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Details:
Safety and efficacy of HMPL-012 (surufatinib), an oral inhibitor of angiogenesis and immune modulation, was demonstrated in SANET-p and SANET-ep studies, in patients with advanced pNETs and epNETs conducted in China.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 02, 2022
Details:
Sulanda (Surufatinib), a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors and fibroblast growth factor receptor.
Lead Product(s): Surufatinib,Toripalimab,Etoposide
Therapeutic Area: Oncology Product Name: Sulanda
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 10, 2021
Details:
SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA), a novel, oral angio-immuno kinase inhibitor in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma.
Lead Product(s): Surufatinib,Toripalimab
Therapeutic Area: Oncology Product Name: Sulanda
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 September 21, 2021
Details:
Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 July 01, 2021
Details:
This trial is to explore potential synergistic activity of the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in enhancing overall antitumor activity from inhibition of angiogenesis along with stimulation of an immune response.
Lead Product(s): Surufatinib,Tislelizumab
Therapeutic Area: Oncology Product Name: Undisclosed
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 24, 2021
Details:
The NMPA approval of Sulanda® was based on results from the SANET-ep study. The Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: Sulanda
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 30, 2020
Details:
The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 December 28, 2020
Details:
Phase III SANET-p demonstrated surufatinib reduces the risk of disease progression or death by 51% in patients with pancreatic neuroendocrine tumors (“NET”).
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 September 20, 2020
Details:
The NDA is supported by data from the successful SANET-p study, a Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic patients in China for whom there is no effective therapy.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 September 17, 2020
Details:
New and updated analyses on the studies of surufatinib and fruquintinib will be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 24, 2020
Details:
Application is based on the scientific advice which the company got from the European Medicines Agency’s Committee for Medicinal Products for Human Use for surufatinib for the treatment of patients with advanced neuroendocrine tumors.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: HMPL-012
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 10, 2020
Details:
CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimab plus surufatinib in the treatment of patients with advanced malignancies.
Lead Product(s): Sintilimab,Surufatinib
Therapeutic Area: Oncology Product Name: Tyvyt
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 July 08, 2020
Details:
Under this agreement, Chi-Med and BeiGene each plan to explore development of the combination of surufatinib with tislelizumab or fruquintinib with tislelizumab in different indications and regions. The companies have agreed to provide mutual drug supply and other support.
Lead Product(s): Surufatinib,Tislelizumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hutchison China MediTech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 26, 2020
Details:
The presentation will highlight data from a Phase I trial of surufatinib plus toripalimab in patients with advanced solid tumors.
Lead Product(s): Surufatinib,Toripalimab
Therapeutic Area: Oncology Product Name: Undisclosed
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, 2020
Details:
The drug, a novel, oral angio-immuno kinase inhibitor, is being developed for patients who are unable to have surgery for these conditions.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: Undisclosed
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 17, 2020
Details:
The IDMC recommended that the study stops early as the pre-defined primary endpoint of progression free survival had already been met.
Lead Product(s): Surufatinib
Therapeutic Area: Oncology Product Name: Undisclosed
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 January 20, 2020
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