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Find Drugs in Development News & Deals for Orelabrutinib

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Details:

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which is being evaluated in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma.


Lead Product(s): ICP-248,Orelabrutinib

Therapeutic Area: Oncology Product Name: ICP-248

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 12, 2024

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Hibruka (orelabrutinib) is a highly selective BTK inhibitor developed for the treatment of cancers and autoimmune diseases. Currently under development for the treatment of primary immune thrombocytopenia (ITP) in China.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: Hibruka

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 26, 2023

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Hibruka (orelabrutinib) is a highly selective BTK inhibitor developed for the treatment of cancers and autoimmune diseases. Currently under development for the treatment of R/R MZL in China.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: Hibruka

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 19, 2023

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Hibruka (orelabrutinib) is a highly selective BTK inhibitor developed for the treatment of cancers and autoimmune diseases. Currently under development for for the treatment of MS, SLE, ITP and NMOSD in China.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: Hibruka

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2023

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Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.


Lead Product(s): Orelabrutinib,Tafasitamab,Lenalidomide

Therapeutic Area: Oncology Product Name: Hibruka

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 20, 2022

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Hibruka (orelabrutinib) is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. As a highly selective BTK inhibitor, orelabrutinib has demonstrated good efficacy and safety in the treatment of R/R MCL.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: Hibruka

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 22, 2022

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InnoCare will use the net proceeds from the STAR offering to fund its drug research and development of ICP-022 (orelabrutinib), drug R&D platform upgrade, marketing network upgrade, information technology upgrade and working capital projects.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: ICP-022

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: China International Capital

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering September 20, 2022

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ICP-022 (orelabrutinib) is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases, was well tolerated with a safety profile in the patients with MZL.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2022

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The study randomized 60 patients with 55 patients who completed 12-week treatment. Baseline disease characteristics were generally balanced across treatment groups. ICP-022 (orelabrutinib) was generally well tolerated in patients with SLE.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2022

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ICP-022 (orelabrutinib) is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. The plasma exposure of orelabrutinib (AUC and Cmax) was proportionally increased with doses.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2022

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Approval received from China National Medical Products Administration for Investigational New Drug, ICP-022 (orelabrutinib), a highly selective Bruton's tyrosine kinase inhibitor for treatment of NMOSD in China.


Lead Product(s): Orelabrutinib

Therapeutic Area: Rare Diseases and Disorders Product Name: ICP-022

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 02, 2022

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InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.


Lead Product(s): Tafasitamab,Orelabrutinib

Therapeutic Area: Oncology Product Name: Monjuvi

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: InnoCare Pharma

Deal Size: $117.5 million Upfront Cash: $35.0 million

Deal Type: Collaboration August 16, 2021

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Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2021

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Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China, while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Biogen

Deal Size: $937.5 million Upfront Cash: $125.0 million

Deal Type: Collaboration July 12, 2021

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This is a phase 3 multicenter, randomized trial of orelabrutinib in combination with R-CHOP versus placebo plus R-CHOP in previously untreated MCL patients.


Lead Product(s): Orelabrutinib,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: ICP-022

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 05, 2021

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The National Drug Administration of China (NMPA) Drug Evaluation Center (CDE) has prioritized the new drug application (NDA) for Orelabrutinib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL).


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: WuXi STA

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2021

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Orelabrutinib is a highly selective and novel BTK inhibitor developed by InnoCare that can avoid off-target-related adverse events with improved safety and efficacy.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: ICP-022

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 27, 2020

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Orelabrutinib is a selective BTK inhibitor to treat cancers and autoimmune diseases, which has been supported by the national special project for the development of major new drugs. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: ICP-022

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2020

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This will be a randomized, double-blind, placebo-controlled and multi-center phase II Study in Relapsing-Remitting multiple sclerosis patients (RRMS). Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications.


Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2020

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Half of the listing proceeds will be used to fund the development of orelabrutinib in China and the US and the rest for developing other drugs.


Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $289.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 20, 2020

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