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Shanghai Henlius Announces Record Net Profit Increase; Denosumab and Pertuzumab Biosimilars in Pipeline

Aug 26, 2024

Shanghai Henlius Biotech has revealed its financial results for the first half of 2024, reporting revenue of RMB2.7461 billion (an increase of 9.8% YOY) and a record net profit of RMB2.7461 million (an increase of 61% YOY).

Henlius attributes its profits to increasing commercial sales of its core products; namely, its trastuzumab biosimilar HANQUYOU/HLX02 (known as HercessiTM in the US and Zercepac® in Europe) and HANSIZHUANG (serplulimab), its treatment for small-cell lung cancer, which has been launched in China, Indonesia, Cambodia and Thailand.  Henlius reports that its MAA for HANSIZHUANG has been validated by the European Medicines Agency (EMA) and is expected to be approved in 2024.  Henlius plans to submit a BLA for the product in the US in early 2025.

Other milestones noted by Henlius include the approval of HANLIKANG (biosimilar rituximab) in Peru and acceptance of its European MAA for HLX14 (biosimilar denosumab) in May 2024.  Henlius plans to submit marketing applications for HLX14 in the US, and for HLX11 (biosimilar pertuzumab) in the US and China, in the second half of 2024.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 and HLX11 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.