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

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            HJB

            • Development Update

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            Lead Product(s): Humanized Claudin18.2 monoclonal antibody

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 May 08, 2020

            Details:

            Per the development and manufacturing agreement between HJB and Mabspace Bioscience, HJB provided one-stop shop end-to-end CMC package for the Claudin18.2 antibody.

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            Lead Product(s): TST001

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 April 20, 2020

            Details:

            Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its ADCC inducing activity against Claudin 18.2 expressing tumors.

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            Lead Product(s): GC007g

            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 April 03, 2020

            Details:

            The company plans to initiate a phase 1 clinical study in patients with CD19 positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) in Q2, 2020.

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            Lead Product(s): Taletrectinib

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 March 24, 2020

            Details:

            The first Phase 2 trial will enroll first-and second-line Non-Small Cell Lung Cancer (NSCLC) patients with ROS1 mutations and is designed as an open-label, single-arm, multi-center study.

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            Lead Product(s): TST001

            Therapeutic Area: Oncology Product Name: Undisclosed

            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 20, 2020

            Details:

            TST001 is the first program developed by Transcenta since merger and it took less than 12 months from the identification of preclinical candidate to IND filing.