Viral hepatitis Archives

Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV

November 20, 2024

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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218), an investigational small interfering ribonucleic acid (siRNA) therapy for chronic hepatitis B virus (HBV) infection. Phase II ENSURE Study Design and Initial FindingsThe active-controlled and randomized Phase II…
Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand

November 20, 2024

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Shanghai-based Epigenic Therapeutics, a biotechnology company specializing in the development of novel gene modulation therapies, has announced that it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to conduct a clinical study for its investigational drug,…
Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus

November 19, 2024

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Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus…
Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment

October 29, 2024

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The National Medical Products Administration (NMPA) has granted market approval for pradefavir, a Category 1 drug developed by Xi’an Xintong Pharmaceutical Research Co., Ltd., for the treatment of adult chronic hepatitis B virus (HBV) infection under the trade name XinShuMu. Pradefavir, a nucleoside liver-targeting drug, functions by inhibiting HBV DNA…
Fujirebio’s HBsAg Detection Kit Receives NMPA Approval, Enhances Early Diagnosis Capabilities

September 6, 2024

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Fujirebio Inc., a leading diagnostic company based in Japan, has received approval from China’s National Medical Products Administration (NMPA) for its innovative hepatitis B virus surface antigen (HBsAg) detection kit, which utilizes the chemiluminescence method. This detection kit, comprising antibody binding particles, enzyme-labeled antibodies, and a sample processing solution, is…
Fujian Cosunter’s Innovative Drug GST-HG141 Exceeds Efficacy in Reducing HBV DNA in Phase II Study

August 12, 2024

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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced the successful conclusion of a Phase II clinical study for its hepatitis B virus (HBV) therapy, GST-HG141, in patients with chronic HBV and low viremia. The study demonstrated the drug’s potential in suppressing HBV DNA, a key…
Aligos Therapeutics and Xiamen Amoytop Biotech Partner to Test Hepatitis B Combination Therapy

July 23, 2024

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Aligos Therapeutics Inc. (NASDAQ: ALGS), a San Francisco-based biotechnology company, has announced a clinical trial collaboration with Xiamen Amoytop Biotech Co., Ltd, a Chinese pharmaceutical firm. The partnership aims to explore the combination therapy of Aligos’ ALG-000184 with Amoytop’s Pegbing (mipeginterferon alfa-2b) for the treatment of chronic hepatitis B (CHB)…
AusperBio’s AHB-137 Antiviral Candidate on Path to Breakthrough Designation for Chronic Hepatitis B in China

July 8, 2024

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AusperBio, a sino-American developer specializing in liver therapies, has announced that its drug candidate AHB-137 is on track to receive breakthrough therapy designation (BTD) in China for the treatment of chronic hepatitis B virus (HBV). AHB-137 is a highly potent, pan-genotypic antisense oligonucleotide (ASO) that targets all HBV RNA, positioning…
Brii Biosciences’ BRII-179 Shows Promise in Phase II Trials for Chronic Hepatitis B at EASL 2024

June 11, 2024

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Brii Biosciences Ltd (HKG: 2137), a leading biotechnology company based in China, has presented new data from two Phase II clinical studies on BRII-179 at the European Association for the Study of the Liver (EASL) 2024 annual conference. The data confirm the efficacy of BRII-179 in combination with BRII-835 or…
Gilead’s Bulevirtide-PegIFN Combo Achieves High HDV Remission Rates in Phase IIb Trial

June 11, 2024

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Gilead Sciences Inc. (NASDAQ: GILD), a biopharmaceutical company at the forefront of HIV and liver disease treatments, last week reported results from a Phase IIb clinical trial for its first-in-class entry inhibitor, bulevirtide, in combination with pegylated interferon alfa-2a (PegIFN) for the treatment of compensated chronic hepatitis delta virus (HDV)…
Sansure Biotech’s HBV RNA Detection Kit Receives NMPA Marketing Approval

June 7, 2024

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Sansure Biotech Inc., (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its hepatitis B virus (HBV) RNA detection kit, which employs the PCR fluorescence probe method. This advanced detection kit is designed…
Brii Biosciences’ HBV Drug Candidates Receive NMPA’s Breakthrough Therapy Designations

May 14, 2024

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Brii Biosciences Ltd (HKG: 2137) has announced that two of its hepatitis B virus (HBV) drug candidates, BRII-835 (elebsiran) and BRII-877 (tobevibart), have been granted breakthrough therapy designations (BTDs) by China’s National Medical Products Administration (NMPA). BRII-877 (tobevibart) is a hepatitis B virus-specific broad-spectrum neutralizing monoclonal antibody (mAb) designed to…
Brii Biosciences’ BRII-835 Aims for Breakthrough Therapy Status in China for Chronic Hepatitis B

