Henlius(02696.HK): Hanbeiyou (Pertuzumab Injection) Passes GMP Compliance Inspection, Songjiang Base Eligible for Commercial Production
NewTimeSpace News: Shanghai Henlius Biotech, Ltd. (02696.HK) announced on 17 June that Hanbeiyou (pertuzumab injection) has passed GMP compliance inspection issued by Shanghai Municipal Drug Administration. The Songjiang manufacturing base is now qualified for domestic commercial production of the product. Independently developed pertuzumab biosimilar for HER2-positive breast cancer, Hanbeiyou has obtained marketing approvals in China, the US and EU. Domestic sales of pertuzumab products reached approximately RMB2.728 billion in 2025 per IQVIA CHPA data.
NewTimeSpace News: On 17 June 2026, Shanghai Henlius Biotech, Ltd. (02696.HK) released a voluntary announcement. Its wholly-owned subsidiary Shanghai Henlius Biopharmaceutical Co., Ltd. received aNotice of Drug GMP Compliance Inspection Resultissued by Shanghai Municipal Drug Administration. The biopharmaceutical manufacturing base in Songjiang (Songjiang Plant I) successfully passed GMP compliance inspection covering the drug substance production line, formulation filling line and packaging line dedicated to Hanbeiyou (pertuzumab injection), with a conclusion of compliance.
Hanbeiyou is the Company’s self-developed pertuzumab biosimilar, indicated for neoadjuvant/adjuvant therapy of HER2-positive early breast cancer and metastatic HER2-positive breast cancer. The asset has made multiple global regulatory breakthroughs: its NDS filing was accepted in Canada in May 2025; US BLA secured approval in November 2025; EU MAA was approved in April 2026; and domestic NDA received approval in China in May 2026. According to IQVIA CHPA statistics, annual domestic sales of pertuzumab products in China hit roughly RMB2.728 billion in 2025.
The Company stated that passing the GMP inspection confirms its quality management system complies with China’s GMP regulations, enabling Songjiang Plant I to conduct full-scale commercial manufacturing of Hanbeiyou for the Chinese market.
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