Henlius Forges Ahead With US PD-1 Plans Despite Peers' Setbacks
Bridging Study Planned
The latest step by the Chinese drug maker to support its international ambitions is a bridging study in the US, which will evaluate its PD-1 contender serplulimab against Roche’s PD-L1-targeted Tecentriq.
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An inability to conduct manufacturing field inspections in China due to strict local COVID-19 policies is cited as the only reason for the delay for the anti-PD-1 drug, for which the timescale for resolution is currently unclear.
Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.
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.