Seqens Seqens

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[{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shanghai Henlius Biotech Announces Results Of Phase 1 Clinical Trial Of Anti-EGFR Monoclonal Antibody Injection","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Sanyou Biopharmaceuticals","pharmaFlowCategory":"D","amount":"$3.5 million","upfrontCash":"Undisclosed","newsHeadline":"Shanghai Henlius Biotech Says Entered Cooperation Agreement With Sanyou Biopharmaceuticals & Shanghai Zj Bio-Tech","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"CHINA","productType":"Large molecule","productStatus":"Undisclosed","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shanghai Henlius Biotech, Inc. (2696 HK) \u2013 Expecting five NDA Approvals Within Two Years","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China's First Trastuzumab Biosimilar Approved by NMPA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Accord healthcare","pharmaFlowCategory":"D","amount":"$565.0 million","upfrontCash":"$27.0 million","newsHeadline":"Henlius Granted Exclusive Development and Commercialisation Rights of HLX02 in the US and Canada to Accord","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shanghai Henlius Biotech First Patient Dosed in Phase 1 Clinical Trial of Henlius Denosumab Biosimilar HLX14","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The IND Application Of Henlius Daratumumab Biosimilar Accepted By NMPA","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Adalimumab Biosimilar Approved by NMPA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NMPA Has Accepted The NDA of HLX01(Rituximab Injection) for the Treatment of Rheumatoid Arthritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Daratumumab Biosimilar Received IND Approval from NMPA","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Plans to File the NDA of Novel anti-PD-1 mAb HLX10 for MSI-H Solid Tumours","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China's NMPA, Phase 3 MRCT Met its Primary Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Novel Anti PD-L1\/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius' Phase 3 Clinical Study of Novel PD-1 Inhibitor Serplulimab for the Treatment of First-Line Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Meets Primary Study Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Receives NMPA Approval for its First Innovative Monoclonal Antibody HANSIZHUANG","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius' Serplulimab Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Organon","pharmaFlowCategory":"D","amount":"$103.0 million","upfrontCash":"$73.0 million","newsHeadline":"Organon Enters into Global License Agreement to Commercialize Henlius\u2019 Investigational Perjeta\u00ae (Pertuzumab) and Prolia\u00ae\/Xgeva\u00ae (Denosumab) Biosimilar Candidates","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Palleon Pharmaceuticals","pharmaFlowCategory":"D","amount":"$196.5 million","upfrontCash":"Undisclosed","newsHeadline":"Palleon Pharmaceuticals and Henlius Enter into Strategic Collaboration to Develop Bifunctional Sialidase Therapies","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ASTRUM-005: The First Immunotherapy Clinical Study of SCLC Published in JAMA, One of the Top Medical Journals in the World","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Completed the Phase 1 Clinical Trial of HLX22 for the Treatment of HER2 Overexpressing Advanced Solid Tumours","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius Received IND Approval from US FDA for HLX07 in CSCC Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Fosun Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$143.6 million","newsHeadline":"Henlius and Fosun Pharma Entered into an Exclusive License Agreement for HANSIZHUANG in the US","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Fosun Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Fosun Pharma and Henlius Entered into an Exclusive License Agreement for Serplulimab in the US","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Kalbe Genexine Biologics","pharmaFlowCategory":"D","amount":"$665.0 million","upfrontCash":"$7.0 million","newsHeadline":"Henlius Expands Collaboration with KGbio to Develop, Commercialize and Supply Henlius' novel anti-PD-1 mAb HANSIZHUANG in MENA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Dosed for MRCT Phase 3 Study on First-Line LS-SCLC of Henlius Anti-PD-1 mAb Serplulimab in Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of non-squamous NSCLC Accepted by the NMPA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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            Hansizhuang (serplulimab) is a PD-1 inhibitor antibody drug candidate, which is currently being evaluated for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.

            Lead Product(s): Serplulimab,Undisclosed

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 12, 2023

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            Hansizhuang (serplulimab) is a novel humanized monoclonal anti-PD-1 antibody, which is approved for the first-line treatment of extensive stage small cell lung cancer in combination with fluorouracil and etoposide.

            Lead Product(s): Serplulimab,Cisplatin,Etoposide

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 25, 2023

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            Hansizhuang (serplulimab) is a novel humanized monoclonal anti-PD-1 antibody, which is approved for the first-line treatment of extensive stage small cell lung cancer in combination with fluorouracil and etoposide.

            Lead Product(s): Serplulimab,Fluorouracil

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2023

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            Under the terms of the agreement, Henlius will be responsible for development and commercialisation of Hansizhuang (serplulimab injection) as a treatment for two indications including ES-SCLC, Henlius' novel anti-PD-1 mAb, in 12 MENA countries.

            Lead Product(s): Serplulimab

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Kalbe Genexine Biologics

            Deal Size: $665.0 million Upfront Cash: $7.0 million

            Deal Type: Licensing Agreement September 12, 2023

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            Hansizhuang (serplulimab), a recombinant humanised anti-PD-1 monoclonal antibody injection, is the first innovative monoclonal antibody developed by Henlius for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC).

            Lead Product(s): Serplulimab

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Fosun Pharmaceutical

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement January 07, 2023

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            HANSIZHUANG (serplulimab), a recombinant humanised anti-PD-1 monoclonal antibody injection, is the first innovative monoclonal antibody developed by Henlius for the first-line treatment of SCLC.

            Lead Product(s): Serplulimab

            Therapeutic Area: Oncology Product Name: Hansizhuang

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Fosun Pharmaceutical

            Deal Size: Undisclosed Upfront Cash: $143.6 million

            Deal Type: Licensing Agreement December 27, 2022

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            HLX22, an anti-human epidermal growth factor receptor-2 (HER2) humanised monoclonal antibody(mAb) injection, has been completed in patients with HER2 overexpressing advanced solid tumours. The results of this study demonstrated the good safety and tolerability of HLX22.

            Lead Product(s): HLX22

            Therapeutic Area: Oncology Product Name: HLX22

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2022

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            Pre-clinical studies have shown that HLX07 binds EGFR with similar affinity and has better bioactivity compared to cetuximab. HLX07 can significantly inhibit growth of tumour cells in different tumour models and synergize with immune checkpoint inhibitors such as HANSIZHUANG.

            Lead Product(s): HLX07

            Therapeutic Area: Oncology Product Name: HLX07

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2022

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            In ASTRUM-005, HLX10 (serplulimab) combined with chemotherapy achieved by far the longest OS in first-line immunotherapy for ES-SCLC. Compared with chemotherapy, the treatment prolonged median OS by 4.5 months and had the lowest HR of 0.63.

            Lead Product(s): Serplulimab,Carboplatin

            Therapeutic Area: Oncology Product Name: HLX10

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2022

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            Under the terms of the agreement, Palleon will perform research for E-602 and the parties will then share preclinical and global clinical development responsibilities and costs for the Bifunctional HER2-Sialidase and a second bifunctional sialidase.

            Lead Product(s): Bifunctional HER2-Sialidase,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Undisclosed

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

            Recipient: Palleon Pharmaceuticals

            Deal Size: $196.5 million Upfront Cash: Undisclosed

            Deal Type: Collaboration June 28, 2022

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