China - Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, it has received GMP certificates issued by the Brazilian National Health Surveillance Agency (Portuguese: Agencia Nacional de Vigilncia Sanitaria,'ANVISA'), one of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating members, indicating that its Xuhui Facility passes the GMP inspection of the drug substance (DS) and drug product (DP) production lines of its rituximab HANLIKANG and trastuzumab HANQUYOU (trade name in Europe: Zercepac; trade names in Australia: Tuzucip and Trastucip) by ANVISA and meets PIC/S GMP standards.
This is the first time that the production lines of HANLIKANG have passed GMP inspection conducted by an overseas authority. The successful inspection by ANVISA, as well as the previous certification by China and the EU GMP, confirms that the company's manufacturing facility and supporting quality management system are in conformity with the highest quality standards, promoting the global launch of more products and thus benefiting more patients, including those in emerging countries.
One of the two inspected products is HANQUYOU, the first China-developed monoclonal antibody biosimilar approved both in China and Europe, indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. Three years after its launch, with a cumulative global shipment volume totaling over 3 million units, HANQUYOU has become the China-developed biosimilar with the most marketing approvals, covering over 40 countries and regions, including China, the UK, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia. In February 2023, the Biologics License Application (BLA) for HANQUYOU was accepted by the U.S. FDA,making it the first Chinese biosimilar approved in both China and the EU, and potentially to be approved in the U.S. The other inspected product HANLIKANG is the first China-developed biosimilar with over 200,000 Chinese patients benefited so far since its launch in 2019. With the newly approved indication rheumatoid arthritis, HANLIKANG has become the rituximab with the most approved indications in China.
In the past few years, Henlius has been expanding global footprint and driving broader access to high-quality biologics worldwide, actively collaborating with global partners such as Accord, Boston Oncology, Getz Pharma, Elea, KGbio and Fosun Pharma to help patients in the U.S., Canada, Europe, and other emerging markets including Brazil, Argentina and Indonesia, with core products including HANQUYOU, anti-PD-1 mAb HANSIZHUNAG, HANLIKANG, adalimumab HANDAYUAN, bevacizumab HANBEITAI, pertuzumab biosimilar HLX11 and denosumab biosimilar HLX14.
Putting quality at the core, Henlius has been advancing production agenda with the construction of Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, and putting in place a quality management system in accordance with the highest quality standards. The system covers the entire product continuum ranging from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. Its commercial production facilities and supporting quality management system have passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person, and multiple international business partners. Notably, the inspected Xuhui Facility, with a capacity of 24,000 Liters, and its supporting quality management system have been certificated by the EU GMP in 2020, making it the first China- and EU-certified GMP site to manufacture self-developed antibody drug in China.Previously, Xuhui Facility also passed GMP Inspection for HANSIZHUANG by another PIC/S member BPOM.Another site Songjiang First Plant, also with a capacity of 24,000 Liters, was certificated by China GMP in 2022 and received the Pre-licencing Inspection (PLI) conducted by the U.S. FDA in August 2023. With a total capacity of 48,000 Liters, the two sites work synergistically to reach the maximum operational scale and maintain stable supply in China, Europe and Latin America. The third facility - Songjiang Second Plant, when fully-operational, will add another 96,000 Liters, making the company's total capacity hit 144,000 Liters in 2026 to address the ever-increasing global market needs. In keeping with the original aspirations of 'affordable innovation and reliable quality', Henlius will work with partners to redouble its efforts in bring more high-quality products to patients worldwide.
About PIC/S
PIC/S is a co-operative arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use. It comprises more than 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) and signs co-operation agreement with the international organisations such as the EMA, the ICH and the WHO. PIC/S aims at harmonising inspection procedures worldwide, developing common standards in the field of GMP and thus increasing mutual confidence between authorities. The PIC/S GMP guide has been the global standard in the field of GMP.
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 and it 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 145,000 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 been pursuing overseas commercialization of HANQUYOU, actively collaborating with global partners to bring its therapeutics to patients in the United States, 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 China, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia.
About HANLIKANG
HANLIKNAG (rituximab) is the company's first proprietary product. It is the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) issued in 2015. As of now, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis for which the originator rituximab has not been approved in China, benefiting a wider patient population with differentiated strategies.
Contact:
Tel: 021-33395800
SHANGHAI HENLIUS BIOTECH, INC. 
