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Details:
Tevimbra (tislelizumab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is indicated for the treatment of advanced squamous NSCLC.
Lead Product(s): Tislelizumab,Paclitaxel,Carboplatin
Therapeutic Area: Oncology Product Name: Tevimbra
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 23, 2024
Details:
Tevimbra (tislelizumab), now FDA approved, is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight with locally advanced, or metastatic ESCC.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: Tevimbra
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 14, 2024
Details:
Tevimbra (tislelizumab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is being evaluated for the treatment of first-line gastric or gastroesophageal junction cancers.
Lead Product(s): Tislelizumab,Carboplatin,Fluoropyrimidine
Therapeutic Area: Oncology Product Name: Tevimbra
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 27, 2024
Details:
Tevimbra (tislelizumab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is being evaluated for the treatment of advanced squamous NSCLC.
Lead Product(s): Tislelizumab,Paclitaxel,Carboplatin
Therapeutic Area: Oncology Product Name: Tevimbra
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 26, 2024
Details:
Tevimbra (tislelizumab) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight with locally advanced, or metastatic ESCC.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: Tevimbra
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 19, 2023
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 mAb, designed to minimize binding to Fcγ receptors on macrophages, helping immune cells to detect and fight tumors. It is being investigated for the treatment of esophageal squamous cell carcinoma.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2023
Details:
IMX-110 demonstrated 100% tumor shrinkage in advanced metastatic colorectal cancer at the lowest dose of IMX-110 Iin combination with tislelizumab (anti-PD-1 antibody).
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
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 July 17, 2023
Details:
Under the termination of the agreement, BeiGene regained full, global rights to develop, manufacture and commercialize BGB-A1217 (ociperlimab), an investigational humanized monoclonal antibody designed to bind to TIGIT with high specificity and affinity.
Lead Product(s): Ociperlimab,Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A1217
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $1,000.0 million Upfront Cash: $300.0 million
Deal Type: Termination July 11, 2023
Details:
HFB200301, a first-in-class agonistic anti-TNFR2 monoclonal antibody, in combination with tislelizumab, an investigational anti-PD-1 immune checkpoint inhibitor, for the treatment of advanced solid tumor.
Lead Product(s): HFB200301,Tislelizumab
Therapeutic Area: Oncology Product Name: HFB200301
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2023
Details:
The Company intends to use net proceeds for its IMX-110 plus tislelizumab Phase 1b combination clinical trial and its IMX-110 monotherapy clinical trial. IMX-110 is a potential first-line therapy for soft tissue sarcoma.
Lead Product(s): Doxorubicin Hydrochloride,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bridgewest Group
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 14, 2023
Details:
IMX-110 demonstrated 100% tumor shrinkage in advanced metastatic colorectal cancer at the lowest dose of IMX-110 Iin combination with tislelizumab (anti-PD-1 antibody).
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 mAb, designed to minimize binding to Fcγ receptors on macrophages, helping immune cells to detect and fight tumors. It is being investigated for Advanced gastric or gastroesophageal junction adenocarcinoma.
Lead Product(s): Tislelizumab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2023
Details:
The collaboration aims to evaluate the safety and efficacy of Allocetra™, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors.
Lead Product(s): Allocetra-OTS,Tislelizumab
Therapeutic Area: Oncology Product Name: Allocetra-OTS
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 03, 2023
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fcγ receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Lead Product(s): Tislelizumab,Fluoropyrimidine
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
IMX-110 monotherapy, developed using SMARxT tissue-specific platform , is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment. It is currently being evaluated for advanced solid tumors.
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
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 February 07, 2023
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fcγ receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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
Details:
BGB-A317 (tislelizumab) is a humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding of Fcγ receptors on macrophages, helping body’s immune cells to detect and fight tumors. It is being evaluated in solid tumor and hematologic malignancies.
