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
The proposed biosimilar to Keytruda demonstrated pharmacokinetic bioequivalence in a multicountry Phase 1 study involving non-small cell lung cancer patients
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
While Drugs for Neglected Diseases initiative (DNDi) drives the R&D for neglected diseases, we collaborate with pharmaceutical companies at multiple stages, including sourcing promising molecules
Our company remains focused on advancing monoclonal antibody therapeutics for solid tumors, with a clear emphasis on combination immunotherapy strategies
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