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Details:

The launch of Pemetrexed for Injection, 100 mg and 500 mg Single-Dose Vials, which is the generic equivalent of ALIMTA® (pemetrexed for injection) in the U.S. Market approved by the U.S. Food and Drug Administration (USFDA).


Lead Product(s): Pemetrexed

Therapeutic Area: Oncology Product Name: Pemetrexed-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2022

Details:

Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with chemotherapy for the treatment of previously untreated EGFR exon 20 insertion mutation-positive NSCLC.


Lead Product(s): Amivantamab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2024

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Dimesna (LP-300) is a cancer causing TK’s proteins and receptors inactivator, is being investigated in non-small cell lung cancer (NSCLC) in never-smokers in both Japan and Taiwan.


Lead Product(s): LP-300,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Dimesna

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 April 22, 2024

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Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404 (ABV-1519), a promising therapeutic agent for the treatment of NSCLC.


Lead Product(s): ABV-1519,Cisplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: BLEX 404

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

Partner/Sponsor/Collaborator: OncoX

Deal Size: $26.2 million Upfront Cash: $13.7 million

Deal Type: Licensing Agreement April 17, 2024

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Pemrydi RTU, a folate analog metabolic inhibitor, is the first and only ready-to-use presentation of pemetrexed for injection and is approved in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC.


Lead Product(s): Pemetrexed,Pembrolizumab

Therapeutic Area: Oncology Product Name: Pemrydi RTU

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 16, 2024

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Pemrydi (pemetrexed) is the first ready-to-use formulation approved for commercialization in the US market. It is indicated for patients suffering from non-small cell lung cancer.


Lead Product(s): Pemetrexed

Therapeutic Area: Oncology Product Name: Pemrydi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Shilpa Medicare

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 16, 2024

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SB27 is the proposed biosimilar to keytruda (pembrolizumab), being investigated for the treatment of metastatic non-squamous non-small cell lung cancer.


Lead Product(s): Pembrolizumab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: SB27

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 05, 2024

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Keytruda (pembrolizumab) is an anti-programmed death receptor-1 (PD-1) therapy, which is being evaluated in combination with Lynparza (olaparib), a PARP inhibitor for the treatment of metastatic nonsquamous non-small cell lung cancer.


Lead Product(s): Pembrolizumab,Olaparib,Pemetrexed

Therapeutic Area: Oncology Product Name: Keytruda

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 21, 2024

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Tagrisso (osimertinib mesylate) is a third-generation, irreversible EGFR-TKI, small molecule drug candidate which is being evaluated for the treatment of EGFR-mutated advanced lung cancer.


Lead Product(s): Osimertinib Mesylate,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tagrisso

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 March 21, 2024

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PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47, is being developed for the treatment of patients with gastric, gastroesophageal junction and pancreatic adenocarcinomas.


Lead Product(s): PT-886,Pembrolizumab,Pemetrexed

Therapeutic Area: Oncology Product Name: PT-886

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 20, 2024

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BGB 324 (bemcentinib) is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase (AXL). It is being evaluated for the treatment of STK11 mutated Non-Small Lung Cancer.


Lead Product(s): Bemcentinib,Pembrolizumab,Pemetrexed

Therapeutic Area: Oncology Product Name: BGB 324

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 March 20, 2024

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AK104 (cadonilimab) is a PD-1/CTLA-4 bi-specific antibody which is being investigated in phase 3 in combination with chemotherapy (Carboplatin, Pemetrexed, Paclitaxel) for PD-L1 negative non-small cell lung cancer.


Lead Product(s): Cadonilimab,Carboplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: AK104

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 06, 2024

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Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with chemotherapy for the treatment of previously untreated EGFR exon 20 insertion mutation-positive NSCLC.


Lead Product(s): Amivantamab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 01, 2024

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Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI which is approved in combination with chemotherapy for the treatment of EGFR-mutated advanced non-small cell lung cancer.


Lead Product(s): Osimertinib Mesylate,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tagrisso

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 16, 2024

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Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with chemotherapy for the treatment of adult patients with advanced egfr-mutated non-small cell lung cancer after failure of prior therapy.


