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
RSM01, a preventive treatment targeting respiratory syncytial virus (RSV), was licensed earlier this month from the Gates Medical Research Institute
The early-stage study will test the drug’s safety, tolerability and biological effects in humans
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The collaboration will leverage this clinical experience to inform NCEL-101 development, streamline regulatory pathways, and potentially accelerate timelines for achieving durable graft survival comparable to donor human islets
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