China, Immuno-oncology

China’s biotech pipeline is brimming with PD-1/L1 checkpoints. Are they really needed?

The big US and European markets aren’t the only place where PD-1/L1 checkpoint drugs are crowding in. Beginning later this year, the data analytics firm PharmCube reports, Keytruda and Opdivo should both be green lighted for marketing in China. And they’ll likely be swiftly followed by 4 Chinese biopharmas angling for their own share of the market — with a dozen more behind them preparing to make an impact on China and the world.

PharmCube tells Endpoints News that Innovent Biologics, Shanghai Junshi, BeiGene (Celgene’s partner) and Jiangsu Hengrui are all being tipped for a market launch in the first half of 2019. Bristol-Myers Squibb has lined up a shot at non-small cell lung cancer, Merck has melanoma, Innovent has Hodgkin lymphoma, while Shanghai Junshi also has melanoma.

And Jiangsu Hengrui and BeiGene? Says PharmCube: “We’re not sure, they both have NSCLC, esophageal cancer and hepatocellular cancer in Phase III.”

There are 5 checkpoints on the US market, with Regeneron $REGN and Sanofi $SNY likely to grab sixth place soon. But the Cancer Research Institute recently counted 164 programs around the world, with 1,502 clinical trials underway involving a PD-1/L1, with 1,105 combo studies in the pipeline. And these Chinese companies are coming on strong, with the 4 leaders followed by 13 more outfits collectively covering 6 Phase I drugs, 3 more programs about to enter clinical trials and 9 at the IND stage.

The unpartnered assets on the list below could make for inexpensive partnerships among Western companies looking for their own clinical-stage PD-1/L1 drugs to add to their pipelines.

All of these other checkpoints could help swamp a field, where generation one drugs are being threatened with commoditization. And that in turn is driving a frenzy of combination studies using a variety of new drugs that can provide a critical assist to the PD-1/L1s, along with other, more targeted drugs.

They are not all problem free. Hengrui’s lead checkpoint is partnered with Incyte $INCY, but was linked to a unique and mild side effect — grade 1 and 2 hemangiomas, small, non-cancerous vascular skin growths — that made it unappealing for combination work in a highly competitive field, forcing Incyte to add MacroGenics as a new partner.


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