The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications
It also empowers domestic precision immunotherapy for tumours and promotes the high-quality development of China's biopharmaceutical industry
The three prequalified products are manufactured by the originator company, Roche, but the listings should pave the way for more companies coming forward to seek WHO prequalification
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24
This marks the second indication for which gumokimab has gained NDA review acceptance
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