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03.12.2021 19:18

Henlius' 4th Biologics: Bevacizumab Biosimilar Hanbeitai Approved by National Medical Products Administration


SHANGHAI, Dec. 3, 2021 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar Hanbeitai, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Hanbeitai is the company's fourth monoclonal antibody (mAb) approved in China, following rituximab biosimilar Hanlikang, trastuzumab biosimilar Hanquyou (Zercepac? in the EU), and adalimumab biosimilar Handayuan. The pipeline has been further replenished with widened indication coverage including hematological malignancies, solid tumors, auto-immune diseases, etc.

Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "We are excited to have Hanbeitai get approved as our fourth product. The credit goes to all the healthcare professionals, patients and regulatory authorities that have contributed to the studies of Hanbeitai. While maximizing the value of biosimilar drugs, we will continue advancing the clinical trial process of its combination with in-house immunotherapy products, such as serplulimab, and growing into a more innovative global biopharmaceutical company."

Mr. Jason Zhu, President of Henlius, said, "Lung cancer and colorectal cancer are ranked second and third with high incidence of cancers in the world, respectively. They are also ranked first and second in China, and there is a huge demand for treatment. The similarity studies showed no statistically significant difference in efficacy, and the safety are highly similar to the originator. It is believed that the approval of Hanbeitai will further improve the accessibility of bevacizumab and provide a high-quality option for patients with lung cancer and colorectal cancer."


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