China Approves World’s First Bispecific IO Drug Amid PD-1/L1 Glut
But Competition Looms
Executive Summary
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.
You may also be interested in...
Chinese Newcomers Look For Niche Immuno-Oncology Opportunities
Chinese pharma companies are continuing to pile into the already overcrowded domestic anti-PD-1/L1 sector in China, but despite the competition and regulatory tightening, the latecomers are looking for opportunities in areas such as cervical and small cell lung cancer with relatively fewer contenders.
China’s CDE Explains Major Issues Around Conditional Approval Scheme
China's conditional approval system, which is an accelerated pathway, is being increasingly used by pharma firms, but some thorny issues remain such as the impact on full approvals, the scheme’s relation to priority reviews and currently available therapies and deadlines for confirmatory studies. Staff from the country's Center for Drug Evaluation discussed various topics around the system in a recent article.
Summit Bets On Akeso IO Bispecific Despite China Firms’ Issues With US FDA
Deal Snapshot: Akeso has already sought to secure FDA approval for its PD-1 inhibitor, but the agency has shown reluctance to approve drugs based on China-only data.