Junshi Bio (01877.HK) announced on July 10th that its wholly-owned subsidiary, Suzhou Zhonghe Biomedical Technology Co., Ltd., recently received a Certificate of GMP Compliance of a Manufacturer issued by The Ireland Health Products Regulatory Authority based on relevant regulations of the European Medicines Agency (EMA). Certified production lines: Raw Liquid Workshop 1, Preparation Workshop 1.
This is the first time that the relevant production facilities for the company's core product, Toripalimab Injection, have passed the EU GMP certification. According to the EU's GMP mutual recognition system, passing the GMP certification indicates that the certified production facilities have met the EU's GMP standards.
The Marketing Authorization Application (MAA) for Toripalimab Injection combined with cisplatin and gemcitabine for first-line treatment of locally recurrent or metastatic Nasopharyngeal Carcinoma, and Toripalimab Injection combined with paclitaxel and cisplatin for first-line treatment of unresectable locally advanced/recurrent or metastatic Esophageal Squamous Cell Carcinoma, has been accepted by the EMA. According to local regulations, Toripalimab Injection still needs to obtain EU marketing authorization approval before being marketed in the EU.
The European market is an important part of the company's overseas commercialization strategy. This GMP certification is conducive to the company further promoting the expansion of overseas markets and improving the company's market competitiveness, and will have a positive impact on the company's operations in the future.