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Lead Product(s): Daratumumab
Therapeutic Area: Oncology Product Name: HLX15
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 13, 2021
Details:
Shanghai Henlius Biotech announced that the Investigational New Drug application of the Company’s daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody injection) to be used in the treatment of multiple myeloma has been accepted by the NMPA.
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Lead Product(s): Daratumumab
Therapeutic Area: Oncology Product Name: HLX15
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 November 12, 2020
Details:
Investigational New Drug (IND) application of the Company’s daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody injection) to be used in the treatment of multiple myeloma has been accepted by the National Medical Products Administration.
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Lead Product(s): Relmacabtagene autoleucel
Therapeutic Area: Oncology Product Name: Relma-cel
Highest Development Status: IND Enabling Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Goldman Sachs
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering November 03, 2020
Details:
Net proceeds from the offering will support the ongoing R&D of other candidates, such as JWCAR-129, JWATM-203, JWATM-204 and Nex-G. The firm will also set aside 16% of the proceeds to license promising assets to expand its pipeline.
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Lead Product(s): MOR210,Checkpoint inhibitor
Therapeutic Area: Oncology Product Name: TJ210
Highest Development Status: IND Enabling Product Type: Large molecule
Partner/Sponsor/Collaborator: MorphoSys
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Oral presentation will highlight the potent anti-tumor effects demonstrated by TJ210, a novel antibody that blocks C5aR by binding to a unique epitope.
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Lead Product(s): TCRT-ESO-A2
Therapeutic Area: Oncology Product Name: TCRT-ESO-A2
Highest Development Status: IND Enabling Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Axis Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 13, 2020
Details:
Axis Therapeutics and PharmaEssentia will collaborate to conduct an initial clinical study of Axis Therapeutics’ TCRT-ESO-A2 therapy, targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients, and to manufacture the investigational products, in Taiwan.
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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.
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