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Brii Biosciences Presents Elebsiran Phase II Data at APASL 2025 Meeting
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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) at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2025). Elebsiran, an investigational small interfering ribonucleic acid (siRNA), is being…
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YiChang HEC’s Yiqibuvir Approved by NMPA for Chronic HCV Infection
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd. (HKG: 1558) announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug yiqibuvir. The non-structural protein 5B (NS5B) inhibitor is approved for use in combination with netanasvir in adult chronic hepatitis C virus (HCV) infections of genotypes…
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Shanghai ZJ Bio-Tech’s HCV Nucleic Acid Test Kit Receives NMPA Approval
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China-based molecular diagnostic reagent specialist Shanghai Liferiver Bio-Tech Co., Ltd (SHA: 688317) has announced receiving Category III medical device license from the National Medical Products Administration (NMPA) for its hepatitis C virus (HCV) nucleic acid test kit (fluorescent PCR method). This product is designed for the quantitative detection of HCV…
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Chipscreen Biosciences’ CS12088 Gets NMPA Clearance for Hepatitis B Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that the National Medical Products Administration (NMPA) has granted clearance to conduct a study of its investigational drug CS12088 in adult patients with chronic hepatitis B. Drug Mechanism and Preclinical DataCS12088 is an HBV nucleocapsid assembly regulator that interferes with the…
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Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study
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Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the US Food and Drug Administration (FDA) to initiate a global, multi-center Phase II study for its Liocyx-M00 therapy. The treatment involves autologous T-cells transfected with mRNA encoding hepatitis B surface antigen (HBsAg) specific toll cell…
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NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
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The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520) finotonlimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb), for use in combination with platinum-based chemotherapy as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Sunshine Lake Pharma’s Antaitasvir…
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Brii Biosciences to Acquire Full Rights to BRII-179 from VBI Vaccines
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China-based Brii Biosciences Ltd (HKG: 2137) has announced its intention to acquire the intellectual property (IP) and other assets related to BRII-179 from its US partner VBI Vaccines, Inc. and certain of its subsidiaries (VBI), as well as its creditor K2 VBI Equity Trust, LLC and K2 HealthVentures LLC. Comprehensive…
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Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for its drug neracorvir (GST-HG141), which is intended to treat chronic hepatitis B virus (HBV). GST-HG141:…
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SCG Cell Therapy Presents Phase I Data for HBV-Specific TCR-T Therapy SCG101 at AASLD 2024
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SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has announced the presentation of new data from the Phase I clinical study of its pioneering therapy, SCG101, at the 2024 AASLD Liver Meeting. SCG101 is an autologous hepatitis B virus (HBV)-specific T-cell receptor-engineered T Cell (TCR-T)…
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Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV
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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…
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Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand
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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,…
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Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
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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…
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Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment
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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…
