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China-based cell therapy specialists GRIT Biotechnology and Shanghai Vitalgen BioPharma Co., Ltd have entered into a collaboration agreement to leverage GRIT’s CRISPR-AaCas12bMAX gene editing tool and related gene editing techniques for the development, manufacturing, and commercialization of certain cell therapies. The agreement, for which no financial details were disclosed, highlights…
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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’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 (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 (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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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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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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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 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, 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…
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced a licensing agreement with fellow Shanghai-based firm Kactus Biosystems, a company specializing in target protein and raw enzyme production. The agreement pertains to the new gene editing tool enzyme, hfCas12Max. According to the terms, Kactus will secure an exclusive license to produce…
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced receiving approval from the US FDA to conduct a clinical study for its pipeline candidate, BD111, in the treatment of type I herpes simplex virus (HSV-1) stromal keratitis. HSV-1 is a pathogen responsible for a range of diseases, including oral…
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HuidaGene (Shanghai) Therapeutics Co., Ltd, a China-based biotechnology company, has made significant strides in the field of CRISPR-Cas genome editing technology. Through protein and sgRNA engineering, HuidaGene has enhanced the OsCas12f1 (enOsCas12f1) and enRhCas12f1 variants of the CRISPR-Cas12f system. These variants exhibit much higher editing efficiency and possess broader PAMs…
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Shanghai BDgene Technology Co., Ltd has announced that a clinical trial filing for its BD111, a CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK), has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of innovative…
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Shanghai-based gene editing firm CorrectSequence Therapeutics announced it has received a patent from the United States Patent and Trademark Office (USPTO) for its variant base editing (tBE) system, a technology designed to enhance precision and reduce off-target mutations in gene editing. Technology HighlightsThe tBE system integrates a deoxycytidine deaminase inhibitor…
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China-based gene editing specialist ZhuHai GeneRulor Medical Technology Co., Ltd. reportedly raised “tens of millions” of renminbi in a recent financing round. The round was led by YF Capital and Gree Group, with contributions from Z & H Investment and Shanzhi Investment. Proceeds will be used to advance the commercialization…
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Shanghai BDgene Technology Co., Ltd has completed efficacy and preliminary safety studies for BD111, its CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK). The company plans to file for Investigational New Drug (IND) approval and was awarded orphan drug designation (ODD) status in the US last week.…