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CASI Pharmaceuticals
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9620 Medical Center Drive Suite 300 Rockville, MD 20850
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BI-1206 is a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB. It is being evaluated in combination with rituximab in patients with Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma.


Lead Product(s): BI-1206,Rituximab

Therapeutic Area: Oncology Product Name: BI-1206

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

Recipient: BioInvent

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 05, 2024

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The partnership aims for the manufacturing and advancement of iTolerance's Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the proprietary iTOL-100 platform technology towards first in human clinical study for lead program, iTOL-102.


Lead Product(s): Pralatrexate

Therapeutic Area: Oncology Product Name: Folotyn

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Acrotech Biopharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 01, 2023

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Through the acquisition, CASI gains global rights to the Cleave's clinical asset, CB-5339 tosylate, an oral, second-generation, small molecule valosin-containing protein (VCP)/p97 inhibitor, in patients with acute myeloid leukemia and myelodysplastic syndrome.


Lead Product(s): CB-5339

Therapeutic Area: Oncology Product Name: CB-5339

Highest Development Status: Phase IProduct Type: Small molecule

Recipient: Cleave Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition July 20, 2023

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CB-5339 is an oral second-generation, small molecule VCP/p97 inhibitor, and is currently in Phase 1 clinical trial in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myeloproliferative neoplasms.


Lead Product(s): CB-5339

Therapeutic Area: Oncology Product Name: CB-5339

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cleave Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2023

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CNCT19 (Inaticabtagene Autoleucel), is the first CAR-T cell therapy for the treatment of B-ALL submitted for NDA and has the potential to be the first approved domestic developed CD19 directed CAR-T therapy in China.


Lead Product(s): Inaticabtagene Autoleucel,Fludarabine Phosphate,Cyclophosphamide

Therapeutic Area: Oncology Product Name: CNCT19

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 15, 2022

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BI-1206, a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB, in combination with rituximab in patients with relapsed/refractory Non-Hodgkin's Lymphoma (NHL).


Lead Product(s): BI1206,Rituximab

Therapeutic Area: Oncology Product Name: BI1206

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

Partner/Sponsor/Collaborator: BioInvent

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2022

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Under the terms of the agreement, CASI maintains exclusive US commercialization and co-marketing rights of CID-103 for the treatment, prevention, and diagnosis of autoimmune diseases, conditions, and disorders in the United States.


Lead Product(s): CID-103

Therapeutic Area: Oncology Product Name: CID-103

Highest Development Status: Phase IProduct Type: Large molecule

Recipient: Precision Autoimmune Therapeutics

Deal Size: $21.0 million Upfront Cash: Undisclosed

Deal Type: Financing July 08, 2022

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Under the terms of the agreement, CASI shall maintain the exclusive commercialization and co-marketing rights of CID-103 in autoimmune indications and book all revenue in the United States.


Lead Product(s): CID-103

Therapeutic Area: Oncology Product Name: CID-103

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Beijing Tianshi Tongda Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: $10.0 million

Deal Type: Licensing Agreement May 24, 2022

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Under the terms of the agreement, China Resources Pharmaceutical Commercial Group International Trading Co., will continue to be the sole distributor for the sale of EVOMELA® (melphalan) for Injection in China.


Lead Product(s): Melphalan

Therapeutic Area: Oncology Product Name: Evomela

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Guokang Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 04, 2022

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Under the terms of the agreement, Cleave and CASI will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in China and associated markets.


Lead Product(s): CB-5339 Tosylate

Therapeutic Area: Oncology Product Name: CB-5339

Highest Development Status: Phase IProduct Type: Small molecule

Recipient: Cleave Therapeutics

Deal Size: $85.0 million Upfront Cash: $5.5 million

Deal Type: Licensing Agreement March 08, 2021

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