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Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion of patient enrollment and dosing in a Phase I/II clinical study for its investigational drug NR082 (rAAV2-ND4; NFS-01) in the United States. The study targets ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). The single-arm, multi-center Phase…
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Neurophth Biotechnology’s NFS-05 Gene Therapy Gets Australian Clinical Trial Approval for ADOA
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that it has received clinical trial approval from the Therapeutic Goods Administration of Australia for its candidate drug NFS-05. The therapy is set to be assessed as a treatment for autosomal dominant optic atrophy (ADOA), an inherited optic neuropathy. Understanding Autosomal…
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Neurophth Biotechnology Secures RMB700 Million in Series C+ Financing for Gene Therapy Development
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China-based gene therapy specialist Neurophth Biotechnology Ltd has reportedly secured close to RMB700 million in a Series C+ financing round. The round was led by Changjiang Zhaoyin Industrial Fund, Optics Valley Financial Holing, Wuhan Hi-Tech, and Optics Valley Industrial Investment, all state-owned entities, along with Guangzhou Finance Holdings. This financing…
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Neurophth Biotechnology Partners with Sinopharm Group to Commercialize Gene Therapy NFS-01
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced a strategic partnership with compatriot firm Sinopharm Group to jointly advance the marketing and commercialization of Neurophth’s NFS-01, an ophthalmic gene therapy targeting ND4 mutation in Leber’s Hereditary Optic Neuropathy (LHON) disease. Neurophth is aiming for NFS-01 to achieve a first-of-its-kind…
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Neurophth Biotechnology Receives NMPA Approval for Phase I/II Gene Therapy Study
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Sino-US multi-center Phase I/II study. The study will assess the safety, efficacy, and tolerability of its gene therapy NFS-02 (rAAV2-ND1) for ND1…
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Neurophth’s NR082 Gene Therapy Completes Phase III Enrollment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced the completion of all-patient enrollment and dosing in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01), a recombinant adeno-associated virus serotype 2 (rAAV2) therapy for ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). This marks a significant milestone in the development…
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Neurophth Partners with Apellis for Gene Therapy Development in AMD
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced a strategic partnership with US firm Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) to develop a gene therapy based on the complement regulation mechanism for geographic atrophy (GA) / dry age-related macular degeneration (dAMD). Financial details of the partnership were not disclosed. Apellis’…
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Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
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Cyagen Biosciences Partners with Neurophth for Ophthalmology AAV Capsid Development
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Cyagen Biosciences, a provider of custom-engineered mouse and rat models with operations in the US and China, has entered into a partnership valued at RMB 1 billion (USD 139.5 million) with China-based gene therapy specialist Neurophth Biotechnology Ltd. The collaboration aims to leverage Cyagen’s professional gene therapy AI high-throughput adeno-associated…
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Neurophth Biotechnology Doses First Patient in Phase III Trial for NR082
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that the first patient has been dosed in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01). The study is being conducted in China to evaluate the efficacy and safety of NR082, a recombinant adeno-associated virus serotype 2 (rAAV2), in…
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Neurophth and Abogen Partner on mRNA Therapy for Retinal Diseases
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China-based Neurophth Biotechnology Ltd, a gene therapy specialist, has partnered with compatriot mRNA drug developer Abogen Biosciences Co., Ltd to develop lipid nanoparticles (LNPs) for mRNA delivery targeting retinal diseases. The collaboration combines Neurophth’s expertise in ophthalmology gene therapy with Abogen’s mRNA and LNP technology. Partnership DetailsThe partnership aims to…
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Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
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China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth Biological Technology Co., Ltd’s NR082 for the treatment of Leber hereditary optic neuropathy (LHON) caused by the G11778A mutation. The drug, an innovative intraocular injection gene therapy, uses a recombinant adeno-associated virus serotype 2 vector…
