Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner Cipla Limited ("Cipla") has received the relevant registration certificates from the Therapeutic Goods Administration of Australia ("TGA") for the approval of Henlius' self-developed and manufactured HANQUYOU (trastuzumab, trade name in Europe: Zercepac®) with the specification of 150mg/vial in Australia under the trade names Tuzucip® and Trastucip®, covering all indications of the reference trastuzumab approved in Australia. Henlius independently developed HANQUYOU in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), US Food and Drug Administration and other international biosimilar guidelines. It was approved for commercialisation by the European Commission and NMPA in July 2020 and August 2020, respectively, and became the first Chinese mAb biosimilar to enter both the EU and China markets. In particular, Zercepac® (150mg/vial) has launched in about 20 European countries and regions, including the United Kingdom, Germany, Spain, France, and Italy, and the dosage forms of 60mg/vial and 420mg/vial were also approved for marketing in the EU. Henlius has taken multiple head-to-head comparisons between HANQUYOU and the reference trastuzumab, including comparative quality studies, preclinical studies, a phase 1 clinical study and a global multi-certre phase 3 clinical study. These data proved that HANQUYOU and reference trastuzumab are highly similar in terms of quality, safety and efficacy. The approval of HANQUYOU by TGA of Australia was mainly based on the review of a series of studies. The relevant application materials are mainly based on the information in the Marketing Authorization Application in relation to the product submitted to the EU. HANQUYOU has been approved in Australia for the treatment of HER2-positive early breast cancer, HER2-positive locally advanced breast cancer, HER2-overexpressing metastatic breast cancer and HER2-positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction. In 2018, Henlius granted Cipla the exclusive rights to develop and commercialize HANQUYOU in several countries including Australia and is solely responsible for the production and supply of HANQUYOU for Cipla in the licensed territories. The manufacturing facilities for HANQUYOU and the quality management system are in line with global standards. Among them, the Xuhui Facility has obtained GMP certifications from China and the EU, making it the first plant that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies in China. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the EMA, the EU qualified person, and multiple international business partners. In May 2022, Songjiang First Plant has been approved for the commercial manufacturing of HANQUYOU by the NMPA with a total capacity of 24,000L, to support the growing global demands for the product. To date, the 150mg form of HANQUYOU has completed the tendering process on the procurement platform and was included in the medical insurance procurement platform for all provinces in the Chinese mainland while the 60mg form has completed the tendering process on the procurement platform in 23 provinces and was included into the medical insurance procurement platform in 30 provinces, benefiting nearly 70,000 patients. In addition, the company has collaborated with global partners such as Cipla, Accord, Abbott, Eurofarma, Mabxience, Jacobson, etc. to bring HANQUYOU to patients in over 90 countries and regions, covering the United States, Canada, Europe, and many emerging markets. Looking forward, Henlius will give full play to the company's footprints in innovation and globalization, continue to promote the company's all-round evolution strategy towards a global Biopharma and boost the accessibility of Henlius' products in the global market by reaching out to strategic partners and bring hope to more patients. source: Henlius