SHANGHAI, China & JERSEY CITY, N.J. - The US Food and Drug Administration (FDA) has officially accepted a Biologic License Application (BLA) for HLX14, a biosimilar to the bone health drugs PROLIA and XGEVA, developed by Shanghai Henlius Biotech, Inc. and Organon. HLX14 is being evaluated as a treatment option for osteoporosis in postmenopausal women at a high risk for fracture, among other uses.
The application submission follows a licensing agreement between Henlius and Organon from 2022, granting Organon exclusive rights to commercialize HLX14 in regions including the United States, European Union, and Canada, with China as an exception.
The BLA for HLX14 is supported by comprehensive data from a series of comparative studies. These include analytical studies assessing the quality of HLX14 and two clinical studies that evaluated its pharmacokinetics, efficacy, safety, tolerability, and immunogenicity against the EU-sourced reference drug, denosumab, used in PROLIA and XGEVA.
Henlius, listed on the Hong Kong Stock Exchange (2696.HK), is recognized for its portfolio of biologic medicines, with six products launched in China, three approved in overseas markets, and several others under review in major regions. The company has been operational since 2010, with facilities certified by regulatory authorities in China, the EU, and the U.S.
Organon, traded on the New York Stock Exchange (NYSE: OGN), is a global healthcare company dedicated to improving women's health. Their portfolio spans over 60 medicines and products across various therapeutic areas. Organon is headquartered in Jersey City, New Jersey, and employs approximately 10,000 people worldwide.
The acceptance of the BLA by the FDA marks a significant step for both Henlius and Organon in the biosimilar space. However, it is important to note that acceptance of a BLA by the FDA does not imply approval but indicates that the application is sufficiently complete to begin a substantive review. The details provided in this article are based on a press release statement.
InvestingPro Insights
Adding to the promising developments for Henlius Biotech (2696.HK), recent InvestingPro data reveals a robust financial position that aligns with the company's advancements in the biosimilar market. The company's revenue growth of 27.45% over the last twelve months as of Q2 2024 demonstrates strong market traction, potentially bolstered by its expanding portfolio of biologic medicines.
Henlius's gross profit margin of 73.23% for the same period indicates efficient cost management, which is crucial for biotechnology firms investing heavily in research and development. This efficiency is further reflected in the company's operating income margin of 14.11%, suggesting that Henlius is effectively translating its revenue growth into operational profits.
InvestingPro Tips highlight that Henlius is a "Prominent player in the Biotechnology industry," which is evident from its FDA application acceptance and international partnerships. The tip that the company is "Trading near 52-week high" (currently at 94.67% of its 52-week high) suggests investor confidence in Henlius's recent developments and future prospects.
For investors seeking more comprehensive analysis, InvestingPro offers 10 additional tips for Henlius Biotech, providing deeper insights into the company's financial health and market position.
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