Oncology | Phase I/ Phase II Developments | CHINA

Ascentage Pharma

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Ascentage Pharma’s BCL-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia

Lead Product(s): APG-2575,Rituximab

Therapeutic Area: Oncology Product Name: APG-2575

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 September 07, 2020

Details:

This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).

BeiGene

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BeiGene Announces Data on Tislelizumab and Pamiparib to Be Presented at the 2020 ESMO Virtual Congress

Lead Product(s): Pamiparib,Temozolomide

Therapeutic Area: Oncology Product Name: BGB-290

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 August 05, 2020

Details:

Clinical and nonclinical data on its anti-PD-1 antibody tislelizumab and its investigational PARP inhibitor pamiparib will be presented in two mini oral presentations and five posters at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress.

Ascentage Pharma

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Ascentage Pharma's Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Waldenström Macroglobulinemia

Lead Product(s): APG-2575

Therapeutic Area: Oncology Product Name: APG-2575

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 July 15, 2020

Details:

The U.s FDA has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM).

EpimAb Biotherapeutics

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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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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.

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Ascentage Pharma

Ascentage Pharma’s BCL-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia

BeiGene

BeiGene Announces Data on Tislelizumab and Pamiparib to Be Presented at the 2020 ESMO Virtual Congress

Ascentage Pharma

Ascentage Pharma's Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Waldenström Macroglobulinemia

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