Business Wire

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

Share

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

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240524114174/en/

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Vitruvian Partners Increases Stake in Civitatis26.6.2024 11:00:00 CEST | Press release

Vitruvian Partners has purchased a further ownership stake in Civitatis, the leading curated online marketplace for guided tours and activities for Spanish and Portuguese speaking consumers, investing an additional USD 50m. Civitatis continues to be led by the founder and CEO Alberto Gutiérrez, who established the company in 2008. Civitatis is a rare example of a company that has been cashflow positive from day one, built by its founder without any external capital. The Company remains on track to be a future Spanish unicorn, as a curated marketplace for the large and growing tours and activities category, underpinned by a rapid digitalization tailwind. Founder and CEO Alberto Gutiérrez said, “Our growth and profitability have been fuelled by a combination of highly effective sales channels, well-invested technology platform, and a customer-centric approach, providing the activities and tours in our customers’ own preferred language. Our customers appreciate our expertly curated catalo

Prodapt Expands Its Americas Presence With Onshore Center in Puerto Rico26.6.2024 10:30:00 CEST | Press release

Prodapt, the largest and fastest-growing specialized company focused on the Connectedness industry, has announced an onshore operations facility in Puerto Rico, aligning with a proven strategy to complement offshore strengths with onshore & nearshore capabilities to enable holistic technology services that include supporting government contracts and multilingual customer engagement. Expanding alongside the facility in Panama, the new center will help Communications Service Providers (CSPs) accelerate transformation and leverage AI-powered managed services to make their IT/Networks agile, streamline business processes, and enhance customer experiences. Prodapt will create 200jobs at the Puerto Rico center in the near future, hiring people skilled in AI-powered Telecom operations, cloud computing, data analytics, and more. Prodapt chose Puerto Rico for its abundant technical talent, growing technology ecosystem, strong engineering skills, and attractive incentives for investors. Invest P

EDX Medical to Market Pioneering Cancer Drugs Response Assay in UK and Nordics26.6.2024 10:21:00 CEST | Press release

EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalised treatments for cancer, heart disease and infectious diseases, announces today it has signed an exclusive distribution agreement with Curesponse Ltd, to market the cResponse™ cancer assay in the UK, Sweden, Finland, Norway and Denmark. cResponse™ is a groundbreaking platform that biologically assesses how an individual patient’s living tumour tissue responds to selected medicines, identifying the most effective treatment options. It is the only clinical-grade technology providing biological response data for chemotherapy, targeted biologics, and immunotherapy drugs. This platform helps clinicians rapidly pinpoint optimal treatments, potentially saving lives, reducing treatment costs, and accelerating the discovery and development cycles for pharmaceutical companies seeking new cancer drugs. The cResponse™ platform generates a report ranking selected cancer drugs based on the

Takeda Announces New Assignments of Directors26.6.2024 09:05:00 CEST | Press release

Takeda (TOKYO:4502/NYSE:TAK) has announced new assignments of directors, determined at the Board of Directors meeting and at the Audit and Supervisory Committee meeting, following the 148th Ordinary Meeting of Shareholders, held in Osaka today. Takeda's Board of Directors has 11 members serving as external directors out of a total of 14 members, helping to ensure transparency and objectivity. An external director will continue to chair the Board of Directors. The Audit and Supervisory Committee, the Nomination Committee and the Compensation Committee will be composed solely of external directors including their chairs. Takeda highly values strong, independent governance and its Board of Directors helps to ensure that all decisions and actions are in the best interests of global stakeholders and aligned with the company’s values. This robust corporate governance model has been, and will continue to be, critical to Takeda's success. Details of the new assignments are as follows: 1. New A

iBASIS Wins New 4-Year SFR International Services Deal26.6.2024 08:00:00 CEST | Press release

iBASIS, the leading provider of communications solutions for operators and digital players worldwide, and SFR, the second largest telecoms operator in France announce today the renewal of their partnership for Voice and Mobile international services. This long-term deal, which is focused on providing SFR with enhanced economies of scale, a future-proof network, systems, and customer service capabilities, enables SFR to get competitive pricing and quality enhancements. “iBASIS is a long-term partner for SFR especially as we share the same vision of providing innovative services that support growth and digital transformation. Their quality commitment and the dedication of the team have fostered a fruitful collaboration across both companies,” said Mehdi Boudah, EVP, Wholesale Division, SFR. “We are extremely pleased to extend the partnership by four years and continue to leverage iBASIS’s robust and flexible platform in carrying international voice and mobile services securely.” This ext

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye