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Apatinib (Aitan®): Market approval in China for advanced gastric cancer, December 2014

Apatinib Mesylate

Apatinib Mesylate is a small molecule drug candidate which has been approved in China and has completed Phase 1/2A development in the US. It is being developed for the treatment of certain solid tumor cancers including Metastatic Gastric Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Metastatic Breast Cancer, and Non-Small Cell Lung Cancer. It was first synthesized and patented by Advenchen Laboratories in Southern California and is being developed in numerous clinical trials throughout the world.

FOR PATIENTS

Apatinib has been approved by the Chinese FDA for late stage gastric cancer in China. Outside of China, apatinib is an investigational drug not yet approved for marketing. Patients are currently being treated in clinical trials which have been approved under certain regulatory authorities. Please discuss options for clinical trials with your physician. If you decide that a trial may be the right option for you, you may contact the research staff that are listed in the trial listings at ClinicalTrials.gov.

CLINICAL TRIALS

Apatinib, approved by Jiansu Hengrui in China, is the first successful small molecule TKi in Gastric Cancer.

LSK has completed a Phase 1/2A dose escalation and safety trial of Apatinib. The purpose of this study was to evaluate the safety and pharmacokinetics of four doses of Apatinib in a 28-day continuous daily administration (Phase 1) as well as to evaluate the safety and preliminary efficacy in open label administration (Phase 2A). In this study, Apatinib demonstrated encouraging clinical benefit in study patients with advanced solid tumors, especially gastric and colorectal patients. Apatinib was well tolerated with rare incidence of grade 3/4 adverse events, with hypertension as the most significant adverse event.

LSK is currently conducting or planning to initiate clinical studies worldwide in Gastric Cancer, Colorectal Cancer, and Hepato Cellular Carcinoma.

Additional information is available at ClinicalTrials.gov (apatinib, NCT01497704).

TECHNICAL DESCRIPTION

YN968D1, apatinib mesylate, is an experimental drug candidate being developed for the treatment of certain solid tumor cancers including metastatic gastric carcinoma, metastatic breast cancer, non small cell lung cancer and advanced hepatocellular carcinoma. It was first synthesized and patented by Advenchen Laboratories in Southern California and is being developed in clinical trials in the US, Korea and China.

YN968D1 is a tyrosine kinase inhibitor that targets inhibition of the vascular endothelial growth factor (VEGF) receptor-2 (known as VEGF-R2 or KDR). This receptor for VEGF is known to be important in tumor-mediated angiogenesis (the formation of new blood vessels). Because tumors cannot grow beyond 1-2mm without blood vessels to carry oxygen and nutrients, stopping new blood vessel growth may be beneficial in the fight against cancer.

Designation: YN968D1
Generic Name: Apatinib Mesylate
Description: Selective VEGF Receptor 2 (KDR) Inhibitor
Administration: Orally Administered Tablets

REFERENCE

A randomized, double-blind, multicenter, phase II, three-arm, placebo-control study of apatinib as third-line treatment in patients with metastatic gastric carcinoma. ASCO 2011

A phase II, multicenter, placebo-controlled trial of apatinib in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after two previous treatment regimens. ASCO 2012

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