Biotech Stocks Facing FDA Decision In February 2022

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Innovent Biologics
Innovent Biologics

An FDA panel is scheduled to review Innovent Biologics Inc (IVBXF.OB)/Eli Lilly and Co.’s (LLY) Sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer on February 10.

Sintilimab is jointly developed by Innovent and Lilly (LLY). This drug is already approved in China, under the brand name Tyvyt, for the treatment of first line non-squamous non-small cell lung cancer, first line squamous non-small cell lung cancer and first line relapsed or refractory classic Hodgkin's lymphoma.

Tyvyt is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells.

For the third quarter of 2021, Lilly’s Tyvyt revenue in China was $125.6 million, up 49% over the year-ago quarter.

The final regulatory decision date for Sintilimab in the U.S. is set for March 18.

IVBXF.OB closed Monday’s (Jan.24, 2022) trading at $5.36.