Lead Product(s): Tislelizumab,Cisplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: BGB-A317
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 17, 2023
Details:
HFB200603 is a single-digit nanomolar binder to human and cynomolgus BTLA, capable of blocking BTLA interaction with its ligand HVEM, inducing the production of inflammatory cytokines in the tumor microenvironment of different human tumor types.
Lead Product(s): HFB200603,Tislelizumab
Therapeutic Area: Oncology Product Name: HFB200603
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2023
Details:
BGB-A317 (tislelizumab), is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2022
Details:
IMX-110, a potential first-line therapy for soft tissue sarcoma, is currently in clinical trials as a monotherapy, and is planned to be combined with tislelizumab (BeiGene anti-PD-1) for advanced solid tumors.
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
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 December 19, 2022
Details:
APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in registration clinical trials in China.
Lead Product(s): APL-1202,Tislelizumab
Therapeutic Area: Oncology Product Name: Vesique
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 December 12, 2022
Details:
PT199 is an anti-CD73 monoclonal antibody with a differentiated mechanism of action and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment (TME).
Lead Product(s): PT199,Tislelizumab
Therapeutic Area: Oncology Product Name: PT199
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 08, 2022
Details:
Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200603 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200603.
Lead Product(s): HFB200603,Tislelizumab
Therapeutic Area: Oncology Product Name: HFB200603
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 18, 2022
Details:
Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.
Lead Product(s): IO-108,Tislelizumab
Therapeutic Area: Oncology Product Name: IO-108
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Immune-Onc Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 10, 2022
Details:
In the RATIONALE 301 trial, BGB-A317 (tislelizumab) was associated with a higher objective response rate (ORR) (14.3% vs. 5.4%) and more durable responses (median duration of response (DoR) 36.1 months vs. 11.0 months) compared with sorafenib.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 10, 2022
Details:
RATIONALE 301 trial met its objective at final analysis, demonstrating non-inferior overall survival for BGB-A317 (tislelizumab) versus sorafenib (median OS: 14.1 months) in patients with previously untreated unresectable hepatocellular carcinoma (HCC).
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 10, 2022
Details:
IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110.
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
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 September 07, 2022
Details:
Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.
Lead Product(s): HFB200301,Tislelizumab
Therapeutic Area: Oncology Product Name: HFB200301
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 15, 2022
Details:
First-line BGB-A317 (tislelizumab) plus chemotherapy showed median overall survival of 17.2 months versus 10.6 months for chemotherapy and reduced risk of death by 34% in patients with advanced esophageal squamous cell carcinoma.
Lead Product(s): Tislelizumab,Cisplatin,Fluorouracil
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2022
Details:
sBLA is supported by data from an interim analysis from the global RATIONALE 305 trial of BGB-A317 (tislelizumab) versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma.
Lead Product(s): Tislelizumab,Cisplatin,Oxaliplatin
Therapeutic Area: Oncology Product Name: BGB-A317
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 June 21, 2022
Details:
RATIONALE 309 met primary endpoint of PFS at planned interim analysis. Updated efficacy analyses at median follow-up of 15.5 months, BGB-A317 (tislelizumab) in combination with chemotherapy demonstrate clinically significant PFS benefit over chemotherapy and placebo.
Lead Product(s): Tislelizumab,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Vesique (APL-1202) is a reversible and orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor activities. Synergistic effects of APL-1202 and tislelizumab have been shown in various model systems of cancer including bladder cancer.
Lead Product(s): APL-1202,Tislelizumab
Therapeutic Area: Oncology Product Name: Vesique
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 May 27, 2022
Details:
Study of ZW25 (zanidatamab) in combination with docetaxel results in 90.5% confirmed objective response rate (cORR) in first-line treatment of advanced HER2-positive breast cancer.
Lead Product(s): Zanidatamab,Tislelizumab,Capecitabine
Therapeutic Area: Oncology Product Name: ZW25
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 26, 2022
Details:
RATIONALE 306 trial met primary endpoint at interim analysis, demonstrating tislelizumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with previously untreated advanced esophageal squamous cell carcinoma (ESCC).
