智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司上海复宏汉霖生物医药有限公司收到比利时联邦药品和保健产品管理局(Federal Agency For Medicines And Health Products)就HLX11(重组抗HER2 结构域Ⅱ人源化单克隆抗体注射液，即帕妥珠单抗注射液)、HLX14(重组抗RANKL 全人单克隆抗体注射液，即地舒单抗生物注射液)所涉生产设施颁发的《Certificate of GMP Compliance of a Manufacturer》(即《药品GMP证书》)。
本次为HLX11、HLX14相关生产设施首次通过欧盟成员国GMP认证。根据欧盟成员国之间的GMP互认制度，本次通过比利时GMP认证表明该等生产设施已符合欧盟GMP标准。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.