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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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HuidaGene (Shanghai) Biotechnology Co., Ltd, a China-based biotech firm, has secured patent approval from the China National Intellectual Property Administration for its proprietary DNA editing system, CRISPR-Cas12i, also known as the Cas12Max system. The patent encompasses the hfCas12Max nuclease, which HuidaGene independently developed, as well as the broader CRISPR-Cas12i system…
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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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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced that it has received Rare Pediatric Disease Designation (RPDD) from the US FDA for its RNA editing therapy, HG204, targeting MECP2 duplication syndrome (MDS). This designation is a significant step forward in the development of novel treatments for this rare pediatric neurodevelopmental…
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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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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy HG004. The company plans to initiate a global, multi-center clinical study for the drug, a single-administered, non-adeno-associated virus serotype 2 (non-AAV2) gene replacement therapy, targeting retinopathy associated…