This invention provides a lyophilized formulation obtained by dissolving active human bone morphogenetic protein-2 homodimer adducted with alanine residues at N-terminus in a strong acidic solution and then having the same lyophilized, a process for producing the formulation, and a kit for bone regeneration or bone therapy comprising the formulation.本發明係提供一種將N末端經加成丙胺酸殘基之活性型人骨形成蛋白-2的同源二聚體溶解於強酸溶液後經凍結乾燥而得之凍結乾燥製劑、該製劑之製造方法、含有該製劑之用於骨再生或骨治療之套組。