Humanigen Recruits Chime Biologics As Manufacturing Partner For Lenzilumab

Humanigen Inc HGEN and Chime Biologics, contract development and manufacturing organization (CDMO), have entered into a manufacturing services agreement to produce Humanigen’s lenzilumab bulk drug substance and drug product for commercial sale.
It will follow the receipt of the requisite regulatory authorizations or approvals in regions outside of the U.S., including Europe, the U.K., India, and Brazil.
Under the terms of this agreement, Chime will use the modular single-use KuBio (Cytiva) biologics facility in China.
The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L, and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually. Technical transfer work has already begun, and the commercial product is planned to be available in 2022.
Last week in its Q1 earnings PR, the company said it is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end.
Price Action: HGEN shares are trading 2.48% higher at $18.18 on the last check Monday.