28.07.2023 – 15:54
Henry
Shanghai (ots/PRNewswire)
HANQUYOU (trastuzumab, trade names in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first trastuzumab biosimilar developed in China to be independently developed by Shanghai Henlius Biotech, Inc. (2696.HK), is celebrating 3 year anniversary .
HANQUYOU is now indicated for the treatment of HER2-positive early breast cancer and gastric cancer. It was developed according to the guidelines of the National Medical Devices Administration (NMPA), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). On July 27th and August 12th, 2020, HANQUYOU was approved for sale in European Union and China respectively. To date, HANQUYOU is the most approved biosimilar developed in China for sale, having been approved in 41 countries and regions and having shipped over 3 million units worldwide. In addition, HANQUYOU’s Marketing Authorization Application (BLA) has been accepted by the US FDA, potentially making HANQUYOU the first Chinese biosimilar to be approved in China, the EU and the US.
Henlius has aggressively pursued the overseas commercialization of HANQUYOU, working with global partners such as Accord, Abbott, Cipla, Eurofarma, Elea, the Jacobson Group and KG Bio to bring its therapeutics to key biopharmaceutical markets in the US, Europe and emerging markets make available to patients. So far, HANQUYOU (Zercepac®) has been launched in about 20 European countries. In addition, in 2022, Henlius further expanded its overseas presence by launching HANQUYOU in Cambodia, Australia, Singapore and Argentina.
HANQUYOU is widely used in clinical practice. Up to now, HANQUYOU has helped about 140,000 patients in China. In order to reach more patients, Henlius continuously improves the accessibility of HANQUYOU through efficient market entry and expansion. Since launch, HANQUYOU has been included in the National Medical Insurance Catalog of China and is used nationally in countries and regions such as the United Kingdom (UK), France and Germany. Thanks to the rapid market acceptance, HANQUYOU achieved strong commercial growth. By the end of 2022, HANQUYOU’s domestic sales reached about 1.69 billion RMB, overseas sales exceeded 120 million RMB, while overseas royalty income was more than 280 million RMB.
With the vision of “Leaving no HER2 positive patient behind”, Henlius will make every effort to enhance innovation, manufacturing and commercialization capabilities, continuously drive HANQUYOU’s market expansion, and bring more hope to patients around the world.
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Original content by: Henlius, transmitted by news aktuell