthcare sector. The company’s strategic initiatives and collaborations aim to address unmet medical needs and improve health outcomes worldwide. The validation of HLX14 by the EMA marks a crucial step towards providing patients with more treatment options.

As more data from ongoing studies become available, the companies anticipate a definitive evaluation of HLX14’s effectiveness, potentially leading to its widespread adoption and improving patient access to essential osteoporosis treatments. This development not only enhances the therapeutic landscape but also underscores the importance of international collaboration in advancing healthcare solutions.


Resource: Business Wire, May 24, 2024

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