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[{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Peter MacCallum Cancer Centre","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa\u2019s Pidnarulex to Combined With Pfizer\u2019s Talazoparib in a Clinical Trial for the Treatment of Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Senhwa Biosciences"},{"orgOrder":0,"company":"OBI Pharma","sponsor":"Biosion","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biosion's Partner OBI Pharma Announces FDA Clearance of IND Application for a Phase 1\/2 Study of OBI-992 (TROP2 ADC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"OBI Pharma"},{"orgOrder":0,"company":"OBI Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1\/2 Study of OBI-992","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"OBI Pharma"},{"orgOrder":0,"company":"Acepodia","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acepodia Announces FDA Clearance of IND for its NK Cell Therapy Drug Candidate ACE1702 to Treat Patients with HER2-expressing Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Acepodia"},{"orgOrder":0,"company":"Acepodia","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acepodia to Present Preclinical Data of Gamma Delta T cell Therapy Candidate, ACE2016, An Off-The-Shelf EGFR-Targeting \u03b3\u03b42 T cell Therapy Against EGFR-Expressing Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Acepodia"},{"orgOrder":0,"company":"Acepodia","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a First-in-Class Allogeneic Anti-EGFR Cell Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Acepodia"}]

Find FDA Investigational New Drug (IND) Submissions for Oncology in TAIWAN

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            ACE2016 is an allogeneic gamma delta 2 T cell therapy. It's IND application is cleared after preclinical studies for the treatment of EGFR-expressing malignancies in patients with solid tumors.

            Lead Product(s): ACE2016

            Therapeutic Area: Oncology Product Name: ACE2016

            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 February 04, 2024

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            OBI-992 is a novel antibody drug conjugate (ADC) cancer therapy targeting TROP2. It is being evaluated for the treatment of non-small cell lung cancer, small cell lung cancer & gastric cancer.

            Lead Product(s): OBI-992

            Therapeutic Area: Oncology Product Name: OBI-992

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Biosion

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 08, 2024

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            OBI-992 is a TROP2-targeted antibody-drug conjugate that carries a potent topoisomerase I inhibitor payload to kill tumor cells. It is being evaluated for the treatment of advanced solid tumors, including non-small cell lung cancer, small cell lung cancer & gastric cancer.

            Lead Product(s): OBI-992

            Therapeutic Area: Oncology Product Name: OBI-992

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2024

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            ACE2016 is an off-the-shelf, gamma delta-2 T cell therapy designed to recognize and engage solid tumors expressing EGFR by ACC technology unlocking multiple receptor signaling causing tumor cell apoptosis.

            Lead Product(s): ACE2016

            Therapeutic Area: Oncology Product Name: ACE2016

            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 March 27, 2023

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            Pidnarulex synthetically derived small molecule in combination with Talazoparib (PARP inhibitor), potential therapy in patients with metastatic castration-resistant prostate cancer.

            Lead Product(s): Pidnarulex,Talazoparib

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Peter MacCallum Cancer Centre

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2021

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            Acepodia received clearance of its Investigational IND application from U.S FDA to start Phase 1 clinical study of its natural killer cell therapy ACE1702 in patients with HER2-expressing solid tumors.

            Lead Product(s): ACE1702

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 January 09, 2020

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