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    [{"orgOrder":0,"company":"HuidaGene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huida Gene's First Gene Therapy Drug Approved By IND in the United States, And International Multi-Center Clinical Trials Will Be Carried Out","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"HuidaGene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HuidaGene Receives Orphan Drug Designation for Gene Therapy of Blindness","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"HuidaGene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huida Genomics HG004 IND Was Approved By NMPA, And China's First International Multi-Regional, Multi-Center Gene Therapy Drug Clinical Trial with The Same Master Plan Will Be Carried Out","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"IND Enabling"},{"orgOrder":0,"company":"HuidaGene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huidagene Therapeutics Receives FDA Rare Pediatric Disease Designation for HG004 to Treat Inherited Blindness","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I"},{"orgOrder":0,"company":"HuidaGene Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huidagene Therapeutics Announces First Patient Dosed in Multinational Phase 1\/2 Trial of HG004 for Inherited Blindness","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I\/ Phase II"}]

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              HuidaGene Therapeutics

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              Huidagene Therapeutics Announces First Patient Dosed in Multinational Phase 1/2 Trial of HG004 for Inherited Blindness

              Details:

              HG004 is an investigational gene replacement therapy product. It uses the recombinant AAV9 vector to deliver a functional human RPE65 gene to the retina and to restore, treat, and prevent blindness of children and adults with RPE65-Inherited Retinal Diseases.

              Lead Product(s): HG004

              Therapeutic Area: Rare Diseases and Disorders Product Name: HG004

              Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 01, 2023

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              HuidaGene Therapeutics

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              Huidagene Therapeutics Receives FDA Rare Pediatric Disease Designation for HG004 to Treat Inherited Blindness

              Details:

              HG004 is a one-time, direct-to-RPE treatment of inherited retinal disease caused by mutations in the RPE65 gene and was previously granted orphan drug designation for RPE65-IRD.

              Lead Product(s): HG004

              Therapeutic Area: Ophthalmology Product Name: HG004

              Highest Development Status: Phase I Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 07, 2023

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              HuidaGene Therapeutics

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              Huida Genomics HG004 IND Was Approved By NMPA, And China's First International Multi-Regional, Multi-Center Gene Therapy Drug Clinical Trial with The Same Master Plan Will ...

              Details:

              HG004 injection is a new ophthalmic gene therapy drug designed to treat RPE65 gene mutation-related retinopathy. It has successfully obtained the IND approval from the US FDA

              Lead Product(s): HG004

              Therapeutic Area: Ophthalmology Product Name: HG004

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 18, 2023

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              HuidaGene Therapeutics

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              HuidaGene Receives Orphan Drug Designation for Gene Therapy of Blindness

              Details:

              HG004 is a gene replacement therapy drug which uses the recombinant non-adeno-associated virus serotype 2 vector to deliver a functional human RPE65 gene to the retina to restore, treat, and prevent blindness of children and adults with RPE65 mutation-associated IRDs.

              Lead Product(s): HG004

              Therapeutic Area: Ophthalmology Product Name: HG004

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 03, 2023

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              HuidaGene Therapeutics

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              • Development Update
              Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
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              Flag China
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              Huida Gene's First Gene Therapy Drug Approved By IND in the United States, And International Multi-Center Clinical Trials Will Be Carried Out

              Details:

              HG004 is an ophthalmic injection intended for the treatment of RPE65 gene mutation-related retinopathy. Based on direct preclinical comparative studies of HG004 and AAV2 in retinal function, HG004 is at least 10 times more efficient at transducing retinal pigment epithelium.

              Lead Product(s): HG004

              Therapeutic Area: Ophthalmology Product Name: HG004

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 27, 2023

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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