Lead Product(s): Amivantamab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 23, 2023

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Company submits sNDA seeking approval of rybrevant (amivantamab-vmjw), a EGFR and MET inhibitor candidate, plus chemotherapy for the treatment of patients with EGFR-mutated non-small cell lung cancer Who progressed on or after osimertinib.


Lead Product(s): Amivantamab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 20, 2023

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ADI-PEG 20 (pegargiminase) ia arginie degrader, which is being evaluated in phase 2/3 clinical trials in combination with cisplatin & pemetrexed for the treatment of malignant pleural mesothelioma.


Lead Product(s): Pegargiminase,Cisplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: ADI-PEG 20

Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 16, 2023

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The net proceeds will be used for the development of CK-301 (cosibelimab), an investigational fully-human monoclonal antibody that binds programmed death-ligand 1 and blocks its interaction with Programmed cell death protein 1.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Roth Capital Partners

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering November 14, 2023

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The net proceeds will be used for the development of CK-301 (cosibelimab), an investigational fully-human monoclonal antibody that binds programmed death-ligand 1 and blocks its interaction with Programmed cell death protein 1.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Roth Capital Partners

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering November 10, 2023

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Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib & chemotherapy for the treatment of adult patients with advanced egfr-mutated non-small cell lung cancer after failure of prior therapy.


Lead Product(s): Amivantamab,Lazertinib,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 23, 2023

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Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with chemotherapy for the treatment of previously untreated EGFR exon 20 insertion mutation-positive NSCLC.


Lead Product(s): Amivantamab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 21, 2023

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Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI which is being evaluated in combination with chemotherapy in phase 3 clinical trials for the treatment of EGFR-mutated advanced lung cancer and brain metastases.


Lead Product(s): Osimertinib Mesylate,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: Tagrisso

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 21, 2023

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Tagrisso (osimertinib) is kinase inhibitor of the epidermal growth factor receptor (EGFR), which is investigated in combination with chemotherapy for patients with EGFR-mutated advanced lung cancer.


Lead Product(s): Osimertinib Mesylate,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tagrisso

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 16, 2023

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Rybrevant (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET, which is investigated in combination with amivantamab for the first-line treatment of adult patients with advanced non-small cell lung cancer.


Lead Product(s): Amivantamab-vmjw,Carboplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2023

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Rybrevant (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET, which is investigated in combination with lazertinib for the treatment in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).


Lead Product(s): Amivantamab-vmjw,Lazertinib,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2023

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RYBREVANT (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET, which is investigated for the treatment of EGFR exon 19 deletions (ex19del) or L858R substitution NSCLC.


Lead Product(s): Amivantamab-vmjw,Carboplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2023

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Rybrevant (amivantamab-vmjw) is being developed in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.


Lead Product(s): Amivantamab-vmjw,Carboplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2023

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TAS6417 (zipalertinib) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR.


Lead Product(s): CLN-081,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: TAS6417

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 August 03, 2023

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Checkpoint intends to use the net proceeds for the manufacturing of CK-301 (cosibelimab), a potential best-in-class anti-PD-L1 antibody, being developed for advanced cutaneous squamous cell carcinoma.


Lead Product(s): Cosibelimab,Cisplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 31, 2023

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Rybrevant (amivantamab-vmjw) is being developed in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.


Lead Product(s): Amivantamab-vmjw,Pemetrexed

Therapeutic Area: Oncology Product Name: Rybrevant

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 17, 2023

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Pemrydi RTU (pemetrexed) is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration..


Lead Product(s): Pemetrexed,Pembrolizumab,Cisplatin

Therapeutic Area: Oncology Product Name: Pemrydi RTU

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 14, 2023

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Checkpoint intends to use the net proceeds for the manufacturing of CK-301 (cosibelimab), a fully human monoclonal antibody of IgG1 subtype that directly binds to PD-L1 and certain pre-commercial activities in anticipation of potential approval and commercial launch.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 23, 2023

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Tagrisso (osimertinib mesylate) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against CNS metastases. It is being investigated in patient with Stage IIIB-IIIC or Stage IV epidermal growth factor receptor-mutated NSCLC.


