Hansoh Pharmaceutical Group (HKG:3692) said the second biologics license application or BLA of its antibody drug XINYUE (Inebilizumab Injection) was accepted by the National Medical Products Administration or NMPA, a Tuesday bourse filing said.
The drug is a targeted CD19 B cell-depleting antibody and is used to treat immunoglobulin G4-related disease, a chronic inflammatory condition.
In May 2019, Viela Bio granted the group the exclusive license to develop and commercialize the drug in China, Hong Kong, and Macau.
NMPA approved the launch of the drug in China in 2022, while the drug was also included in the national reimbursement drug list in 2023, a status that was renewed in November 2024.
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