Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K., and University of Oxford COVID-19 Vaccine Astrazeneca (formerly AZD-1222) Vaccine COVID-19 infection U.K. Medicines and Healthcare products Regulatory Agency provided authorization for emergency supply 
Biocure Technology Corp., of Vancouver, British Columbia, Canada, and Pharos Vaccine Inc., of Seongnam, South Korea CD-19  CAR T therapy  Relapse and refractory B-cell precursor acute lymphoblastic leukemia Submitted IND application to the Korean Ministry of Food and Drug Safety to proceed with phase I trial
Hepion Pharmaceuticals Inc., of Edison, N.J. CRV-431 Hepatitis B structural protein inhibitor; peptidyl-prolyl cis-trans isomerase A inhibitor Nonalcoholic steatohepatitis Independent data safety monitoring board  approved continuation of the phase IIa AMBITION trial
Hutchison China Meditech Ltd., of Hong Kong Surufatinib (Sulanda in China)  Vascular endothelial growth factor receptor and fibroblast growth factor receptor tyrosine kinase inhibitor Non-pancreatic neuroendocrine tumors  Approved by National Medical Products Administration of China 
Lygenesis Inc., of Pittsburgh Allogeneic cell therapy Allogeneic cell therapy End-stage liver disease  FDA cleared IND; phase IIa trial
Osmotica Pharmaceuticals plc, of Bridgewater, N.J. Arbaclofen extended release  GABA B receptor agonist Spasticity resulting from multiple sclerosis FDA issued CRL, stating the company didn't provide adequate justification (including in its most recent NDA amendment) for the statistical analysis of the change from baseline to day 84 in TNmAS-MAL scores comparing arbaclofen 40 mg to placebo, one of the co-primary endpoints; FDA made a number of recommendations, including conducting a new study 
Tetra Bio-Pharma Inc., of Ottawa, Ontario, Canada Dronabinol soft gel capsules (PPP-002) Cannabinoid receptor agonist AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy New drug submission filed with Health Canada
Tracon Pharmaceuticals Inc., of San Diego Envafolimab Subcutaneously administered single-domain antibody against PD-L1 MSI-H/dMMR cancer Chinese National Medical Products Administration accepted new drug application for review

Notes

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