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Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioNTech and Fosun Pharma Provide COVID-19 Vaccine Doses For Vaccination of German Expatriates in China","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Vaccine","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"BioNTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on First BioNTainer for African-based mRNA Manufacturing Facility","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"BioNTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioNTech Starts Phase 1 Clinical Trial for Prophylactic Herpes Simplex Virus-2 Vaccine Candidate BNT163","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"BioNTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine Program BNT165","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Vaccine","productStatus":"New Molecular Entity","date":"December 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Applicable","newsHeadline":"Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Omicron BA.4\/BA.5-Adapted Bivalent COVID-19 Vaccine for Ages 12 Years and Older as Primary Series or Booster","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Vaccine","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"BioNTech","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4\/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Vaccine","productStatus":"Approved","date":"March 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II"},{"orgOrder":0,"company":"BioNTech","sponsor":"OncoC4","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1\/2 Trial of BioNTech-partnered BNT316\/ONC-392 Program","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"BioNTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Three-year Phase 1 Follow-up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase 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            Autogene cevumeran (RO7198457) is a messenger RNA (mRNA)-based personalized cancer vaccine, which is being evaluated in combination with atezolizumab for the treatment of resected pancreatic ductal adenocarcinoma.

            Lead Product(s): Autogene Cevumeran,Atezolizumab,Oxaliplatin

            Therapeutic Area: Oncology Product Name: RO7198457

            Highest Development Status: Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 07, 2024

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            BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development in combination with lutetium (177Lu) vipivotide tetraxetan in patients with mCRPC.

            Lead Product(s): Gotistobart,Lutetium Vipivotide Tetraxetan

            Therapeutic Area: Oncology Product Name: ONC-392

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Recipient: OncoC4

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2024

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            The collaboration aims to support Autolus in the development of BNT211 (CLDN6 CAR-T/CLDN6 CAR-T(A)) for the treatment of relapsed or refractory advanced solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer.

            Lead Product(s): BNT211,CARVac

            Therapeutic Area: Oncology Product Name: BNT211

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

            Recipient: Autolus Therapeutics

            Deal Size: $250.0 million Upfront Cash: $50.0 million

            Deal Type: Collaboration February 08, 2024

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            DB-1305 (BNT325) is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the TROP2. It is being evaluated in phase 1/2 clinical trials for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer.

            Lead Product(s): BNT325

            Therapeutic Area: Oncology Product Name: DB-1305

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Duality Biologics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 31, 2024

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            BNT323 (DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2. It is under phase 3 clinical development for the treatment of metastatic breast cancer.

            Lead Product(s): DB-1303

            Therapeutic Area: Oncology Product Name: BNT323

            Highest Development Status: Phase III Product Type: Large molecule

            Recipient: Duality Biologics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 22, 2024

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            Under the terms of the agreement, WuXi Biologics leverages its proprietary antibody discovery technology platforms to discover two undisclosed targets of preclinical investigational monoclonal antibodies for BioNTech to develop next-generation therapeutic product candidates.

            Lead Product(s): Undisclosed

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Discovery Platform Product Type: Large molecule

            Recipient: WuXi Biologics

            Deal Size: Undisclosed Upfront Cash: $20.0 million

            Deal Type: Agreement January 11, 2024

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            BNT323 (DB-1303) is a next-generation Topoisomerase 1 inhibitor, ADC candidate targeting HER2, a cell surface protein. It is under phase 1/2 clinical development for the treatment of HER2-expressing advanced endometrial cancer.

            Lead Product(s): DB-1303

            Therapeutic Area: Oncology Product Name: BNT323

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Duality Biologics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 21, 2023

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            BioNTech will be developing, manufacturing and commercializing PM8002, a bispecific antibody candidate being evaluated in patients with advanced solid tumors, globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China.

            Lead Product(s): PM8002

            Therapeutic Area: Oncology Product Name: PM8002

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Recipient: Biotheus

            Deal Size: $1,055.0 million Upfront Cash: $55.0 million

            Deal Type: Licensing Agreement November 07, 2023

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            COMIRNATY® (tozinameran), a mRNA based COVID-19 Vaccine, which is investigated in combination with BNT-161 for the treatment of Influenza and COVID-19.

            Lead Product(s): Tozinameran,BNT-161

            Therapeutic Area: Infections and Infectious Diseases Product Name: Comirnaty

            Highest Development Status: Phase II Product Type: Vaccine

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2023

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            Details:

            BNT122 is a mRNA-based individualized neoantigen-specific immunotherapy (iNeST) candidate autogene cevumeran, which is investigated for the treatment of resected pancreatic ductal adenocarcinoma.

            Lead Product(s): Autogene Cevumeran,Atezolizumab,Oxaliplatin

            Therapeutic Area: Oncology Product Name: BNT122

            Highest Development Status: Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Genentech

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 19, 2023

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