Lead Product(s): Osimertinib Mesylate,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tagrisso

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 May 17, 2023

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SMT112 (ivonescimab) is an investigational bispecific antibody which blocks PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. It is being investigated for EGFR mutated NSCLC.


Lead Product(s): Ivonescimab,Carboplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: SMT112

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2023

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China NMPA approves TYVYT® (sintilimab injection), an antibody that inhibits PD-1, in combination with bevacizumab and chemotherapy in patients with EGFR-mutated non-squamous NSCLC who progressed after EGFR-TKI therapy.


Lead Product(s): Sintilimab,Cisplatin,Pemetrexed

Therapeutic Area: Oncology Product Name: Tyvyt

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2023

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Under the agreement, Reprocell will provide support for Lantern Pharma's Phase 2 trial of LP-300 (tavocept) in combination with carboplatin and pemetrexed in patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with TKIs.


Lead Product(s): Dimesna,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: LP-300

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Reprocell

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 03, 2023

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Checkpoint intends to use the net proceeds of this offering for the manufacturing of CK-301 (cosibelimab) and certain pre-commercial activities in anticipation of potential approval and commercial launch.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $6.1 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 31, 2023

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LP-300 is intended to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.


Lead Product(s): LP-300,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: LP-300

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 March 28, 2023

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Keytruda® (pembrolizumab) is a humanized monoclonal anti-PD-1 therapy that works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.


Lead Product(s): Pembrolizumab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: Keytruda

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2023

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BGB324 (bemcentinib) is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase (AXL) a promising therapeutic target for serious diseases. It is being developed for the treament of NSCLC.


Lead Product(s): Bemcentinib,Pembrolizumab,Pemetrexed

Therapeutic Area: Oncology Product Name: BGB324

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 March 09, 2023

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CK-301 (cosibelimab) is a fully-human mAb of IgG1 subtype that directly binds to PD-L1 and blocks the PDL1 interaction with the PD-1 and B7.1 receptors, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 02, 2023

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Checkpoint intends to use the net proceeds for the manufacturing of CK-301 (cosibelimab), a potential best-in-class anti-PD-L1 antibody, and certain pre-commercial activities in anticipation of potential approval and commercial launch.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $7.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 21, 2023

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Tuoyi (toripalimab) is an anti-PD-1 monoclonal antibody which promotes immune system’s ability to attack and kill tumor cells by blocking PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor endocytosis function.


Lead Product(s): Toripalimab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tuoyi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 18, 2023

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BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed.


Lead Product(s): BLEX 404,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: ABV-1519

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: BIOKEY

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2023

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IOA-244 is a first-in-class semi-allosteric, non-ATP competitive, small molecule PI3Kδ inhibitor which has shown high beneficial tolerability and clinical benefit profile. PI3Kδ over-expression stimulates multiple cancer mechanisms and an oncogenic role in many tumor types.


Lead Product(s): Roginolisib,Avelumab,Pemetrexed

Therapeutic Area: Oncology Product Name: IOA-244

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2023

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PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations.


Lead Product(s): Pemetrexed,Pembrolizumab

Therapeutic Area: Oncology Product Name: Pemfexy

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 19, 2022

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CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors.


Lead Product(s): Cosibelimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: CK-301

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $7.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 15, 2022

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Tuoyi (toripalimab) is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function).


Lead Product(s): Toripalimab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tuoyi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Shanghai Junshi Biosciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2022

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  • Development Update

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Full results from the PERLA phase II trial, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, with results by programmed death ligand-1 (PD-L1) expression subgroups.


Lead Product(s): Dostarlimab,Pemetrexed,Cisplatin

Therapeutic Area: Oncology Product Name: Jemperli

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: AnaptysBio

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 05, 2022

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Toripalimab (tuoyi) is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function).


Lead Product(s): Toripalimab,Pemetrexed,Carboplatin

Therapeutic Area: Oncology Product Name: Tuoyi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 20, 2022

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