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HuidaGene Receives FDA Clinical Clearance for HG202 in Neovascular AMD Treatment
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its drug candidate HG202, an innovative treatment for neovascular age-related macular degeneration (nAMD). BRIGHT Study to Assess Safety and Tolerability of HG202The upcoming BRIGHT study, an open-label, multicenter dosage escalation…
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China Issues Ethical Guidelines for Human Genome Editing, Prohibits Germline Editing
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China’s Ministry of Science and Technology (MOST) has issued the Ethical Guidelines for Human Genome Editing Research, establishing a framework to regulate such activities and ensure their responsible development. The guidelines place a stringent prohibition on germline editing, which involves genetic modifications that could be passed down to future generations.…
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HuidaGene and Synthego Form Strategic Partnership for CRISPR-Based Therapies
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HuidaGene (Shanghai) Biotechnology Co., Ltd, a clinical-stage biotechnology company based in China, has entered into a strategic partnership and licensing agreement with Synthego Corporation, a U.S.-based leading provider of CRISPR solutions for cell and gene therapy development. The agreement grants Synthego access to Huida’s high-fidelity Cas12 CRISPR nuclease (hfCas12Max), strengthening…
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HuidaGene’s MECP2 Duplication Syndrome Therapy Earns Positive EMA Opinion
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HuidaGene (Shanghai) Biotechnology Co., Ltd, a biotech company based in China, has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding its orphan drug filing for HG204. HG204 is an RNA editing therapy developed independently by HuidaGene,…
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ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
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Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from the Center for Drug Evaluation (CDE) for its ophthalmic gene therapy ZVS101e, designed to treat retinitis pigmentosa (RP) patients with the RHO-R135W (RHO c.403C>T) mutation. This follows a tacit trial approval granted in the United…
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Danaher Corporation to Establish Northern China Headquarters in Beijing’s Changping District
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The Changping District People’s Government of Beijing Municipality has entered into a strategic cooperation agreement with Danaher Corporation (NYSE: DHR), a leading science and technology services provider based in the United States. The agreement encompasses the establishment of Danaher’s northern China headquarters in the district, along with the development of…
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FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
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Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval from the US Food and Drug Administration (FDA) for the treatment of patients aged 12 and above with transfusion-dependent β-Thalassemia (TDT). This marks a significant milestone as Casgevy becomes the world’s first CRISPR-based gene editing…
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Shanghai BDgene’s BD112 Earns Orphan Drug Designation from US FDA for Huntington’s Disease
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Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has announced that its drug candidate BD112, which utilizes virus-like particle (VLP) delivery technology for in vivo gene editing, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). This follows a previous ODD granted by…
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Epigenic Therapeutics Secures $32 Million in Series A Funding for Gene Modulation Therapy
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Epigenic Therapeutics, a Shanghai-based biotech company specializing in gene modulation therapy through epigenome regulation, has successfully raised USD 32 million in a Series A financing round. The round was co-led by Qiming Venture Partners and OrbiMed, with participation from existing investor Morningside Venture Capital. The funds will be utilized to…
