Mabwell wins China nod for first innovative biologic, eyes Hong Kong listing

Shanghai-based Mabwell Bioscience (SH: 688062) has secured approval from the Chinese regulator for its first locally developed novel biologic, marking a pivotal moment in the company's ambitions to expand its oncology pipeline and strengthen its commercial presence in Asia and beyond.

The injectable drug, branded as Mailisheng (agestine alfa), is the first domestically approved granulocyte colony-stimulating factor (G-CSF) in China that uses albumin-fusion technology. It was developed by a wholly-owned subsidiary of the firm,T-mab.

A Phase III study of the product enrolled nearly 500 patients with breast cancer, comparing Mailisheng with a reference G-CSF drug, Teyoulike. Mabwell highlighted consistent benefits across multiple chemo cycles. Safety and tolerability were found to be comparable to the control.