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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。