复星医药(02196)：国家药监局同意HLX6018用于治疗特发性肺纤维化开展临床试验
复星医药(02196)发布公告，该公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司(以下合称“复宏汉霖”)于近日收到国家药品监督管理局关于同意HLX6018(即重组抗GARP/TGF-β1人源化单克隆抗体注射液，以下简称“该新药”)用于治疗特发性肺纤维化开展临床试验的批准。复宏汉霖拟于条件具备后于中国境内(不包括港澳台地区，下同)开展该新药的I期临床试验。
该新药为本集团(即本公司及控股子公司/单位，下同)自主研发的创新型抗GARP/TGF-β1复合物单抗，拟用于纤维化相关疾病的治疗。
截至2024年2月，集团现阶段针对该新药累计研发投入约为人民币4945万元(未经审计)。
截至本公告日，全球范围内尚无靶向GARP/TGF-β1复合物的单克隆抗体获批上市。
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