Fast moving Chinese regulators wave third homegrown PD-1 to market

Jiangsu Hengrui has secured an OK for its PD-1 drug, marking the fifth PD-1 approval in China and tilting the scale toward homegrown checkpoints.
Hengrui — a top 25 biopharma company globally led by Piaoyang Sun — joins Junshi and Innovent in facing foreign counterparts: Merck’s Keytruda and Bristol Myers’ Squibb’s Opdivo.

Its drug, camrelizumab, has long been tapped as one of the first finishers in China’s heated checkpoint race. Incyte dished out $25 million plus $770 million in biobucks to partner on its PD-1, although an odd adverse reaction diminished the American biotech’s enthusiasm.
Regardless, the National Medical Products Administration sanctioned camrelizumab as a treatment for recurrent or refractory classical Hodgkin’s lymphoma following two lines of systemic chemotherapy.

That’s the exact indication that Innovent scored for its drug Tyvyt, which goes to show how quickly indications can get crowded.

Meanwhile, Junshi’s Tuoyi is indicated for melanoma, as is Keytruda — though Merck recently racked up an additional approval in non-small cell lung cancer.

All told, these drugs totaled $6.4 million in sales in 2018, according to IMS data quoted by Hengrui.

BeiGene, CStone and Alphamab are among the more well-known players also angling for near-term approval of their own checkpoints, with Hodgkin’s lymphoma set to be a key battleground.

Hengrui, though, is also exploring NSCLC, esophageal cancer and hepatocellular cancer in Phase III while also eyeing a green light in the US.

Fast moving Chinese regulators wave third homegrown PD-1 to market