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At present, the international treatment of HER2-positive breast cancer in the large molecule targeted drugs have curto-bead monoanti and pato-pearl monoanti.
almost all HER2-positive metastasis breast cancer patients develop the disease.
preclinical studies have shown that cell cycle protein-dependent kinase 4 and 6 (CDK4/6) inhibitors show increased HER2 activity and increased sensitivity to HER2 kinase inhibitors or antiHER2 antibodies.
combination therapy of standard HER2 targeted therapy with CDK4/6 inhibitors can improve the outcome of treatment in patients with hormone-positive (HR-plus)/HER2-positive metastases breast cancer.
KN026 is an anti-HER2 dual-specific antibody developed by CorningErry, which binds to both non-overlapping tables of HER2, blocking the dual HER2 signal.
phase I./II. clinical trials have shown that KN026 has good tolerance and safety, and has significant anti-tumor activity in HER2-positive breast cancer patients who progress after multi-line anti-HER2 treatment.
March 2020, CorningEry signed a clinical supply agreement with Pfizer to advance the KN026's joint drug trial with the oral CDK4/6 inhibitor Aibo new ® (Pybersili).
The joint drug will begin with a multi-center, open-label phase I.b/II clinical study to assess the effectiveness, safety and tolerance of KN026 combined pyridoxie in the treatment of local late-stage non-removable or metastasis HER2-positive breast cancer patients.
by Fudan University Affiliated Oncology Hospital Professor Wu Wei as the lead researcher, the main endpoints of the study are dose-limiting toxicity (DLT) and objective mitigation rate (ORR).
trial as a potential chemotherapy-free option will give new hope to HER2-positive breast cancer patients.
this time, based on a large number of previous research work, KN026 liquid large-size dosage form has also been approved for clinical use.
than previous freeze-dried preparations, liquid preparations reduce process steps and facilitate clinical use.
About KN026 KN026 is Corning Jerry's anti-HER2 dual-specific antibody developed with independent intellectual property Fc isoid platform technology (CRIB), which can bind to two non-overlapping tables of HER2 at the same time, resulting in double HER2 signal blocking, to achieve the effects of cratural bead monoantitor and patoju single anti-monosovironment and association, such as showing higher affinity, as well as excellent tumor inhibition in HER2-positive tumor cells.
, KN026 also inhibited her2 medium- and low-expression tumors and crater-beaded single resistant cell strains.
KN026 has been approved by China's State Drug Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in 2018, and is currently conducting a number of Phase I./II. clinical trials in China, as well as advancing Phase I. clinical trials in the United States.
phase I clinical trial results showed that KN026 had good tolerance and safety, and showed significant anti-tumor activity in HER2-positive breast cancer patients who progressed after multi-line anti-HER2 treatment.
references: s1, W., et al., Cancer statistics in China, 2015. CA Cancer J Clin, 2016. 66(2): p. 115-32. [2] Iqbal, N. and N. Iqbal, Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int, 2014. 2014: p. 852748. [3] Qiu, M.Z., et al., HER2-positive patients receiving trastuzumab treatment have a comparable prognosis with HER2-negative advanced gastric cancer patients: a prospective cohort observation. Int J Cancer, 2014. 134(10): p. 2468-77. [4] Kai Zhang, Ruoxi Hong, Lee Kaping, et al. CDK4/6 inhibitor palbociclib enhances the effect of pyrotinib in HER2-positive breast cancer. Cancer Lett. 2019 Apr 10; 447:130-140. [5] Sara M Tolaney , Andrew M Wardley, Stefania Zambelli, et al. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol .2020 Jun; 21(6):763-775. Source: Corning Jerry Note: The original text has been cut