Lilly/Innovent Experience Show Hurdles Remaining For Chinese PD-1 Inhibitors
Executive Summary
China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.
You may also be interested in...
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.
Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?
Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.
Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?
Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.