CSBio CSBio

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2023","url1":"","url2":"","graph1":"Large molecule","graph2":"BioRay Pharmaceutical"},{"orgOrder":0,"company":"Tianweiyuanhe Biomedical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ITabMed Announces The IND Approval From NMPA for A-337, a CD3-Activating Bispecific Antibody Targeting EpCAM To Treat Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Tianweiyuanhe Biomedical"},{"orgOrder":0,"company":"TG ImmunoPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TG ImmunoPharma Announces FDA Clearance for Clinical Trial of TGI-6 Bispecific Antibody","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"TG ImmunoPharma"},{"orgOrder":0,"company":"TG ImmunoPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TG ImmunoPharma Announces FDA Approval for Clinical Trial of TGI-6 Bispecific Antibody","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"TG ImmunoPharma"},{"orgOrder":0,"company":"InnoCare Pharma","sponsor":"Arrivent","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"InnoCare and ArriVent Announce Clinical Development Collaboration","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"InnoCare Pharma"},{"orgOrder":0,"company":"Mabwell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mabwell Announces the NMPA Approval of Novel Trop-2 ADC (9MW2921) for IND","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Mabwell"},{"orgOrder":0,"company":"Mabwell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Mabwell"},{"orgOrder":0,"company":"InnoCare Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InnoCare Announces Approval of Clinical Trial of pan-TRK Inhibitor Zurletrectinib for the Treatment of Pediatric Patients in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"InnoCare Pharma"},{"orgOrder":0,"company":"BioCity Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioCity Announces FDA Clearance of Investigational New Drug Application for its First-in-Class CD3\/EGFR Bispecific Antibody","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"BioCity Biopharma"},{"orgOrder":0,"company":"OriCell Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oricell OriCAR-017 CAR-T Therapy Clears IND Hurdle, Paving the Way for Global Impact","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"OriCell Therapeutics"},{"orgOrder":0,"company":"InxMed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InxMed Receives Approval to Initiate Phase I Clinical Trial in China for OMTX705, a First-in-Class FAP-Targeting ADC","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"InxMed"},{"orgOrder":0,"company":"InnoCare Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InnoCare Announces Approval of Clinical Trial of SHP2 Inhibitor ICP-189 in Combination with EGFR Inhibitor Furmonertinib","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"InnoCare Pharma"},{"orgOrder":0,"company":"BioCity Biopharma","sponsor":"AstraZeneca","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BioCity Signs Collaboration Agreement with AstraZeneca on BC3402, a Monoclonal Antibody Targeting Anti-TIM-3, in Combination with IMFINZI (durvalumab) for the Treatment of Advanced Hepatocellular Carcinoma in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"BioCity Biopharma"},{"orgOrder":0,"company":"BioRay Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Clinical Trial Application (IND) for BioRay Pharmaceutical's BR105 Injection Receives U.S. FDA Approval","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"BioRay Pharmaceutical"},{"orgOrder":0,"company":"MediLink Therapeutics","sponsor":"F. Hoffmann-La Roche","pharmaFlowCategory":"D","amount":"$1,000.0 million","upfrontCash":"$50.0 million","newsHeadline":"MediLink Therapeutics Announces Worldwide Collaboration and License Agreement with Roche to Develop Next-Generation Antibody Drug Conjugate in Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"MediLink Therapeutics"},{"orgOrder":0,"company":"NK CellTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NK CellTech Announces FDA Clearance for Clinical Trial of NK010","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"NK CellTech"},{"orgOrder":0,"company":"Immunofoco","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Immunofoco"}]

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            IMC001 is an EpCAM-targeting autologous CAR-T cell product. It is being evaluated for the treatment of EpCAM-positive advanced gastrointestinal tumors including but not limited to advanced gastric cancer and gastroesophageal junction adenocarcinoma.

            Lead Product(s): IMC001

            Therapeutic Area: Oncology Product Name: IMC001

            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 22, 2024

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            NK010 is the first non-genetically modified NK cells expended from allogeneic peripheral blood cell (PBMC). It is being evaluated in IND-enabling studies for the treatment of ovarian cancer.

            Lead Product(s): NK010

            Therapeutic Area: Oncology Product Name: NK010

            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 22, 2024

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            Under the agreement, MediLink will grant Roche exclusive global rights for the development, manufacturing, and commercialization of MediLink's YL211, a next-generation antibody-drug conjugate specifically targeting c-Mesenchymal-epithelial transition factor against solid tumors.

            Lead Product(s): YL211

            Therapeutic Area: Oncology Product Name: YL211

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

            Deal Size: $1,000.0 million Upfront Cash: $50.0 million

            Deal Type: Collaboration January 02, 2024

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            BR105 Injection is a humanized monoclonal antibody developed in-house, specifically targeting SIRPα. It can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the "don't eat me" signal between macrophage and tumor cell.

            Lead Product(s): BR105

            Therapeutic Area: Oncology Product Name: BR105

            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 October 24, 2023

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            The collaboration aims to evaluate BioCity's BC3402, a mAb targeting the T cell immunoglobulin and mucin domain-containing protein 3, in combination with AstraZeneca's anti-PD-L1 mAb IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma in China.

            Lead Product(s): BC3402,Durvalumab

            Therapeutic Area: Oncology Product Name: BC3402

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: AstraZeneca

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 27, 2023

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            ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR inhibitor.

            Lead Product(s): ICP-189,Furmonertinib

            Therapeutic Area: Oncology Product Name: ICP-189

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2023

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            OMTX705 is a novel antibody–drug conjugate (ADC) molecule targeting fibroblast-activating protein alpha, which is investigated for the treatment of hard-to-treat solid tumors.

            Lead Product(s): OMTX705

            Therapeutic Area: Oncology Product Name: OMTX705

            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 August 29, 2023

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            OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed or refractory multiple myeloma, received the green light for its Investigational New Drug (IND) application.

            Lead Product(s): GPRC5D-CAR-T

            Therapeutic Area: Oncology Product Name: OriCAR-017

            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 August 10, 2023

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            BC3448 is a CD3-based BsAb that recruits T cells to tumors cells with high EGFR expression resulting in T cell-driven tumor cell killing and is being developed in solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC.

            Lead Product(s): BC3448

            Therapeutic Area: Oncology Product Name: BC3448

            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 August 07, 2023

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            ICP-723 (zurletrectinib) is a second generation pan-TRK inhibitor, which is investigated for the treatment of advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma.

            Lead Product(s): Zurletrectinib

            Therapeutic Area: Oncology Product Name: ICP-723

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 25, 2023

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