Lead Product(s): Tislelizumab,Paclitaxel,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer.
Lead Product(s): Tislelizumab,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
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 27, 2022
Details:
Updated efficacy analyses showed that, at a median follow-up of 15.5 months, tislelizumab in combination with chemotherapy continued to demonstrate a clinically significant progression-free survival benefit over chemotherapy alone for patients with RM-NPC.
Lead Product(s): Tislelizumab,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
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 19, 2022
Details:
As a second-line treatment for patients with ESCC, this differentiated checkpoint inhibitor demonstrated significant improvements in overall survival and was generally well-tolerated in our Phase 3 trial of tislelizumab.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 15, 2022
Details:
JDQ443, an investigational selective, covalent, and orally bioavailable KRASG12C inhibitor, shows 57% confirmed ORR at recommended dose of 200 mg twice daily in Phase Ib study in patients with advanced non-small cell lung cancer (NSCLC).
Lead Product(s): JDQ443,TNO155,Tislelizumab
Therapeutic Area: Oncology Product Name: JDQ443
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 April 11, 2022
Details:
BGB-A317 (tislelizumab), an anti-programmed death receptor-1 inhibitor in pre-clinical studies binding to FcγR on macrophages showed compromise anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 08, 2022
Details:
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages, demonstrated significant improvement in overall survival and was generally well-tolerated in RATIONALE 302, Phase 3 trial.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Submissions based on data from Phase III RATIONALE 302, 303, 304 and 307 trials, in which tislelizumab monotherapy and in combination with chemotherapy demonstrated significant clinical benefits versus chemotherapy in multiple cancer types and lines of therapy.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
The submissions also include data from the pivotal Phase III RATIONALE 303 trial, which showed tislelizumab significantly improved overall survival versus chemotherapy in people with NSCLC after treatment with chemotherapy.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumors demonstrated that tislelizumab’s treatment effect was consistent and durable across tumor types and endpoints.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 11, 2022
Details:
IMX-110, currently in Phase 1b/2a clinical trials, holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) for the treatment of rhabdomyosarcoma.
Lead Product(s): IMX-110,Tislelizumab
Therapeutic Area: Oncology Product Name: IMX-110
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2022
Details:
The approval was supported by results from the global Phase 3 trial RATIONALE 303, in which BGB-A317 (tislelizumab) significantly prolonged overall survival in these patients compared to docetaxel and was generally well-tolerated, consistent with known risks.
Lead Product(s): Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A317
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 06, 2022
Details:
Under terms of the agreement, Novartis would obtain the development and commercialization rights to ociperlimab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan.
Lead Product(s): Ociperlimab,Tislelizumab
Therapeutic Area: Oncology Product Name: BGB-A1217
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: $2,895.0 million Upfront Cash: $300.0 million
Deal Type: Expanded Collaboration December 20, 2021
Details:
In RATIONALE 309, tislelizumab in combination with chemotherapy significantly prolonged progression-free survival for patients, with survival benefit observed across patient subgroups.
Lead Product(s): Tislelizumab,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
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 December 10, 2021
Details:
BGB-A317 (Tislelizumab), anti-PD-1 antibody results from an interim analysis of the randomized, double-blind, Phase 3 RATIONALE 309 trial evaluating in combination with chemotherapy for treatment of recurrent or metastatic nasopharyngeal cancer.
Lead Product(s): Tislelizumab,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: BGB-A317
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 December 02, 2021
Details:
APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment.
Lead Product(s): APL-1202,Tislelizumab
Therapeutic Area: Oncology Product Name: APL-1202
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity in first-line patients with gastric or gastroesophageal junction cancer. DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein.
Lead Product(s): DKN-01,Tislelizumab
Therapeutic Area: Oncology Product Name: DKN-01
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 September 16, 2021