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Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment
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China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co., Ltd (SHA: 688068), has announced receiving Fast Track Designation from the United States Food and Drug Administration (FDA) for its SGC001, which is described as the world’s first acute myocardial infarction (AMI) antibody drug. Drug…
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Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
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Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of…
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Hotgen Biotech Gains NMPA Approval for AA001 Clinical Trials in Alzheimer’s Disease
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China’s Hotgen Biotech Co., Ltd (SHA: 688068) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb) AA001. The drug is intended for the treatment of mild cognitive impairment caused by Alzheimer’s disease (AD) and mild to moderate AD. This…
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Hotgen Biotech’s SGC001 Receives NMPA Approval for Clinical Trials in Myocardial Infarction
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb), SGC001. This emergency use mAb is intended for the treatment of anterior ST segment elevation myocardial infarction…
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Hotgen Biotech Receives FDA Approval to Begin Clinical Trials for Acute Myocardial Infarction Drug
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001, a monoclonal antibody (mAb) co-developed with Capital Medical University, is intended for the emergency…
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Hotgen Biotech Receives FDA Clearance to Initiate Clinical Trials for SGC001
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001 is an investigational monoclonal antibody (mAb) co-developed with Capital Medical University, designed for the…
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Hotgen Biotech’s COVID-19 Antigen Home Test Approved in Russia
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) announced receiving market approval in Russia for its Hotgen COVID-19 antigen home test. The product, used for household testing of novel Coronavirus (2019-nCoV), previously received approvals in the US, the European Union, and the UK. Global Approvals and Market ExpansionHotgen Biotech’s COVID-19 antigen…
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Hotgen Biotech Receives FDA EUA for COVID-19 Antigen Home Test
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving Emergency Use Authorization (EUA) from the US FDA for its Hotgen COVID-19 antigen home test. This approval marks a significant milestone in the company’s efforts to provide accessible and convenient testing solutions for the novel Coronavirus (2019-nCoV). Test ProfileThe Hotgen…
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Hotgen Receives NMPA Approval for HBV RNA Assay Kit
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed hepatitis B virus RNA (HBV RNA) assay kit, utilizing the PCR fluorescence probe method. This approval marks a significant milestone for Hotgen in expanding…
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Hotgen Biotech Gains Regulatory Approvals in Saudi Arabia and India
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving one certificate from the Saudi Food & Drug Authority (SFDA) and six certificates from the Drugs Controller General of India (DCGI) for its in-house developed products. These approvals mark significant milestones in the company’s global expansion efforts. Saudi Arabia ApprovalSpecifically,…
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Hotgen Biotech Receives UK Approvals for Monkeypox and COVID-19 Antigen Detection Kits
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Shanghai-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced significant regulatory milestones in the United Kingdom. The company’s monkeypox virus antigen detection kit, utilizing a colloidal gold method, has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for marketing. Additionally, its novel coronavirus (2019-nCoV) antigen detection…
