Shanghai Henlius Biotech Inc. has announced that its wholly-owned subsidiary, Shanghai Henlius Biologics Co., Ltd., has successfully obtained Certificates of GMP Compliance from the Federal Agency for Medicines and Health Products in Belgium. This certification applies to the drug substance and drug product lines for HLX11 and HLX14, indicating that these production lines meet the European Union's Good Manufacturing Practice standards. The approval facilitates the commercial production and distribution of HLX11 and HLX14 within the EU, bolstering the company's global pharmaceutical market presence. This development follows a previous exclusive licensing agreement with Organon LLC for the global commercialization of these products, excluding mainland China, Hong Kong, Macau, and Taiwan.
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