信达生物和礼来合作的双特异性抗体临床试验获NMPA批准
GBI获悉，信达生物制药上周宣布其双特异性抗体（研发代号：IBI318），已于近期获得国家药品监督管理局（NMPA）颁发的药物临床试验批件，拟开展针对血液肿瘤和晚期实体瘤的临床研究。
IBI318由信达生物和美国礼来制药公司共同研发，并由信达生物负责在中国进行开发。GBI此前曾报道，信达生物和礼来于2015年达成三个肿瘤免疫治疗双特异性抗体药物的开发合作协议，三个抗体均使用来自于信达生物自主研发的PD-1单抗。
IBI318是针对PD-1及TAA的另一未披露靶点的重组全人源IgG1双特异性抗体，通过同时阻断PD-1及另一肿瘤相关靶点的信号通路，增强免疫突触的形成，从而有望提高抗肿瘤活性及疗效。
Suzhou-based Innovent Biologics Inc., a biotech company focused on oncology, autoimmune and other major diseases, last week announced that its investigational new drug (IND) application for bispecific antibody IBI318 was approved by the National Medical Products Administration (NMPA) to conduct trials for hematological and advanced solid tumors. The drug is the result of a collaboration with Eli Lilly, and is being developed in China by Innovent. As GBI reported, in 2015 the two companies penned a cooperation agreement under which Eli Lilly would create three pre-clinical anti-programmed death-1 (PD-1) bispecific antibodies using an antibody sequence contributed by Innovent.
A recombinant fully human immunoglobulin G1 (IgG1) antibody, IBI318 targets the PD-1 pathway and an undisclosed tumor-related signaling route while enhancing immune response. According to the company, this makes it more effective than current anti-PD-1 antibody therapies.
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