European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11

Rhea-AI Summary

Henlius Biotech (2696.HK) and Organon (NYSE: OGN) announced that the European Medicines Agency (EMA) has validated their marketing authorization application for HLX11, a biosimilar candidate of Perjeta® (pertuzumab).

The application is supported by a multicenter, randomized, double-blind phase 3 clinical study that compared HLX11 with Perjeta® in HER2-positive breast cancer patients. The study met its primary endpoint of total pathological complete response (tpCR) rate, with secondary endpoints showing comparable results between groups.

Through a 2022 license and supply agreement, Organon holds exclusive commercialization rights for HLX11 in the United States, European Union, and Canada, excluding China.

Positive

• EMA validation enables potential market entry in Europe
• Successful Phase 3 trial results meeting primary endpoint
• Broad commercial rights in major markets (US, EU, Canada)

Negative

• None.

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 application (MAA) for HLX11, an investigational biosimilar of Perjeta^® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications.

The submission was based on a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study (NCT05346224) aimed to compare the efficacy and safety of HLX11 with reference Perjeta^® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early-stage, or locally advanced breast cancer as part of a complete treatment regimen. HLX11 met the primary endpoint, which was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee (IRC). Other secondary endpoint indicators are also comparable between the two groups.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement covers markets such as the United States, the European Union, 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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 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 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 over 70 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. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s 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 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

Except for historical information, this press release includes “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 HLX11. Forward-looking statements may be identified by words such as “explore,” “opportunity,” “expect,” “pursuing,” “future,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to market HLX11, an investigational biosimilar of Perjeta® (pertuzumab), in Europe, an inability to execute on Organon’s business development strategy; weakening of economic conditions that could adversely affect the level of demand for HLX11; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans; governmental initiatives that adversely impact Organon’s marketing activities; manufacturing difficulties or delays; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; disruptions at the U.S. Food and Drug Administration, the U.S. Securities and Exchange Commission (the “SEC”) and other U.S. and comparable foreign government agencies; and the failure by Organon or its third party collaborators and/or their suppliers to fulfill its or their regulatory or quality obligations. 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 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). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250328881021/en/

Organon Media:

Karissa Peer

(614) 314-8094

Barbara Coyle

+353 868371701

Organon Investors:

Jennifer Halchak

(201) 275-2711

Henlius Media

Bella Zhou

wenting_zhou@henlius.com

Janice Han

jiayi_han@henlius.com

Source: Organon & Co.

FAQ

What is the significance of EMA's validation of HLX11 for Organon (OGN) and Henlius?

The validation allows the review process to begin for their Perjeta® biosimilar candidate in Europe, potentially leading to market approval for breast cancer treatment.

What markets are covered in the Organon (OGN) and Henlius partnership for HLX11?

The partnership covers the United States, European Union, and Canada, with China being excluded from the agreement.

What were the key results of HLX11's Phase 3 clinical trial?

The trial met its primary endpoint for total pathological complete response (tpCR) rate, with secondary endpoints showing comparable results to Perjeta®.

What type of breast cancer is HLX11 designed to treat?

HLX11 targets HER2-positive, HR-negative early-stage or locally advanced breast cancer as part of a complete treatment regimen.