Oncology | Phase I/ Phase II Developments | CHINA

EpimAb Biotherapeutics

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CHINA China

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INTERPHEX 2020

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EpimAb Biotherapeutics Presents Preclinical Data Characterizing EMB-01 at AACR Virtual Annual Meeting II

Lead Product(s): EMB-01

Therapeutic Area: Oncology Product Name: EMB-01

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2020

Details:

The data presented in the poster characterizes EMB-01, EpimAb’s lead bispecific antibody candidate developed based the company’s proprietary FIT-Ig® platform to target EGFR and cMet on tumor cells simultaneously.

BeiGene

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INTERPHEX 2020

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BeiGene and SpringWorks Announce Presentation of Preclinical Data Combining RAF Dimer Inhibitor Lifirafenib with MEK Inhibitor Mirdametinib ...

Lead Product(s): Beigene-283,Mirdametinib

Therapeutic Area: Oncology Product Name: BGB-283

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

Partner/Sponsor/Collaborator: SpringWorks Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2020

Details:

BeiGene provided a program update on their ongoing Phase 1b/2 study evaluating the combination of BeiGene’s investigational RAF dimer inhibitor, lifirafenib, with SpringWorks’ MEK inhibitor, mirdametinib, in solid tumors harboring mutations in the MAPK pathway.

I-Mab Biopharma

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First Patient Dosed with I-Mab's CD73 Antibody TJD5 in Phase 1/2 Clinical Trial in China for Advanced Solid Tumors

Lead Product(s): TJD5

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 13, 2020

Details:

Phase 1/2 study is a multicenter, open-label, dose escalation and cohort expansion study, which will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TJD5.

Ascentage Pharma

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Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of Bcl-2 Inhibitor APG-2575

Lead Product(s): APG-2575

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2020

Details:

Phase Ib/II study will evaluate the safety, tolerability, and preliminary anticancer activity of APG-2575 as a single agent or in combination therapies for the treatment of patients with r/r CLL/SLL.

Shanghai Henlius Biotech

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Shanghai Henlius Biotech Announces Results Of Phase 1 Clinical Trial Of Anti-EGFR Monoclonal Antibody Injection

Lead Product(s): HLX07

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2020

Details:

HLX07 demonstrated favorable safety and tolerability profile in a prospective, open-label, dose-escalation Phase 1 clinical study (HLX07FIH, NCT02648490) for the treatment of advanced solid tumours.

Ascentage Pharma

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Ascentage Pharma Announces First Patient Dosed in the Global Phase Ib/II Clinical Study

Lead Product(s): APG-2575

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 23, 2020

Details:

The study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with rituximab or acalabrutinib in patients with r/r CLL/SLL.

Ascentage Pharma

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Ascentage Pharma Announces Clearances for Three Phase Ib/II Clinical Studies

Lead Product(s): APG-2575

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 09, 2020

Details:

The company will initiate a Phase Ib study of APG-2575 as a single agent or in combination for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML) in China.

Ascentage Pharma

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Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Trial of APG-1387 in Combination with Chemotherapy

Lead Product(s): APG-1387,Paclitaxel,Gemcitabine

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2020

Details:

The multi-center, open-label clinical trial is comprised of a Phase Ib dose-escalation study and a Phase II efficacy study.

CStone Pharmaceuticals

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CStone announces first patient dosed in the global proof-of-concept study of CS1001 in combination with Bayer's regorafenib

Lead Product(s): CS1001,Regorafenib

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 24, 2020

Details:

This is the first global study carried out as a collaboration between CStone and Bayer assessing the safety, tolerability, pharmacokinetics, and antitumor activity of the CS1001 plus regorafenib combination in cancer.

CStone Pharmaceuticals

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CStone Pharmaceuticals and Blueprint Medicines Initiate Phase 1b/2 Clinical Trial of Fisogatinib in Combination with CS1001 for Patients wit...

Lead Product(s): Fisogatinib,CS1001

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2020

Details:

This trial will assess the potential for two complementary treatment approaches – precision therapy and immuno-oncology therapy – to enhance anti-tumor activity in locally advanced or metastatic HCC.

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Find Oncology Drugs in Phase I/II Clinical Development in CHINA

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EpimAb Biotherapeutics

EpimAb Biotherapeutics Presents Preclinical Data Characterizing EMB-01 at AACR Virtual Annual Meeting II

BeiGene

BeiGene and SpringWorks Announce Presentation of Preclinical Data Combining RAF Dimer Inhibitor Lifirafenib with MEK Inhibitor Mirdametinib ...

I-Mab Biopharma

First Patient Dosed with I-Mab's CD73 Antibody TJD5 in Phase 1/2 Clinical Trial in China for Advanced Solid Tumors

Ascentage Pharma

Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Study of Bcl-2 Inhibitor APG-2575

Shanghai Henlius Biotech

Shanghai Henlius Biotech Announces Results Of Phase 1 Clinical Trial Of Anti-EGFR Monoclonal Antibody Injection

Ascentage Pharma

Ascentage Pharma Announces First Patient Dosed in the Global Phase Ib/II Clinical Study

Ascentage Pharma

Ascentage Pharma Announces Clearances for Three Phase Ib/II Clinical Studies

Ascentage Pharma

Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Trial of APG-1387 in Combination with Chemotherapy

CStone Pharmaceuticals

CStone announces first patient dosed in the global proof-of-concept study of CS1001 in combination with Bayer's regorafenib

CStone Pharmaceuticals

CStone Pharmaceuticals and Blueprint Medicines Initiate Phase 1b/2 Clinical Trial of Fisogatinib in Combination with CS1001 for Patients wit...