Henlius Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02

Shanghai, China, February 14, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Henlius’ HLX02 (trastuzumab for injection, trade name in Europe: Zercepac ^® , trade name in China: HANQUYOU; trade names in Australia: Tuzucip ^® and Trastucip ^® ) submitted by the company’s business partner Accord BioPharma Inc. (Accord US). The BLA seeks approval of HLX02 for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In 2021, the company granted Accord US the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

Mr. Jason Zhu, President of Henlius, said, "Henlius independently developed HLX02 in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients. The U.S. FDA’s acceptance of the BLA filing not only expands the Henlius’ international footprint. More importantly, we prioritize the needs of patients. As breast cancer has become the most prevalent cancer in the world, trastuzumab has been the cornerstone of treating HER2-positive cases. In collaboration with Accord, we look forward to bringing HLX02 to more patients around the world.”

HLX02 is the first China-developed mAb approved both in China and Europe. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. HLX02 is now 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. The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head to head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results proved that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Henlius has established a quality management system in line with international quality standards, 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, laying the foundation for globalisation. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 litres, and the total production capacity in 2026 is expected to reach 144,000 litres. In 2022, Songjiang First Plant was approved for the commercial production of HLX02 and has been officially put into operation, which effectively ensures market penetration and forms synergy with the Xuhui Facility with a commercial production capacity of 24,000 litres. The company's commercial production facility and supporting quality management system have been certificated by China and the EU GMP. They have also passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person, and multiple international business partners. At the present, a stable supply has been achieved in the Chinese and the EU markets, strongly supporting the continuous expansion of the products globally.

Henlius has aggressively pursued international commercialization of HLX02, actively collaborating with global partners such as Accord Healthcare, Abbott, Cipla, Eurofarma, Mabxience and the Jacobson Group to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to now, HLX02 (trade name in China: HANQUYOU, trade name in Europe: Zercepac ^® , trade names in Australia: Tuzucip ^® and Trastucip ^® ) has launched in over 30 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.