US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.

Inclusion into China's national reimbursement drug list alone does not guarantee revenue growth but in some cases higher volumes seem to be offsetting the requisite big price cuts, reveal second-quarter results from some leading publicly-traded biotechs in the country.

The latest approval for AnNiKe (penpulimab) from Akeso/Sino Biopharm adds further competition to a crowded space where six PD-1 immuno-oncology drugs elbow each other.

Within months, one of the three latest immuno-oncology drugs from Chinese firms Innovent, Junshi and Akeso is likely to be approved, providing new competition to global giants such as BMS and Merck & Co. as they race each other over to the finish line.