Company Product Description Indication Status
Beigene Ltd., of Beijing Tislelizumab Monoclonal antibody targeting PD-1 Second- or third-line non-small-cell lung cancer China's NMPA accepted the sBLA 
Betta Pharmaceuticals Co. Ltd., of Hangzhou, China BPI-D0316 EGFR inhibitor  Locally advanced or metastatic non-small-cell lung cancer China's NMPA accepted the NDA
Kintor Pharmaceutical Ltd., of Suzhou, China Proxalutamide Androgen receptor antagonist COVID-19 IND application for the phase III trial was approved by FDA
Moderna Inc., of Cambridge, Mass. mRNA-1273 (TAK-919) COVID-19 spike glycoprotein modulator COVID-19 prophylaxis Takeda Pharmaceutical Co. Ltd. submitted an NDA to Japan’s MHLW to import and distribute the vaccine  
Ocular Therapeutix Inc., of Bedford, Mass. Dextenza (dexamethasone ophthalmic insert) Glucocorticoid receptor agonist Ocular itching associated with allergic conjunctivitis FDA accepted the sNDA for review, with a PDUFA date of no later than Oct. 18, 2021 
Roche Holding AG, of Basel, Switzerland Actemra/Roactemra (tocilizumab) IL-6 inhibitor To slow the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease Approved by the FDA, marking the 6th FDA-approved indication since it launched in the U.S. in 2010
Seqirus Inc., of Summit, N.J. Flucelvax Quadrivalent Cell-based quadrivalent vaccine Influenza FDA approved an expanded age indication for people 2 and older
Sigilon Therapeutics Inc., of Cambridge, Mass. SIG-007 Genetically modified cells with a nonviral vector to express human alpha-galactosidase A Fabry disease FDA granted orphan drug designation
Turnsole Biologics, of Pécs and Budapest, Hungary TS-020  Prophylactic antiviral agent that blocks virus replication Acute COVID-19 infection Received regulatory authority approval in Hungary and initiated a phase Ib/II trial to evaluate the efficacy and the safety in patients with severe infection with risk of progression 

Notes

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