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Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards.
The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). The National Medical Products Agency (NMPA) has also accepted the application for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC). The European Medicines Agency (EMA) has validated the application for the first-line treatment of ESCC of HANSIZHUANG with the expected approval in the first half of 2024. Previously in October 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG. The EU GMP inspection success stands a major step in speeding HANSIZHUANG to EU launch and lays a solid foundation for expanding its global presence with the concerted efforts from both parties.