SHANGHAI, July 28, 2023 /PRNewswire/ — HANQUYOU (trastuzumab, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed trastuzumab biosimilar independently developed by Shanghai Henlius Biotech, Inc. (2696.HK), welcomes the 3rd anniversary of its marketing approval in the European Union.
HANQUYOU is now indicated for the treatment of HER2-positive early breast cancer, and gastric cancer. It was developed in accordance with the guidelines from the National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). In 27 July and 12 August 2020, HANQUYOU was approved for marketing in European Union and China successively. Up to date, HANQUYOU is the China-developed biosimilar with the most marketing approvals, covering 41 countries and regions with a global shipment totaling over 3 million units. Moreover, its Biologics License Application (BLA) was accepted by the U.S. FDA, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S.
Henlius has aggressively pursued overseas commercialization of HANQUYOU, collaborating with global partners such as Accord, Abbott, Cipla, Eurofarma, Elea, the Jacobson Group, and KG Bio to bring its therapeutics to patients in major biopharmaceutical markets in the U.S., Europe, likewise emerging markets. As of now, HANQUYOU (Zercepac®) has been launched in approximately 20 European countries. Moreover, Henlius further expanded its overseas presence in 2022, with the launch of HANQUYOU in Cambodia, Australia, Singapore, and Argentina.
HANQUYOU has been widely used in clinical practice. As of now, HANQUYOU has benefitted about 140,000 patients in China. To benefit more patients, Henlius is continuously enhancing the accessibility of HANQUYOU through efficient market access and expansion. HANQUYOU was included in the National Medical Insurance Catalog of China since it was launched, and it is reimbursed nationally in countries and regions including the United Kingdom (UK), France and Germany. With the rapid market acceptance, HANQUYOU achieved the strong commercial growth. As of the end of 2022, the domestic sales revenue of HANQUYOU reached approximately RMB1.69 billion, and its overseas sales revenue exceeded RMB120 million, while the overseas license revenue was more than RMB280 million.
With the vision of “Leaving no HER2-positive patient behind”, Henlius will make all-round efforts to enhance the capabilities of innovation, manufacturing, and commercialization, steadily advancing the market expansion of HANQUYOU, and bringing more hopes to patients across the world.
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