HENLIUS: Obtained two EU GMP certificates

Zhitong
2025.07.03 11:45

On July 3rd, HENLIUS announced on the Hong Kong Stock Exchange that its wholly-owned subsidiary, Shanghai HENLIUS Biopharmaceuticals Co., Ltd., has received two GMP certificates issued by the Federal Agency For Medicines And Health Products of Belgium. The raw material production line for HLX11, the formulation production line, and the packaging production line, as well as the raw material production line for HLX14, the formulation line 2, formulation line 3, and the packaging production line have passed GMP certification. According to the GMP mutual recognition system among EU member states, this GMP certification indicates that the production lines for HLX11 and HLX14 comply with EU GMP standards