Company Product Description Indication Status
Antengene Corp. Ltd., of Shanghai Xpovio (selinexor, ATG-010) Selective inhibitor of nuclear export Relapsed/refractory multiple myeloma National Medical Products Administration in China accepted the NDA
Bio-Thera Solutions, of Guangzhou, China BAT-1706 Biosimilar to Avastin (bevacizumab) Metastatic colorectal cancer, non-squamous non-small-cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma and persistent, recurrent or metastatic cervical cancer FDA accepted the BLA; Biosimilar User Fee Act action date is Nov. 27, 2021
Harbour Biomed, also known as HBM Holdings Ltd., of Suzhou, China Batoclimab (HBM-9161) Anti-FcRn monoclonal antibody  Myasthenia gravis China Center for Drug Evaluation granted breakthrough therapy designation
Immunoforge Co. Ltd., of Seoul, South Korea PF-1801 Repositioned drug Duchenne muscular dystrophy FDA granted orphan drug designation
Kintor Pharmaceutical Ltd., of Suzhou, China. Proxalutamide  Androgen receptor antagonist Hospitalized COVID-19 Institutional Review Board of Brazil approved the start of the study with a primary endpoint of WHO COVID-19 ordinal scale score on day 14
M6P Therapeutics, of St Louis, Mo. Undisclosed 4 recombinant enzyme and 2 gene therapy programs Various lysosomal storage disorders FDA granted 6 rare pediatric disease designations
M6P Therapeutics, of St Louis, Mo. Undisclosed Gene therapy Gaucher disease and mucolipidosis FDA granted 2 orphan drug designations
Opko Health Inc., of Miami, and Pfizer Inc., of New York Somatrogon Long-acting recombinant human growth hormone Growth hormone deficiency Submitted an NDA to the Ministry of Health, Labour and Welfare in Japan
Passage Bio Inc., of Philadelphia PBFT-02 Adeno-associated virus-based gene therapy expressing granulin Frontotemporal dementia with granulin mutations FDA cleared the IND for the phase I/II study expected to start in the first half of 2021

Notes

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