HAN QU YOU® (60 mg/bottle) Officially Approved for Marketing for More Flexible Medication
On August 17, 2021, Henlius (2696. HK) announced that the Company had recently received the Approval Letter of Supplementary Application issued by the National Medical Products Administration (NMPA): HAN QU YOU® (trastuzumab, Zercepac in the EU) was formally approved by the NMPA for the sNDA of new strength (60 mg/vial, free of preservatives). After adding a new strength of 60 mg/vial in China, patients can use different strengths of HAN QU YOU® for more flexible medication.
HAN QU YOU® (150 mg/vial) is a Trastuzumab developed and produced by Henlius in accordance with the relevant regulations of China and the EU on biosimilars. It was approved for marketing by EC and NMPA in July and August 2020 respectively, pioneering the participation of Chinese pharmaceutical companies in the world-class competition of mAb biosimilars. HAN QU YOU® is available for HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, covering all indications approved for the innovator drug in China. It has been included in the payment scope of the basic medical insurance fund.
HAN QU YOU® is the first product sold and promoted in China by the Company's commercialization team. The first prescription was issued simultaneously in multiple hospitals within 6 working days after approval. As of April 2021, HAN QU YOU® (150 mg/vial) has been approved for medical insurance in all provinces and municipalities throughout China and completed online bidding in 30 provinces and municipalities. In 2021, the Guidelines of Chinese Society of Clinical Oncology (CSCO) Breast Cancer introduced sections of biosimilars for the first time, and the Guidelines of Chinese Society of Clinical Oncology (CSCO) Gastric Cancer included HAN QU YOU®, marking that it was recognized by authoritative medical guidelines, which laid a solid foundation for benefiting more patients.
The marketing application for Zercepac® (150 mg/vial) was again approved by the Swiss Agency for Therapeutic Products in July 2021. Moreover, to further enhance the economical efficiency of HAN QU YOU® and implement flexible clinical dose adjustment, in addition to the new strength of 60 mg/vial in China, Henlius, together with its partner Accord, also strived to apply the new drug strength of HAN QU YOU® in the EU. In April and June 2021, the sNDA for new strengths of 60 mg/vial and 420 mg/vial of Zercepac® has been successively approved by EC.
With the core concept of "Reliable Quality, Affordable Innovation", Henlius will continue to upgrade its product line through constant innovation, while ensuring the efficacy and safety of its products, to provide more flexible and convenient medication and benefit more cancer patients.
HAN QU YOU® (150 mg/vial) is a Trastuzumab developed and produced by Henlius in accordance with the relevant regulations of China and the EU on biosimilars. It was approved for marketing by EC and NMPA in July and August 2020 respectively, pioneering the participation of Chinese pharmaceutical companies in the world-class competition of mAb biosimilars. HAN QU YOU® is available for HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, covering all indications approved for the innovator drug in China. It has been included in the payment scope of the basic medical insurance fund.
HAN QU YOU® is the first product sold and promoted in China by the Company's commercialization team. The first prescription was issued simultaneously in multiple hospitals within 6 working days after approval. As of April 2021, HAN QU YOU® (150 mg/vial) has been approved for medical insurance in all provinces and municipalities throughout China and completed online bidding in 30 provinces and municipalities. In 2021, the Guidelines of Chinese Society of Clinical Oncology (CSCO) Breast Cancer introduced sections of biosimilars for the first time, and the Guidelines of Chinese Society of Clinical Oncology (CSCO) Gastric Cancer included HAN QU YOU®, marking that it was recognized by authoritative medical guidelines, which laid a solid foundation for benefiting more patients.
The marketing application for Zercepac® (150 mg/vial) was again approved by the Swiss Agency for Therapeutic Products in July 2021. Moreover, to further enhance the economical efficiency of HAN QU YOU® and implement flexible clinical dose adjustment, in addition to the new strength of 60 mg/vial in China, Henlius, together with its partner Accord, also strived to apply the new drug strength of HAN QU YOU® in the EU. In April and June 2021, the sNDA for new strengths of 60 mg/vial and 420 mg/vial of Zercepac® has been successively approved by EC.
With the core concept of "Reliable Quality, Affordable Innovation", Henlius will continue to upgrade its product line through constant innovation, while ensuring the efficacy and safety of its products, to provide more flexible and convenient medication and benefit more cancer patients.