European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14

Rhea-AI Summary

Shanghai Henlius Biotech and Organon announced that the European Medicines Agency (EMA) has validated the marketing authorization applications for HLX14. HLX14 is a biosimilar candidate for Prolia® and Xgeva® (denosumab), used primarily to treat osteoporosis in postmenopausal women at high risk for fractures. The applications are based on a comprehensive phase 3 clinical study comparing HLX14 with EU-sourced reference denosumab. In 2022, Henlius granted Organon exclusive commercialization rights for HLX14 in the EU, US, and Canada, excluding China. Notably, 32 million Europeans aged 50 or above suffer from osteoporosis, highlighting the market potential for HLX14.

Positive

• European Medicines Agency (EMA) validation of marketing authorization applications for HLX14.
• HLX14 is based on a phase 3 clinical study, ensuring a high standard of efficacy and safety data.
• Henlius partnered with Organon in 2022, granting commercialization rights for HLX14 in the EU, US, and Canada.
• 32 million Europeans aged 50+ have osteoporosis, indicating a significant market opportunity.
• Comprehensive clinical data supporting HLX14 enhances its reliability and market readiness.

Negative

• HLX14 is still an investigational product, pending final approval and market entry.
• The PR does not provide specific clinical trial results, leaving uncertainty about comparative effectiveness.
• Market approval is to specific regions, excluding China.

Insights

Financial Analyst

The validation of marketing authorization applications (MAAs) for HLX14, a biosimilar to Prolia® and Xgeva®, could be significant for Henlius and Organon. Given the high prevalence of osteoporosis in Europe, the potential market size is substantial. For investors, this could translate to substantial future revenue streams, particularly as Prolia and Xgeva are leading treatments in this category. The prior agreement between Henlius and Organon for commercialization rights in major markets could enhance their financial positions by tapping into existing distribution networks and marketing strategies. It’s important to keep an eye on the approval timelines and market entry strategies, as these will directly impact financial forecasts.

Short-term potential: The announcement itself may boost investor confidence and stock prices in the short term as it marks a critical milestone towards bringing the product to market.

Long-term potential: If the biosimilar secures approval and gains market traction, it can lead to a steady revenue stream, bolstered by the growing aging population and the high demand for osteoporosis treatments.

Medical Research Analyst

The Phase 3 clinical study comparing HLX14 with Prolia is a critical data point for understanding the drug's market potential. The results, if favorable, validate the efficacy, safety, tolerability and immunogenicity of HLX14. Biosimilars generally offer a cost-effective alternative to existing treatments, which can be particularly advantageous in markets with high healthcare expenditure like the EU.

Understanding the clinical trial outcomes and how HLX14 matches up against its reference product will be crucial. If HLX14 can demonstrate equal or better performance, it can quickly gain acceptance among healthcare providers, insurers and patients.

Short-term potential: The clinical study results will be pivotal. Positive outcomes can accelerate the approval process and market entry.

Long-term potential: Successful approval and market acceptance can lead to greater healthcare cost savings and improved patient access to treatment, thereby increasing adoption rates and market penetration.

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- 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

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240524114174/en/

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

Source: Organon & Co.

FAQ

What is HLX14 in relation to Organon?

HLX14 is a biosimilar candidate for Prolia® and Xgeva® (denosumab) developed by Henlius, with exclusive commercialization rights granted to Organon.

What recent actions has the EMA taken regarding HLX14?

The EMA has validated the marketing authorization applications for HLX14.

What conditions does HLX14 aim to treat?

HLX14 aims to treat osteoporosis in postmenopausal women at high risk for fractures.

When did Henlius and Organon enter into an agreement for HLX14?

Henlius and Organon entered into a license and supply agreement for HLX14 in 2022.

Which markets does the HLX14 agreement between Henlius and Organon cover?

The agreement covers the European Union, the United States, and Canada.