• HANQUYOU is the China-developed biosimilar with the most marketing approvals, covering 41 countries and regions

• The launch of HANQUYOU kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies

• Henlius will continue to expand its overseas footprint and accelerate the delivery of high-quality and affordable biological medicines to patients worldwide

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 3^rd anniversary of its launch in the European Union today. Dating back to July 27, 2020, the approval of HANQUYOU by the European Commission (EC) signalled that Henlius took the lead among the Chinese biopharmaceutical companies in breaking into the European Union market and kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies. Up to date, HANQUYOU has received marketing approvals in 41 countries and regions globally with a cumulative global shipment volume totaling over 3 million units. With world-class quality, clinically-proven safety and efficacy, and high accessibility, HANQUYOU is highly recognized by doctors and patients at home and abroad. It has also achieved significant milestones in major and emerging biopharmaceutical markets to deliver warmth and hope to patients all over the globe.

Commercialization sees bountiful accomplishments

HANQUYOU is a trastuzumab biosimilar developed in accordance with the guidelines from the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other international biosimilar regulations. In July and August 2020, it was approved in European Union and China successively for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer, which covers all indications of the trastuzumab originator, and embarked on a new journey in global pharmaceutical market. HANQUYOU is the China-developed biosimilar with the most marketing approvals covering 41 countries and regions, including China, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia. The Biologics License Application (BLA) for HANQUYOU was accepted by the FDA in February 2023, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S., and further consolidates its global commercialization network.

Up to now, Henlius has established a specialized commercial team with more than 550 sales agents 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. In 2022, the domestic sales revenue of HANQUYOU reached approximately RMB1.69 billion, and in the first quarter of 2023, its domestic sales revenue surged approximately 66.7% year-on-year to RMB538.6 million during the same period. As of now, HANQUYOU has benefitted about 140,000 patients in China.

Henlius has aggressively pursued overeseas commercialization of HANQUYOU, collaborating with global renowned 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. and Europe, as well as emerging markets. After HANQUYOU (Zercepac^®) in 150mg dosage forms was approved for marketing in EU in July 2020, HANQUYOU (Zercepac^®) in 60mg and 420mg dosage forms were approved for marketing in EU, respectively. The marketing application of HANQUYOU (Zercepac^®) in 150mg dosage forms was also approved by Swissmedic in July 2021. Up to date, HANQUYOU (Zercepac^®) has been launched in approximately 20 European countries, and it is reimbursed nationally in countries and regions including the United Kingdom (UK), France and Germany. Henlius further expanded its overseas presence in 2022, with the launch of HANQUYOU in Cambodia, Australia, Singapore, and Argentina. As of the end of 2022, the overseas sales revenue of HANQUYOU exceeded RMB120 millon and its overseas license revenue was in excess of RMB280 million.

Make solid strides in manufacturing and innovation to further improve competitiveness

By virtue of Henlius' world-class quality management systems and increasing manufacturing capabilities, HANQUYOU is seeing a robust expansion in the global market, with a total supply over 3 million units worldwide. Henlius has established a quality management system in line with international quality standards of China, the U.S., and the EU, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance. The company's commercial production facility and supporting quality management system have been certificated by China and the EU Good Manufacturing Practice (GMP). They have also passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person (QP), and multiple international business partners. In April 2020, Henlius' Xuhui Facility successfully passed the on-site inspection for EU GMP certification, making HANQUYOU the first domestically produced biosimilar in China to receive such certification and breaking the GMP barriers for China-developed mAb biologics launched in global market. In 2022, the Songjiang First Plant was approved for the commercial production of HANQUYOU, which works in synergy with the Xuhui Facility in manufacturing and product supply. To meet ever-expanding market demand, Henlius has established three manufacturing facilities: Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant, with the total commercial production capacity of 48,000 liters so far, and it is expected to reach 144,000 liters by 2026. A giant leap in productivity also promotes the global sales growth of HANQUYOU. Notably, Henlius has achieved a stable supply in the Chinese and EU markets to meet the growing demand for clinical medication worldwide, and will continue to adhere to international high standards to improve the production efficiency and capacity of HANQUYOU, thereby establishing a solid foundation for medium- to long-term global commercial production and business development.

