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Details:
Tyvyt (sintilimab), an investigational PD-1 inhibitor a type of immunoglobulin G4 monoclonal antibody, binds to PD-1 molecules on surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
Tyvyt (sintilimab),is a novel PD-1 inhibitor, is under review for the first-line treatment of people with non-squamous non-small cell lung cancer based on the ORIENT-11 trial conducted exclusively in China.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
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 February 11, 2022
Details:
TYVYT (sintilimab injection), is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-L1 pathway, and reactivates T-cells to kill cancer cells.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
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 February 10, 2022
Details:
KEYTRUDA is a humanized monoclonal antibody that blocks 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,Fluoropyrimidine,Platinum
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Lead Product(s): Pembrolizumab,Fluoropyrimidine,Platinum
Therapeutic Area: Oncology Product Name: Keytruda
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 24, 2021
Details:
A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every 3 weeks for up to four cycles, followed by either sintilimab or placebo plus pemetrexed maintenance therapy.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2021
Details:
The ORIENT-11 primary clinical results were released during the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium as an oral presentation and simultaneously published by the Journal of Thoracic Oncology.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT® or placebo in combination with GEMZAR® and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer.
Lead Product(s): Sintilimab,Gemcitabine,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
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 21, 2020
Details:
TYVYT is the only PD-1 inhibitor to be included in China's National Reimbursement Drug List (NRDL) and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: $1,025.0 million Upfront Cash: $200.0 million
Deal Type: Licensing Agreement August 18, 2020
Details:
National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application for TYVYT® (sintilimab injection) in combination with Gemzar® (gemcitabine) and platinum as first-line therapy in squamous non-small cell lung cancer (squamous NSCLC).
Lead Product(s): Sintilimab,Gemcitabine,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2020
Details:
TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA® (pemetrexed) and platinum chemotherapy.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Tyvyt
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2020
Details:
TYVYT in combination with gemcitabine+ platinum chemotherapy demonstrated significant improvement in PFS compared to placebo+ gemcitabine and platinum chemotherapy.
Lead Product(s): Sintilimab,Gemcitabine,Platinum
Therapeutic Area: Oncology Product Name: Undisclosed
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 06, 2020
Details:
The NDA was based on the pre-specified interim analysis of a Phase 3 clinical trial Tyvyt or placebo in combination with ALIMTA and platinum as first-line therapy for Non-squamous NSCLC.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Undisclosed
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 23, 2020
Details:
Based on the interim analysis, sintilimab in combination with ALIMTA and platinum demonstrated a statistically significant improvement in PFS compared with placebo with ALIMTA and platinum combo.
Lead Product(s): Sintilimab,Pemetrexed,Platinum
Therapeutic Area: Oncology Product Name: Undisclosed
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 January 12, 2020
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