The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Ichnos will receive an upfront payment of Euro 20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales
Data builds on promising signal published last week, underscoring the importance of sotrovimab for early treatment of COVID-19
Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron
CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region
The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
Second interchangeable biosimilar product approved by agency
Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors
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