Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) Antibody-drug conjugate targeting HER2 HER2-positive gastric or gastroesophageal junction adenocarcinoma FDA approved supplemental BLA to treat adults with locally advanced or metastatic disease who have received a prior trastuzumab-based regimen
C4 Therapeutics Inc., of Watertown, Mass. CFT-7455 Oral MonoDAC targeting IKZF1/3 Hematologic malignancies FDA cleared the IND for a phase I/II trial
Dr. Reddy’s Laboratories Inc., of Hyderabad, India Sputnik V Vaccine COVID-19 Received approval from Drugs Control General of India to conduct phase III trial
Edigene Inc., of Beijing ET-01 CRISPR/Cas9 gene editing therapy Transfusion-dependent beta-thalassemia China’s NMPA cleared the IND for a phase I trial
Genmab A/S, of Copenhagen, Denmark, Johnson & Johnson, of New Brunswick, N.J., and Halozyme Inc., of San Diego Darzalex Faspro (daratumumab and hyaluronidase-fihj) ADP ribosyl cyclase-1 inhibitor Newly diagnosed light-chain amyloidosis FDA approved supplemental BLA for use in adults; submission reviewed under Real-Time Oncology Review pilot and Project Orbis
Gracell Biotechnologies Inc., of Suzhou, China GC-019F FasTCAR-enabled CAR T therapy Relapsed or refractory adult B-cell acute lymphoblastic leukemia  China's NMPA approved the IND application
Immunitybio Inc., of Culver City, Calif. hAD5 T-cell vaccine Vaccine targeting outer spike protein and inner nucleocapsid protein  COVID-19 Received authorization from South African Health Products Regulatory Authority to begin phase I trial
Khondrion BV, of Nijmegen, the Netherlands Sonlicromanol (KH-176) Redox modulator with anti-inflammatory properties Mitochondrial disease EMA accepted its pediatric investigation plan
Metacrine Inc., of San Diego MET-642 Farnesoid X receptor agonist Nonalcoholic steatohepatitis FDA granted fast track designation
Molecular Templates Inc., of Austin, Texas MT-6402 PD-L1-targeted, antigen seeding engineered toxin body PD-L1-positive cancers FDA accepted the IND application, and the company expects to start a phase I study in 2Q21
Omeros Corp., of Seattle Narsoplimab Mannan-binding lectin serine protease-2 inhibitor Hematopoietic stem cell transplant-associated thrombotic microangiopathy FDA accepted the BLA for priority review
Pieris Pharmaceuticals Inc., of Boston PRS-343 4-1BB/HER2 bispecific antibody Gastroesophageal cancer FDA lifted the partial clinical hold on the phase I trial
Precision Biosciences Inc., of Durham, N.C. PBCAR-19B Stealth cell, CD19 product candidate  Relapsed or refractory non-Hodgkin lymphoma FDA accepted the IND application
Steba Biotech SA, of Luxembourg Padeliporfin Impact Vascular-targeted photodynamic therapy  Low-grade upper tract urothelial cancer FDA granted fast track designation
Takeda UK Ltd., of High Wycombe, U.K., a unit of Takeda Pharmaceutical Co. Ltd. Alunbrig (brigatinib) Tyrosine kinase inhibitor targeting ALK ALK+ non-small-cell lung cancer Scottish Medicines Consortium accepted it for use in NHS Scotland
Takeda UK Ltd., of High Wycombe, U.K., a unit of Takeda Pharmaceutical Co. Ltd. Adcetris (brentuximab vedotin) Antibody-drug conjugate directed to CD30 Previously untreated systemic anaplastic large-cell lymphoma Scottish Medicines Consortium accepted it for use in NHS Scotland
Tessa Therapeutics Pte Ltd., of Singapore CD30 CAR T Autologous cell therapy Relapsed/refractory Hodgkin lymphoma EMA granted priority medicines (PRIME) designation
Tracon Pharmaceuticals Inc., of San Diego Envafolimab Subcutaneously administered single-domain antibody against PD-L1 MSI-H/dMMR cancer, including colorectal and gastric cancer China's NMPA accepted the NDA for priority review
Transgene SA, of Strasbourg, France, and Bioinvent International AB, of Lund, Sweden BT-001 Oncolytic vaccinia virus Solid tumors Received approval from France's ANSM to proceed with a phase I/IIa study 

Notes

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