Shanghai, China, August 22, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord Healthcare Inc. (an affiliate of Intas Pharmaceuticals, Ltd.), has received marketing approval (Notice of Compliance) from the Health Canada for HLX02 (trade name: HANQUYOU in China, HERCESSI™ in U.S., Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved under the trade name of Adheroza in Canada for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and United States (U.S.), with previous approvals for commercialization by the European Commission (EC), National Medical Products Administration (NMPA), and United States Food and Drug Administration (FDA) in July and August 2020 and April 2024, respectively. So far, HLX02 has been successfully approved in 48 countries and regions, including China, U.S., the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Brazil, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania. To date, HLX02 has benefited more than 200,000 patients.
HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) was granted approval by the Health Canada based on a comprehensive package of analytical, non-clinical and clinical study data submitted by Henlius. Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study. The data demonstrated that HLX02 is highly similar to the reference product trastuzumab in terms of quality, safety, and efficacy.
HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the U.S., Zercepac® in Europe) has received recognition from global regulatory authorities for its longstanding commitment to maintaining manufacturing systems that comply with the highest quality standards. The manufacturing facilities for HLX02 has successfully passed the on-site inspections and audits conducted by the NMPA, European Medicines Agency (EMA), U.S. FDA, PIC/S Member Brazilian National Health Surveillance Agency (Portuguese: Agência Nacional de Vigilância Sanitária, “ANVISA”) and Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat and Makanan, the“BPOM”), as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies. The company has built 3 manufacturing facilities, and its current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Europe, Southeast Asia, Latin America, and Middle East and North African countries. The company is also continuing to expand its total commercial capacity to address the ever-increasing global market needs.
Henlius has aggressively pursued international commercialization of HLX02 and is actively collaborating with global partners such as Accord, Abbott, Eurofarma, and KGbio to bring its therapeutics to patients in the U.S., Canada, Europe, and other emerging markets, covering about 100 countries and regions. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.