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.
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The submission was based on a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study 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.
