Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

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 This press release features multimedia. View the full release here: 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 or connect with us on LinkedIn at . 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 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 ( ). 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 . View source version on businesswire.com: Contacts 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. 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The FDA’s decision was based on pre-clinical and clinical data demonstrating that HERCESSI and Herceptin are highly similar. Credit: Alexander Raths/Shutterstock.com. Accord BioPharma, the US speciality division of Intas Pharmaceuticals , has secured approval from the US Food and Drug Administration (FDA) for HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab). The approval marks a significant milestone for the treatment of HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. The therapy is indicated for the adjuvant treatment of HER2-overexpressing cancers. The FDA’s decision was based on a comprehensive package of analytical, pre-clinical and clinical outcomes, demonstrating that HERCESSI and Herceptin are similar in terms of safety, efficacy and quality. HERCESSI’s clinical programme included three trials aimed at showing pharmacokinetic comparability, clinical efficacy and safety similarity with its reference product. See Also: Enlaza Therapeutics secures $100m in Series A funding Pfizer and Genmab’s Tivdak wins full FDA approval for cervical cancer The studies adhered to the FDA’s current biosimilar guidance, confirming the similarity between HERCESSI and Herceptin. HERCESSI has been approved at a 150mg dosage, with a 420mg-strength version currently in development which is expected to receive an FDA decision in the fourth quarter of 2024. Its development was a collaborative effort with Shanghai Henlius Biotech , which granted Accord BioPharma exclusive rights for the US and Canada. Accord US president Chrys Kokino stated: “The approval of HERCESSI — our first biosimilar to be approved in the US — marks an important milestone for Accord BioPharma in our efforts to improve access for patients. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.” Accord BioPharma is also pursuing FDA approval for biosimilar versions of other drugs and plans to introduce additional biosimilars to the US market in the coming years.