May 9, 2024

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The Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137), a biopharmaceutical company based in China, is poised to secure breakthrough therapy designation (BTD) for its drug BRII-835 (VIR-2218) from the National Medical Products Administration (NMPA). The drug is intended for the treatment of chronic…
Chia Tai Tianqing’s TQA3038 siRNA Drug Completes Phase I Clinical Trial for Chronic Hepatitis B

April 26, 2024

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Chia Tai Tianqing has announced the successful completion of a Phase I clinical study for its in-house developed Category 1 drug, TQA3038 (siRNA), with plans to advance to subsequent clinical trials for the treatment of chronic hepatitis B virus (HBV) in the near future. TQA3038 is a GalNAc-conjugated siRNA drug…
Brii Biosciences Acquires VBI Vaccines’ Intellectual Property and Manufacturing Rights in Strategic Deal

February 18, 2024

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Brii Biosciences Ltd (HKG: 2137), based in China, has reached an agreement with US-based VBI Vaccines Inc. to acquire all intellectual property rights to VBI-1901 (BRII-179), along with the manufacturing technologies for BRII-179 and PreHevbrio/PreHevbri. The agreement also grants Brii marketing rights for VBI-1901 in the Asia Pacific region, excluding…
Staidson Pharmaceutical Halts Clinical Trial for Hepatitis B Drug Due to Efficacy Concerns

December 12, 2023

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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the cancellation of a Phase Ib/II study for its Category 1 genetic drug, STSG-0002, which is intended for the treatment of diseases related to hepatitis B virus (HBV) infection. STSG-0002 is a hepatic phagocytic replication-deficient recombinant adeno-associated…
Sino Biopharmaceutical Initiates Phase I Trial for Hepatitis B siRNA Drug TQA3038

December 6, 2023

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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the initiation of a Phase I trial with the first doses administered for TQA3038, a small interfering RNA (siRNA) drug targeting the hepatitis B virus (HBV) for the treatment of chronic hepatitis B (CHB). The trial…
Brii Biosciences’ BRII-179 Vaccine on Track for Breakthrough Therapy Designation in China

November 23, 2023

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China’s Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137), a China-based company, is poised to secure breakthrough therapy designation (BTD) status for its BRII-179 (VBI-2601), a first-in-class therapeutic vaccine targeting Pre-S1/Pre-S2/S for the treatment of chronic hepatitis B virus (HBV) infection. The potential designation…
Gilead Reports Q3 2023 Financials with 1% YOY Revenue Increase and Updates 2023 Outlook

November 8, 2023

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Gilead (NASDAQ: GILD) has released its financial results for the third quarter of 2023, showing a 1% year-on-year (YOY) increase in revenues over the first nine months, reaching USD 20.0 billion. This modest performance was influenced by a 50% decrease in demand for the COVID-19 therapy Veklury (remdesivir). Excluding Veklury…
GSK Acquires Global Rights to Janssen’s Hepatitis B Antiviral JNJ-3989 in $1 Billion Deal

November 7, 2023

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GlaxoSmithKline (GSK; NYSE: GSK) has announced the acquisition of global rights to the hepatitis B virus (HBV)-targeted siRNA antiviral JNJ-3989 from Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen. The agreement includes Arrowhead Pharmaceuticals, the original discoverer of the investigational drug, which was initially licensed to Janssen in 2018. GSK’s…
Fujian Cosunter Gains Ethical Approval for Phase IIa Study of GST-HG131 in Hepatitis B

October 27, 2023

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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the receipt of ethical approval from the Chinese PLA General Hospital to commence a randomized, double-blind, placebo-controlled Phase IIa clinical study. The study will assess the safety and efficacy of GST-HG131, which the company describes as a first-in-class hepatitis B…
Beijing SL Pharmaceutical Gains NMPA Approval for Phase I Trial of MBT-1608 for Hepatitis C

October 20, 2023

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China’s Beijing SL Pharmaceutical Co., Ltd (SHE: 002038) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its Category 1 chemical drug, MBT-1608. The drug is targeted for the treatment of hepatitis C virus (HCV) and will…
Gilead Partners with Assembly Biosciences in $84.8 Million Collaboration for Antiviral Therapies

October 18, 2023

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Gilead Sciences (NASDAQ: GILD) has announced a significant 12-year collaboration with antiviral specialist Assembly Biosciences (NASDAQ: ASMB) aimed at developing innovative therapies targeting herpesviruses, hepatitis B virus (HBV), and hepatitis D virus (HDV). This partnership allows Gilead to acquire Assembly’s promising programs, which include a next-generation core inhibitor for HBV,…
Brii Biosciences Announces Positive Interim Data for BRII-179 Vaccine in Chronic Hepatitis B

September 7, 2023

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China-based Brii Biosciences Ltd (HKG: 2137) has announced topline cohort-level unblinded Week 36 data from an interim analysis of a randomized, placebo-controlled, and double-blinded Phase II study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, used in combination with pegylated interferon-alpha (PEG-IFNα) for the treatment of chronic hepatitis B virus…