Shanghai Junshi Biosciences Co., Ltd. Class H (HK:1877) has released an update.
Shanghai Junshi Biosciences Co., Ltd. is pleased to announce that its subsidiary Suzhou Union Biopharm Co., Ltd. has secured the EU Good Manufacturing Practice (GMP) certificate, paving the way for the expansion of its core product, toripalimab injection, into the European market. The certificate, which is recognized by all EU member states, affirms the company’s compliance with EU GMP standards, although the product still awaits approval from the European Medicines Agency. The company cautions investors that the impact on short-term financial results may not be significant and acknowledges the uncertainty and risks involved in the approval and marketing process.
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