The 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) is held online and in-person from 25th to 29th September 2021. In this meeting, Henlius releases phase 3 study results of HLX04 (bevacizumab biosimilar), in patients with metastatic colorectal cancer in an oral presentation. The NDA of HLX04 was accepted by NMPA in September 2020 and is expected to be approved in Q4 2021 or Q1 2022. Unlike the marketed products in China, mCRC was explored in the phase 3 clinical study of HLX04, making HLX04 the only bevacizumab biosimilar holding mCRC clinical data in China.
Details of this study are as follows:
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).
Henlius has proactively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康 (rituximab), the first China-developed biosimilar, 汉曲优 (trastuzumab, Zercepac in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远 (adalimumab), the Company's first product indicated for autoimmune diseases, the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX04 (bevacizumab), HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 11 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.