Oncology | IND Enabling Drugs | CHINA

HJB

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HJB & Mabspace Biosciences' Develop, Mfg Agreement for Novel Humanized Claudin1

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.

Transcenta Holding

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Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Monoclonal Antibody TST001

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.

Gracell Biotechnologies

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Gracell Announces China NMPA Acceptance of Investigational New Drug Application for GC007g Cell Therapy

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.

AnHeart Therapeutics

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China clears Taletrectinib IND, issues clinical trial authorizations

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.

Transcenta Holding

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Transcenta Announces Acceptance by NMPA of IND Application of a Novel Humanized Claudin 18.2 Monoclonal Antibody

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

China

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Companies

HJB

HJB & Mabspace Biosciences' Develop, Mfg Agreement for Novel Humanized Claudin1

Transcenta Holding

Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Monoclonal Antibody TST001

Gracell Biotechnologies

Gracell Announces China NMPA Acceptance of Investigational New Drug Application for GC007g Cell Therapy

AnHeart Therapeutics

China clears Taletrectinib IND, issues clinical trial authorizations

Transcenta Holding

Transcenta Announces Acceptance by NMPA of IND Application of a Novel Humanized Claudin 18.2 Monoclonal Antibody