BrightGene Bio-Medical Technology is a biopharmaceutical company in research and development as well as manufacturing of medicines. BrightGene manufactures active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) with a focus on the regulated market. BrightGene works on immune-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.
The company has a pipeline of generic drugs with molecules like Eribulin, Trabectedin, Fondaparinux, Caspofungin and non-biological macromolecules such as Ferumoxytol and Ferric pyrophosphate citrate, also we have developed ADC cytotoxic payloads, like Maytansinoids, Auristatins, and Calicheamicin. BrightGene has cGMP compliance factories and has received approval from USFDA, EU, PMDA, KFDA and CFDA.
BrightGene manufactured the active pharmaceutical ingredients (APIs) of a remdesivir (GS-5734) imitation product. Remdesivir is the antiviral candidate from Gilead Sciences for treatment of infections with SARS-CoV-2 (2019-nCoV) that cause COVID-19 (coronavirus disease). Marketing of the imitation product was said to need authorization from Gilead. It is not known if any efforts were made by BrightGene to pursue authorization from Gilead. BrightGene stated that the product, if approved for marketing, will be supplied mainly through donations during the epidemic.