Henlius planned to pitch HANQUYOU to the global market at the early-stage of research and was heading for the global commercialization. Therefore, Henlius has initiated a series of head-to-head clinical studies 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. Several real-world studies on HANQUYOU conducted at esteemed medical institutions, including Fudan University Shanghai Cancer Center, The Affiliated Drum Tower Hospital of Nanjing, and Mudanjiang Tumor Hospital. In 2021, the results of a prospective, open, multi-center clinical study of pyrotinib combined with trastuzumab (HANQUYOU) and nab-paclitaxel in neoadjuvant treatment for stage II-III HER2-positive breast cancer patient was released as the abstract and poster at the San Antonio Breast Cancer Symposium (SABCS). What's more, the results of a real-world study featuring trastuzumab (HANQUYOU) plus Pertuzumab as dual-target neoadjuvant therapy for HER2-positive breast cancer was published at the 2022 SABCS. This study included 85 patients, and the overall pathologic complete response rate reached 64.7%, aligning closely with the efficacy results observed in real-world studies and previous Phase 3 clinical trials of the originator. With these scientific study data, HANQUYOU is proved as a world-class monoclonal antibody with outstanding efficacy and reliable safety, which boosts the confidence in clinical practice.

Over the past three years, HANQUYOU has provided economical and convenient options to patients with its advantages in clinical care, pharmacoeconomics, gaining wide recognition in the field of oncology. 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. Moreover, HANQUYOU is highly recoginzied by all walks of life. It was honored with a national key new drug creation program during the "12th Five-Year Plan" and "13th Five-Year Plan" ,  "Famous and Excellent Products" by Shanghai Pharmaceutical Profession Association, listed in the "2022 Shanghai Biomedical 'New Excellent Medical Equipment' Product Catalog" by Shanghai Municipal Commission of Economy and Informatization, and the "13th China Health Annual Forum – Top 10 New Medicine" by People's Daily Health APP.

Focus on unmet clinical needs and push ahead with patient-centric ecosystem

Henlius is devoted to anti-HER2 studies to meet unmet clinical needs and address the challenges of medication. Following the launch of 150mg dosage form, HANQUYOU was launched with another dosage form of 60mg in August 2021. Nowadays, it has been widely used in clinical practice due to its advantages such as dual-dosage form (150mg& 60mg), "ready-to-use" formulation and flexible combination in use. In addition, HANQUYOU has no preservatives, which plays a positive role in treatment.

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 since it was launched. In 2021 H1, all the provincial medical insurance access work and tendering process completed for 150mg dosage form. By the end of 2022, the 60mg dosage form of HANQUYOU had completed the tendering process in 29 provinces and was included into the medical insurance procurement platform in all provinces in Chinese mainland. 

To improve the diagnosis and treatment level in HER2-positive tumors and maximize the benefits for patients, Henlius collaborates with various partners to create an integrated medical ecosystem of "Leaving No HER2-positive Patients Behind". It connects patients and their families with medical institutions and doctors, associations, government, and relevant enterprises and tries to optimize the entire chain of HER2-positive treatment on leveraging the market access, big data analysis, HER2 testing, patient management and healthcare education, etc. On the other hand, Henlius actively practice corporate social responsibility and has initiated a series of public welfare projects in science popularization on breast cancer, clinical diagnosis and treatment and patient care, etc. As one of the key projects, the "Medical Care for Rural Patients" was initiated by the Fosun Foundation, the CSCO Foundation, People's Daily Health app, Health Times and Henlius in 2020, aiming to improve the medical infrastructure, diagnosis and treatment, and hospital management capabilities in remote villages in China, and to raise the awareness of health among villagers. Over the past three years, the project teams have visited 19 counties, involving 162 experts, benefiting near 3,400 patients and 1,500 local medical staff. They have also donated a total of more than RMB 190,000 to support local hospitals and village clinics.

With the vision of "Leaving no HER2-positive patient behind," Henlius will make all-round efforts to help patients achieve longer survival and improve the quality of life. In addition, the company will continue 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.

About HANQUYOU

HANQUYOU (trastuzumab,  trade name in Europe: Zercepac® ; trade names in Australia: Tuzucip® and Trastucip®） is the trastuzumab biosimilar developed in accordance with the guidelines from the National Medical Products Administration (NMPA), the European Medicines Agency (EMA). In 2020 HANQUYOU was launched in European Union and China successively. HANQUYOU is now indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. Henlius has established a specialized commercial team with more than 550 sales agents to make full efforts to develop and further tap into China market. As of now, HANQUYOU has benefitted about 140,000 patients in China. In August 2021, HANQUYOU was launched with another dosage form of 60mg, which can  be flexibly combined with 150 mg dosage form to provide a personalized and more cost-effective option for patients with different weights. On the other hand, Henlius has aggressively pursued overseas commercialization of HANQUYOU, actively collaborating with global partners to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to date, HANQUYOU has received marketing approvals globally covering over 40 countries and regions, including China, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Argentina, and Saudi Arabia. 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.