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Find Clinical Drug Pipeline Developments & Deals by Shanghai Junshi Biosciences

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            Lead Product(s): Toripalimab,Gemcitabine

            Therapeutic Area: Oncology Product Name: JS001

            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 29, 2020

            Details:

            The results of the study showed that Toripalimab in combination with Gemcitabine/Cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly extended the progression-free survival than Gemcitabine/Cisplatin.

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            Lead Product(s): Toripalimab

            Therapeutic Area: Oncology Product Name: JS001

            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 17, 2020

            Details:

            This is the third such designation granted to Toripalimab. The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

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            Lead Product(s): WJ1075

            Therapeutic Area: Oncology Product Name: WJ1024

            Highest Development Status: Undisclosed Product Type: Small molecule

            Recipient: Wigen Biomedicine Technology

            Deal Size: $69.2 million Upfront Cash: $5.2 million

            Deal Type: Collaboration September 16, 2020

            Details:

            Wigen Biomedicine will transfer its 50% interest in four of its drug candidates, XPO1 inhibitor, Aurora-A inhibitor, EGFR-exon20 inhibitor, and 4th generation EGFR inhibitor. Junshi will be granted the exclusive rights for production and commercialization for these drugs.

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            Lead Product(s): Immunotherapy compound

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Discovery Product Type: Undisclosed

            Recipient: Revitope Oncology

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration July 14, 2020

            Details:

            Revitope will leverage its proprietary protein engineering platform together with Junshi's novel antibody components to develop dual-antigen targeting cancer therapies. Revitope is granting Junshi an exclusive license on products arising from the research collaboration.

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            Lead Product(s): JS016

            Therapeutic Area: Infections and Infectious Diseases Product Name: JS016

            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 July 12, 2020

            Details:

            The study is a randomized, double-blind, placebo-controlled Phase I trial is intended to investigate the safety and tolerability of single dose JS016 intravenous injection (IV) in 40 healthy subjects.

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            Lead Product(s): JS016

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 June 07, 2020

            Details:

            JS016 is a recombinant fully human monoclonal neutralizing antibody that blocks the binding of the SARS-CoV-2 virus to the host cell surface receptor ACE2.

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            Lead Product(s): Toripalimab,Cetuximab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Merck & Co. Inc.

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration June 01, 2020

            Details:

            The companies are collaborating for a clinical trial program to investigate the efficacy & safety of anti-PD-1 mAb toripalimab (TUOYI®) in combination with Cetuximab (Erbitux®) as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head & neck.

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            Lead Product(s): JS016

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Eli Lilly

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 04, 2020

            Details:

            Junshi Biosciences and Lilly aim to submit an IND application and initiate clinical studies in the U.S. in the second quarter of the year.

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            Lead Product(s): Toripalimab

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 April 30, 2020

            Details:

            The sNDA is the world’s first new drug application of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma.

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            Lead Product(s): Toripalimab,Axitinib

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 March 30, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma.

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