Chinese firms win subcutaneous checkpoint inhibitor approval, beating global heavyweights to new opportunity 

A trio of Chinese biopharma companies has won the first approval for a subcutaneous checkpoint inhibitor, beating rivals including Merck and Pfizer by securing authorization in its home market. 

Multiple companies are studying subcutaneous formulations of checkpoint inhibitors. Merck posted data on its subcutaneous version of Keytruda earlier this year, putting it on the tail of Pfizer, a big proponent of the approach that began a phase 3 trial of its candidate sasanlimab late in 2019. The work could slash the time taken to administer checkpoint inhibitors, thereby reducing the burden on patients.

China will now serve as a proving ground for whether the convenience of subcutaneous delivery drives sales. 3D Medicines, Alphamab Oncology and Simcere Pharmaceutical jointly developed the subcutaneous PD-L1 antibody, envafolimab, and picked up approval in China.

The Chinese approval covers the use of the medicine, which will be sold as Enweida, in adults with microsatellite instability-high or mismatch repair deficient advanced solid tumors. The developers of Enweida said the approval marks the first time China has granted a tissue-agnostic indication to an immune checkpoint inhibitor.

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Work to expand the use of envafolimab into new indications and geographies is underway. Tracon Pharmaceuticals is running a pivotal clinical trial in U.S. patients with forms of sarcoma who have progressed after treatment with chemotherapy. 3D Medicines is running trials in other diseases.

Advocates of subcutaneous delivery see the route of administration shaking up the market. Earlier this year, John Young, chief business officer at Pfizer, told investors on a quarterly results conference call there is a “very significant” opportunity for a drug that combines the proven efficacy of checkpoint inhibitors with the “significant convenience enhancements” of subcutaneous delivery.