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Henlius Passes Its Second EU GMP Inspection


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.

Henlius has been upholding the highest quality standards. It has built up a quality management system in line with quality standards in China, Europe, the U.S., etc. The system covers the entire product continuum ranging from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. The sites and the supporting quality management system have passed nearly 100 inspections and audits conducted by the NMPA, the EMA, PIC/S participating members, the EU Qualified Person, and multiple international business partners. Notably, its Xuhui Facility, with a capacity of 24,000 Liters, and its supporting quality management system have been certificated by the EU GMP in 2020, making it the first China- and EU-certified GMP site to manufacture self-developed antibody drug in China. Xuhui Facility and Songjiang First Plant, also with a capacity of 24,000 Liters, hit a total capacity of 48,000 Liters and work synergistically to reach the maximum operational scale and maintain stable supply in China, Europe, and Latin America. The third facility - Songjiang Second Plant, when fully-operational, will add another 96,000 Liters of capacity, making the total capacity hit 144,000 Liters in 2026 to address the ever-increasing global market needs.

For HANSIZHUANG, Henlius has been amplifying its reach by joining hands with global partners such as Intas, PT Kalbe Genexine Biologics(KGbio)and Fosun Pharma to speed up the launch progress of HANSIZHUANG in the U.S., Europe and emerging markets including Southeast Asia, MENA, and India. Staying true the original aspirations of “affordable innovation, reliable quality”, Henlius will keep redoubling its efforts in upholding the highest quality standards throughout the product lifecycle to benefit more patients worldwide with high-quality products.