· HANQUYOU is the China-developed monoclonal antibody(mAb) biosimilar approved in China, the EU and the U.S.

· HANQUYOU has been approved in 47 countries and regions with 5,500,000+ units shipped.

· Henlius is actively collaborating with global partners to bring its therapeutics to patients worldwide and has licensed HANQUYOU out to ~100 countries and regions.

· HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), the first China-developed trastuzumab biosimilar independently developed by Henlius, has been approved in China, the European Union (EU) and the United States (U.S.). As the pioneering Chinese mAb biosimilars to go overseas, HANQUYOU was first approved in the EU on 27 July, 2020 and has been progressing for four years with proven international quality. Up to now, it has been approved in 47 countries and regions, benefiting 200,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide. 

Shine with differentiated advantages and demonstrated international quality

The breast cancer is the cancer with highest incidence and mortality rates among women globally. According to the data from GLOBOCAN, there were 2.3 million new cases of breast cancer worldwide in 2022 ^[1], among which, HER2-positive breast cancer accounts for approximately 20% to 25% of all breast cancer cases ^[2]. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23% ^[3]. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers.

HANQUYOU is the trastuzumab biosimilar developed in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other international biosimilar guidelines, indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. In July and August 2020, it was approved in EU and China successively. In April 2024, it received marketing approval from FDA, a significant milestone for the product, making it a China-developed mAb biosimilar approved in China, the EU, and the U.S.

Henlius has proactively pursued overseas commercialization of HANQUYOU, collaborating with global renowned partners such as Accord, Abbott, Eurofarma and KGbio to bring its therapeutics to patients in major biopharmaceutical markets in the U.S. and Europe, as well as emerging markets, covering about 100 countries and regions. Up to date, HANQUYOU has been approved in 47 countries and regions, including China, the U.S., the UK, France, Germany, Switzerland, Australia, Singapore, Thailand, Argentina and Brazil, covering Asia, Europe, Latin America, North America, and Oceania, making it the China-developed mAb biosimilar with the most marketing approvals. Over the past year, HANQUYOU has successfully obtained approvals in the U.S., Thailand, the Philippines, Brazil and other countries and regions, further expanding its overseas layout, and its overseas revenue from product sales for the full year of 2023 also achieved a YoY growth of 162.3%. On the other hand, it is reimbursed nationally in countries and regions including China, the UK, France and Germany, providing more dosage forms and flexible combination drug solutions for local patients and contributing to the high-quality development of global oncology diagnosis and treatment.

Henlius has established a specialized commercial team to make full efforts to develop and further tap into China market. With the advantages of dual-dosage form, no preservatives and "ready-to-use" formulation, HANQUYOU has been widely used in clinical practice and achieved rapid market acceptance and strong commercial growth. Many authoritative guidelines and regulations, such as the Chinese Consensus on Biosimilars (2020), CSCO Guidelines for Breast Cancer (2023), CSCO Guidelines for Gastric Cancer (2023), and CACA Breast Cancer Guideline (2022), recommend HANQUYOU. It was also honored as "13th China Health Annual Forum – Top 10 New Medicine" by Health Times. In addition, HANQUYOU has achieved record sales in recent years. Its domestic sales revenue in 2023 reached approximately RMB2.6444 billion, up by 56.1% YoY. 

Benefit global patients through robust manufacturing and R&D capabilities

With its internationally certified quality management system and strong production capacity, Henlius is able to guarantee the global supply of HANQUYOU. In 2023, the manufacturing site and facility where HANQUYOU is manufactured underwent and successfully passed the Pre-License Inspection (PLI) by the FDA. The success of the FDA PLI, as well as the previous GMP certifications from China and EU regulatory agencies, make Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs. Meanwhile, the company has achieved commercial supply of HANQUYOU to countries and regions including China, Europe, Southeast Asia, Latin America and the Middle East to meet the growing global market demand. In June 2024, HANQUYOU made its first delivery to Saudi Arabia, a milestone that marks company’s first commercialized delivery to the Middle East and North Africa (MENA) countries. To date, a total of 5,500,000+ units of HANQUYOU have been shipped globally, bringing survival benefits to a large number of HER2-positive breast cancer and gastric cancer patients around the world.

Henlius has benchmarked HANQUYOU against international standards in the early stages of research to enable its global commercialization. A series of head-to-head clinical studies were initiated that compared HANQUYOU with the trastuzumab originator. The clinical results demonstrated the remarkable similarity between HANQUYOU and the trastuzumab originator in terms of quality, safety, and efficacy. The results of some comparative studies, preclinical research, as well as Phase 1 and international multicenter Phase 3 clinical trials on HANQUYOU have been published on many prestigious international journals such as BioDrugs, Cancer Chemotherapy and Pharmacology, and the Journal of Oncology. In addition, Henlius has also continued its efforts in clinical research. A number of real-world studies on HANQUYOU have been conducted at esteemed medical institutions, including Fudan University Shanghai Cancer Center, The Affiliated Drum Tower Hospital of Nanjing, and Mudanjiang Tumor Hospital, which have further provided scientific data to support the efficacy and safety of HANQUYOU, boosting the confidence in its clinical practice and bringing more enlightenment to clinical research of breast cancer and gastric cancer.

After four years of dedicated effort, Henlius remains committed to patient-centricity, and will give full play to the advantages of the integration of R&D, manufacturing and commercialization, and bring domestic affordable, high-quality treatment options such as HANQUYOU to a wider stage in the world, so that Chinese pharmaceuticals will truly empower more patients around the world.

Reference

[1] International Agency for Research on Cancer. Global Cancer Observatory: Cancer Today [DB/OL]. http://gco.iarc.who.int/today [2024-02-01]

[2] Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40.

[3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Gastric Cancer V.3.2023

About HANQUYOU

HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe） is the trastuzumab biosimilar developed in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and other international biosimilar guidelines, indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. It is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and the United States (U.S.). Henlius has established a specialized commercial team to make full efforts to develop and further tap into China market. As of now, HANQUYOU has benefited over 200,000 patients in China. In August 2021, HANQUYOU was launched with another dosage form of 60mg, which can be flexibly combined with 150mg dosage form to provide a personalized and more cost-effective option for patients with different weights. On the other hand, Henlius has been pursuing overseas commercialization of HANQUYOU, actively collaborating with global partners to bring its therapeutics to patients in the U.S., Canada, Australia, Europe, and other emerging markets, covering about 100 countries and regions. Up to date, HANQUYOU has received marketing approvals in more than 40 countries and regions, including the U.S, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand.