Chinese Biotech’s Herceptin Biosimilar Meets Endpoint & Moves Closer to Approval

Nov 25, 2019 | China, HER2-Positive Breast Cancer, Shanghai Henlius Biotech’s

Chinese Biotech’s Herceptin Biosimilar Meets Endpoint & Moves Closer to Approval

Shanghai Henlius Biotech’s HLX02, a trastuzumab biosimilar, achieved similar overall response rates (ORR) to reference trastuzumab (Herceptin®; Roche) in women with human epidermal growth factor receptor 2-positive (HER2+) recurrent or previously untreated metastatic breast cancer.

The Background

These results are based the outcomes of a large, randomized, Phase III clinical trial were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2019, November 22-24, 2019 in Singapore.

A First for China

This investigational agent represents a first in that it is the first fully-humanized anti-HER2 monoclonal antibody, made in China and accepted for Marketing Authorization Application (MAA) review by the European Medicines Agency (EMA).

Competition & Access

Professor Binghe Xu, MD, PhD, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, in Beijing noted, “Trastuzumab is not widely accessible around the world due to its high cost. The entry of more affordable versions of trastuzumab such as HLX02 could open up treatment access

The Results

The sponsor and investigators report that the treatment has far improved overall survival in patients with HER2-positive breast cancer—Trastuzumab has become a standard of care but it is costly and in many regions its maker Roche doesn’t change business model for greater access. The biosimilar movement offers a way to overcome these challenges.

Dr. Xu reported that “HLX02 is equally safe and effective as the reference trastuzumab and has been rigorously evaluated by regulatory authorities such as the European Medicines Agency (EMA), based on sound scientific principles.”

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About Shanghai Henlius Biotech

Founded in 2009, Shanghai Henlius Biotech is a global clinical-stage company focusing on the discovery, development, manufacturing and commercialization of high-quality and innovative biologics to treat a range of chronic and life-threatening diseases. Publicly traded, their parent organization is Fosun Pharmaceuticals.

With a team of over 600 employees, their pipeline includes 11 clinical-stage product candidates with 24 successful IND/CTA filings (14 approvals from China; 3 from the United States; 3 from Taiwan; 1 from the EU; 1 from Ukraine; 1 from Philippines and 1 from Australia. They are on the verge of having HLX01 be the first approved biosimilar in China according to their LinkedIn site.

Lead Research/Investigator

Professor Binghe Xu, MD, PhD, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences

Source: Onco'Zine

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