Company Product Description Indication Status
Aruvant Sciences Holdings Ltd., of London ARU-1801 HBG gene stimulator Sickle cell disease EMA granted priority medicines designation
Asana Biosciences LLC, of Lawrenceville, N.J. Gusacitinib (ASN-002) Janus kinase and spleen tyrosine kinase inhibitor Moderate to severe chronic hand eczema FDA granted fast track designation
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. Rapivab (peramivir) Cyclopentane analogue Acute uncomplicated influenza FDA approved the supplemental NDA, lowering the approved age to children 6 months and older
Innovent Biologics Inc., of San Francisco, and Indianapolis-based Eli Lilly and Co. Tyvyt (sintilimab) Monoclonal antibody targeting PD-1 Nonsquamous non-small-cell lung cancer National Medical Products Administration of China approved the supplemental NDA for use of the drug in combination with pemetrexed and platinum chemotherapy in the first-line setting
Prothena Corp. plc, of Dublin Birtamimab Serum amyloid A protein inhibitor; amyloid protein deposition inhibitor AL amyloidosis Following discussions with FDA, advancing into confirmatory phase III Affirm-AL study, to be conducted with a primary endpoint of all-cause mortality at p<0.10 under a special protocol assessment agreement
Russian Direct Investment Fund, of Moscow Sputnik V Adenoviral vector-based vaccine COVID-19 prophylaxis Federal Commission for the Protection against Sanitary Risk of Mexico approved the vaccine under the emergency use authorization procedure
Russian Direct Investment Fund, of Moscow Sputnik V Adenoviral vector-based vaccine COVID-19 prophylaxis Ministry of Health of the Republic of Nicaragua approved the vaccine under the emergency use authorization procedure 

Notes

For more information about individual companies and/or products, see Cortellis.