US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)
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Denosumab has been approved in various countries and regions under different trade names for a range of different indications, such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as
The filing is based on data from a series of head-to-head studies for HLX14, including comparative quality analytical studies and two clinical studies. The first was a two-part phase 1 clinical study in Chinese healthy adult male subjects. Part 1 was an open-label, randomized, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2. Part 2 was a double-blind, randomized, parallel-controlled, single-dose, four-arm study with the primary objective to compare the pharmacokinetic similarity of HLX14 with US-, EU-, and
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Henlius has launched HANLIKANG (rituximab), the first
To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
About Organon
Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.
Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in
For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the
XGEVAand PROLIA are trademarks registered in
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Organon Media:
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Henlius Media:
wenting_zhou@henlius.com
jiayi_han@henlius.com
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