Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN)
today announced that the European Medicines Agency (EMA) has
validated the marketing authorization applications (MAAs) for
HLX14, an investigational Prolia® and Xgeva® (denosumab)
biosimilar. 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
2019, it was estimated that 32 million Europeans ages 50 or above
had osteoporosis, 25.5 million of which were women.1
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The submissions were based on a randomized, double-blind,
international multicenter, parallel-controlled phase 3 clinical
study that 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
fracture.
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 European Union, the United States, and
Canada. An exception to the agreement is China.
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, 5 products have been launched in
China, 2 have been approved for marketing in overseas markets, 23
indications are approved worldwide, and 3 marketing applications
have been accepted for review in China and the EU, respectively.
Since its inception in 2010, Henlius has built an integrated
biopharmaceutical platform with core capabilities of
high-efficiency and innovation embedded throughout the whole
product life cycle including R&D, manufacturing and
commercialization. It has established global innovation center and
Shanghai-based manufacturing facilities certified by China, the EU
and U.S. GMP.
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 backbone. Apart from the launched
products HANLIKANG (rituximab), the first China-developed
biosimilar, HANQUYOU (trastuzumab for injection, trade name:
HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb
biosimilar approved in China, Europe and U.S., HANDAYUAN
(adalimumab) and HANBEITAI (bevacizumab), the innovative product
HANSIZHUANG has been approved by the NMPA for the treatment of
MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC)
and 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. What’s
more, Henlius has conducted over 30 clinical studies for 16
products, expanding its presence in major markets as well as
emerging markets.
To learn more about Henlius, visit
https://www.henlius.com/en/index.html or connect with us on
LinkedIn at https://www.linkedin.com/company/henlius/.
About Organon Organon is a global healthcare company
formed to focus on improving the health of women throughout their
lives. Organon offers more than 60 medicines and products in
women’s health in addition to a growing biosimilars business and a
large franchise of established medicines across a range of
therapeutic areas. Organon’s existing products produce strong cash
flows that support investments in innovation and future growth
opportunities in women’s health and biosimilars. In addition,
Organon is pursuing opportunities to collaborate with
biopharmaceutical innovators looking to commercialize their
products by leveraging its scale and presence in fast growing
international markets.
Organon has a global footprint with significant scale and
geographic reach, world-class commercial capabilities, and
approximately 10,000 employees with headquarters located in Jersey
City, New Jersey.
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 Some
statements and disclosures in this press release are
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about expectations
regarding marketing authorization applications and prospects for
Prolia® and Xgeva® (denosumab) biosimilar products in Europe, as
well as the future business plans of Henlius and Organon.
Forward-looking statements include all statements that do not
relate solely to historical or current facts and can be identified
by the use of words such as "may," “expects,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,”
or words of similar meaning. These forward-looking statements are
based on Organon’s current plans and expectations and are subject
to a number of risks and uncertainties that could cause Organon’s
plans and expectations, including actual results, to differ
materially from the forward-looking statements. Risks and
uncertainties that may affect Organon’s future results include, but
are not limited to, an inability to market Prolia® and Xgeva®
(denosumab) biosimilar throughout Europe; an inability to fully
execute on the product development and commercialization plans for
Prolia® and Xgeva® (denosumab) biosimilar throughout Europe and
worldwide; the performance, operations and regulatory compliance of
Henlius and its suppliers, efficacy, safety, or other quality
concerns with respect to marketed products, including market
actions such as recalls, withdrawals, or declining sales; political
and social pressures or regulatory developments, that adversely
impact demand for, availability of, or patient access to Organon’s
products; general economic factors, including recessionary
pressures, interest rate and currency exchange rate fluctuations;
general industry conditions and competition; the impact of
pharmaceutical industry regulation and health care legislation in
the Europe and internationally; global trends toward health care
cost containment; technological advances; new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining further regulatory approval;
Organon’s ability to accurately predict its future performance;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; difficulties developing
and sustaining relationships with commercial counterparties;
dependence on the effectiveness of Organon’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Organon undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Organon’s filings with
the Securities and Exchange Commission ("SEC"), including Organon’s
most recent Annual Report on Form 10-K and subsequent SEC filings,
available at the SEC’s Internet site (www.sec.gov).
1 J. Kanis, Norton, N., Harvey, N., et al. SCOPE 2021: a new
scorecard for osteoporosis in Europe. Archives of Osteoporosis.
(2021) 16:82. Accessed 6 May 2024. Available at
https://www.osteoporosis.foundation/sites/iofbonehealth/files/2021-06/Kanis2021_Article_SCOPE2021ANewScorecardForOsteo.pdf.
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Organon Media Contacts:
Felicia Bisaro (646) 703-1807
Hannah Silver (917) 509-8864
Organon Investor Contacts:
Jennifer Halchak (201) 275-2711
Renee McKnight (551) 204-6129
Henlius Media Contacts:
Bella Zhou wenting_zhou@henlius.com
Janice Han jiayi_han@henlius.com
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