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
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
The new site will increase Syngene's total single-use bioreactor capacity to 50,000L
This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation
Overall investment in the US facility is estimated around US$50 million
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
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