A plethora of positive results from Phase III multi-regional clinical trials sponsored by Chinese firms specializing in oncology are buoying hopes for regulatory approvals and globalization ambitions.
It is notable that all the studies reported by the companies at the European Society for Medical Oncology (ESMO) Congress enrolled US patients, after the US Food and Drug Administration earlier this year turned down a string of new drug applications from Chinese companies on grounds of inadequate of US-derived data. (Also see "BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges" - Pink Sheet, 18 July, 2022.) (Also see "Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do" - Pink Sheet, 6 May, 2022