Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that its wholly-owned subsidiary, Suzhou Zhonghe Biomedical Technology Co., Ltd., has obtained the Certificate of GMP Compliance from the European Medicines Agency following a successful inspection by the Ireland Health Products Regulatory Authority.
This GMP certification signifies that the manufacturing facilities for Junshi Bio’s Loqtorzi (toripalimab) are now recognized as compliant with the Good Manufacturing Practice standards by the member countries of the European Union (EU). Loqtorzi, a programmed death-1 (PD-1) inhibitor, is currently under regulatory review in the EU for its use as a first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma in combination with chemotherapy, as well as for the first-line treatment of locally advanced/recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy.- Flcube.com
