2012年上半年,全球共首次批准了12个新分子实体和6个新生物制剂(表1),其中包括1个血管和血液系统疾病治疗药物、4个内分泌和代谢性疾病治疗药物、7个抗肿瘤新药、2个呼吸系统疾病治疗药物、1个泌尿道疾病治疗药物、1个免疫系统疾病治疗药物、1个齿科疾病治疗药物和1个诊断试剂。这些新药大多数具首创性,临床地位重要,其中长效促红细胞生成药物培格伊奈沙肽 In the first half of 2012, a total of 12 new molecular entities and 6 new biological agents were approved for the first time in the world (Table 1), including one for the treatment of vascular and hematological diseases, four for the treatment of endocrine and metabolic diseases, and seven Antitumor drugs, two respiratory disease drugs, one urinary tract drug, one immune system drug, one dental disease drug and one diagnostic reagent. Most of these new drugs are original and clinically important. Among them, the long-acting erythropoietic drug,