SANET

HUTCHMED Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

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måndag, maj 2, 2022
CRL, EDT, Wilms' tumor, Population, PFS, SANET, GLOBE, NDA, Lancet, Food, Safety, Physician, Endpoint security, Patient, NET, HCM, FGFR, Review, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, New Drug Application, Pnet, Tumor-associated macrophage, HKT, BST, VEGFR, Pharmaceutical industry, Agency

Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.

Key Points: 
  • Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.
  • Surufatinib received U.S. FDA Fast Track Designations in April 2020 for the treatment of pNETs and epNETs.
  • The FDA evaluated the applicability of the SANET studies data generated in one country to U.S. patients and U.S. medical practice.
  • epNETs in China: On December 29, 2020, surufatinib was granted drug registration approval in China for the treatment of epNET.

HUTCHMED Highlights Surufatinib and Toripalimab Combination Clinical Data being Presented at the ESMO Immuno-Oncology 2021 Meeting

Retrieved on: 
fredag, december 10, 2021
FGFR, PFS, National Medical Products Administration, VEGFR, Tumor-associated macrophage, Lancet, SANET, Patient, Pharmaceutical industry

The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170 ) in patients with advanced epNETs conducted in China.

Key Points: 
  • The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170 ) in patients with advanced epNETs conducted in China.
  • The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology1.
  • Pancreatic Neuroendocrine Tumors (pNETs) in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET.
  • Earlier, the FDA granted 2 Breakthrough Therapy designations, 1 Fast Track designation, 4 Orphan Drug designations for toripalimab.

HUTCHMED Initiates SURTORI-01, a Phase III Trial of SULANDA® in Combination with TUOYI® in the Treatment of Advanced Neuroendocrine Carcinoma in China

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tisdag, september 21, 2021
FOLFIRI, Tumor-associated macrophage, NEC, SANET, Günther Nenning, Hormone, Patient, Death, Annual general meeting, Toxicity, HCM, FGFR, Phase, ASCO, Gastrointestinal tract, ORR, Dor, Disease, CSCO, VEGFR, Prognosis, NETS, American Society of Clinical Oncology, DCR, AES, Pancreas, National Medical Products Administration, Safety, Chinese, Progression-free survival, NEN, PFS, Society, GLOBE, Pharmaceutical industry

Treatment related adverse events (TRAEs) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively.

Key Points: 
  • Treatment related adverse events (TRAEs) were manageable, with surufatinib or toripalimab interruption occurred in 6 (28.6%) and 4 (19%) patients respectively.
  • The SURTORI-01 Phase III study is a randomized, controlled, open-label, multi-center study where approximately 200 patients are expected to be enrolled.
  • HUTCHMED is the sponsor of SURTORI-01 and responsible for all clinical and regulatory execution of the Phase III study.
  • The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821 ) in patients with advanced pNET in China.

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors

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måndag, september 20, 2021
Food, Marketing, Neoplasm, Tumor-associated macrophage, Pharmacokinetics, Review, NET, PK, Nervous system, NDA, SANET, Lancet, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Medicines Agency, Hormone, AstraZeneca, Frost & Sullivan, Patient, HCM, MAA, FGFR, Malignancy, PMDA, Medicine, United Kingdom, European Union, Growth, Large-cell lung carcinoma, Dor, Savolitinib, ORR, Disease, MET, VEGFR, NETS, DCR, Union, National Medical Products Administration, Medicines and Healthcare products Regulatory Agency, Cell, Safety, Incidence, Survival, PFS, GLOBE, Pharmaceutical industry, Medical imaging

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Sept. 19, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors (NETs).
  • This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited.
  • In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR).
  • Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan.

BINOVI ACADEMY ANNOUNCES RELEASE OF THE SANET VISION SEMINAR SERIES PREMIUM EDUCATIONAL MODULE BY DR. ROBERT SANET AND DR. LEONARD PRESS

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torsdag, januari 23, 2020
Optometry, SANET, OTC Markets Group

Toronto, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Eyecarrot Innovations Corp., (Eyecarrot) (TSX-V: EYC | OTCQB: EYCCF) is pleased to announce the exclusive release of the complete Sanet Vision Seminar Series , a premium educational module for Binovi Academy, part of Binovi Pro.

Key Points: 
  • Toronto, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Eyecarrot Innovations Corp., (Eyecarrot) (TSX-V: EYC | OTCQB: EYCCF) is pleased to announce the exclusive release of the complete Sanet Vision Seminar Series , a premium educational module for Binovi Academy, part of Binovi Pro.
  • With this release, the Sanet Vision Seminar Series is now available to optometry professionals for use as an educational tool for both themselves and their staff.
  • Binovi Academy content packs include testing and therapy protocols and pre-set activities for Binovi Pro, as well as custom test configurations for Binovi Touch, and more.
  • Binovi Academy helps tie together the four pillars of the Binovi Platform and aims to bring as much new information, tools, and techniques to users as possible.