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[{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Meiji Seika Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HUYA Bioscience International Appoints Meiji Seika Pharma as Exclusive Distributor For HBI-8000 in Japan and Other Asian Countries","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYA Bioscience International\u00ae Announces the Successful Completion of Phase 1 Trial of HBI-3000","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"HUYA Bioscience International","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HUYA Bioscience International Licenses the Novel SHP2 Inhibitor HBI-2376 for Development in Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 Monotherapy Adult T-cell Leukemia-Lymphoma ATL in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYA Bioscience International Presents Positive Data On HBI-8000 at Society for Immunotherapy of Cancer Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Genhouse Bio","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYABIO Files an Investigational New Drug Application with the FDA for the Novel SHP2 Inhibitor HBI-2376","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYABIO International Launches Hiyasta as Monotherapy for Adult T-cell Leukemia\/Lymphoma in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Shenzhen Chipscreen Biosciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUYABIO International Receives Regulatory Approval for Hiyasta\u00ae Monotherapy of Peripheral T-Cell Lymphoma in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huyabio International Announces Completion Of HBI-3000 Phase 1 Trial And Fda Approval To Proceed With Dose Escalation In Phase 2","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"HUYA Bioscience International","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Huyabio International Announces Initiation Of Hbi-3000 Phase 2 Trial","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"}]

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            Details:

            The drug's preclinical and clinical pharmacology supports the potential of HBI-3000 (sulcardine sulfate) to restore sinus rhythm in Atrial Fibrillation. The drug has demonstrated a low risk for proarrhythmia in preclinical testing.

            Lead Product(s): Sulcardine Sulfate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: HBI-3000

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 14, 2022

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            The drug’s preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in Atrial Fibrillation. The drug has demonstrated a low risk for proarrhythmia in preclinical testing.

            Lead Product(s): Sulcardine Sulfate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: HBI-3000

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 17, 2022

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            Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population.

            Lead Product(s): Chidamide

            Therapeutic Area: Oncology Product Name: HBI-8000

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Shenzhen Chipscreen Biosciences

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 30, 2021

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            Hiyasta (HBI-8000) is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer. it targets class I histone deacetylases and suppresses expression of viral oncogene HTLV-I bZIP factor, NF-kB and the inflammasome in ATLL cells.

            Lead Product(s): Tucidinostat

            Therapeutic Area: Oncology Product Name: Hiyasta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 19, 2021

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            HBI-2376 is an oral small molecule inhibitor of SHP2 for multiple tumor types whose cellular growth is dependent on MAPK pathway. Both in vitro and in vivo studies HBI-2376 has shown a very good PK and safety profile.

            Lead Product(s): HBI-2376

            Therapeutic Area: Oncology Product Name: GH21

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Genhouse Bio

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2021

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            Study confirms tolerability and significant anti-tumor activity of HBI-8000 in combination with nivolumab in checkpoint naive melanoma patients.

            Lead Product(s): Chidamide,Nivolumab

            Therapeutic Area: Oncology Product Name: HBI-8000

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 2020

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            HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. HBI-8000 targets class I histone deacetylase and suppresses the expression of the viral oncogene HTLV-I bZIP factor, NF-kB and the inflammasome in ATL cells.

            Lead Product(s): Chidamide

            Therapeutic Area: Oncology Product Name: HBI-8000

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2020

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            HUYA Bioscience has exclusively licensed worldwide rights, outside of China, to the SHP2 inhibitor, HBI-2376, from Suzhou GenHouse. SHP2 is an important component of RAS signaling pathway leading to activation of ERK/MAPK pathways in a variety of cancer cells.

            Lead Product(s): HBI-2376

            Therapeutic Area: Oncology Product Name: HBI-2376

            Highest Development Status: Preclinical Product Type: Small molecule

            Recipient: Suzhou GenHouse

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement August 04, 2020

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            Phase 2 trial will test the unique multi-channel ion blocker in acute atrial fibrillation.

            Lead Product(s): Sulcardine Sulfate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 28, 2020

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            HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights.

            Lead Product(s): Tucidinostat

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Meiji Seika Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 08, 2020

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