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Beijing Hotgen Biotech is an innovative, publicly listed Chinese biotech company specializing in in vitro diagnostics (IVD) with global regulatory clearances. Its flagship pipeline includes both diagnostic and drug assets, notably the world’s first antibody drug for emergency myocardial infarction with dual IND approvals (China, US, FDA Fast Track)[3][10]. COVID-19 antigen kits have received major country authorizations, including NMPA, CE, FDA EUA; clinical sensitivity for diagnostics varies by disease[9].
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