China Approves World’s First Bispecific IO Drug Amid PD-1/L1 Glut

But Competition Looms

Akeso’s PD-1/CTLA-4-targeting therapy cadonilimab has been the front-runner in the bispecific antibody field in China, leading about 50 other similar agents under development by domestic pharma firms. With a new conditional approval, it has also gained a head start over home-grown PD-1/L1 antibody rivals in the cervical cancer space.

China’s top drug regulator granted on 29 June a marketing green light to what appears set to be the world’s first immune checkpoint inhibitor-based bispecific antibody to be commercialized, as other pharma firms in the country remain mired in an increasingly overcrowded domestic market for anti-PD-1/L1 antibodies.

Hong Kong-listed Akeso Inc. gained a conditional approval for its PD-1/CTLA-4-targeting bispecific Kaitanni (cadonilimab; AK104) from the National Medical...