Lilly/Innovent Experience Show Hurdles Remaining For Chinese PD-1 Inhibitors
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.
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The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.
Nanjing Legend gains FDA approval for its BCMA cell therapy, the second to go to market in the US marks a win for true innovators from China, not cheaper but similar products, some say.
Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.